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In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation

United States District Court, Third Circuit

May 8, 2013

IN RE: DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION MDL No. 1203,
v.
AMERICAN HOME PRODUCTS CORPORATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al.

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9059

HARVEY BARTLE, III, District Judge.

Dianne T. Cofer ("Ms. Cofer" or "claimant"), a class member under the Diet Drug Nationwide Class Action Settlement Agreement ("Settlement Agreement") with Wyeth, [1] seeks benefits from the AHP Settlement Trust ("Trust").[2] Based on the record developed in the show cause process, we must determine whether claimant has demonstrated a reasonable medical basis to support her claim for Matrix Compensation Benefits ("Matrix Benefits").[3]

To seek Matrix Benefits, a claimant must first submit a completed Green Form to the Trust. The Green Form consists of three parts. The claimant or the claimant's representative completes Part I of the Green Form. Part II is completed by the claimant's attesting physician, who must answer a series of questions concerning the claimant's medical condition that correlate to the Matrix criteria set forth in the Settlement Agreement. Finally, claimant's attorney must complete Part III if claimant is represented.

In April, 2005, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Andrew S. Fireman, M.D. Dr. Fireman is no stranger to this litigation. According to the Trust, he has attested to at least 92 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated May 2, 2001, Dr. Fireman attested in Part II of Ms. Cofer's Green Form that she suffered from severe mitral regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) after use of Pondimin§ and/or Redux§[4] Based on such findings, claimant would be entitled to Matrix A-1, Level III benefits in the amount of $748, 344.[5]

Dr. Fireman also attested in claimant's Green Form that Ms. Cofer did not suffer from mitral valve prolapse. Mitral valve prolapse is defined in the Settlement Agreement as:

[A] condition where (a) the echocardiogram video tape or disk includes the parasternal long axis view and (b) that echocardiographic view shows displacement of one or both mitral leaflets >2mm above the atrial-ventricular border during systole, and >Smm leaflet thickening during diastole, as determined by a Board-Certified Cardiologist.

Settlement Agreement § I.39. Under the Settlement Agreement, the presence of mitral valve prolapse requires the payment of reduced Matrix Benefits. Id . § IV.B.2.d. (2) (c)ii)b). As the Trust does not contest Ms. Cofer's entitlement to Level III benefits, the only issue before us is whether claimant is entitled to payment on Matrix A-1 or B-1.

In January, 2006, the Trust forwarded the claim for review by Waleed N. Irani, M.D., one of its auditing cardiologists.[6] In audit, Dr. Irani concluded that there was no reasonable medical basis for the attesting physician's finding that claimant did not have mitral valve prolapse. In support of this conclusion, Dr. Irani stated that the "[echocardiogram] dated 5/2/01 [was] of borderline quality with no obvious [mitral valve] prolapse - cardiac [catherization] dated 5/16/01 with evidence of bileaflet prolapse."

Based on Dr. Irani's finding that claimant had mitral valve prolapse, the Trust issued a post-audit determination that Ms. Cofer was entitled only to Matrix B-1, Level III benefits. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.[7] In contest, claimant argued that the auditing cardiologist's determination of mitral valve prolapse was improper because it was based on the report of the cardiac catheterization rather than a review of an echocardiogram as required by the Settlement Agreement. In addition, Ms. Cofer submitted a Declaration from Manoj R. Muttreja, M.D., who opined, in relevant part, as follows:

2. I reviewed a copy of the above-referenced Claimant's left ventriculography videotape dated May 16, 2001, a copy of the transthoracic echocardiogram (TTE) videotape dated May 2, 2001, and I reviewed a copy of the Claimant's transesophageal echocardiogram (TEE) videotape dated May 16, 2001.
3. I reviewed these two echocardiogram and one left ventriculography videotapes, in detail, for the purpose of finding any evidence of mitral valve prolapse (MVP).
4. On the basis of my review of these two echocardiogram and one left ventriculography videotapes, I found no evidence of MVP.
5. In addition to my review of these three videotapes, I reviewed the cardiac catheterization report dated May 16, 2001, wherein the doctor stated that he found "Prolapse of the anterior and posterior mitral valve leaflets."
6. In my review of the TTE videotape dated May 2, 2001, I had clear parasternal long-axis views of both the anterior and posterior mitral valve leaflets as well as other views of these leaflets. MVP was clearly not present. The cardiac catheterization report, or even the left ventriculography itself, ...

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