Date: 08-04-2012

Case Style: Sam Johnson v. Actavis Totway, LLC

Case Number: CJ-2009-5292

Judge: Edward C. Cunningham

Court: District Court, Oklahoma County, Oklahoma

Plaintiff's Attorney: Brad R. Miller and R. Ryan Deligans, Durbin, Larimore & Bialick, P.C., Oklahoma City, Oklahoma

Defendant's Attorney: David K. McPhail and Nancy R. Potter, Foliart, Huff, Ottaway & Bottom, Oklahoma City, Oklahoma

Thomas E. Steichen, McAfee & Taft, Tulsa, Oklahoma for Wal-Mart Stores East, L.P.

Matthew P. Moriarty and Michael Andeton, Tucker Ellis & West, Cleveland, Ohio and Dylan M. Carson, Tucker, Ellis & West, LLP, Denver, Colorado for Totowa, LLC.

Description: COMES NOW Plaintiff, Sam Johnson, as Personal Representative of the Estate of Martha Bea Johnson, deceased (‘Plaintiff”), and alleges and states as follows:

1. Sam Johnson is the surviving spouse of Martha Bea Johnson who lived together as husband and wife in Comanche County, Oklahoma.

2. Actavis Totowa, L.L.C., formerly Amide Pharmaceuticals (“Actavis”) is incorporated in the State of Delaware with its principal place of business in New Jersey.

3. Mylan Bertek Pharmaceuticals, Inc. (Bertek) has its principal place of business in Sugarland, Texas, where they act as distributor for certain generic drugs manufactured by Actav is.

4. UDL Laboratories (UDL) has its principal place of business in Rockford, Illinois, where it acts as a distributor/packager for certain generic drugs manufactured by Actavis.

5. Wal-Mart, Inc. (Wal-Mart), is a retail sales business operating pharmacies across the United States, with its principal place of business in Bentonville, Arkansas. Wal-Mart operates a pharmacy in Lawton, Comanche County, as well as throughout Oklahoma County, Oklahoma.

6. McBride Clinic Orthopedic Hospital (McBride) operates an orthopedic hospital in Oklahoma County, Oklahoma.

7. On or about March 29, 2008, Martha Bea Johnson refilled her prescription for Digitek .25 mg tablets, manufactured by Amide Pharmaceuticals, Inc. (Actavis Totowa), distributed by Bertek, and packageWdistributed by UDL.

8. Martha Bea Johnson administered Digitek to herself until on or about April 25, 2008.

9. On April 25, 2008, Martha Bea Johnson checked into McBride for an elective shoulder operation. She brought her prescribed medication to McBride as instructed by McBride personnel. The shoulder surgery was performed without complication. Martha Bea Johnson was hospitalized overnight.

10. On April 25, 2008, unbeknownst to Martha Bea Johnson, Actavis Totowa issued an “immediate and urgent recall” of all Digitek medications, including the Digitek tablets put in to the stream of commerce by Actavis, Bertek, UDL and Wal-Mart, ultimately being dispensed at the Lawton Wal-Mart Pharmacy to Martha Bea Johnson.

11. On April 26, 2008, at 9:43 a.m., McBride’s pharmacy and healthcare staff administered to Martha Bea Johnson one of the Digitek tablets recalled by Actavis.

12. On April 26, 2008, Martha Bea Johnson was released from McBride. She became ill later that day with stomach cramps and diarrhea. This illness lasted on and off through the night and the next day. Personnel at the McBride ER advised Sam Johnson between 3:00-4:00 a.m., on April 27, 2008, that the symptoms did not seem to be related to the surgery.

13. At approximately 4:00 p.m., on April 27, 2008, Martha Bea Johnson suffered sudden cardiac death as a result of digoxin toxicity.

14. On May 5, 2008, Wal-Mart mailed an “urgent drug recall” notice on Digitek, from Bentonville, Arkansas, to the Johnson home in Comanche County.

FIRST CAUSE OF ACTION — PRODUCT LIABILITY

Plaintiff adopts and incorporates the allegations of paragraphs 1 through 14 above, and, in addition, alleges and states as follows:

15. At all times material to this action, Defendants Actavis, Bertek and UDL were responsible for designing, developing, man ufacturing, testing, packaging, promoting, marketing, distributing, labeling and selling Digitek.

16. Digitek was expected to and did reach consumers in Oklahoma, and the customers at the Wal-Mart pharmacy in Lawton, Oklahoma.

17. Digitek was placed in the stream of commerce by Defendants Actavis, Bertek, UDL and Wal-Mart in a defective condition as a result of a defective design, manufacture, or other problem within Defendants’ control.

18. As a direct and proximate result of these defects, Martha BeaJohnson suffered and died.

19. Defendants Actavis, Bertek, U DL, McBride and Wal-Mart failed to adequately warn Martha Bea Johnson of the damages of digoxin toxicity once they knew or had reason to know such a warning was necessary.

20. As a direct and proximate cause of the Defendants, Actavis, Bertek, UDL, McBride and Wal-Mart’s failure to warn Martha Bea Johnson of the defective and dangerous nature of the Digitek tablet sold and administered to her, she suffered a loss of chance to avoid digoxin toxicity and death.

SECOND CAUSE OF ACTION - BREACH OF WARRANTY

Plaintiff adopts and incorporates the allegations of paragraphs 1 through 20 above, and, in addition, alleges and states as follows:

21. Defendants, Actavis, Bertek and UDL expressly warranted that Digitek was a safe and effective drug.

22. The Digitek manufactured by these Defendants did not conform to these express representations because it caused death by digoxin toxicity even when taken as recommended.

23. As a direct and proximate result of these Defendants’ breach of warranty, Martha Bea Johnson died.

THIRD CAUSE OF ACTION - NEGLIGENCE

Plaintiff adopts and incorporates the allegations of paragraphs 1 through 23 above, and, in addition, alleges and states as follows:

24. Defendants, Actavis, Bertek, UDL, McBride and Wal-Mart had a duty to exercise reasonable care in the design, development, formulation, manufacture, marketing, promotion, sale, labeling, distribution and administration of Digitek into the stream of commerce, including the duty to assure that the product did not pose a significant risk of injury or death.

25. Defendants had a duty to exercise the utmost care to execute the ‘urgent’ recall of Digitek to give immediate notice to Martha Bea Johnson to protect her from lethal digoxin toxicity, which is the direct result of her continued ingestion of the defective tablets.

26. Defendants breached their duty of care to Martha Bea Johnson which was the direct and proximate cause of her death.

FOURTH CAUSE OF ACTION — STRICT LIABILITY

Plaintiff adopts and incorporates the allegations of paragraphs 1 through 26 above, and, in addition, alleges and states as follows:

27. Defendants placed a lethally defective, orally ingested drug into the stream of commerce. They failed to stop consumers of the drug from ingesting it, even after it was recalled. This failure resulted in Martha BeaJohnson’s death. The Defendants are strictly liable for her death and the damage stemming therefrom.

FIFTH CAUSE OF ACTION - LOSS OF CONSORTIUM

Plaintiff adopts and incorporates the allegations of paragraphs 1 through 27 above, and, in addition, alleges and states as follows:

28, Plaintiff was Martha Bea Johnson’s husband and was so on the date of her death.

As a result of the negligence of Defendants Actavis, Bertek, UDL, McBride and WalMart, the Plaintiff has suffered severe mental and emotional distress, loss of consortium, companionship and the services of his wife.

SIXTH CAUSE OF ACTION - PUNITIVE DAMAGES

Plaintiff adopts and incorporates the allegations of paragraphs 1 through 28 above, and, in addition, alleges and states as follows:

29. Defendants Actavis, Bertek and UDL knew or should have known that Digitek was highly and unreasonably dangerous.

30. Defendants, Actavis, Bertek and UDL intentionally and/or recklessly failed to disclose information regarding Digitek that deprived Martha Bea Johnson of necessary information to enable her to stop ingesting the pills.

31. Instead, the Defendants, Actavis, Bertek and UDL continued to manufacture, market, sell and deliver into the stream of commerce Digitek for profit at the expense of the public health, safety and particularly disregarding the well-being of Martha Bea Johnson.

32. Defendant McBride acted in a reckless disregard for the health of its patient, Martha Bea Johnson, by failing to timely act on the recall of Digitek by delivering to Martha BeaJohnson Digitek from the tainted prescription on April 26, 2008, and then failing to timely notify Martha Bea Johnson of the recall and need for immediate medical attention thereafter.

33. Defendant Wal-Mart acted in reckless disregard for the health of its customers by failing to timely act on the recall of Digitek by waiting until May 5 2008, to mail by regular post, notification of the recall to Martha Bea Johnson.

WHEREFORE, the Plaintiff demands compensation and punitive damages against the Defendants and each of them, in excess of $1 0,00.00, to include pain and suffering, emotional distress, loss of enjoyment of life, loss of chance, medical expenses, burial expenses and for such other and further relief are statutorily allowed.


WAL-MART STORES EAST, L.P. ‘S ANSWER TO PLAINTIFF’S AMENDED PETITION

Defendant, Wal-Mart Stores East, LP., a Delaware limited partnership, incorrectly identified in Plaintiff’s Petition as Wal-Mart, Inc., (“Wal-Mart”), for its Answer to Plaintiff’s Amended Petition (“Petition”) states as follows: Wal-Mart generally and specifically denies each and every allegation of Plaintiff’s Pejition, unless such allegation is specifically admitted.

1. As to the allegations in paragraph no. I of Plaintiffs Petition, Defendant WalMart is without sufficient information to admit or deny that Plaintiff is the surviving spouse of Martha Bea Johnson or that they lived together as husband and wife in Comanche County, Oklahoma; therefore, Wal-Mart denies the allegations.

2. As to the allegations in paragraph no. 2 of Plaintiffs Petition, Defendant Wa!.Mart is without sufficient information to admit or deny whether Actavis Totowa, L.L.C., formerly Amide Pharmaceuticals (“Actavis”) is incorporated in the State of Delaware with its principal place of business in New Jersey; therefore, Wal-Mart denies the allegations.

3, As to the allegations in paragraph no. 3 of Plaintiff’s Petition, Defendant Wa!Mart is without sufficient information to admit or deny whether Mylan Pharmaceuticals, Inc. (“MPI”) has its principal place of business in Sugarland, Texas, where they act as distributor for certain generic drugs manufactured by Actavis; therefore, Wal-Mart denies the allegations.

4, As to the allegations in paragraph no. 4 of Plaintiffs Petition, Defendant WalMart is without sufficient information to admit or deny whether UDL Laboratories (“UDL”) has its principal place of business in Rockford, Illinois, where it acts as a distributor/packager for certain generic drugs manufactured by Actavis; therefore, Wal-Mart denies the allegations.

5. As to the allegations in paragraph no. 5 of Plaintiffs Petition, it is admitted to the extent that Wal-Mart Stores East, L.P., a Delaware limited partnership, is a retail business operating pharmacies across the United States, its principal place of business is in l3entonville, Arkansas, it does operate a pharmacy in Lawton, Comanche County, and it does operate pharmacies throughout Oklahoma County, Oklahoma; otherwise, Wal-Mart denies the allegations.

6. As to the allegations in paragraph no. 6 of Plaintiffs Petition, it is Defendant Wal-Mart’s belief that McBride Clinic Orthopedic Nospital (“McBride”) may operate an orthopedic hospital in Oklahoma County, Oklahoma; otherwise, Wal-Mart denies the allegations.

7. As to the allegations in paragraph no. 7 of Plaintiffs Petition, itis Wal-Mart’s belief that Martha Bea Joimson may have refilled a Digitek .25mg prescription on March 29, 2008, but is without sufficient information to admit or deny the remaining allegations; therefore, Wal-Mart denies the remaining allegations.

8. As to the allegations in paragraph no. 8 of Plaintiffs Petition, it is Wal-Mart’s belief that Martha Bea Johnson may have administered her own prescriptions, but is without sufficient infonnation to admit or deny whether Martha Bea Johnson administered Digitek to herself until on or about April 25, 2008; therefore, Wal-Mart denies the allegations.

9. As to the allegations in paragraph no. 9 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny whether Martha Bea Johnson checked into McBride for an elective shoulder operation, brought her prescribed medication to McBride, was instructed by McBride personnel to bring prescribed medication, had shoulder surgery perfonned without complications, or was hospitalized overnight; therefore, Wal-Mart denies the allegations.

10. As to the allegations in paragraph 10 of Plaintiffs Petition, it is Wal-Mart’s belief that Aetavis Totowa may have issued a voluntary recall of Digitek on April 25, 2008 but as to the remaining allegations, this Defendant is without sufficient information to admit or deny the allegations; therefore, Wal-Mart denies the allegations.

11. As to the allegations in paragraph no. 11 of Plaintiff’s Petition, Wal-Mart is without sufficient information to admit or deny that McBride’s pharmacy and healthcare staff administered Martha Bea Johnson one of the Digitek tablets recalled by Actavis; therefore, WalMart denies the allegations.

12. As to the allegations in paragraph no. 12 of Plaintiff’s Petition, Wal-Mart is without sufficient information to admit or deny the allegations; therefore, Wal-Mart denies the allegations.

13. As to the allegations in paragraph no. 13 of Plaintiff’s Petition, Wal-Mart is without sufficient information to admit or deny the allegations; therefore, Wal-Mart denies the allegations.

14. As to the allegations in paragraph 14 of Plaintiffs Petition, it is Wal-Mart’s belief that a voluntary recall letter was distributed in May 2008; otherwise, Wal-Mart denies the allegations.

FIRST CAUSE OF ACTION - PRODUCT LIABILITY

Wal-Mart restates and reincorporates by reference its answers to PlaintifFs allegations in the preceding paragraphs.

15. As to the allegations in paragraph 15 of Plaintiff’s Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MN and UDL; therefore, Wal-Mart denies the allegations.

16. As to the allegations in paragraph 16 of Plaintiffs Petition, it is Wal-Mart’s belief that Digitek may have been distributed at the Wal-Mart pharmacy in Lawton, Oklahoma; otherwise, Wal-Mart denies the allegations.

17. As to the allegations in paragraph 17 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI and UDL; therefore, Wal-Mart denies the allegations. As to the allegations against Wal$4art, the allegations are denied.

18. As to the allegations in paragraph 18 of Plaintiff’s Petition, Wal-Mart denies the allegations.

19. As to the allegations in paragraph 19 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MP1, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against Wal-Mart, the allegations are denied.

20. As to the allegations in paragraph 20 of Plaintiff’s Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against Wal-Mart, the allegations are denied.

SECOND CAUSE OF ACTION - BREACH OF WARRANTY

Wal-Mart restates and reincorporates by reference its answers to Plaintiffs allegations in the preceding paragraphs.

21. As to the allegations in paragraph no. 21 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Aetavis, MN and UDL; therefore, WaJ-Mart denies the allegations.

22. As to the allegations in paragraph 22 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against Wal-Mart, the allegations are denied.

23. As to the allegations in paragraph 23 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Aetavis, MN, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against Wal-Mart, the allegations are denied.

THIRD CAUSE OF ACTION - NEGLIGENCE

Wal-Mart restates and reincorporates by reference its answers to Plaintiffs allegations in the preceding paragraphs.

24. As to the allegations in paragraph no. 24 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against WalMart, the allegations are denied.

25. As to the allegations in paragraph no. 25 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against WalMart, the allegations are denied.

26. As to the allegations in paragraph no. 26 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MN, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against Wa!Mart, the allegations are denied,

FOURTH CAUSE OF ACTION - STRICT LIABJLITY

Wal-Mart restates and reincorporates by reference its answers to Plaintiff’s allegations in the preceding paragraphs.

27. As to the allegations in paragraph no. 27 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against Wal-Mart, the allegations are denied.

FIFTH CAUSE OF ACTION - LOSS 01? CONSORTIUM

Wal-Mart restates and reincorporates by reference its answers to Plaintiffs allegations in the preceding paragraphs.

28. As to the allegations in paragraph no. 28 of Plaintiff’s Petition, Wal-Mart is without sufficient information to admit or deny the allegations that Plaintiff was Martha Ben Johnson’s husband on the date of her death; therefore, Wal-Mart the allegations are denied.

As to the allegations in the unnumbered paragraph following paragraph no. 28 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI, UDL and McBride; therefore, Wal-Mart denies the allegations. As to the allegations against Wal-Mart, the allegations are denied.

SIXTH CAUSE OP ACTION - PUNITIVE DAMAGES

Wal-Mart restates and reincorporates by reference its answers to Plaintiff’s allegations in the preceding paragraphs.

29. As to the allegations in paragraph no. 29 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Aclavis, MPJ, and UDL; therefore, Wal-Mart denies the allegations.

30. As to the allegations in paragraph no. 30 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MPI, and UDL; therefore. Wal-Mart denies the allegations.

31. As to the allegations in paragraph no. 30 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to Actavis, MN, and UDL; therefore, Wal-Mart denies the allegations.

32. As to the allegations in paragraph no. 32 of Plaintiffs Petition, Wal-Mart is without sufficient information to admit or deny the allegations relating to McBride; therefore, Wal-Mart denies the allegations.

33. As to the allegations in paragraph no. 33 of Plaintiffs Petition, Wal-Mart denies the allegations.

As to the allegations in the unnumbered paragraph following paragraph no. 33 of Plaintiffs Petition, Wal-Mart admits that Plaintiff seeks relief as set forth in the unnumbered paragraph following paragraph no. 33 of Plaintiff’s Petition, but denies that Plaintiff is entitled to the relief requested, or any relief or damages whatsoever.

ADDITIONAL DEFENSES

For its Affirmative Defenses, Defendant Wal-Mart states as follows:

1. Defendant Wal-Mart generally and specifically denies Plaintiffs claims of product liability, Breach of Warranty, negligence, strict liability, loss of consortium, and punitive damages.

2. Failure to state a claim upon which relief can be granted.

3. Contributory/comparative negligence of Plaintiff.

4. The alleged accident was caused by the acts or omissions of third parties not under the control of Defendant WaI-Mart.

5. Plaintiff’s injuries, if any, were brought about by superceding and intervening cause.

6. Plaintiffs injuries, if any, were pro-existing.

7. Defendant Wal-Mart had no notice of the alleged defect.

8. If a defective condition is proven to have existed, it was open and obvious to the users, and Defendants had no duty to warn about it.

9. Plaintiffs actions were the sole cause of any injuries.

10. Plaintiff failed to mitigate his damages.

11. Assumption of the risk is a known condition.

12. Unforeseeable use.

13. Product was not defective.

14. Actions of Defendant Wal-Mart were no cause of Naintiff’s damages, if any.

15. Defendant Wal-Mart had no duty to Plaintiff under Oklahoma law under the circumstances of this case.

16. Misuse.

17. Punitive damages are unconstitutional.

18. Defendant Wal-Mart reserves the right to amend its Answer to Plaintiffs Petition, including asserting additional affirmative defenses, as discovery continues.

WHEREFORE, having fully answered and for reasons stated herein, Defendant, Wa!Mart Stores East, L.P., a Delaware limited partnership, requests that judgment be entered in its favor and against Plaintiff on all claims, and that Defendant Wal-Mart be awarded its costs incurred in defending this case, as well as any other relief to which it is entitled.

MYLAN DEFENDANTS’ ANSWER AND ADDITIONAL DEFENSES TO PLAINTIFFS AMENDED PETITION

Defendants Mylan Pharmaceuticals Inc. (“MPI”) and UDL Laboratories, Inc. (“UDL”) (collectively, “Mylan Defendants”), by and through counsel, state as follows for their answer to Plaintiffs Amended Petition (“Petition”):

1. Mylan Defendants lack knowledge or information sufficient to form a beJief as to the truth of the allegations contained in Paragraph I of Plaintiff’s Petition, and therefore deny the same.

2. The allegations iii paragraph 2 of Plaintiffs Petition are not directed at Mylan Defendants, and, thetefore, no response is required. To the extent a response is deemed necessary, Mylan Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations contained in paragraph 2 of Plaintiffs Pctition, and therefore deny the same.

3. Mylan Defendants deny that MPI has had its principal place of business in Sugarland, Texas at any time relevant to the captioned matter, Mylan Defendants deny the remaining allegations in Paragraph 3 of Plaintiff’s Petition.

4. Mylan Defendants athnit that at all times relevant to the captioned matter, UDL Laboratories, Inc. was an Illinois corporation with its principal place of business in Rockford, illinois. Mylan Defendants deny the remaining allegations in Paragraph 4 of Plaintiffs Petition.

5. The allegations in paragraph 5 of Plaintiff’s Petition arc not directed at Mylan Defendants, and, therefore, no response is required. To the extent a response is deemed necessary, Mylan Defendants are without knowledge or information sufficient to fonn a belief as to the truth of the allegations contained in paragraph 5 of Plaintiff’s Petition, and therefore deny the same.

6. The allegations in paragraph 6 of Plaintiffs Petition are not directed at Mylan Defendants, and, therefore, no response is required. To the extent a response is deemed necessary, Mylan Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations contained in paraapb 6 of Plaintiffs Petition, and therefore deny the same.

7. Myian Defendaiits admit that at all times relevant to the captioned matter, IvIPI distributed Digitek® under a “Bertek” label and UDL Laboratories distributed Digitek® under a “UDL” label. Mylan Defendants are without knowledge or information sufficient to form a belief as to the truth of the remaining allegations contained iii Paragraph 7 of Plaintiffs Petition, and therefore deny the same.

8. Mylan Defendants lack knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 8 of Plaintiff’s Petition, and therefore deny the same.

9. Mylan Defendants lack knowledge or information sufficient to form a belief as to the isuth of the allegations in Paragraph 9 of Plaintiff’s Petition, and therefore deny the same.

10. Mylan Defendants admit that on April 25, 2008, Actavis Totowa initiated a vohmtary nationwide recall of all lots of Digitek®. Mylan Defendants lack knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 10 of Plaintiffs Petition, and therefore deny the same.

11. Mylan Defendants lack knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 11 of Plaintiffs Petition, and therefore deny the same.

12. Mylan Defendants lack knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 12 of Plaintiffs Petition, and therefore deny the same.

13. Mylan Defendants lack knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 13 of Plaintiff’s Petition, and therefore deny the same,

14. Mylan Defendants lack knowledge or infonnation sufficient to form a belief as to the tTuth of the allegations in Paragraph 14 of Plaintiff’s Petition, and therefore deny the same.

ANSWER TO FIRST CAUSE OF ACTiON PRODUCT LIABILiTY

15. In response to the statements in the unnumbered paragraph above Paragraph 15 of Plaintiffs Petition, ]V1ylan Defendants reallege and incorporate by reference their answers to Paragraphs I — 14 of Plaintiff’s Petition, as if hilly set forth herein. In response to Paragraph 15 of Plaintiffs Petition, Mylan Defendants admit that at all times relevant to the captioned matter, MPI distributed Digitek® under a “Bertek” label and UDL Laboratories distributed Digitek® under a “UDL” label. To the extent that the remaining allegations are directed at them, Mylan Defendants deny any remali’ng allegations in Paragraph 15 of Plaintiff’s Petition.

16. Mylan Defendants admit that Digitek® tablets were expected to reach patients without a substantial change in their condition from the time they were sold. Mylan Defendants deny any remaining allegations in Paragraph 16 of Plaintiffs Petition.

17. Mylan Defendants deny the allegations in Paragraph 17 of Plaintiff’s Petition.

18. Mylan Defendants deny the allegations in Paragraph 18 of Plaintiff’s Petition.

19. Mylan Defendants deny the allegations in Paragraph 19 of Plaintiffs Petition.

20. Mylan Defendants deny the allegations in Paragraph 20 of Plaintiffs Petition.

ANSWER TO SECOND CAUSE OF ACTION - BREACH OF WARRANTY

In response to the statements in the unnumbered paragraph above Paragraph 21 of Plaintiffs Petition, Mylan Defendants reallege and incorporate by reference their answers to Paragraphs 1 —20 of Plaintiff’s Petition, as if filly set forth herein.

21. In response to Paragraph 21 of Plaintiff’s Petition, Mylan Defendants deny the allegations.

22. Mylan Defendants deny the allegations in Paragraph 22 of Plaintiffs Petition.

23. Mylan Defendants deny the allegations in Paragraph 23 of Plaintiffs Petition.

ANSWER TO THIRD CAUSE OF ACTION NEGLIGENCE

In response to the statements in the unnumbered paragraph above Paragraph 24 of Plaintiffs Petition, Mylan Defendants reallege and incorporate by reference their answers to Paragraphs 1 — 23 of Plaintiffs Petition, as if fully set forth herein.

24. In response to Paragraph 24 of Plaintiffs Petition, Mylan Defendants admit that they were subject only to those duties imposed by applicable law and deny that any such duty was breached. Mylan Defendants deny the remaining allegations in Paragraph 24.

25. Mylan Defendants admit that they were subject only to those duties imposed by applicable law and deny that any such duty was breached. Mylan Defendants deny the remaining allegations in Paragraph 25 of Plaintiffs Petition.

26. Mylan Defendants admit that they were subject only to those duties imposed by applicable law and deny that any such duty was breached. Mylan Defendants deny the remaining allegations in Paragraph 26 of Plaintiff’s Petition.

ANSWER TO FOURTH CAUSE OF ACTION - STRICT LIABILITY

In response to the statements in the unnumbered paragraph above Paragraph 27 of Plaintiffs Petition, Mylan Defendants reallege and incorporate by reference their answers to Paragraphs 1 —26 of Plaintiffs Petition, as if fully set forth herein.

27. In response to Paragraph 27 of Plaintiffs Petition, Mylan Defendants deny the allegations.

ANSWER TO FIFTH CAUSE OF ACTION - LOSS OF CONSORTIUM

In respQnse to the statements in the unnumbered paragraph above Paragraph 27 of Plaintiffs Petition, Mylan Defendants reallege and incorporate by reference their answers to Paragraphs 1 —27 of Plaintiffs Petition, as if fully set forth herein.

28. In response to Paragraph 28 of Plaintiffs Petition, Mylan Defendants lack knowledge or information sufficient to form a belief as to the truth of tile allegations in Paragraph 28 of Plaintiff’s Petition, and therefore deny the same, Mylan Defendants also deny the allegations in the unnumbered paragraph following paragraph 28 of Plaintiffs Petition.

ANSWER TO SIXTH CAUSE OF ACTION - PUNITIVE DAMAGES

In response to the statements in the unnumbered paragraph above Paragraph 29 of Plaintiffs Petition, Mylan Defendants reallege and incorporate by reference their answers to Paragraphs 1 —28 of Plaintiffs Petition, as if fUlly set forth herein.

29. In response to Paragraph 29 of Plaintiffs Petition, Mylan Defendants deny the allegations.

30. Mylan Defendants deny the allegations contained in PaTagraph 30 of Plaintiffs Petition.

31. Mylan Defendants deny the allegations contained in Paragraph 31 of Plaintiff’s Petition.

32. The allegations in paragraph 32 of Plaintiffs Petition are not directed at Mylan Defendants, and, therefore, no response is required. To the extent a response is deemed necessary, Mylan Defendants are without knowledge or information sufficient to foim a belief as to the truth of the allegations contained in paragraph 32 of Plaintiffs Petition, and therefore deny the same.

33. The allegations in paragraph 33 of Plaintiffs Petition are not directed at Mylan Defendants, and, therefore, no response is required. To the extent a response is deemed necessary, Mytan Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations contained in paragraph 33 of Plaintiffs Petition, ad therefore deny the same.

As to the allegations in the unnumbered paragraph following paragraph 33 of Plaintiffs Petition, Mylan Defendants admit that Plaintiff seeks relief as set forth in the unnumbered paragraph following paragraph 33 of Plaintiffs Petition, but denies that Plaintiff is entitled to the relief requested, or any relief or damages whatsoever.

ADDITIONAL DEFENSES

Further answering, Mylan Defendants interpose and preserve the following additional defenses:

FIRST SEPARATE DEFENSE

Plaintiff’s Complaint fails to state a claim upon which relief can be granted as to some or all of Plaintiff’s claims,

SECOND SPEARATE DEFENSE

Plaintiff’s claims are barred by the applicable statute of limitations, statute of repose, and/or the equitable doctrines of laches and estoppels and/or the entire controversy doctrine.

THIRD SEPARATE DEFENSE

Mylan Defendants hereby raise, assert, and preserve their defense of lack of personal jurisdiction.

FOURTH SEPARATE DEFENSE

Mylan Defendants hereby raise, assert, and preserve their defense of insufficiency of process.

FIFTH SEPARATE DEFENSE

Mylan Defendants hereby raise, assert, and preserve their defense of insufficiency of process.

SIXTH SEPARATE DEFENSE

Plaintiffs Complaint has failed to name necessary and indispensable parties.

SEVENTH SEPARATE DEFENSE

Plaintiff’s claims are barred by the doctrines of informed consent, release, and waiver.

EIGHTH SEPARATE DEFENSE

Plaintiff is responsible in whole or in part for any injuries suffered as a result of his contributory negligence, comparative negligence, or assumption of the risk.

NINTH SEPARATE DEFENSE

Some or all of Plaintiffs claims are barred because Plaintiff’s alleged injuries were actually or proximately caused, in whole or in part, by the intervening, superseding, or illegal conduct of Plaintiff, independent third parties, or events that were extraordinary under the circumstances, not foreseeable in the normal course of events, or independent of or far removed from Mylan Defendants’ conduct or control.

TENTh SEPARATE DEFENSE

Plaintiff’s alleged injuries and damages, if any, have been caused by factors unrelated to the product, including, but not limited to, preexisting medical, genetic and/or environmental conditions, diseases, illnesses, accidents or idiosyncratic or idiopathic reactions. Mylan Defendants have no control over such factors, and such factors were not due to, or caused by, any fault, lack of care, negligence or breach on Mylan Defendants’ part.

ELEVENTH SEPARATE DEFENSE

Plaintiff’s claims are barred to the extent that any injuries were caused by a misuse, abuse, alteration, and/or failure to properly maintain or care for the subject product by persons other than Mylan Defendants.

TWELFTH SEPARATE DEFENSE

Plaintiffs claims are barred by the “state of the art” and “state of scientific knowledge” defenses.

THIRTEENTH SEPARATE DEFENSE

Plaintiff’s claims against Mylan Defendants are expressly and/or impliedly preempted by federal law; including but not limited to, the regulations promulgated by the U.S. Food and Drug Administration as codified in Chapter 21 of the Code of Federal Regulations. See 21 U.S.C. § 301 etseq.; see also 71 Fed, Reg. 3922 (Jan. 24,2006).

FOURTEENTH SEPARATE DEFENSE

Plaintiffs claims are barred because Mylan Defendants complied with all applicable state and federal statutes regarding the product in question including the requirements and regulation promulgated by the U.S. Food and Drug Administration as codified in Chapter 21 of the Code of lederaI Regulations. Specifically, Plaintiffs failure to warn claims are preempted by federal Food and Drug regulations specifying that the warning language that can be used by generic manufacturers must be exactly the same as That approved by FDA for use by the innovator manufacturer. Plaintiffs design defect claims are also preempted because FDA made a specific determination that Digitek® was safe and effective, in the event that Plaintiffs claims are not barred, Mylan Defendants are entitled to the presumption that the product in question was free from any defect or defective condition and that its labeling was adequate.

FIFTEENTh SEPARATE DEFENSE

Plaintiffs claims are barred, in whole or in part, by the deference that common law gives to discretionary actions by FDA under the Federal Food, Drug & Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., and regulations promulgated thereunder.

SIXTEENTH SEPARATE DEFENSE

Plaintiffs claims may be barred, in whole or in part, under the doctrine of primary jurisdiction, in that the pertinent conduct of Mylan Defendants and all theft activities with respect to the subject product have been and are conducted under the supervision of the FDA.

SEVENTEENTH SEPARATE DEFENSE

Plaintiffs claims are barred in whole or in part under the applicable state law because Digitek® was subject to and received p

EIGHTEENTH SEPARATE DEFENSE

The manufacture, distribution and sale of Digitek® were at all times in compliance with all federal regulations and statutes, and Plaintiffs claims are preempted.

NINETEENTH SEPARATE DEFEN SE

Mylan Defendants did not make nor did they breach any express or implied warranties andlor breach any warranties created by law. To the extent that Plaintiff relies on any theory of breach of warranty, such claims are baited by applicable law, by the lack of privity between Plaintiff and Mylan Defendants, and/or by the failure of Plaintiff to give Mylan Defendants timely notice of the alleged breach of warranty. Mylan Defendants flirther specifically plead as to any breach of warranty claim all separate defenses under the Uniform Commercial Code, as enacted in the State of Oklahoma and any other state whose law is deemed to apply in this case.

TWENTIETH SEPARATE DEFENSE

Plaintiffs claims are barred by comments j and k to Section 402A of the Restatement (Second) of Torts.

TWENTY-FIRST SPEARATE DEFENSE

Plaintiffs claims are barred by Sections 2, 4, 6(c), and 6(d) of the Restatement (Third) of Torts: Products Liability.

TWENTY-SECOND SEPARATE DEFENSE

Plaintiff’s product liability claims are baited because the benefits of the relevant product outweighed its risks.

TWENTY-THIRD SEPARATE DEFENSE

Plaintiffs claims are barred in whole or in part because the product at issue was at all times properly prepared, packaged, and distributed, and was not defective or unreasonably dangerous. re-market approval by the Food and Drug Administration under 52 Stat. 1040,21 U.S.C. § 301. TWENTY-FOURTH SEPARATE DEFENSE

Plaintiffs claims are batTed, in whole or in part, because Mylan Defendants acted in good faith at all relevant times and gave adequate warnings of all known or reasonably knowable risks associated with the use of their product.

TWENTY-FIFTH SEPARATE DEFENSE

An imposition of punitive damages in this case against Mylan Defendants is barred to the exteni that the manner in which such punitive damages are calculated violates the Constitution of the United States or the Constitution of the State of Oklahoma and any other state whose ]aw is deemed to apply in this case.

TWENTY-SITH SEPARATE DEFENSE

Any award of punitive damages in this case against Mylan Defendants is baiTed to the extent that the amount of such an award violates the Constitution of the United States or the Constitution of the State of Oklahoma and any other state whose law is deemed to apply in this case.

TWENTY-SEVENTH SEPARATE DEFENSE

Punitive damages are inappropriate to serve detenence objectives because those will be fully served by past and future liability for any compensatory damages for the same conduct at issue in this case.

TWENTY-EIGHTH SEPARATE DEFENSE

Plaintiff’s Complaint fails to state sufficient facts under any theory or cause of action which would justify imposition of punitive or exemplary damages under any applicable law.

IWENTY-FOURTH SEPARATE DEFENSE

Plaintiffs claims are batTed, in whole or in part, because Mylan Defendants acted in good faith at all relevant times and gave adequate warnings of all known or reasonably knowable risks associated with the use of their product.

TWENTY-FIFTH SEPARATE DEFENSE

An imposition of punitive damages in this case against Mylan Defendants is barred to the exteni that the manner in which such punitive damages are calculated violates the Constitution of the United States or the Constitution of the State of Oklahoma and any other state whose ]aw is deemed to apply in this case.

TWENTY-SIXTH SEPARATE DEFENSE

Any award of punitive damages in this case against Mylan Defendants is baiTed to the extent that the amount of such an award violates the Constitution of the United States or the Constitution of the State of Oklahoma and any other state whose law is deemed to apply in this case.

TWENTY-SEVENTH SEPARATE DEFENSE

Punitive damages are inappropriate to serve detenence objectives because those will be fully served by past and future liability for any compensatory damages for the same conduct at issue in this case.

TWENTY-EIGHTH SEPARATE DEFENSE

Plaintiff’s Complaint fails to state sufficient facts under any theory or cause of action which would justify imposition of punitive or exemplary damages under any applicable law.

TWENTY-NINTH SEPARATE DEFENSE

Plaintiffs Complaint fails to allege facts from which it can reasonably be inferred that Mylan Defendants acted with reckless indifference to or conscious disregard for the safety of other sufficient to warrant punitive damages.

THIRTIETH SEPARATE DEFENSE

The imposition of punitive damages against Mylan Defendants violates their rights to due process under the Fiflh and Fourteenth Amendments to the Constitution of the United States, as well as the Constitution of Oklahoma.

THIRTY-FIRST SEPARATE DEFENSE

Mylan Defendants are entitled to set-off for all amounts paid, payable by, or available from collateral sources, including write-offs/write-downs in charges.

THIRTY-SECOND SEPARATE DEFENSE

Plaintiff impermissibly seeks to impose liability on conduct protected from liability by the First Amendment to the United States Constitution and by the Constitution of the State of Oklahoma and any other state whose law is deemcd to apply in this case.

THIRTY-THIRD SEPARATE DEFENSE

Plaintiffs claims are baned by Plaintiffs failure to comply with conditions precedent to their right to recover.

THIRTY-FOURTH SEPARATE DEFENSE

The claims asserted in Plaintiff’s Complaint are barred, in whole or in part, because they did not incur any ascertainable loss as a result of Mylan Defendants’ conduct.

THIRTY-FIFTH SEPARATE DEFENSE

Plaintiffs alleged damages were not caused by any failure to warn on the part of Mylan Defendants.

THIRTY-SIXTH SEPARATE DEFENSE

plaintiffs claims against Mylan Defendants are barred because Mylan Defendants neither owed nor breached any duty to Plaintiff.

THIRTY-SEVENTH SEPARATE DEFENSE

Mylan Defendants had no duty to warn about any possible dangers in using their products which were not known at the time of manufacture and sale of the products.

THIRTY-EIGHTH SEPARATE DEFENSE

Plaintiff’s claims are barred in whole or in part because there is no private right of action concerning matters regulated by the Food and Drug Administration under applicable federal laws, regulations, and rules.

THIRTY-NINTH SEPARATE DEFENSE

The claims asserted in Plaintiffs Complaint are barred, in whole or in part, because the manufacturing, labeling, packaging, and any advertising of the product complied with the applicable codes, standards and regulations established, adopted, promulgated or approved by any applicable regulatory body, including but not limited to the United States, any state, and any agency thereof

FORTIETH SEPARATE DEFENSE

Any product supplied by Mylan Defendants and sod in the normal stream of commerce was reasonably safe for its intended use and was not defective in any nrnnner.

FORTY-FIRST SEPARATE DEFENSE

If Plaintiff was exposed tc any product manufactured, produced, sold, or supplied by Mylan Defendants, which is specifically denied, said exposure was de minitnis and insufficient as a matter of law to establish with a reasonable degree of probability that the product at caused Plaintiffs injuries.

FORTY-SECOND SEPARATE DEFENSE

Plaintiff may not recover on the claims pleaded in the Complaint because the damages sought are too speculative and remote.

FORTY-ThIRD SEPARATh DEFENSE

The damages recoverable by Plaintiff, if any, must be reduced by any amount of damages legally caused by Plaintiffs failure to mitigate such damages in whole or in part.

FORTY-FOURTH SEPARATE DEFENSE

Digitek®, if in fact ingested by Plaintiff, did not cause or contribute to any alleged injuries.

FORTY-FIFTH SEPARATE DEFENSE

Digitek® was not unreasonably dangerous in formulation or composition at the time it left Defendants’ control as it did not deviate in any way from Mylan Defendants’ and the FDA’s mandatory specifications.

FORTY-SIXTH SEPARATE DEFENSE

Plaintiff has not standing to bring this action and/or to seek the relief requested in the Complaint.

FORTY-SEVENTH SEPARATE DEFENSE

Some or all of Plaintiffs claims are ban-ed by reason of spoliation of evidence.

FORTY-EIGHTH SEPARATE DEFENSE

Plaintiff’s claims are barred by the doctrine of forum non conveniens.

FORTY-NINTH SEPARATE DEFENSE

Plaintiffs claims are barred by the learned inteimediary doctrine.

FIFTIETH SEPARATE DEFENSE

Some or all of Plaintiffs claims should be dismissed due to misjoinder.

FIFTY-FIRST SEPARATE DEFENSE

Plaintiffs’ claims are barred against Mylan Defendants because Mylan Defendants did not design, manufacture, alter, or modify the product at issue, did not exercise control over the warnings accompanying the product, did not make representations regarding the product, and were unaware of any defect in the product.

FIFTY-SECOND SEPARATE DEFENSE

Mylan Defendants hereby reserve the right to amend their answer to assert any other defenses, separate or otherwise, that may become available during discovery proceedings in this case.

DEMAND FOR JURY TRIAL

Mylan Defendants specifically requests a trial by jury on all facts and issues in this action, made up of the maximum allowable number of jurors.

WHEREFORE, Mylan Defendants demand judgment dismissing Plaintiffs Petition with prejudice, and granting such other further relief as this Court may deem just and proper, together with the costs and disbursements of this action.

ANSWER 01? DEFENDANT ACTAVIS TOTOWA LLC TO PLAINTIFF’S AMENDED PETITION

Defendant Actavis Totowa LLC (Actavis Totowa), for its Answer to Plaintiffs Amended Petition, states that all of the allegations in Plaintiffs Amended Petition are denied unless specifically admitted herein, and more specifically alleges and states as follows:

I. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 1 of Plaintiff’s Amended Petition, and therefore denies the same.

2. Defendant admits that Aetavis Totowa is a Delaware limited liability company with its principal place of business in New Jersey. Defendaffi denies the remaining allegations in Paragraph 2 of Plaintiff’s Amended Petition.

3. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 3 of Plaintiff’s Amended Petition, and therefore denies the same.

4. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 4 of Plaintiff’s Amended Petition, and therefore denies the same.

5. Defendant Jacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 5 of Plaintiff’s Amended Petition, and therefore denies the same.

6. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 6 of Plaintiff’s Amended Petition, and therefore denies the same.

7. Defendant admits that at all times relevant to the captioned matter, Aetavis Totowa manufactured Digitek® pursuant to an Abbreviated New Drug Application (‘ANDA”), Mylan Pharmaceuticals, Inc. distributed Digitek® under a “Bertek” label, and UDL Laboratories, Inc. distributed Digitek® under a “UDL” label. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations in Paragraph 7 of Plaintiff’s Amended Petition, and therefore denies the same.

8. Defendant lacks knowledge or information suflicient to form a belief as to the truth of the allegations in Paragraph S of Plaintiff’s Amended Petition, and therefore denies the same.

9. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 9 of Plaintiff’s Amended Petition, and therefore denies the same.

10. Defendant admits that on April 25, 2008, Aetavis Tolowa initiated a voluntary nationwide recall of all lots of Digitek®. Defendant denies the remainiug allegations in Paragraph 10 of Plaintiff’s Amended Petition.

11. Defendant lacks knowledge or information sufficient to form a belief as to the Iruth of the allegations in Paragraph 11 of Plaintiff’s Amended Petition.

12. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 12 of Plaintiff’s Amended Petition, and therefore denies the same.

13. Defendant lacks knowledge or information sufficient to form a he]ief as to the truth of the allegations in Paragraph 13 of Plaintiff’s Amended Petition, and therefore denies the same.

14. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 14 of Plaintiff’s Amended Petition, and therefore denies the same.

ANSWER TO FIRST CAUSE OF ACTION-PRODUCT LIABJLJTY

15. In response to the unnumbered paragraph above Paragraph 15 of Plaintiff’s Amended Petition, Defendant realleges and incorporates by reference its answers to Paragraphs 1 through 14 of Plaintiff’s Amended Petition, as if ftuily set forth herein. In response to Paragraph 15 of Plaintiff’s Amended Petition, Defendant admits that at all times relevant to the captioned matter, Actavis Totowa manufactured Digitek® pursuant to an ANDA, Mylan Pharmaceuticals, Inc. distributed Digitek® under a “Bertek” label, and UDL Laboratories, Inc. distributed Digitek® under a “UDL” label. Defendant denies the remaining allegations in Paragraph 15 of Plaintiff’s Amended Petition.

16. Defendant admits that Digitek® was expected to reach patients without a substantial change in their condition from the time they were sold. Defendants deny the remainthg allegations in Paragraph 16 of Plaintiff’s Amended Petition.

17. Defendant denies the allegations in Paragraph 17 of Plaintiff’s Amended Petition, specifically denying that any Digitek® tablets ingested by Decedent were defective.

18. Defendant denies the allegations in Paragraph 18 of Plaintiff’s Amended Petition, specifically denying that any Digitek® tablets ingested by Decedent were defective and that Digitek® was the proximate cause of the injuries and damages alleged in Paragraph 18 of Plaintiff’s Amended Petition.

19. Defendant denies the allegations in Paragraph 19 of Plaintiff’s Amended Petition.

20. Defendant denies the allegations in Paragraph 20 of Plaintiff’s Amended Petition, specifically denying that any Digitek® tablets ingested by Decedent were defective and that Digitek® was the proximate cause of the injuries and damages alleged in Paragraph 20 of Piaintiff’s Amended Petition.

ANSWER TO SECOND CAUSE. OF ACTIONBREACH OF WARRANTY

21. In rcsponse to the unnumbered paragraph above Paragraph 21 of Plaintiff’s Amended Petition, Defendant realleges and incorporates by reference its answers to Paragraphs I through 20 of Plaintiff’s Amended Petition, as if huilly set forth herein. In response to Paragraph 21 of Plaintiff’s Amended Petition, Defendant denies the allegations, specifically denying the existence or breach of any warranties in favor of, or representations to, Plaintiff andlor Decedent by Defendant regarding Digitek®.

22. Defendant denies the allegations in Paragraph 22 of Plaintiff’s Amended Petition, specifically denying the existence or breach of any warranties in favor of, or representations to, Plaintiff and/or Decedent by Defendant regarding Digitek®, that any Digitek® tablets ingested by Decedent werc defective, and that Digitek® was the proximate cause of any injuries and damages alleged in Plaintiff’s Amended Petition.

23. Defendant denies the allegations in Paragraph 23 of Plaintiff’s Amended Petition, specifically denying the existence or breach of any warranties in favor of. or representations to, Plaintiff andlor Decedent by Defendant regarding Digitek®, that any Digitek® tablets ingested by Decedent were defective and that Digitek® was the proxunate cause of any injuries and damages alleged in Plaintiff’s Amended Petition.

ANSWER TO THiRD CAUSE OF ACTION-NEGLIGENCE

24. in response to the unnumbered paragraph above Paragraph 24 of Plaintiff’s Amended Petition, Defendant realleges and incorporates by reference its answers to Paragraphs 1 through 23 of Plaintiff’s Amended Petition, as if fully set forth herein. In response to Paragraph 24 of Plaintiff’s Amended Petition, Defendant admits that Defendant was subject only to those duties imposed by applicable law and denies that any such duty was breached. Defendant denies the remaining allegations in Paragraph 24 of Plaintiff’s Amended Petition.

25. Defendant admits that Deibndant was subject only to those duties imposed by applicable law and denies that any such duty was breached. Defendant denies the remaining allegations in Paragraph 25 of Plaintiff’s Amended Petition, specifically denying that any Digitek® tablets ingested by Decedent were defective and that Digitek® was the proximate cause of the injuries and damages alleged in Paragraph 25 of Plaintiff’s Amcnded Petition.

26. Defendant admits that Defendant was subject only to those duties imposed by applicable law and denies that any such duty was breached. Defendant denies the remaining allegations in Paragraph 26 of Plaintiff’s Amended Petition, specifically denying that any Digilek® tablets ingested by Decedent were defective and that Digitek® was the proximate cause of the injuries and damages alleged in Paragraph 26 of Plaintiff’s Amended Petition.

ANSWER TO FOURTH CAUSE OF ACTION-STRICT LiABILITY

27. In response to the unnumbered paragraph above Paragraph 27 of Plaintiff’s Amended Petition, Defendant realleges and incorporates by reference its answers to Paragraphs 1 through 26 of Plaintiti’s Amended Petition, as if fully set forth herein. In response to Paragraph 27 of Plaintiff’s Amended Petition, Defendant denies the allegations, specifically denying (lint any Digitek® tablets ingested by Decedent were defective and that Digitek® was the proximate cause of any injuries and damages alleged in Paragraph 27 of Plaintiff’s Amended Petition,

ANSWER TO FIFTH CAUSE OF ACTION-LOSS OF CONSORTIUM

28. In response to the unnumbered paragraph above Paragraph 28 of Plaintiff’s Amended Petition, Defendant realleges and incorporates by reference its answers to Paragraphs I through 27 of Plaintiff’s Amended Petition, as if fully set forth herein. in response to Paragraph 28 of Plaintiff’s Amended Petition, Defendant lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations in Paragraph 28 of Plaintiff’s Amended Petition, and therefore denies tile same, specifically denying that any Digitek® tablets ingested by Decedent were defective and that Digitek® was the proximate cause of any injuries and damages alleged in Plaintiff’s Amended Petition.

ANSWER TO SIXTH CAUSE OF ACTION-PUNITIVE DAMAGES

29. In response to the utmumbered paragraph above Paragraph 29 of Plaintiff’s Amended Petition, Defendant realleges and incorporates by reference its answers to Paragraphs I through 28 of Plaintiff’s Amended Petition, as if fully set forth herein. In response to Paragraph 29 of Plaintiff’s Amended Petition, Defendant denies the allegations, specifically denying that any Digitek® tablets ingested by Decedent were defective.

30. Defendant denies the allegations in Paragraph 30 of Plaintiff’s Amended Petition, specifically denying that any Digitek® tablets ingested by Decedent were defective.

31. Defendant denies the allegations in Paragraph 31 of Plaintiff’s Amended Petition.

32. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 32 of Plaintiff’s Amended Petition, and therefore denies the same.

33. Defendant lacks knowledge or information sufficient to form a belief as to the truth of the allegations in Paragraph 33 of Plaintiff’s Amended Petition, and therefore denies the same. Defendant also denies that Plaintiff is entitled to the relief requested in the uimumbered paragraph following Paragraph 33 of Plaintiff’s Amended Petition.

ADDITIONAL DEFENSES

Defendant asserts and preserves the following by way of additional defense as to the claims and causes of action which Plaintiff has alleged in this suiL

FIRST ADDITIONAL DEFENSE

Plaintiff’s Amended Petition fails to state a claim upon which relief can be granted as to some or all of Plaintiff’s claims.

SECOND ADDITIONAL DEFENSE

Plaintiff’s claims are barred by the applicable statute of limitations, statute of repose, and/or the equitable doctrines of lathes and estoppel.

THIRD ADDITIONAL DEFENSE

Defendant hereby raises, asserts, and preserves its defense of lack of personal jurisdiction.

FOURTH ADDITIONAL DEFENSE

Defendant hereby raises, asserts, and preserves its defense of insufficiency of process.

FIFTH ADDITIONAL DEFENSE

Defendant hereby raises, asserts, and preserves its dcfcnse of insufficiency of service of process.

SIXTH ADDITIONAL DEFENSE

Plaintiff’s Amendcd Petition fails to name neccssary and indispensable partics.

SEVENTH ADDITIONAL DEFENSE

Plaintiff’s claims are barred by the doctrines of informed consent, release, and waiver.

EIGHTH ADDITIONAL DEFENSE

The injuries and damages allegedly suffered in this action, which are denied, may have been caused in whole or in part by the own culpable conduct, intentional acts, comparative responsibility or comparative negligence, assumption of risk, and want of care, of Plaintiff and/or Decedent.

NINTH A1)DITIONAL DEFENSE

Some or all of Plaintiffs claims ace barred by the doctrine of superseding and/or intervening cause.

TENTH ADDITIONAL DEFENSE

The injuries and damages allegedly suffered in this action, which are denied, were due to an allergic, idiosyncratic, or idiopathic reaction to the product at issue in this case, or by an unforesceable illness, unavoidable accident, or preexisting condition, without any negligence or culpable conduct by Defendant.

ELEVENTH ADDITIONAL DEFENSE

The injuries and damages allegedly suffered in this action, which are denied, were caused in whole rn in part by the acts (wrongful or otherwise), negligence, sole fault, misuse, abuse, modification, alteration, omission, or fault of one or more persons or entities over whom Defendant exercises no control and for whom Defendant is not legally responsible, including, without limitation, Plaintiff and/or Decedent.

TWELFTH AIWITIONAL DEFENSE

Plaintiff’s claims are barred by the “state of the art” and “state of scientific knowledge” defnses.

THIRTEENTH ADDITIONAL DEFENSE

Plaintiff’s claims are barred by the learned intermediary doctrine.

FOURTEENTH ADDITIONAL DEFENSE

Plaintiff’s claims against Defendant are expressly and/or iinpliedly preempted by federal law; including but not limited to, the regulations promulgated by the U.S. Food and Drug Administration as codified in Chapter 21 oC the Code of Federal Regulations. See 21 U.S .C. § 301 et seq.; see also 71 Fed. Reg. 3922 (Jan. 24, 2006).

FIFTEENTH ADDITIONAL DEFENSE

Plaintiffs claims are barred because Del bndant complied with all applicable state and federal statutes regarding the product in question including the requirements and regulations promulgated by the U.S. Food and Drug Administration as codified in Chapter 21 of the Code of Federal Regulations. Specifically, Plaintiff’s failure to warn claims are preempted by federal Food aLid Dntg regulations specifying that the warning language that can be used by generic manufacturers must be exactly the same as that approved by FDA for use by the innovator manufacturer. Plaintiffs design defect claims are also preempted because FDA made a specific determination that Digitek® was safe and effective. In the event that Plaintiffs claims are not bared, Defendant is entitled to a presumption that the product in question is free from any defect or defective condition and that its labeling was adequate.

SIXTEENTH ADDiTIONAL DEFENSE

Plaintiff’s claims are barred, in whole or in part, by the deference that common law gives to discretionary actions by FDA tinder the Federal Food, Drug & Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., and regulations promulgated thereunder.

SEVENTEENTH ADDITIONAL DEFENSE

Plaintiff’s claims may be barred, in whole or in part, under the doctrine of primary jurisdiction, in that the pertinent conduct of Defendant and all its activities with respect to the subject product have been and arc conducted under the supervision of the FDA.

EIGHTEENTH ADDITIONAL DEFENSE

Plaintiff’s claims are barred in whole or in part under the applicable state law because Digitek® was subject to and received pre-market approval by the Food and Drug Administration under 52 Stat. 1040, 21 U.S.C. § 301.

NINETEENTH ADDITIONAL DEFENSE

The manufacture, distribution and sale of Digitek® were at all times in compliance with all federal regulations and statutes, and Plaintiff’s claims are preempted.

TWENTIETH ADDITiONAL DEFENSE

Defendant did not make nor did it breach any express or implied warranties and/or breach any warranties created by law. To the extent that Plaintiff relies on any theory of breach of wan’anty, such claims are barred by applicable law, by the lack of priviLy between Plaintiff and!or Decedent and Defendant, and/or by the failure of Plaintiff to give Defendant timely notice of the alleged breach of warranty, Defendant further specifically pleads as to any breach of warranty claim all affinnative defenses under the Uniform Commercial Code, as enacted in the State of Oklahoma and any other state whose law is deemed to apply in this case.

TWENTY-FIRST ADDITIONAL DE1?ENSE

Plaintiff’s claims are barred by comments j and k to Section 402A of the Restatement (Second) of Torts.

TWENTY-SECOND ADDITIONAL DEFENSE

Plaintiff’s claims are barred by Sections 2, 4, 6(c), and 6(d) of the Restatement (Third) of Torts: Products Liability.

TWENTY-THIRD ADDITIONAL DEFENSE

Plaintiff’s product liability claims are barred because the benefits of the relevant product outweighed its risks.

TWENTY-FOURTH ADDITIONAL DEFENSE

Plaintiff’s claims are barred in whole or in part because the product at issue was at all times properly prepared, packaged, and distributed, and was not defective & unreasonably dangerous.

TWENTY-FIFTH ADDITIONAL DEFENSE

Plaintiff’s claims are barred, in whole or in part, because Defendant acted in good faith at all relevant limes and gave adequate warnings of all known or reasonably knowable risks associated with the use of its product.

TWENTY-SIXTH ADDITIONAL DEFENSE An imposition of punitivc damages in this case against Defendant is barred to the extent that the manner in which such punitive damages are calculated violatcs the Constitution of the United States or the Constitution of the State of Oklahoma and any other state whose law is deemed to apply in this ease.

TWENTY-SEVENTH ADDITIONAL DEFENSE

Any award of punitive damages in this case against Defendant is barred to the extent that the amount of such an award violates the Constitution of the Uni ted States or the Constitution of the State of Oklahoma and any other state whose law is deemed to apply in this case.

TWENTY-EIGHTh ADDITIONAL DEFENSE

Plaintiff’s claim for punitive damages is subject to the limitations and requirements of the aw of the State of Oklahoma and any other state whose law is deemed to apply in this case.

TWENTY-NINTH ADDITIONAL DEFENSE

Punitive damages are inappropriate to serve deterrence objectives because those will be fully served by past and future liability for any compensatory damages for the same conduct at issue in this case.

THIRTIETH ADDITIONAL DEFENSE

Plaintiffs Amended Petition fails to state sufficient facts under any theory or cause of action which would justit’ imposition of punitive or exemplary damages under any applicable law.

THIRTY-FIRST ADDITIONAL I)EFENSE

Plaintiffs Amended Petition fails to allege facts from which it can reasonably be inferred that Defendant acted with reckless indifference to or conscious disregard for the safety of others sufficient to warrant punitive damages.

THIRTY-SECOND ADDITIONAL DEFENSE

The imposition of damages against Defendant violates its rights to due process under the Fifth and Fourteenth Amendments to the Constitution of the United States, as well ns the Constitution of the State of Oklahoma.

THIRTY-THIRD ADDITIONAL DEFENSE

Defendant is entitled to a set-off for all amounts paid, payable by, or available from collateral sources and/or write-oil’s/write-downs in charges.

THIRTY-FO URTIT ADDITIONAL DEFENSE

Plaintiff impe1missibly seeks to impose liability on conduct protected from liability by the First Amendment to the United States Constitution and by the Constitution of the State of Oklahoma and any other state whose law is deemed to apply in this case.

THIRTY-FIFTH ADDITIONAL DEFENSE

Plaintiff’s claims are barred by Plaintiff’s failure to comply with conditions precedent to his right to recover.

THIRTY-SIXTH ADDITIONAL DEFENSE

Defendant is entitled to, and claims the benefit of, all defenses and presumptions set forth in or arising from any rule of law or statute in Oklahoma and any other state whose law is deemed to apply in this case. THIRTY-SE VENTII

ADDITIONAL DEFENSE The claims nssertcd in Plaintiff’s Amended Petition are barred, in whole or in part. because
Plaintiff did not incur any ascertainable loss as a result of Defendant’s conduct. THIRTY-EIGHTH ADDITIONAL DEFENSE Plaintiff’s alleged damages were not caused by any failure to warn on the part of Defendant. THIRTY-NINTh ADDITIONAL

DEFENSE Plaintiff’s claims against Defendant are barred bccause Defendant neither owed nor breached any duty to Plaintiff and/or Decedent. FORTIETH ADDITIONAL DEFENSE Defendant had no duty to warn about any possible dangers in using its products which were not known at the time of manufacture and sale of the products

FORTY-FIRST ADDITIONAL DEFENSE Plaintiffs claims are barred in whole or in part because there is no private right of action concerning matters regulated by the Food and Drug Administration under applicable federal laws, regulations, and rules.

FORTY-SECOND ADDITIONAL DEFENSE The claims asserted in Plaintiff’s Amended Petition are barred, in whole or in part, because the manufacturing, labeling, packaging, and any advertising of the product complied with the applicable codes, standards and regulations established, adopted, promulgated or approved by any applicable regulatory body, including but not limited to the United States, any state, and any agency thereof

FORTY-THIRD ADDITIONAL DEFENSE Any product supplied by Defendant and sold in the normal stream of commerce was reasonably safe for its intended use and was not defective in any manner.

FORTY-FOURTH ADDITIONAL DEFENSE If Decedent was exposed to any product manufactured, produced. so]d, or supplied by Defendant, which is specifically denied, said exposure was de inininiEs and insufficient as a nmltcr of law to establish with a reasonable degree or probability that the product at issuc caused Plaintiff’s and/or Decedent’s injuries.

FORTY-FiFTH ADDITIONAL DEFENSE Plaintiff may not recover on the claims pleaded in the Amended Petition because the damages sought are too speculative and remote. FORTY-SIXTH ADDITiONAL DEFENSE The damages recoverable by Plaintift if any, must be reduced by any amount of damages legally caused by Plaintiff and/or Decedent’s failure to mitigate such damages in whole or in part. FORTY-SEVENTH ADDITIONAL DEFENSE Plaintiff’s claims are barred by the doctrine of forum non conveniens.

FORTY-EIGHTH ADDITIONAL DEFENSE Digitek®, if in fact ingested by Decedent, did not cause or contribute to any alleged injuries.

FORTY-NINTH ADDITIONAL DEFENSE Digitek® was not unreasonably dangerous in formulation or composition at the time it left Defendant’s control as it did not deviate in any way from Defendant’s and the FDA’s mandatory specifications.

FIFTIETh ADDITIONAL DEFENSE Plaintiff has no standing to bring this action and/or to seek the relief requested in the Petition. FIFTY-FIRST ADDiTIONAL DEFENSE Some or all of Plaintiff’s claims are barred by reason of spoliation of evidence.

FIFTY-SECOND ADDITIONAL DEFENSE Defendant hereby reserves the right to amend its answer to assert any other defenses, affirmative or otherwise, that may become available during discovery proceedings in this case.

DEMAND FOR JURY TRIAL Defendant Actavis Totowa LLC specifically requests and demands a trial by jury on all facts and issues in this action.

PRAYER WHEREFORE, having fully answered, Actavis Totowa LLC respectfully requests that this Court enter an Order dismissing Plaintiff’s Amended Petition with prejudice at Plaintiff’s costs and granting the Defendant such other relief as it deems just and equitable.

DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

Defendants, by and through counsel, respectfully move this Court to grant them summary judgment pursuant to Oklahoma District Court Rule 13, 12 O.S. Supp.20l0, ch. 2, app, and Okia. Stat. tit. U, § 2056, because the pleadings and record demonstrate that there remains no genuine issue as to any material fact and that Defendants are entitled to judgment as a matter of law. In support of this Motion, Defendants state as follows.

Defendants, to the extent deemed necessary, adopt and incorporate by reference Defendants’ general statement of facts, all dispositive and all Dauber! motions, all motions in limine, and all related briefing, inclusive of all supporting exhibits contained in Defendants’ exhibit submission. 12O.S. §2010(C).

INTRODUCTION

In the nearly four years since the recall of Digitek® tablets in the spring of 2008, which precipitated this litigation, no plaintiff has discovered or produced a single double-thick Digitek®
tablet, nor any scientifically reliable evidence that even one Digitek® tablet on the market was out of specification because it contained too much digoxin. This case is no exception.

Under Oklahoma law, every plaintiff in a product liability case must prove the essential elements of defect and causation. Here, Plaintiff cannot. After nearly four years of searching for “smoking gun” evidence—proof that out-of-specification Digitek® tablets made it to market and, ultimately, to Martha Johnson—he, like Digitek® plaintiffs across the country, has fallen back on a circular attempt to use “speculation about a defect to prove causation and speculation about causation to prove a defect.” In i-c Digitek Prods. Liab. Litig., MDL No. 1968, 2011 WL 5282595, at *2 (S.D. W.Va. Nov. 3, 2011). This falls well short of the “reasonable” inferences required by Oklahoma law where a plaintiff seeks to prove defect via circumstantial evidence alone, as Plaintiff does here.

The four different types of circumstantial evidence on which Plaintiff relies are:

(1) allegations that Actavis has a history of production deficiencies; (2) the fact of the 2008 Digitek® recall;
(3) testimony that Mrs. Johnson’s clinical course on April 26, 2008, was “consistent with” digoxin toxicity; and
(4) evidence that a post-mortem blood sample taken from the decedent exhibited a higher-than-expected level of digoxin.

But inferring defect from any of these types of evidence is both factually and legally unreasonable. Rather than bearing at all on the existence of a defect, this evidence represents Plaintiffs attempt to place certain otherwise irrelevant buzz words, like “recall” and “adulteration,” before a jury. None of this evidence furnishes a legally valid basis for inferring that Actavis manufactured (much less disseminated to market) out-of-specification Digitek®.
Plaintiff, simply, lacks any evidence of defective Digitek®—clirect or circumstantial. Nor
do the experts retained in this case offer any opinion that Actavis manufactured and disseminated
out-of-specification Digitek® tablets. This total failure of proof calls for this Court to bring this protracted litigation to an end by granting Defendants’ Motion for Summary Judgment.

STATEMENT OF FACTS

Defendants herein refer to and incorporate by reference the General Background Statement of Key Factual Information Regarding Digitek®, which supplies background relevant to all of Defendants’ motions. (hereinafter, “Background Statement”).

LAW AND ARGUMENT

A. Plaintiff’s Burden is to Prove that Actavis Manufactured and Distributed Out-of-Specification Diitek® Tablets.

It is an essential requirement in every product liability case under Oklahoma law that the plaintiff prove, to a preponderance of the evidence, that the product he or she received is defective. See, e.g., Kirklandv. Gen. Motors Corp., 521 P.2d 1353, 1364 (OkIa. 1974) (“[file must prove that his injury has been caused not necessarily by the negligence of the Defendant but by reason of a defect ‘built in’ and existing at the time of injury.”); Lee v. Volkswagen of Am., Inc., 688 P.2d 1283, 1288 (OkIa. 1984) (“Plaintiffs ... under the manufacturers’ products liability theory must prove their case by a preponderance of evidence.”). Summary judgment is therefore appropriate where a plaintiff cannot prove to a probability that the product contained a manufacturing defect. See Green v. Safeway Stores, Inc., 541 P.2d 200, 203 (OkIa. 975) (affirming summary judgment because “{t]here is no competent evidence whatsoever, direct, circumstantial, or otherwise that would sustain a finding that there was a defect in the carton.”).

In this case, where Plaintiff’s lawsuit is predicated on allegations that Mrs. Johnson consumed a Digitek® tablet containing too much of the active pharmaceutical ingredient digoxin, the burden of proof is relatively straightforward. Plaintiff must establish that Actavis manufactured, and Mrs. Johnson received, consumed, and was harmed by Digitek® that exceeded its FDA-approved content specifications. Theoretically, Plaintiff could support this theory with direct evidence, such as scientific testing results. But Plaintiff lacks any direct evidence. Instead, his case rests entirely on an attempt to infer the existence of out-of-specification Digitek® from a cobbled-together array of circumstantial evidence.

Circumstantial evidence can only prove defect where the inference between the evidence and defect is a “reasonable” one. Beverly v. Wal-Mart Stores, Inc., 2000 OK CIV APP 45, ¶J
12-15, 3 P.3d 163, 166-67 (affirming summary judgment where plaintiffs failed to “rais[e] ‘a reasonable inference from which a fact finder may rationally conclude that plaintiff[s’l injuries and damages proximately resulted from the . . defective condition.”). For example, in the non- pharmaceutical context, a plaintiff may establish his case by showing that an injury occurred while using a product in its ordinary and intended manner, and that the event that caused the injury is of the type that would not normally occur absent a defect.’ For example, the owner of a well that produces water unfit for drinking could prove that the well has a defect by establishing that numerous nearby wells, several of which were installed by the same defendant and all of which draw water from the same source, do produce fit drinking water. That evidence, the Supreme Court of Oklahoma determined, supported a “reasonable inference” that the unfit drinking water resulted from a defect in the well. See Jean guneat v. Jackie Hames Constr. Co., 576 P.2d 761, 765 (OkIa. 1978).

But prescription drugs are different. With drugs, the inference between a malfunction and defect is not reasonable, for several reasons. For one, harm does not mean malfunction, much less defect, in the prescription drug context. McKee v. Moore, 648 P.2d 21, 23 (OkIa. 1982) (“Unlike most other products, however, prescription drugs and devices may cause unwanted side effects even though they have been carefully and properly manufactured.”). Consumers may experience idiosyncratic reactions to any medicine. See Agee v. Purdue Pharm., Inc., No. CIV-03-0787-FIE, 2004 WL 5352989, at *4 n.12 (W.D. OkIa. Nov. 22, 2004) (recognizing that “[pjrescription drugs are considered to be ‘unavoidably unsafe products’”); In re Serzone Prods. Liab. Litig., 231 F.R.D. 221, 225-26 (S.D. W.Va. 2005) (“With drug-induced liver injury, however, a medication capable of causing severe liver damage in some people may cause no liver harm at all in the vast majority of patients taking the drug.”).

Moreover, adverse reactions can occur when a patient takes two or more drugs that interact with one another. (See Background Statement at 1-2). Adverse reactions will inevitably occur, too, in some percentage of patients even where the drug itself was pharmaceutically perfect and within all specifications. (See id). Indeed, as the federal MDL court assigned to hear consolidated Digitek®-related products liability claims explained:

Although patients injured by medical devices may rely on a product malfunction approach, injuries associated with drug products rarely lend themselves to this sort of an analysis; given the variability in patient response and the inevitability of unexpected adverse events, a seemingly inexplicable failure of a metabolized chemical hardly bespeaks some deviation from the manufacturer’s specifications.

In re Digitek, 2011 WL 5282595 at * 11 n.j 1 (citing Lars Noah, This is Your Products Liability Restatement on Drugs, 74 Brook. L. Rev. 839, 842 (2009))2 (emphasis added). Consequently, a
plaintiff who intends to prove defect via circumstantiai evidence must demonstrate why, precisely, the evidence they
proffer reliably establishes that the drug was out-of-specification.

Oklahoma law is in accord. Oklahoma courts have not only accepted that “harm” does not mean “defect” in the context of prescription drugs, see McKee, 648 P.2d at 23, but also have rejected the tenuous inference between harm and defect in a products liability case:

It is not enough to merely contend that a defect existed, show that an accident occurred, and assume the two are necessarily related.” Beverly v. Wal-Mart Stores, Inc., 3 P.3d 163, 167 (OkIa. Ct. App. 1999) (internal quotations and citations omitted). See Gates v. Ford Motor Co.! 494 F.2d 458, 459 (10th Cir. 1974) (“[Ijnjury, of itself, is not proof of a defect and raises no presumption of defectiveness.” Instead, in order to survive summary judgment a plaintiff must provide sufficient evidentiary material which raises a reasonable inference from which the fact finder may rationally conclude that the plaintiff’s injuries “proximately resulted from the product’s failure of performance causally related to its defective condition.” Kaye v. Ronson Consumer Prods. Corp., 921 P.2d 1300, 1302 (OkIa. Ct. App, 1996).
Agee, 2004 WL 5352989 at *4 Oklahoma courts, then, require more than proof “based on
inference upon inference or presumption upon presumption.” Hart v. McVay, 832 P.2d 822, 824
(OkIa. 1992). It is Plaintiff’s burden to show, either directly or by reasonable inference, that
Mrs. Johnson was injured by defective, meaning out of specification, Digitek®.
B. Plaintiff Lacks Direct Evidence that Defective Dipitek® Reached the Market. The record in this case is devoid of any evidence that a single out-of-specification
Digitek® tablet reached the market, much less that Mrs. Johnson consumed one. Plaintiff has not produced any physical or reliable scientific evidence of an out-of-specification tablet. (Background Statement at 7-8). In fact, all of the evidence uncovered by discovery suggests that the 20 double-thick tablets initially identified from batch 70924A (the batch that preceded the
2008 recall) were an aberration, were not released to the market, and Actavis consistently produced within-specification Digitek®.3 The Digitek® manufacturing process was validated and its batches repeatedly tested within specifications. (ii at 8-19). This direct evidence of non- defective Digitek® is confirmed by substantial affirmative product testing and record reviews conducted by the FDA, Mylan, UDL, and Quantic Regulatory Services. (See Id. at 10-1 5).

The total lack of direct evidence proved compelling to the Digitek® MDL Court, which recognized the dearth of evidence of defective tablets on the market:

Different types of defects can occur during the tableting process. One is oversized pills. Another is a normal size tablet with too much [active pharmaceutical ingredient]. The two defects are very different. The plaintiffs have focused until recently on the former. Years after the recall, however, and following a large amount of discovery, neither the Plaintiffs’ Steering Committee nor any individual plaintiffs counsel has ever identified a single defective Digitek® tablet in their clients’ hands.

In re Digitek, 2011 WL 5282595 at *3 And while not dispositive, the absence of any direct proof, given the volume of non-defective Digitek® produced, made the plaintiffs’ burden even more imposing:

The plaintiffs’ experts’ opinions rely on the one and only verified instance of an extra thick Digitek® tablet making it to market in 2004. A pharmacist found and returned the tablet to Actavis. A manufacturing investigation was conducted and the situation was reported to FDA. After reviewing the investigation, the FDA said:

No additional complaints or reports of thick tablets have been received for this high volume product. The event was considered an isolated incident and corrective actions were put in place to prevent its reoccurrence. Corrective actions (procedural enhancements and review of complaint files) were verified during the investigation.
This is the only verified report of a thick tablet leaving Actavis’s facilities. The tablet was made in 2003. All recalled Digitek® was produced in 2006 or later. Since 2003, over one billion Dipitek® tablets have been made and distributed in the marketplace. This single 2003-produced tablet is the only Digitek® tablet in the marketplace found and confirmed to be out of specification.4

Id. at *6 (internal citations omitted, emphasis added). Put simply, proving that defective tablets evaded detection and
eventually injured a plaintiff through circumstantial evidence is a daunting task when the record itself is devoid of any sign of defective Digitek® on the market. The balance of this brief addresses Plaintiffs attempt to do just that.
C. Violation of FDA Regulations Does Not Constitute Proof of Defect.

Without direct evidence, Plaintiff has no choice but to attempt to prove defect circumstantially—an uphill battle, given that his experts cannot identi& any reliable evidence that out-of-specification tablets reached the market. Undeterred, Plaintiff has crafted a theory that relies on FDA documents, alleged production deficiencies, and evidence that the Digitek® manufacturing process was creating “adulterated” product. He wants to put Defendants on trial for a 20-year history of interaction with the FDA, without proof that even a single Digitek® tablet that was part of either the recall or Mrs. Johnson’s batch was defective. The Digitek® MDL Court considered and rejected this approach, concluding that plaintiffs could not prove defect in this manner because they relied on “speculation, not evidence.” In re Digitek, 2011 WL 5282595 at * 13. This Court should likewise reject Plaintiffs adulterated-product theory.

1. Proof of “adulteration” is not proof of “defect.”

“Adulteration” does not, and cannot, prove defect. Its meaning is limited by a statute, 21 U.S.C. § 351(a)(2)(B), which defines an adulterated drug to be one in which “the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing Practice.” In other words, a drug is deemed adulterated if it was manufactured under conditions that violated any one of the FDA’s current Good Manufacturing Practices (“cGMP”) regulations, whether or not it actually fails to meet product specifications. These regulations—the primary way in which the FDA governs the manufacturing process—are process-related “prophylactic measures” designed “to prevent the distribution of poorly manufactured drugs and devices ‘by giving the Food and Drug Administration . . additional authority to require that sound methods, facilities, and controls be used in all phases of drug manufacturing and distribution.” United States v, 789 Cases, More or Less, of Latex Surgeons ‘Gloves, 799 F. Supp. 1275, 1285 (D. P.R. 1992) (“[T]he cGMP regulations are intended to be preventive,”). Accordingly, cGMP violations lead only to “regulatory action,” see 21 C.F.R. § 210.1(b), and are not a basis for civil suits, see, e.g., Howardv. Suizer Orthopedics, Inc., No. 02—CV—0564--CVE—FHM, 2011 WL 2472594 at *6 (ND. OkIa, June 21, 2011) (“Based on the lack of a private cause of action in the FDCA, ‘many courts have held plaintiffs cannot seek to enforce it through negligence per se tort actions.”) (citing Bartlett v. Mitt. Pharmaceutical Co., Inc., 731 F.Supp.2d 135, 154 (D.N.H.2010)).5

Nothing in the adulteration statute states that an adulterated drug is either outside of United States Pharmacopeia specifications or defective under state tort law. See 21 U.S.C. § 351(a)(2)(B). Moreover, the FDA itself rejects attempts to equate adulteration with evidence of a manufacturing defect. The agency has repeatedly explained that adulteration means only “that the drug was not manufactured under condiUons that comply with cUMP,” and “does not mean that there is necessarily something wrong with the drug.” Food and Drug Administration, “Facts
About Current Good Manufacturing Practices (cGMPs),

http://www. fda. gov/Dru gs!DevelopmentApproval Process/Manufacturin afticm 169105 .htm (last visited January 5, 2012).6

Federal courts, too, acknowledge that allegations of adulteration fall well short of proof of defect. See, e.g., In re Digitek, 2011 WL 5282595 at *56; Krueger v. Johnson & Johnson Frof’l, Inc., No. 4:OO-cv-10032, 2002 WL 34371190, at *5 (S.D. Iowa Sept. 10, 2002) (“[T]estimony [of failure to comply with FDA regulationsi does not prove that the . . . device implanted in Krueger was defective, or that it was a proximate cause of his injuries.”); Geilman
v. United Slates, 159 F,2d 881, 882 (8th Cir. 1947) (finding that an entire shipment of medical devices was “adulterated,” although “a much larger percentage of the shipment” was not defective). In fact, several courts have held that adulteration is not even a sufficient basis upon which to state a claim for a manufacturing defect. See, eg., Myers-Armstrong v. Actavis Thlowa LLC, No. C 08-04741 WHA, 2009 WE 1082026, atM (N.D. Cal. Apr. 22, 2009), aff’dNo. 09- 16055, 2010 WL2232652 (9th Cir. June 3,2010) (“That the [drugj was adulterated due to a lack of compliance with GMP requirements is not enough, without more, to state a claim.”); In re Medtronic Sprint Fidelis Leads Prods. Liab. Litig., 592 F, Supp. 2d 1147, 1157 (D. Minn. 2009) (cGMPs are “too generic, standing alone, to serve as the basis for plaintiffs’ manufacturing defect claims.”); Ilarraza v. Medtronic, 677 F. Supp. 2d 582, 588 (same).

2. Allegations of adulteration arc not circumstantial evidence of defect.

Evidence that a drug is adulterated cannot support the inference that Plaintiff seeks, which is that an adulterated drug must somehow be flawed, dangerous, or defective. Courts have rejected that very inference because a drug may be “pharmaceutically perfect in content but still regarded as adulterated under the law.” See, e.g., United States v. Lit Drug Co., 333 F. Supp. 990, 998 (D. N.J. 1971). And the FDA too rejects any assumption that an adulterated drug is out of specification or dangerous. When the FDA examines whether a product is adulterated, it does not ask whether the drug is harmffil or meets content specifications. See, e.g., United States v. Barr Labs,, Inc., 812 F. Supp. 458, 486 (D. N.J. 1993) (explaining that the relevant inquiry to determine whether a drug is adulterated does not focus on the drug’s pharmaceutical content); United States v. Bel-Mar Labs., Inc., 284 F. Supp. 875, 881-83 (E.D.N.Y. 1968) (a drug manufactured in violation of GMPs is adulterated, whether or not it is actually deficient).

Further, courts have cautioned against exporting regulatory conclusions like adulteration into civil tort cases for another reason—the differences between the burdens of proof. The FDA, as the agency charged with protecting public health, applies “a much lower [risk-utility] standard [of harm] than that which is demanded by a court of law.” McClain v. MetaboIfe Int’l, Inc., 401 F.3d 1233, 1249-1250 (11th Cir. 2005). This lower standard favors overestimating risks as part of “the preventive perspective that the agenc[y] adopt[s] . . . to reduce public exposure to harmful substances.” Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 991 (8th Cir. 2001); see also McClain, 401 F.3d at 1249-50 (the FDA takes enforcement action “upon a lesser showing of harm to the public than the preponderance-of-the-evidence or the more-like[lyl-than-not standard used to assess tort liability.”). So when the FDA prevents a manufacturer from selling an adulterated product, it does so out of an abundance of caution, not because it has reason to believe the product contains a defect.

The In re Dignrelc MDL Court found the distinction between an adulterated and defective drug to be essential for summary judgment purposes. A drug could be rendered “adulterated,” the court explained, by “something as mundane as inadequate lighting or the lack of hot and cold running water in the building.” 2011 WL 5282595 at *5 So while one may infer “adulteration” from “defect,” the converse inference is not reasonable. See Ed. And for that reason, the court found that evidence of Actavis’s past alleged production deficiencies and cGMP violations did not “give rise to a reasonable inference that defective Digitek® reached the market and caused harm to either of the plaintiffs’ decedents.” Id. at * 12. Here too, the inference from past regulatory problems to defect is not a reasonable one; adulteration, accordingly, is not valid circumstantial evidence of defect.

3. Agency forms, reports, and letters criticizing Actavis’s manufacturing processes are not proof that Digitek® tablets contained too much or too little digoxin.

Just as adulteration is not proof of defect, neither are the regulatory documents that the FDA uses to communicate allegations of adulteration. In this litigation, Plaintiff has asked his expert, Dr. David Bliesner, to review—and would present to a jury—documents including Form 483s, Establishment Inspection Reports, and Warning Letters. (See Background Statement at 18- 20). But none of these documents are final agency action, and none say anything about the composition or content of any Digitek® tablets.7 At most, they are recordings of an FDA employee’s belief that an Actavis manufacturing process violated a cGMP regulation—an observation that, for the reasons explained above, has nothing to do with whether Digitek® released to the market was defective.

Plaintiff particularly emphasizes communications between the FDA and Actavis, such as Warning Letters issued by the FDA, and would lift these agency allegations of adulterated product out of their regulatory context in an attempt to transform them into proof of defect. For example, Defendants anticipate that Plaintiff will rely on language from a February 2007 Warning Letter, which reported that because Actavis’ 5 quality control unit fell short of cGMPs, “there is no assurance that many drug products manufactured and released into interstate commerce by your firm have the identity, strength, quality and purity that they purport to possess.” (See Feb. 1, 2007 Warning Letter at 1, attached to Background Statement as Act. Ex. 22). But on its face, this letter says only that the FDA cannot ver(fy that Actavis’s products are of the quality, strength, and purity that they purport to be. Plaintiff cannot recast this statement as an agency finding that Actavis’s products are in fact not of the specified quality, strength, and purity, and therefore are defective.

And if agency forms and FDA communications cannot support a reasonable inference of defect, then external e-mail communications from third parties or internal speculation as to what caused the isolated double-thick tablets in Batch 70924A certainly cannot. Yet that is precisely the sort of evidence on which Defendants expect Plaintiff to rely, notwithstanding the fact that none of that evidence so much as hints at the existence of out-of-specification Digitek® released to market.

Neither communications from the FDA, nor external or internal communications that have nothing to do with defective product on the market, support Plaintiffs theory. And certainly none of this evidence can shift the burden of proof onto Defendants to disprove the existence of defects. The FDA’s Warning Letter itself acknowledges that Actavis’s products may be within specification and “that to provide such assurance, [Actavis] should promptly initiate an audit program by a third-party having appropriate cGMP expertise, to provide assurance that all marketed lots of drug products that remain within expiration have their appropriate identity, strength, quality, and purity.” (in at 6). Actavis did so, and Quantic
Regulatory Services concluded that Actavis’s records reliably confirmed that its products were within specifications, including 19 batches of Digitek® that had been part of the recall. (See Background Statement at 14-15).

P. Evidence of the 2008 Dipitek® Recall Cannot Satisfy Plaintiff’s Burden to Prove that Mrs. Johnson Received an Out-of-Specification Dipitek® Tablet.

Once the distraction of adulteration is filtered out, this case can be seen for what it has always been—a reaction to a high-profile drug recall. There are both factual and legal reasons why the 2008 recall cannot satisf5i Plaintiff’s burden of proof. Simply, recalls are preventative measures; they do not mean that the same problem that prompted the recall occurred in any specific consumer’s product. Thus, the fact that Actavis recalled Digitek® due to the possibility of double-thick tablets cannot prove that Mrs. Johnson received an out-of-specification tablet.
Recall evidence cannot sustain Plaintiffs burden to prove that the Digitek® consumed by Mrs. Johnson was defective. Indeed, the Supreme Court of Oklahoma has confirmed that a Plaintiff must go beyond evidence of a recall “to present testimony that the described defect actually existed.” Fields v. Volkswagen of Am., Inc., 555 P.2d 48, 58 (OkIa. 1976) (“Evidence of a recall, standing alone is not sufficient to sustain a verdict against the defendant.”). And, as the In re Digitek MDL court noted, the inference between recall and defect is especially tenuous where the recall is required by the FDA because “[tihe FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability.” 2011 WL 5282595 at *12. Accordingly, the MDL court concluded that the 2008 recall did not “give rise to a reasonable inference that defective Digitek® reached the market and caused harm to either of the plaintiffs’ decedents.” Id. Simply, the fact that a recall for the possibility of double-thick tablets occurred gets Plaintiff nowhere. Even Plaintiffs experts admit that a product recall can occur where no true defect in the drug exists. (See Background Statement at 6-7).

A recent decision from the Middle District of Pennsylvania is instructive and offers a compellingly similar set of facts. See Dickv. Am. Home Prods. Corp., No. l:05-cv-2384, 2009 WL 1542773 (M.D. Penn. June 2, 2009). In Dick, Wyeth, the manufacturer of a generic drug, voluntarily recalled one lot of drug capsules “after the company discovered that some capsules from the lot contained variable and unknown amounts” of an additional chemical. Id. at * 1. The plaintiff sued after learning of this recall, alleging that her late husband consumed contaminated capsules that caused his death. Id. at *2. After noting the elements common to a products liability suit (namely, proof of defect and causation), the Court granted summary judgment, finding that the plaintiff had:

[N]o evidence to support Plaintiff’s claim that Mr. Dick actually received or ingested any capsules that may have come from this lot. Even more fUndamentally, there is no evidence to show that any etodolac capsules Mr. Dick did ingest—whether from Lot No. 9991052 or otherwise—actually contained any acebutolol, much less a quantity of acebutolol sufficient to cause him to suffer adverse health effects or cause his death.

Id. at *3 Here too, Plaintiff has not put forth any evidence that Mrs. Johnson received tablets that contained too much digoxin, much less tablets of a sufficiently high dose to cause harm. Without that evidence, he cannot draw a reasonable inference of defect from the 2008 recall.

E. Speculation Repardin the Cause of Plaintiff’s Clinical Course and Death Cannot Support a Reasonable Inference of Defect.

The mechanism underlying digoxin toxicity8—the buildup of digoxin in blood, then tissue—can occur for many reasons besides a defective tablet. Plaintiffs own expert, Dr. Ralph Lazzara, admits that there are many alternative causes of toxicity, including infection, dehydration, renal insufficiency, electrolyte abnormalities, and interactions with other drugs. (See Lazzara Dep. at 21; see also Defs’ Mot. to Exclude Testimony of Dr. Ralph Lazzara at 18- 19). These alternative explanations underscore the complicated nature of pharmaceuticals and demonstrate why, as the Supreme Court of Oklahoma explained in McKee, defect cannot be inferred from harm. See 648 P.2d at 23. With digoxin, a drug with a narrow therapeutic range, toxicity can occur when patients are taking regular, normal doses. (See Lazzara Dep. at 20) (describing digoxin toxicity as “one of the more frequently encountered adverse drug events in the elderly”). Accordingly, even if this Court were to assume that Mrs. Johnson became digoxin toxic, evidence of toxicity does not support the inference of product defect that Plaintiff seeks.

But here, the inference of defect from toxicity is even weaker because Plaintiff cannot establish that Mrs. Johnson was even “probably” toxic. At most, Dr. Lazzara testified that the symptoms Mrs. Johnson allegedly had were consistent with toxicity. (See Id. at 32). While toxicity was in his opinion more likely than other alternatives, he could not, and did not opine that toxicity more likely than not caused her death. Yet under Oklahoma law, “[t}he mere possibility that a defect caused the injury is not sufficient; the evidence must support both a probability of defect and a probability that the defect caused the injury.” Carver v. Kia Motors Corp., No. 10-CV-642-JHP-PJC, 2012 WL 119587, 4 (N.D. OkIa. Jan. 12, 2012) (citing Dutsch v. Sea Ray Boats, Inc., 1992 OK 155, ¶ 11, 845 P.2d 187, 190) (“decision must be based upon probabilities, not possibilities”)). As a matter of law, then, Dr. Lazzara’s testimony is insufficient to support a reasonable inference of defect.

F. Post-Mortem Blood Test Results Shawinn an Elevated Dipoxin Blood Level Cannot Satisfy Plaintiff’s Burden of Proof.
Unable to make this a case about Actavis’s regulatory history or the 2008 recall, Plaintiff
is left with one last card to play—the allegation that digoxin killed Mrs. Johnson because a post-
mortem Mood draw tested positive for a higher-than-expected level of digoxin in her blood. This is the weakest of Plaintiff’s arguments and it too is legally incapable of satisl5’ing Plaintiffs burden of proof. Even if the results of the post-mortem testing are admissible—and Defendants have moved to exclude that evidence as unreliable because the results are affected by the well- established phenomenon of post-mortem redistribution (see Defs’ Mot. to Exclude Decedent’s Post-Mortem Blood Digoxin Concentration)—none of this circumstantial evidence proves that Digitek® tablets contained erratic or uncontrolled amounts of digoxin, much less supports a reasonable inference that Mrs. Johnson’s individual Digitek® contained a defect.

Essentially, Plaintiff wants to encourage the fact finder to make two inferential leaps: (1) that because a post-mortem analysis of Mrs. Johnson’s blood reported an elevated digoxin level, Mrs. Johnson’s digoxin blood level must have been elevated at the time of her death; and (2) that, assuming her ante-mortem digoxin level was elevated, the elevated blood level must have been because she received an out-of-specification Digitek® tablet. The first inference is patently unreasonable for the reasons explained in Defendants’ Motion to Exclude. Simply, there is no reliable way to back-calculate an ante-mortem blood level from a post-mortem blood test result given the undisputed occurrence of post-mortem redistribution. See id. at 10. Even Plaintiffs own expert, Dr. Edward Barbieri, admits that the scientific consensus is that “you cannot calculate with scientific probability someone’s pre-death drug level based on a post mortem finding.” (Barbieri Dep. (Johnson) at 53, 162). Indeed, he agreed that “a high degree of error can arise” when any such back-calculation is attempted. (Id. at 163). Accordingly, the inference from an elevated post-mortem result to an elevated ante-mortem result is not a “reasonable” one, as Oklahoma law requires.

But even assuming that the first inference was reasonable, the second is not. As explained above,, there is no reasonable inference from injury to defect in the prescription drug context. Where plaintiffs seek to infer a defect from the fact of a malfunction or injury, courts seek proof that the injury would not occur in the absence of a product defect. See Kirkland, 521 P.2d at 1363 (“[W]e do not infer that the injury is of itself proof of the defect, or that proof of injury shifts the burden to the Defendant.”); Agee, 2004 WL 5352989 at *4 (holding in a
prescription drug product-defect case that “[ut is not enough to merely contend that a defect existed, show that an accident occurred, and assume the two are necessarily related.”); Lyons v. Valley Vie! Hosp., 0/cl., 341 P.2d 261, 262 (OkIa. 1959) (“Cases are legion in which we have held that the mere happening of an accident raises no presumption of negligence on the part of the defendant.”); Payne v, Holder, 219 P. 372, 372 (Okla. 1923) (“A defect cannot be inferred from the mere fact of an injury.”). Plaintiff, as Section F above explained, cannot prove, or even reasonably infer, that what happened to Mrs. Johnson would not have occurred but-for her consumption of a too-thick Digitek® tablet.
There is, in short, proof that the injury Plaintiff alleges Mrs. Johnson sustained commonly occur’s in the absence of a product defect. Consequently, the post-mortem blood test cannot satistS’ Plaintiff’s burden of proof.

CONCLUSION

Plaintiff’s burden in this product liability case is straightforward: prove that Mrs. Johnson received, ingested, and was harmed by defective Digitek®. But Plaintiff lacks any direct evidence. What circumstantial evidence he does have—regulatory criticism of Actavis’s adherence to cGMPs, external and FDA communications unrelated to Digitek® on the market, a high-profile drug recall, and an admittedly skewed post-mortem blood test result—cannot satisfy
the burden of proof as a matter of law. For these reasons, this Court should end this protracted
litigation by finding that Plaintiff has failed to carry the burden of proving defect as a matter of
law and by granting summary judgment on all remaining claims.



PLAINTIFF’S MOTION TO SETTLE JOURNAL ENTRY

Plaintiff Sam Johnson hereby moves the Court to enter an Order overruling and denying each of the Defendants’ Motions for Summary Judgment in this case. Plaintiff’s proposed Order is attached hereto as Exhibit A. Defendants will not agree to Plaintiff’s proposed Order and have instead proposed the form of Order attached hereto as Exhibit B. Plaintiff submits that his proposed Order (Exhibit A) accurately and more specifically addresses this Court’s rulings at the hearing held on May 10, 2010 and, therefore, should be adopted by the Court. In further support of his proposed Order (Exhibit A), Plaintiff would show the Court has follows:

1. Defendants filed the following Motions for Summary Judgment in this case:

• Defendants’ Motion for Summary Judgment;

• Defendants’ Motion for Summary Judgment on Plaintiff’s Punitive Damages Claim

• Defendant Wal-Mart’s Motion for Summary Judgment on Plaintiff’s Negligence Claim

• Mylan and UDL’s Motion to Exclude Certain Testimony of Plaintiff’s General Liability Expert, David Bliesner, Ph.D.,
and for Summary
Judgment

2. Plaintiff responded to all of the above-named Motions, and Defendants replied. The Court read all of these briefs. [See Exhibit C, Transcript at 79.]

3. On May 10, 2012, these Motions came on for hearing and oral argument was had on same. Counsel for all Defendants argued their respective clients’ positions. Argument specific to each of Defendants’ Motions was heard. [See, e.g., Exhibit C, Transcript at 22-23, 66-67.]

4. Upon the close of oral argument, the Court issued its rulings, as follows:

[T]he rulings that I’m announcing at this point in time incorporate and include all of the records made concerning the argument today as well as the written documentation and evidentiary matters that [were] reviewed in support of the motions. The Court at this time is going to overrule and deny the Motion for Summary Judgment as argued by Actavis Totowa. The Court will overrule and deny the Motion for SummaryJudgment as argued and presented on behalf of Mylan, UDL, and Wal-Mart.

* * *

The Court also specifically would overrule the motion at this point in time on behalf of the parties as presented concerning the punitive damages issues.

[Exhibit C, Transcript at 79-80.] That is, the Court denied all of Defendants’ Motions for Summary Judgment. [See also Exhibit C, Transcript at 80 (noting that the rulings were announced “as to each of the defendants”).]

5. Plaintiff provided his proposed Order for Defendants’ review on May 18, 2012. [See Exhibit D, Exchange dated 5/18 - 5/29/1 2.] As of May 23, 2012, Plaintiff had not yet heard back from Defendants. [Exhibit D.] Indeed, Defendants did not respond until May 29, 2012 and, even then, did not specifically address the content of Plaintiff’s proposed Order. [See Exhibit D.] Once again, the “my way or the highway” litigation approach has been invoked by this group of Defendants. Defendants continue to create obstacles and force Plaintiff to jump through hoops on the simplest of issues -- even rulings and the basis of the rulings clearly reflected in the record of the proceedings.


6. Defendants did not submit a counter-proposal until June 5, 2012. [Exhibit E, Email Exchange between David McPhail and Ryan Del igans dated 6/5/12.] Notably, however, as soon as Plaintiff voiced his disagreement with Defendants’ counter-proposal, Defendants sent a letter to the Court in which the Defendants inappropriately argued their position that two of the four above-named Motions for Summary Judgment were not addressed by the Court. Defendants’ argument in this regard flies in the face of this Court’s express statement that summary judgment was denied “as to each of the defendants.” Moreover, this disagreement between counsel should be resolved by Motion to Settle (as is routinely done across the state) so the record in this case can continue to be clear. This is not an issue that should spark a unilateral letter-writing campaign to the Court.

7. Plaintiff’s proposed Order addresses only the Summary Judgements as ruled upon by the Court. Plaintiff in no way suggests that the Court has made a specific ruling as to Defendants’ Daubert and/or Limine Motions. However, the Court made clear when it overruled and denied each of Defendants’ Motions for Summary Judgment that the rulings were made and premised upon a review of the briefs and ii evidentiary matters in support of the motions filed with the Court, including, for purposes of ruling on the Motions for Summary Judgment, the evidentiary matters related to Dr. Bliesner as submitted and argued in the briefs filed by the Defendants. Accordingly, the Order submitted by Plaintiff (Exhibit A) is an accurate and specific memorialization. Any confusion experienced by Defendants is of their own making, as a result of combining multiple motions into one document, and i2 as a result of this Court’s rulings. Indeed, Plaintiff submits that the Court’s rulings need no clarification.

Above premises considered, Plaintiff respectfully requests this Court to settle the parties’ dispute as to the proper form of Order, and to enter Plaintiff’s proposed Order denying all Defendants’ Motions for Summary Judgment.

Outcome: Settled during mediation on July 10, 2012 for an undisclosed sum.

Plaintiff's Experts: David Bliesner, Ph.D.; Dr. Ronald Woodson, M.D.; Ralph Lazzara, cardiology; Ernest Lykissa, Ph.D., toxicology; Chai Choi, M.D., pathologist; Dr. Edward Barbier, serology

Defendant's Experts:

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