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

United States District Court, Third Circuit

June 26, 2013



HARVEY BARTLE, III, District Judge.

Janice M. Chaffins ("Ms. Chaffins" 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"). 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").[2]

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 December, 2003, claimant submitted a completed Green Form to the Trust signed by her attesting physician, David Bayne, M.D. Based on an echocardiogram dated March 11, 2002, Dr. Bayne attested in Part II of claimant's Green Form that Ms. Chaffins suffered from moderate mitral regurgitation and a reduced ejection fraction in the range of 50% to 60%. Based on such findings claimant would be entitled to Matrix A-1, Level II benefits in the amount of $500, 195.[3]

In the report of claimant's echocardiogram, the reviewing cardiologist, Karl C. Stajduhar, M.D., stated that Ms. Chaffins had" [m]oderate mitral regurgitation." Dr. Stajduhar, 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 Atrial Area ("LAA"). See Settlement Agreement Ā§ I.22.

In September, 2005, the Trust forwarded the claim for review by Irmina Gradus-Pizlo, M.D., F.A.C.C., one of its auditing cardiologists. In audit, Dr. Gradus-Pizlo concluded that there was no reasonable medical basis for the attesting physician's finding that claimant had moderate mitral regurgitation because her echocardiogram demonstrated only mild mitral regurgitation. In support of this conclusion, Dr. Gradus-Pizlo explained, "No color scale on the digital images[.] One view in the long axis view is suggestive of moderate [mitral regurgitation] but the jet lasts only for two frames and clearly is not persistent through systole."

Based on the auditing cardiologist's findings, the Trust issued a post-audit determination denying the claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.[4] In contest, claimant submitted a letter from Stuart W. Zarich, M.D., F.A.C.C., F.A.S.E., F.A.H.A., wherein he agreed with the attesting physician that Ms. Chaffins had moderate mitral regurgitation. In his letter, Dr. Zarich stated:

... [T]here is moderate mitral regurgitation in the apical views, although the degree of mitral regurgitation is difficult to access in other views. However, there are several indirect echocardiographic signs that support the diagnosis of moderate mitral regurgitation. First of all, as agreed on by the auditing cardiologist[, ] left ventricular function is hyperdynamic which is one of the hallmarks of mitral regurgitation. Second, the left atrial size is well out of portion for any abnormalities in left ventricular diastolic function, which is typically seen in patients with mitral regurgitation. As there is no left ventricular hypertrophy one would not expect such an enlarged left atrium without regurgitation. Finally, there is mild to moderate pulmonary hypertension which is also quite consistent with moderate mitral insufficiency. I disagree wholeheartedly with... the criticism of the reviewer that the mitral regurgitation lasts for only two frames and is not persistent through out systole. There are clearly technical difficulties so the mitral regurgitation is not seen on all frames, however, it does persist through systole (as would be expected for all degrees of mitral insufficiency[)].

The Trust then issued a final post-audit determination, again denying the claim. Claimant disputed this final determination and requested that the claim proceed to the show cause process established in the Settlement Agreement. See Settlement AgreementĀ§ VI.E.7.; PTO No. 2807, Audit Rule 18(c). The Trust then applied to the court for issuance of an Order to show cause why the claim should be paid. On March 3, 2010, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 8408 (Mar. 3, 2010).

Once the matter was referred to the Special Master, the Trust submitted its statement of the case and supporting documentation. Claimant then served a response upon the Special Master. The Trust submitted a reply on November 17, 2010. Under the Audit Rules, it is within the Special Master's discretion to appoint a Technical Advisor[5] to review claims after the Trust and claimant have had the opportunity to develop the Show Cause Record. See Audit Rule 30. The Special Master assigned a Technical Advisor, Gary J. Vigilante, M.D., F.A.C.C., to review the documents submitted by the Trust and claimant and to prepare a report for the court. The Show Cause Record and Technical Advisor Report are now before the court for final determination. See id. Rule 35.

The issue presented for resolution of this claim is whether claimant has met her burden of proving that there is a reasonable medical basis for the attesting physician's finding that she had moderate mitral regurgitation. See id. Rule 24. Ultimately, if we determine that there is no reasonable medical basis for the answer in claimant's Green Form that is at issue, we must affirm the Trust's final determination and may grant such other relief as deemed appropriate. See id. Rule 38(a). If, on the other hand, we determine that there is a reasonable medical basis for the answer, we must enter an Order directing the Trust to pay the claim in accordance with the Settlement Agreement. See id. Rule 38(b).

In support of her claim, Ms. Chaffins repeats the arguments she made in contest; namely, that the opinions of Dr. Bayne and Dr. Zarich, as well as the finding of the reviewing cardiologist, Dr. Stajduhar, provide a reasonable medical basis for the finding of moderate mitral regurgitation.[6]

In response, the Trust argues that the opinions of claimant's physicians do not establish a reasonable medical basis for her claim simply because she "collect[ed] more opinions." The Trust also notes that claimant did not identify any specific errors in the conclusion of the auditing cardiologist. In addition, the Trust argues that neither claimant nor her experts identified a "holosytolic jet of mitral regurgitation that appears in consecutive frames and meets the 20% ratio required by the Settlement Agreement." Finally, the Trust contends that Dr. Gradus-Pizlo performed her review of claimant's March 11, 2002 echocardiogram in accordance with the Audit Rules.

The Technical Advisor, Dr. Vigilante, reviewed claimant's echocardiogram and concluded that there was no reasonable medical basis for the attesting physician's finding of moderate mitral ...

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