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

United States District Court, Third Circuit

November 26, 2013

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

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER No. 9168

HARVEY BARTLE, III, District Judge.

Robert J. Johnson ("Mr. Johnson" 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").[2] 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").[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 March, 2008, claimant submitted a completed Green Form to the Trust signed by his attesting physician, Allan J. Stahl, M.D., F.A.C.C., F.A.C.P. Based on an echocardiogram dated April 10, 2002, Dr. Stahl attested in Part II of Mr. Johnson's

Green Form that claimant had moderate mitral regurgitation;[4] surgery to repair or replace the aortic and/or mitral valve(s) following the use of Pondimin® and/or Redux2122;[5] and a stroke due to (a) bacterial endocarditis contracted after use of Pondimin® and/or Redux™, or (b) chronic atrial fibrillation with left atrial enlargement as defined in Green Form Question F.5., or (c) valvular repair and/or replacement surgery that resulted in a permanent condition that meets the criteria for Functional Level IV of the AHA Stroke Outcome Classification System, [6] determined six months or later after the event.[7]

In addition, Dr. Stahl attested that claimant did not suffer from chordae tendineae rupture. Under the Settlement Agreement, the presence of chordae tendineae rupture requires the payment of reduced Matrix Benefits for a claim based on damage to the mitral valve. See Settlement Agreement § IV. B. 2. d. (2) (c) ii) c).

In July, 2008, the Trust forwarded the claim for review by Craig M. Oliner, M.D., one of its auditing cardiologists.[8] In audit, Dr. Oliner concluded that there was a reasonable medical basis for Dr. Stahl's findings that claimant had moderate mitral regurgitation and surgery to replace his mitral valve. Dr. Oliner, however, determined that there was no reasonable medical basis for Dr. Stahl's Green Form representation that claimant did not have chordae tendineae rupture. In support of this conclusion, Dr. Oliner explained, "There is definite flail posterior mitral valve leaflet, which is due to chordae tendinae rupture."

Based on Dr. Oliner's findings, the Trust issued a post-audit determination that Mr. Johnson was entitled only to Matrix B-1, Level III benefits. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.[9] In contest, claimant contended that he was entitled to Level V benefits as a result of his stroke. In support of this argument, Mr. Johnson submitted a number of records, including the reports of several evaluations performed in connection with his application for Social Security Disability benefits and a March 6, 2009 declaration of Dr. Stahl. In his declaration, Dr. Stahl stated:

The stroke that [Mr. Johnson] suffered in July 2007 has left him legally blind in the right eye and [claimant] states [he] "is no longer able to care for himself or be left alone because he cannot be trusted to safely cook without supervision, the stroke also has left him unable to drive and [he] has to rely on others to manage his money and do his shopping". These symptoms score Mr. Johnson on the AHA stroke outcome score of 3 with more than 2 domains impaired, severity of C in 1 or more domains and leaving him with a function level of III. He has been found to, and remains disabled by the Social Security Administration as a direct result from this stroke.

Finally, notwithstanding Dr. Stahl's earlier statement in the Green Form that claimant did not have chordae tendineae rupture, claimant asserted that the presence of chordae tendineae rupture should not reduce his Matrix Benefits because his chordae tendineae rupture was a result of his ingestion of Diet Drugs or was caused by a prior episode of bacterial endocarditis. In support, Mr. Johnson submitted various materials, including a November 4, 2008 letter from Dr. Stahl, and relied again on the March 6, 2009 declaration of Dr. Stahl. In his November 4, 2008 letter, Dr. Stahl stated, in relevant part, that:

.... I have reviewed the two [echocardiograms] in question, and agree that they show posterior movement of the mitral valve into the left atrium. Mr. Johnson contends that although there is a chordal rupture that it is still related to heart damage from the drugs. He states that he had previous febrile illnesses which could have been subclinical episodes of endocarditis. He also contends that the chordal damage itself could have been a result of the drug's effects.
I feel that although it is impossible to know with assurance what was the exact cause of the cord rupture, that I have seen other patients with lesions of healed endocarditis which was never diagnosed or specifically treated. I also feel that although chordal rupture is not classically associated with anorexic drug use, that it is possible that damage from the drug enabled a preexisting condition, and hence played a role.[10]

In his March 6, 2009 declaration, Dr. Stahl stated, in relevant part, the following:

I met with him recently to review his medical history which was unremarkable prior to Pondimin exposure that started late in 1996 with duration of approx[imately] 6 months. He presented me with a treatment summary [sic] including a history and physical and blood work that was performed prior to the weight loss therapy that was performed by Felix N Sabates Jr. ...

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