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

United States District Court, Third Circuit

June 6, 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. 9086

HARVEY BARTLE, III, District Judge.

Margaret R. Williams ("Ms. Williams" or "claimant"), a class member under the Nationwide Class Action Settlement Agreement ("Settlement Agreement") with Wyeth, Inc.[1] seeks benefits from the AHP Settlement Trust ("Trust").[2] Based on the record developed in the show cause process, we must determine whether claimant has demonstrated a reasonable medical basis to support her claims for Matrix Compensation Benefits ("Matrix Benefits").[3]

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 October, 2002, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Robert N. Notske, M.D., F.A.C.C., F.A.C.P. Based on an echocardiogram dated June 5, 2002, Dr. Notske attested in Part II of claimant's Green Form that Ms. Williams suffered from moderate mitral regurgitation, an abnormal left atrial dimension, and a reduced ejection fraction in the range of 50% to 60%.[4] Based on such findings, claimant would be entitled to Matrix A-1, Level II benefits in the amount of $453, 042.[5]

In the report of claimant's echocardiogram, the reviewing cardiologist, Susan J. Alexander, M.D., F.A.C.C., stated that claimant had "2 mitral regurgitation, " which she measured at 24%. 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 § I.22.

In February, 2004, the Trust forwarded the claim for review by Kevin S. Wei, M.D., one of its auditing cardiologists. In audit, Dr. Wei concluded that there was no reasonable medical basis for Dr. Notske's finding that claimant had moderate mitral regurgitation. Dr. Wei explained, "Multiple measurements of different [mitral] RJAs = 1.9, 2, 1.7 cm2. LAA = 17 cm2. [Mitral] RJA/LAA all <20%." based="" on="" dr.="" wei's="" finding="" that="" claimant="" did="" not="" have="" moderate="" mitral="" regurgitation,="" the="" trust="" issued="" a="" post-audit="" determination="" denying="" this="" claim.="" pursuant="" to="" the="" rules="" for="" the="" audit="" of="" matrix="" compensation="" claims="" ("audit="" rules"),="" claimant="" contested="" this="" adverse="">[6] In contest, Ms. Williams submitted a declaration of Dr. Notske wherein he stated:

The Auditing Cardiologist found "mild regurgitation of <20%, measuring="" different="" locations."="" different="" jet="" areas="" would="" be="" a="" normally="" expected="" finding.="" but="" the="" placement="" of="" the="" cursor="" is="" a="" subjective="" phenomenon,="" and="" is="" part="" of="" the="" reason="" for="" the="" variation="" in="" these="" figures.="" on="" the="" patient's="" tape,="" there="" is="" a="" well-demarcated="" area="" of="" the="" left="" atrium="" and="" the="" mitral="" regurgitation="" jet.="" this="" definitely="" fits="" the="" accepted="" matrix="" criteria="" for="" moderate="" regurgitation.="" the="" auditor's="" measurements="" are="" not="" even="" near="" the="" measurement="" of="" this="" well="" demonstrated="" view.="" therefore,="" i="" believe="" the="" patient's="" degree="" of="" mitral="" regurgitation,="" as="" moderate,="" is="" well="">

The Trust then issued a final post-audit determination, again denying this claim. Claimant disputed this final determination and requested that the claim proceed to the show cause process established in the Settlement Agreement. See Settlement Agreement§ 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 this claim should be paid. On May 20, 2005, we issued an Order to Show Cause and referred the matter to the Special Master for further proceedings. See PTO No. 5239 (May 20, 2005).

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 August 23, 2005.

In support of her claim, Ms. Williams argues that there is a reasonable medical basis for Dr. Notske's representation that she had moderate mitral regurgitation because that finding was corroborated by Dr. Alexander, who performed claimant's echocardiogram as part of the Trust's Screening Program.[7] In addition, Ms. Williams contends that Dr. Notske followed the guidelines of Weyman while the auditing cardiologist "subjectively measured jet areas that were not even close in proximity to a well-demarcated area of left atrium and mitral regurgitation jet."

In response, the Trust argues that Dr. Notske's declaration does nothing more than repeat his Green Form representation that claimant had moderate mitral regurgitation. In addition, the Trust argues that Dr. Wei properly evaluated claimant's level of mitral regurgitation, including providing specific measurements of the RJA/LAA ratio.[8]

In September, 2005, claimant submitted a second completed Green Form to the Trust signed by her attesting physician, Dr. Notske. Based on an echocardiogram dated June 14, 2005, Dr. Notske attested in Part II of claimant's Green Form that Ms. Williams suffered from moderate mitral regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) after use of Pondimin® and/or Redux2122.[9] Based on such findings, claimant would be entitled to Matrix A-1, Level III benefits in the amount of $702, 666.[10]

As the Trust does not contest claimant's entitlement to Level III benefits, the only issue in this second claim is whether claimant is entitled to payment on Matrix A-1 or Matrix B-1. Specifically, the Settlement Agreement requires the payment of reduced Matrix Benefits to a claimant who is diagnosed with mild mitral regurgitation[11] by an echocardiogram, like claimant's June 5, 2002 here, which was performed between the commencement of Diet Drug use and the end of the Screening Period. See Settlement Agreement § IV.B.2.d. (2) (a).

In March, 2008, the Trust forwarded the claim for review by Craig M. Oliner, M.D., one of its auditing cardiologists. Because claimant's June 14, 2005 echocardiogram of attestation was performed after the end of the Screening Period established under the Settlement Agreement, claimant also had to establish her eligibility for Matrix Benefits. See generally Settlement Agreement § IV.B.1.a. In PTO No. 3192 at 3 (Jan. 7, 2004), we stated, "Experiencing left sided valvular heart disease is of no moment unless the claimant also passes muster under§ IV.B.1.a.". Accordingly, Dr. Oliner reviewed claimant's June 5, 2002 echocardiogram, which previously was provided by claimant to the Trust in connection with her claim for Level II Matrix Benefits. Dr. Oliner ...


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