Free Expert Witness Designation - District Court of Colorado - Colorado

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

Document 50

Filed 10/04/2006

Page 1 of 6

UNITED STATES DISTRICT COURT EL PASO COUNTY STATE OF COLORADO LORNA FOOSHEE, individually and as personal representative of the estate of MICHAEL FOOSHEE, deceased, and as parent of DARLENE FOOSHEE, a minor, RICK FOOSHEE and MARILYN FOOSHEE, Plaintiffs, v. JOHN E. RISING, R. Ph., LYNN BEAULIEU, M.D., COMMUNITY HEALTH CENTERS, and MYLAN PHARMACEUTICALS, INC., Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )

Case No. 03-CV-02608 Division 14

DISCLOSURE OF EXPERTS ON BEHALF OF DEFENDANT, MYLAN PHARMACEUTICALS, INC. AND NOW, comes the defendant, Mylan Pharmaceuticals Inc., (hereinafter "Mylan"), by and through its counsel, and files this Disclosures of Experts pursuant to Rule 26(a)(2) of the Federal Rules of Civil Procedure.

I.

PRELIMINARY STATEMENT

Pursuant to the Scheduling Order issued on April 20, 2006, Plaintiffs were required to disclose expert witnesses by September 5, 2006. To date, they have not disclosed any experts. Instead, they have filed a Motion for Extension of Time to

identify experts. This Motion is pending.

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

Document 50

Filed 10/04/2006

Page 2 of 6

The Plaintiffs have the burden of proof for the claims raised in the Amended Complaint. With respect to Mylan, Plaintiffs have the burden of proving that any pharmaceutical product manufactured by this defendant and ingested by the decedent was defective. Without expert testimony, Mylan submits that the Plaintiffs cannot meet their burden. Mylan intends to move for summary judgment if the Court denies Plaintiffs' Motion for Extension of Time. However, if Plaintiffs are given additional time to disclose experts, Mylan reserves the right to supplement this list. It is expected that other

individuals may be designated by Mylan to testify concerning relevant issues, once Mylan has the benefit of reviewing Plaintiffs' experts' reports. This determination will be made when Plaintiffs file their Rule 26(a)(2) Disclosure and Mylan will supplement its Rule 26(a)(2) Disclosure accordingly.

II.

LIST OF POTENTIAL EXPERT WITNESSES

Mylan hereby discloses the following individuals as expert witnesses who may testify at the trial of this matter: 1) Jerome P. Skelly, Ph.D. 9321 Coral Lane Alexandria, VA 22309 Dr. Jerome P. Skelly is the president of the American Association of Pharmaceutical Scientists and a Professor of Biopharmaceutics, College of Pharmacy at the University of Cincinnati. Dr. Skelly was employed by the FDA from 1968 to 1992. Dr. Skelly is familiar with the practices of the FDA and can provide testimony as to the procedures, practices and protocols that must be followed to bring a generic drug to market, including the drug approval process; the active role of the FDA in that process; and the research and review of Mylan's product that would have been conducted by the government before this drug ever went to market. Among other things, Dr. Skelly will opine that the FDA determined as a

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

Document 50

Filed 10/04/2006

Page 3 of 6

fact that Mylan's Phenytoin product was bioequivalent to the referenced drug. A report and CV from Dr. Skelly will be provided once Plaintiffs produce expert reports, if permitted by the Court.

2)

Marvin C. Meyer, Ph.D. 1700 SW 6th Ave. Boca Raton, FL 33486 Dr. Meyer is a professor and former Chairman of the Department of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the College of Pharmacy, University of Tennessee Health Science Center. Dr. Meyer has conducted research in the areas of bioavailability, pharmacokinetics and assay methodology. It is anticipated that Dr. Meyer will testify about his research and, based upon his review of Mylan's testing, will opine that Mylan's product is bioequivalent, and safe and effective when used in accordance with its labeling. A report and CV from Dr. Meyer will be provided once Plaintiffs produce expert reports, if permitted by the Court.

3)

Joel Philip Freiman, M.D., M.P.H. 27 Mistflower Place The Woodlands, Texas 77381 Dr. Freiman has extensive experience with the FDA in the areas of epidemiology and biostatistics. Dr. Freiman is an expert in the area of epidemiology. He will respond to any criticism of the Mylan product offered by Plaintiffs. Dr. Freiman is familiar with the testing conducted to establish the bioequivalency of Mylan's product and its is expected that he will opine that no reliable scientific evidence exists to question the bioequivalency of this product. A report and CV from Dr. Freiman will be provided once Plaintiffs produce expert reports, if permitted by the Court.

4)

Mr. John O'Donnell Chief Scientific Officer Mylan Laboratories Inc. 1500 Corporate Drive Suite 400 Canonsburg, PA 15317 Mr. John O'Donnell is employed with Mylan Laboratories Inc. as the Chief Scientific Officer. Mr. O'Donnell is generally familiar with the extended Phenytoin sodium product at issue, and it is expected that Mr. O'Donnell will be in a position to testify concerning the approval, formulation and manufacturing of this product. Mr. O'Donnell will testify that the extended

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

Document 50

Filed 10/04/2006

Page 4 of 6

Phenytoin sodium product has been tested and proven to be bioequivalent to the Dilantin Kapseals and that the product is safe, effective and therapeutic when used in accordance with the product labeling. His testimony will be based upon his review and familiarity with Mylan's product testing and his knowledge of the product, its formulation and manufacture. A report from Mr. O'Donnell will be provided once Plaintiffs produce expert reports, if permitted by the Court. 5) Emanuel Rubin, M.D. 1505 Monk Road Gladwyne, PA 19035 Dr. Rubin is a Board Certified Pathologist and Chairman Emeritus of the Department of Pathology, Anatomy and Cell Biology at Jefferson Medical College, Philadelphia. Dr. Rubin may be called to offer an opinion on the medical records of the decedent and offer causation testimony. His opinion will be based upon a review of the medical records, autopsy report and autopsy slides. A report and CV from Dr. Rubin will be provided once Plaintiffs produce expert reports, if permitted by the Court. 6) Rodney A. Radtke, M.D. Duke University School of Medicine Box 3678 Durham, NC 27710 Dr. Radtke is a Professor of Medicine at Duke University Medical Center and is Board Certified by the American Board of Clinical Neurophysiology and the American Board of Sleep Medicine. His clinical interests include epilepsy (medical and surgical treatment), sleep disorders and, EEG. It is anticipated that Dr. Radtke will offer testimony concerning the disease of epilepsy, the use of AED's in the management of patients of epilepsy and seizure disorders and the importance of compliance with medical treatment. A report and CV from Dr. Radtke will be provided once Plaintiffs produce expert reports, if permitted by the Court. 7) Patricia L. Pacey, Ph.D. Pacey Economics Group 6630 Gunpark Drive, Suite 200 Boulder, CO 80301 Dr. Pacey is founder of Pacey Economics and is an expert in the field of Economics. She has a Ph.D. in Economics and B.A. in Mathematics from the University of Florida. Dr. Pacey will respond to any economic loss claims made by Plaintiffs. Depending on the report and the economic loss claims of Plaintiffs, Dr. Pacey may provide a report and CV in response thereto.

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

Document 50

Filed 10/04/2006

Page 5 of 6

Respectfully submitted, JACKSON KELLY, PLLC

By:

/s/ William David Byassee William David Byassee 1099 18th Street, #2150 Denver, CO 80202 Phone: (303) 390-0003 Fax: (303) 390-0177 [email protected]

PIETRAGALLO, BOSICK & GORDON

By:

/s/ Clem C. Trischler Clem C. Trischler, Esquire The Thirty-Eighth Floor One Oxford Center Pittsburgh, PA 15219 Phone: (412) 263-2000 Fax: (412) 261-5295 [email protected] Attorneys for Defendant, Mylan Pharmaceuticals Inc.

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

Document 50

Filed 10/04/2006

Page 6 of 6

CERTIFICATE OF SERVICE This is to certify that a copy of the Rule 26(a)(2) Disclosure of Mylan Pharmaceuticals Inc. was filed electronically with the Clerk of Court to be served by operation of the Court's electronic filing system upon all attorneys of record on this 4th day of October, 2006 to:

D. Robert Jones, Esq. 219 West Colorado Avenue, #210 Colorado Springs, CO 80903 Counsel for Plaintiffs Kurt J. Bohn, Esq. U.S. Attorney's Office 1225 Seventeeth Street, #700 Denver, CO 80202 Counsel for Defendant United States

/s/ William David Byassee