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

United States District Court, E.D. Pennsylvania

February 5, 2014

IN RE: DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION
v.
AMERICAN HOME PRODUCTS CORPORATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al. No. 2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9203

HARVEY BARTLE, III, District Judge.

Michael Hirschbein ("Mr. Hirschbein" 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 his 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 June, 2011, claimant submitted a completed Green Form to the Trust signed by his attesting physician, Manoj R. Muttreja, M.D. Based on an echocardiogram dated May 19, 2002, Dr. Muttreja attested in Part II of Mr. Hirschbein's Green Form that claimant suffered from mild aortic regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) following the 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 $760, 588.[5]

In the report of claimant's November 3, 2010 echocardiogram, the reviewing cardiologist, Ashok K. Agarwal, M.D., F.A.C.C., noted "aortic stenosis" with an "aortic valve area of 0.9 cm square." Dr. Muttreja, however, attested in claimant's Green Form that Mr. Hirschbein did not suffer from aortic stenosis. Under the Settlement Agreement, the presence of aortic stenosis, which is defined as "[a]ortic stenosis with an aortic valve area < 1.0="" square="" centimeter="" by="" the="" continuity="" equation,="" "="" requires="" the="" payment="" of="" reduced="" matrix="" benefits.="" see="" settlement="" agreement="" §="" iv.b.2.d.="" (2)(c)i)e).="" as="" the="" trust="" does="" not="" contest="" mr.="" hirschbein's="" entitlement="" to="" level="" iii="" benefits,="" the="" only="" issue="" before="" us="" is="" whether="" claimant="" is="" entitled="" to="" payment="" on="" matrix="" a-1="" or="" matrix="">

In October, 2011, the Trust forwarded the claim for review by M. Michele Penkala, M.D., one of its auditing cardiologists. In audit, Dr. Penkala concluded that there was no reasonable medical basis for Dr. Muttreja's finding that claimant did not have aortic stenosis with an aortic valve area of less than 1.0 square centimeter by the Continuity Equation. In support of this conclusion, Dr. Penkala explained:

Based on the [echocardiogram] study dated 11/3/10 the [aortic valve area] was <0.9cm2, (x="" gradient="" 38="" mmhg="" peak="" 52="" mmhg.)="" there="" was="" no="" [aortic="" valve="" area]="" mentioned="" on="" the="" heart="" [catheterization]="" report="" dated="" 1/5/11="" but="" the="" peak="" to="" peak="" gradient="" was="" 40="" mmhg.="" at="" the="" time="" of="" the="" [intraoperative]="" inspection="" the="" [aortic="" valve]="" was="" noted="" to="" be="" "a="" three-leaflet="" valve,="" severely="">

Based on Dr. Penkala's finding, the Trust issued a post-audit determination that Mr. Hirschbein 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.[6] In contest, claimant argued that the auditing cardiologist erred by finding aortic stenosis as defined in the Settlement Agreement. In support, claimant submitted declarations from Dr. Muttreja and Paul W. Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A. In his declaration, Dr. Muttreja stated, in pertinent part, that:

3. In my opinion, even the 11/03/10 echocardiogram did not show an aortic valve area (AVA) less than 1.0 cm2, and there is a reasonable medical basis for this finding.
4. On the 11/03/10 echocardiogram, there was only one loop (#55) that showed any gradients using continuous wave doppler recordings. There were only three (3) full signals (beats) and a½ signal recorded on this loop. The overall quality of the signal recording was poor. In my opinion, one could not accurately trace the gradients given the quality and faintness of these signals.
5. On the 11/03/10 echocardiogram, the technician traced the first gradient from the first signal on loop #55. This gradient grossly appeared to be the highest gradient, and it was likely over-traced by the technician. As noted by Dr. Penkala, the peak gradient was 52 mmHG and the mean gradient was 38 mmHg.
6. In choosing a gradient for the Continuity Equation, the cardiologist should review multiple signals or beats, and he/she should choose the signal that is very similar or representative of other signals found throughout the study. By reviewing multiple signals, the cardiologist will avoid the use of an aberrant gradient, such as one that may result from a premature ventricular contraction or a premature atrial contraction that occurred before the recorded signal.
7. By using gradients only from the beats that occur regularly, the cardiologist will avoid falsely elevated gradients which will result in erroneous reports of smaller AVAs.
8. In this case, Dr. Penkala used what appeared to be the highest gradient from the first signal, without regard to whether or not the preceding beat ...

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