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

United States District Court, E.D. Pennsylvania

March 25, 2014

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

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9217

HARVEY BARTLE, Judge.

The Estate of Lois Goldblatt ("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").[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 July, 2011, Mr. Goldblatt, the personal representative of the Estate, submitted a completed Green Form to the Trust signed by the attesting physician, Paul W. Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A. Based on an echocardiogram dated November 3, 2002, Dr. Dlabal attested in Part II of the Estate's Green Form that Ms. Goldblatt suffered from moderate mitral regurgitation, had surgery to repair or replace the aortic and/or mitral valve(s) following the use of Pondimin® and/or Redux™, and had ventricular fibrillation or sustained ventricular tachycardia which resulted in hemodynamic compromise. Dr. Dlabal also attested that Ms. Goldblatt died as a result of a condition caused by VHD or valvular repair/replacement surgery.[5] Based on such findings, the Estate would be entitled to Matrix A-1, Level V benefits in the amount of $972, 751.[6]

Dr. Dlabal also attested that Ms. Goldblatt did not suffer from mitral annular calcification. Under the Settlement Agreement, the presence of mitral annular calcification requires the payment of reduced Matrix Benefits. See Settlement Agreement § IV.B.2.d. (2) (c)ii)d). As the Trust does not contest the Estate's entitlement to Level V benefits, the only issue before us is whether the Estate is entitled to payment on Matrix A-1 or Matrix B-1.

In September, 2011, the Trust forwarded the claim for review by Waleed N. Irani, M.D., F.A.C.C., one of its auditing cardiologists. In audit, Dr. Irani concluded that there was no reasonable medical basis for Dr. Dlabal's finding that Ms. Goldblatt did not have mitral annular calcification. In support of this conclusion, Dr. Irani explained, "Mild posterior [mitral annular calcification] on [the November 3, 2003] study. Severe [mitral annular calcification] on 4/2002 study and all subsequent studies."

Based on the auditing cardiologist's finding that Ms. Goldblatt had mitral annular calcification, the Trust issued a post-audit determination that the Estate was entitled only to Matrix B-1, Level V benefits. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), the Estate contested this adverse determination.[7] In contest, the Estate argued that there was a reasonable medical basis for finding that Ms. Goldblatt did not have mitral annular calcification on the April 11, 2002 and November 3, 2002 echocardiograms. In support, the Estate submitted declarations from Leon J. Frazin, M.D., F.A.C.C., and Michael E. Staab, M.D., F.A.C.C., wherein they stated that they reviewed Ms. Goldblatt's April 11, 2002, November 3, 3002, October 4, 2010, and January 12, 2011 echocardiograms and determined that there was no mitral annular calcification present on Ms. Goldblatt's April 11, 2002 and November 3, 2002 echocardiograms.[8] In addition, Dr. Frazin noted that mitral annular calcification was not the cause of Ms. Goldblatt's mitral regurgitation.

The Estate also argued that its claim should not be reduced because the Settlement Agreement required that the presence of a reduction factor such as mitral annular calcification must be diagnosed between the commencement of Diet Drug use and the end of the Screening Period.[9] In support, the Estate submitted a declaration from Manoj R. Muttreja, M.D., who stated, in pertinent part:

3. [Mitral annular calcification] is sometimes a cause of mitral regurgitation.... When the mitral valve annulus becomes thick and rigid due to the presence of [mitral annular calcification], these conditions might interfere with valve closure, thus causing low levels of [mitral regurgitation].
4. However, if [mitral annular calcification] was not present at the time of the patient's diagnosis of moderate [mitral regurgitation], then [mitral annular calcification] could not possibly cause this condition.
5. Therefore, if a patient had moderate [mitral regurgitation], any later finding of [mitral annular calcification] would be an incidental finding, and it would have no bearing on the patient's actual medical or clinical condition.

Although not required to do so, the Trust forwarded the claim to the auditing cardiologist for a second review. Dr. Irani submitted a declaration in which he again concluded that there was no reasonable medical basis for Dr. Dlabal's finding that Ms. Goldblatt did not have mitral annular calcification. Specifically, Dr. Irani stated, in pertinent part:

9. Based on my review, I confirm my finding at audit that there is no reasonable medical basis for the Attesting Physician's finding that Claimant did not have mitral annular calcification. I reviewed the [echocardiograms] dated 4/11/02, 11/3/02, 10/4/10 and 1/12/11. Mitral annular calcification is seen on all of these studies.
10. Mitral annular calcification is present on the 11/3/02 echocardiogram of attestation. This was a much better study than any of the others, with lower gain settings. Mitral annular calcification is evident on this study, ...

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