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

United States District Court, E.D. Pennsylvania

June 8, 2018

IN RE DIET DRUGS (PHENTERMINE/ FENFLURAMINE/ DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al.
v.
AMERICAN HOME PRODUCTS CORPORATION 2:16 MD 1203

          MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9500

          Bartle, J.

         Miguel A. Larrieu ("Mr. Larrieu" 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 his 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, the claimant's attorney must complete Part III if the claimant is represented.

         In June 2015, Mr. Larrieu submitted a completed Green Form to the Trust signed by his attesting physician, Marta C. Sayers, M.D., F.A.C.C. Based on an echocardiogram dated March 5, 2015, [3] Dr. Sayers attested in Part II of Mr. Larrieu's Green Form that claimant suffered from severe mitral 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-l, Level III benefits in the amount of $823, 285.[5]

         Dr. Sayers also attested that Mr. Larrieu did not suffer from mitral annular calcification. Significantly, the Settlement Agreement requires the reduced payment of Matrix Benefits for a claim based on damage to the mitral valve when mitral annular calcification is present. See Id. § IV.B.2.d. (2)(c)ii)d).

         The Trust does not contest claimant's entitlement to Level III benefits. Thus the only issue before us is whether claimant is entitled to payment on Matrix A-l or Matrix B-l.

         In October 2015, the Trust forwarded the claim to M. Michele Penkala, M.D., one of its auditing cardiologists, for review. In audit, Dr. Penkala concluded that there was no reasonable medical basis for finding that claimant did not have mitral annular calcification. In particular, Dr. Penkala stated, "From my review of all the studies (12/9/2002, 4/14/12 and 3/5/15) I did think that significant [mitral annular calcification] was present. In addition, the surgeon noted in his [operative] report: * evidence that the [mitral valve] had severe calcification of the posterior leaflet, as well as the annulus.'[6]

         Based on Dr. Penkala's findings, the Trust issued a post-audit determination that Mr. Larrieu was entitled only to Matrix B-l, Level III benefits. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), Mr. Larrieu contested this adverse determination.[7] He argued that there was a reasonable basis for finding that he did not have mitral annular calcification on the December 9, 2002 and March 5, 2015 echocardiograms. In support, Mr. Larrieu submitted a letter from Dr. Sayers that stated that "there is no evidence of mitral annual calcification" and that "[n]o [mitral] annular calcification was mentioned on the [echocardiogram] from 2 015 also indicating there would be no [mitral] annular calcification on the [echocardiogram] done in 2002." He also submitted a letter from Kaye M. Bass, B.S., R.D.C.S., R.V.T., which did not address the issue of mitral annular calcification. He noted that two of his echocardiograms have been reviewed by auditing cardiologists who did not find the presence of any mitral annular calcification. Finally, Mr. Larrieu asserted that any mitral annular calcification, if present, was either due to his advanced age or was a relatively minute or insignificant quantity.

         Although not required to do so, the Trust forwarded the claim to the auditing cardiologist for a second review. Dr. Penkala submitted a declaration in which she again concluded that there was no reasonable medical basis for finding that Mr. Larrieu did not have mitral annular calcification. Specifically, Dr. Penkala stated:

14. As I noted at audit, the [echocardiogram] study dated 12/9/02 is a very technically difficult study which had limited images and limited number of views.
15. The 12/9/02 study was apparently performed as a part of a diet drug valve assessment rather than one performed based upon clinical necessity.
16. I agree that no clear [mitral annular calcification] is visible in the parasternal long or short axis views of the 12/9/02 study. However, in the apical 4 chamber and apical 2 chamber view there is a strong suggestion of [mitral annular calcification] especially on the part of the tape, approximately from 11:24:34-11:24:42. It should be noted that the timer is difficult to see clearly. The suggestion of calcification in the annulus is most prominent in the intervalvular area between the mitral and the aortic valves.
17. I also reviewed again the study dated 4/14/12. On this study, the presence of [mitral annular calcification] was most evident in loops 1, 9, 2 5 and 26. Again, the calcification is most notable in the intervalvular area between the mitral and aortic valves.
18. Further, I reviewed again the Echocardiogram of Attestation identified in the Green Form, the [transesophageal echocardiogram] dated 3/5/15. On review of this study, [mitral annular calcification] is seen in images (runs) 12, 15, 16 and 41. Although the report of this study is silent as to the presence or absence of mitral ...

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