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

United States District Court, Third Circuit

January 10, 2014

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. 9194

HARVEY BARTLE, III, District Judge.

The Estate of Thomas Harold ("Estate"), a representative claimant 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 the Estate has demonstrated a reasonable medical basis to support its claim for Matrix Compensation Benefits ("Matrix Benefits") and, if so, whether the Estate met its burden of proving that the claim was not based, in whole or in part, on any intentional material misrepresentation of fact.[3]

To seek Matrix Benefits, a representative claimant[4] must first submit a completed Green Form to the Trust. The Green Form consists of three parts. The representative claimant completes Part I of the Green Form. Part II is completed by an attesting physician, who must answer a series of questions concerning the Diet Drug Recipient's medical conditions that correlate to the Matrix criteria set forth in the Settlement Agreement. Finally, if the representative claimant is represented by an attorney, the attorney must complete Part III.

In June, 2002, Mr. Harold submitted a completed Green Form to the Trust signed by his attesting physician, Roger w. Evans, M.D., F.A.C.P., F.A.C.C. Dr. Evans is no stranger to this litigation. According to the Trust, he has signed at least 355 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated August 12, 1998, Dr. Evans attested in Part II of the Green Form that Mr. Harold suffered from severe mitral regurgitation, an abnormal left ventricular end-systolic dimension, an abnormal left atrial dimension, and a reduced ejection fraction of less than 30%.[5] Based on such findings, Mr. Harold would be entitled to Matrix A-1, Level II benefits in the amount of $424, 211.[6]

In the report of Mr. Harold's August 12, 1998 echocardiogram, the reviewing cardiologist, Robert E. Roeder, M.D., F.A.C.C., observed that Mr. Harold had "moderate to severe mitral valve insufficiency." Dr. Roeder, however, did not specify a percentage as to claimant's level of mitral regurgitation. Under the definition set forth in the Settlement Agreement, moderate or greater mitral regurgitation is present where the Regurgitant Jet Area ("RJA") in any apical view is equal to or greater than 20% of the Left Atrium Area ("LAA"). See Settlement Agreement ยง I.22.

In September, 2003, the Trust forwarded the claim for review by Maged M. Rizk, M.D., Ph.D., F.A.C.C., one of its auditing cardiologists. In audit, Dr. Rizk concluded that there was no reasonable medical basis for the attesting physician's finding of severe mitral regurgitation based on Mr. Harold's August 12, 1998 echocardiogram because Mr. Harold only had mild mitral regurgitation. Specifically, Dr. Rizk explained, "[Mitral regurgitation] is not traced but appears only mild. More importantly this mild-moderate [mitral regurgitation] is diagnosed on [echocardiogram] on file in 9/1996 three months prior to earliest drug use and is associated by the severe cardiomyopathy which is also precedent to drug use."

Based on Dr. Rizk's finding that Mr. Harold had mild mitral regurgitation, the Trust issued a post-audit determination denying the claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), Mr. Harold contested this adverse determination.[7] In contest, claimant submitted affidavits from Dr. Evans, G. Whitney Reader, M.D., F.A.C.P., F.A.C.C., Gregory R. Boxberger, M.D., F. A. C. C., and Dan A. Francisco, M.D., F.A.C.C. Each of these physicians opined that claimant's August 12, 1998 echocardiogram was of adequate technical quality and concluded that it was reasonable for the attesting physician to state that Mr. Harold had at least moderate mitral regurgitation because the regurgitation shown was not an artifact, phantom jet, or backflow. Mr. Harold argued, therefore, that there was a reasonable medical basis for his claim because these Board Certified Cardiologists independently agreed that he had at least moderate mitral regurgitation. Mr. Harold further asserted that the auditing cardiologist "apparently did not understand the difference between his personal opinion... and the reasonable medical basis' standard."

Although not required to do so, the Trust forwarded the claim to the auditing cardiologist for a second review. Dr. Rizk submitted a declaration wherein he amended his Report of Auditing Cardiologist Opinions Concerning Green Form Questions at Issue as follows: "I find a reasonable medical basis for the answer given by the Attesting Cardiologist to Green Form Question II.C.3.A that the Claimant does have moderate mitral regurgitation."

Based on Dr. Rizk's amended findings, the Trust issued a post-audit determination awarding Mr. Harold Matrix Benefits. Before the Trust paid Mr. Harold's claim, we imposed a stay on the processing of claims pending implementation of the Seventh Amendment to the Settlement Agreement. See PTO No. 3511 (May 10, 2004). Prior to entry of the stay, the Trust identified a number of Matrix claims that had passed audit but which the Trust alleged contained intentional material misrepresentations of fact. Following the end of the stay, we ordered the Trust to review these claims and issue new post-audit determinations, which claimants could contest. See PTO No. 5625 (Aug. 24, 2005)

On November 22, 2006, prior to the Trust's issuance of a new post-audit determination on Mr. Harold's claim, this court approved Court Approved Procedure ("CAP") No. 13, which provided these claimants with the option either to submit their claims to a binding medical review by a participating physician or to opt out of CAP No. 13. See PTO No. 6707 (Nov. 22, 2006). The Estate elected to opt out of CAP No. 13.[8]

The Trust therefore undertook to determine whether there were any intentional material misrepresentations of fact made in connection with the Estate's claim. As part of this review, the Trust engaged Joseph Kisslo, M.D., to review the integrity of the echocardiogram system used during the performance of echocardiographic studies and the resulting interpretations submitted in support of the Estate's claim. As stated in his March 22, 2007 declaration, Dr. Kisslo determined, in pertinent part, that:

Mr. Harold has cardiomyopathy with mild mitral regurgitation. In Mr. Harold's study, the use of high color gain, high image gain and low frame rate and the selection of a still frame of backflow are the result of choices and conduct engaged in by the sonographer performing this study and at a minimum, acquiesced in by the Attesting Physician. Each of these factors exaggerated the appearance of regurgitation and jet duration. There is no responsible physiologic or hemodynamic construct under which this echocardiogram can be assessed as demonstrating severe or moderate mitral regurgitation. Mr. Harold has only mild mitral regurgitation-not severe mitral regurgitation as claimed by the Attesting Physician, Dr. Evans.[9]

Thus, notwithstanding Dr. Rizk's findings at audit, the Trust rescinded its prior final post-audit determination letter and issued a new post-audit determination denying the Estate's claim based on its conclusion that there was substantial evidence of intentional material misrepresentations of fact in connection with the claim. Pursuant to the Audit Rules, the Estate contested this adverse determination. In contest, the Estate made reference to the affidavits of Dr. Evans, Dr. Reader, Dr. Boxberger, and Dr. Francisco, none of whom the Estate says "noted any problem with either the color gain or frame settings." The Estate also referenced the declaration of Dr. Rizk, who the Estate says "made no finding or mention of there being any problem with the color gain or frame rate setting."

In addition, the Estate submitted affidavits from Dr. Roeder; K. C. O'Neil-Vantuyl, the sonographer who performed Mr. Harold's echocardiogram; Ms. Harold; and the Estate's counsel. In his supplemental ...


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