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

United States District Court, Third Circuit

August 21, 2013

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. 9134

HARVEY BARTLE, District Judge.

Donna M. Rivas ("Ms. Rivas" 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 March, 2010, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Paul W. Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A. Based on an echocardiogram dated June 28, 2002, Dr. Dlabal attested in Part II of claimant's Green Form that Ms. Rivas suffered from mild aortic regurgitation and moderate mitral regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) following the use of Pondimin® and/or Redux™.[3] Based on such findings, claimant would be entitled to Matrix A-1, Level III benefits in the amount of $671, 107.[4]

In the report of claimant's echocardiogram, the reviewing cardiologist, George G. Miller, M.D., F.A.C.C., stated that claimant had moderate mitral regurgitation of 28%. Under 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 § I.22.

In August, 2010, the Trust forwarded the claim for review by Alan Bier, M.D., one of its auditing cardiologists. Dr. Bier accepted the attesting physician's representations that claimant had mild aortic regurgitation, moderate mitral regurgitation, and surgery to replace her aortic and mitral valves. Dr. Bier also determined, however, that there was no reasonable medical basis for Dr. Dlabal's representation that Ms. Rivas did not suffer from aortic sclerosis at the time she was first diagnosed as FDA Positive.[5] Pursuant to Court Approved Procedure ("CAP") No. 11, the Consensus Expert Panel[6] subsequently reviewed the claim and determined that it should be re-audited because the "[g]roup does not find [a] [reasonable medical basis] for [the] auditor['s] findings of no [mitral annular calcification] and moderate [mitral regurgitation]."[7] In November, 2010, the Trust informed Ms. Rivas that it had accepted the Consensus Expert Panel's recommendation that her claim be re-audited.

In November, 2010, the Trust forwarded the claim for review by another auditing cardiologist, M. Michele Penkala, M.D. Dr. Penkala concluded that there was a reasonable medical basis for the attesting physician's findings that claimant had mild aortic regurgitation and surgery to replace her aortic and mitral valves. Dr. Penkala also determined, however, that there was no reasonable medical basis for Dr. Dlabal's representation that Ms. Rivas did not aortic sclerosis at the time she was first diagnosed as FDA Positive and that there was no reasonable medical basis for Dr. Dlabal's finding that claimant had moderate mitral regurgitation. Specifically, Dr. Penkala observed:

The claimant appears to have had at most trace/trivial [mitral regurgitation] present prior to the end of the screening period. The putative [mitral regurgitation] jets that were traced clearly demonstrate low velocity brief duration flow limited to early systole consistent with typical "backflow." These jets are seen during the early systolic "red-blue" portion of the cardiac cycle. The [color wave] signal also demonstrates only very minimal early systolic flow.[8]

Based on Dr. Penkala's findings that claimant had mild aortic regurgitation, surgery to replace her aortic valve, and aortic sclerosis at the time she was first diagnosed as FDA Positive, the Trust issued a post-audit determination that Ms. Rivas was entitled only to Matrix B-1, Level III benefits. The Trust also determined that claimant was not eligible to receive benefits for damage to her mitral valve because she did not have an echocardiograrn that demonstrated the presence of at least mild mitral regurgitation between the time of Diet Drug use and the end of the Screening Period. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.[9] In contest, Ms. Rivas disputed Dr. Penkala's determination that claimant's level of mitral regurgitation was less than moderate.[10] Ms. Rivas argued that Dr. Penkala did not properly apply the standards set forth in the Settlement Agreement. She also contended that the Trust improperly submitted her claim to the Consensus Expert Panel because it was not satisfied with Dr. Bier's conclusions. Ms. Rivas also asserted there was a reasonable medical basis for Dr. Dlabal's determination that Ms. Rivas had moderate mitral regurgitation. In support, Ms. Rivas submitted declarations from Michael E. Staab, M.D., F.A.C.C., Leon J. Frazin, M.D., F.A.C.C., and Dr. Dlabal. Dr. Staab stated, in relevant part, as follows:

4. On the basis of my review of this study, I found moderate mitral regurgitation (MR).
5. I re-measured the left atrial area (LAA), and I found that it measured 19.7 cm2.
6. The mitral regurgitant jet area (RJA) was accurately measured at time 12:13:22 and 12:13:49, where the RJAs measured 4.2 cm2 and 3.8 cm2, respectively.
7. Accordingly, the RJA/LAA ratio was in the moderate range (RJA/LAA 21.32%) at time= 12:13:22, and the RJA/LAA ratio was close to the moderate range (RJA/LAA = 19.29%) at time 12:13:49. The average of the two ratios was in the moderate range (RJA/LAA avg. = 20.30%).
8. The jets that I identified as showing moderate and close-to-moderate regurgitation were representative of the level of regurgitation seen throughout the study, and these jets represented true regurgitation at the levels specified.
9. I also reviewed the Attestation of Auditing Cardiologist dated 11/29/10, and I could easily refute all of the opinions which were expressed in Section II of that attestation.
10. Clearly, the regurgitant jets that I found were typical holosystolic jets. They were not low velocity and they were not backflow.

Dr. Frazin observed, in pertinent part, that:

4. On the basis of my review of this study, I found moderate mitral regurgitation (MR), which was best seen in the apical 2-chamber view.
5. The left atrial area (LAA) was measured at 22 cm2, at time 12:16:45.
6. Regurgitant jet areas (RJAs) were accurately measured at four (4) different times, as follows:
RJA = 6.51 cm2 at 12:16:19
RJA = 7.11 cm2 at 12:16:40
RJA = 6.21 cm2 at 12:16:59
RJA = 7.17 cm2 at ...

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