Free Expert Witness Designation - District Court of Colorado - Colorado

Case 1:03-cv-02608-WDM-MJW

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO Civil Action No. 03 - cv - 02608 ­ WDM - MJW LORNA FOOSHEE, individually, as personal representative of the estate of MICHAEL FOOSHEE, deceased, and as parent of DARLENE FOOSHEE, a minor; RICK FOOSHEE, and MARILYN FOOSHEE Plaintiff, v. THE UNITED STATES OF AMERICA, and MYLAN PHARMACEUTICALS, INC. Defendants. PLAINTIFFS' DISCLOSURE OF EXPERT WITNESSES COME NOW, the Plaintiffs, by and through undersigned counsel, would respectfully show as follows: 1. Plaintiffs hereby disclose the following retained expert witness

pursuant to F.R.C.P. 26(a)(2)(B): a. Charles D. Marable, M.D. 1400 S. Main, Ste. 207 Fort Worth, Texas 78104 (817) 334-0338

Dr. Marable is a board certified Neurologist. His CV, Fee Schedule and list of testimony are attached. He is expected to testify consistent with the attached report. In addition to medical literature specifically cited within the report, Dr. Marable and each of the retained and non-retained experts may rely upon the following scientific and medical literature, available publicly:

Besag FM., Drug Saf. 2000 Sep;23(3): 173-82 Rosenbaum DH, Rowan AJ, Tuchman L, French JA., Epilepsia.

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Case 1:03-cv-02608-WDM-MJW 1994 May-June;35(3): 656-60

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Burkhardt RT, Leppik IE, Blesi K, Scott S, Gapany SR, Cloyd JC., Neurology. 2004 Oct 26;63(8): 1494-6. Soral I, Richens A., J Neurol Neurosurg Psychiatry. 1992 Aug;55(8): 688-91. Borgheini G, Clin Ther. 2003 Jun;25(6): 1578-92. Yamaguchi T, Mukai S, Uotani S, Ohtani H, Sawada Y., Yakugaku Zasshi. 2002 May; 122(5):331-8 Gogtay NJ, Dalvi SS, Mhatre RB, Kirodian BG, Gupta AH, Jadhav SP, Kshirsagar NA., Ther Drug Monit. 2003 Apr; 25(2): 215-20. Spino M, Tsang YC, Pop R., Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar; 25(1): 18-24. Meyer MC, Straughn AB, Mhatre RM, Shan VP, Chen ML, Williams RL, Lesko LJ. Pharm Res. 2001 Mar; 18(3): 394-7. Tomson T, Skold AC, Holmgen P, Nilsson L, Danielsson B, Ther Drug Monit., 1998 Jun;20(3): 309-12. Chua HC, Venketasubramanian N, Tjia H, Chan SP., Clin Neurol Neurosurg. 2000 Mar;102(1): 6-8. May T, Jurgens U, Rambeck B, Schnabel R., Epilepsy Res. 1999 Jan; 33(1): 57-65. Wilder BJ, et. al. Effects of Food on Absorption of Dilantin Kapseals and Mylan Extended Phenytoin Sodium Capsules. Neurology, 2001; 57: 698-700. Statement on Substitution of Generic Antiepileptic Drugs, Epilepsy Foundation of Idaho, June 1996 (Revised 2001). Posey LM, Phenytoin Bio-availability Problems Surface with Generic Products with Absorption Decreased by High Fat Meals, Pharmacy Today, 2001. Burkhart RT, Lower Phenytoin Levels in a Person Switched from Brand to Generic Phenytoin, Neurology 2004; 63: 1494-96. Wilder BJ, Clinical implications of the effect on the bioavailability of Dilantin Kapseals versus Mylan extended phenytoin sodium capsules. Neurology 2000; 54 (Supp 3): A 193.

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Welage LS, Understanding the scientific issues embedded in the generic drug approval process. J Am Pharm Assoc 2001; 41(6): 856 ­ 67.

b.

Ilo Leppik, M.D. 7500 Western Ave. Golden Valley, MN 55427 (763) 546-3328

Dr. Leppick is a board certified Neurologist who specializes in care, treatment and research regarding patients with seizure disorders. Dr. Leppick has requested, in lieu of expert witness fees, that donations be made to the University of Minnesota Foundation Epilepsy Research Fund. To date, a donation of $800.00 has been made. Dr. Leppick is expected to testify, consistent with his attached report, that the Mylan generic phenytoin is an unreasonably dangerous product because Mylan has failed to adequately inform the public and the medical profession of documented problems when patients are switched from name brand Dilantin to generic phenytoin. He is expected to explain that the study submitted by Mylan to the United States Food and Drug Administration ("FDA") was wholly inadequate under the circumstances. He has

specifically requested all information submitted by Mylan to FDA regarding this product and, to date, Mylan has failed to disclose or describe a single document although the undersigned is informed, and believes, that more than 30,000 pages of relevant documentation exists and is maintained by Mylan. Accordingly, Dr. Leppick reserves the right to revise and expand upon the opinions expressed herein once Mylan complies with applicable disclosure obligations or responds to appropriate requests for information. Dr. Leppick recalls providing testimony, at deposition, in two cases

pending in Ohio during the last four years. He does not keep files in this regard and this information is being requested directly from the attorneys involved. It may be that the

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Case 1:03-cv-02608-WDM-MJW

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testimony, in fact, occurred outside the time period envisioned by the Federal Rules of Civil Procedure in terms of disclosure. His CV is attached and Dr. Leppick may rely upon any of the materials and presentations, articles, abstracts or text book chapters listed on the CV in addition to the bibliography set out above and the articles list appended to his report.

c.

Ashraf Mozayani, Ph.D., Pharm D. National Forensic Science Consultants, LLC 4059 Breakwood Dr. Houston, TX 77025 (713) 667-1140

Dr. Mozayani is a board certified forensic toxicologist. She will testify consistent with the attached report that to a reasonable degree of probability Michael Fooshee died as a result of the switch from name brand Dilantin to Mylan's generic phenytoin. Her CV, testimony list and fee schedule are attached.

d.

John Mahan 1499 W. Braewood Ave. Highlands Ranch, CO 80129 (720)344-1479

Mr. Mahan charges $250.00/hr for all services. In the last four years he has testified as follows:

a.

Sierra Club & Mineral Policy Center v. El Paso Gold Mines, Inc., # 01-PC-2163 (December 2002 trial date). Testified on behalf of the Plaintiffs. Stalcup, et. al. v. Schlage Lock Company, Inc., #02-CV-01188, Deposition testimony on behalf of the Plaintiffs ( March 2006).

b.

A report has been requested and will be provided upon receipt. He will address issues of past and future pecuniary loss. He will project the present value of income

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associated with the Social Security Disability determination and probable future earnings over Michael Foshee's statutory life expectancy. His CV is attached. e. James W. Bartling, Pharm. D. 3531 Lochwolde Lane Snellville, GA 30039 (678) 547-6232

Dr. Bartling's CV and testimony history are attached. He charges $250/hour for all services. He will testify consistent with his attached report regarding the particular care required of pharmacists regarding Dilantin prescription because of its narrow therapeutic index. He will testify that under the circumstances it was below the standard of care for a pharmacist to fill a prescription for Dilantin with generic phenytoin.

2.

Pursuant to F.C.R.P. 26(a)(2)(a) Plaintiff hereby discloses the following

"non-retained" expert witnesses: a. Robin Morgan, M.D. The Children's Hospital 1056 East 19th Ave. Denver, CO 80218 (303) 861-8888

Dr. Morgan will have information regarding his evaluation, care and treatment of the deceased, as well as the deceased's past medical history. He will testify consistent with his medical records and any deposition provided herein. He will have information regarding his observations of conversations with the deceased, as well as other of the deceased's health care providers. He may have information regarding other issues related to this suit. He will testify regarding his specific experience with patients switched form Dilantin to generic phenytoin, his custom and routine in such situations, his preference for the name brand product, and the basis for this.

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Case 1:03-cv-02608-WDM-MJW b.

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Bruce H. Peters, M.D. Academic Neurology & Headache Clinic, P.C. 320 E. Fontanero, Ste. 304 Colorado Springs, Colorado 80907 (719) 630-1510

Dr. Peters will have information regarding his evaluation, care and treatment of the deceased, as well as the deceased's past medical history. He will testify consistent with his medical records and any deposition provided herein. He will have information regarding his observations of conversations with the deceased, as well as other of the deceased's health care providers. He may have information regarding other issues related to this suit. He will testify regarding his specific experience with patient's switched form Dilantin to generic phenytoin, his custom and routine in such situations, his preference for the name brand product, and the basis for this. c. Mario Oliveira, M.D. 1519 East Boulder Colorado Springs, CO 80903 (719) 632-5155

Dr. Oliveira will have information regarding his evaluation, care and treatment of the deceased, as well as the deceased's past medical history. He will testify consistent with his medical records and any deposition provided herein. He will have information regarding his observations of conversations with the deceased, as well as other of the deceased's health care providers. He may have information regarding other issues related to this suit. He will testify regarding his specific experience with patients switched form Dilantin to generic phenytoin, his custom and routine in such situations, his preference for the name brand product, and the basis for this.

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Case 1:03-cv-02608-WDM-MJW d.

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Plaintiffs may call any of the disclosed health care providers, any health

care providers identified in medical records, and any expert disclosed by any other party to the extend of their records and disclosures. Respectfully submitted this 5th day of October 2006. s/D. Robert Jones D. Robert Jones, #25393 219 W. Colorado Ave, #210 Colorado Springs, CO 80903 (719) 630-1556 Attorney for Plaintiffs CERTIFICATE OF SERVICE I hereby certify that on 5th day of October, 2006, I electronically filed the foregoing with the Clerk of Court using the CM/ECF system which will send notification of such filing. I hereby certify that I have mailed or served the document or paper to the following non CM/ECF participants in the manner indicated by the non-participant's name: Kurt J. Bohn, Esq. Assistant United States Attorney 1225 Seventeenth Street, Suite 700 Denver, CO 80202 Counsel for the United States of America Michael Matthews, Esq. Jackson Kelly 1099 18th St. #2150 Denver, CO 80202 Attorney for Defendant Mylan Clem C. Trishler, Esq. Pietragallo, Bosick & Gordon The Thirty-Eighth Floor One Oxford Center Pittsburgh, PA 15219 Co-Counsel for Defendant Mylan s/D. Robert Jones D. Robert Jones, #25393 219 W. Colorado Ave, #210 Colorado Springs, CO 80903 (719) 630-1556 Attorney for Plaintiffs

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