JURIST - Paper Chase: Third Circuit upholds denial of diet-drug settlement claim

[JURIST] The US Court of Appeals for the Third Circuit [official website; JURIST news archive] on Thursday ruled [opinion, PDF] that a claimant had produced insufficient medical evidence to recover from a settlement fund established to compensate those harmed by the weight-loss medication known as fen-phen [FDA backgrounder]. The Philadelphia-based court affirmed a decision by the US District Court for the Eastern District of Pennsylvania [official website] denying Gay Patterson's claim against the AHP Settlement Trust [trust website] as lacking a reasonable medical basis. Patterson alleges she suffers from moderate mitral regurgitation [Mayo Clinic backgrounder], or a leaky heart valve - a condition that would qualify her for compensation from the trust. She argued that the district court had erred by failing to accept a single frame of an echocardiogram as sufficient evidence of her condition and by relying instead on an auditing cardiologist's visual assessment of an echocardiogram. Chief Circuit Judge Anthony J. Scirica [official profile] wrote for the three-member panel:

We cannot agree with Patterson's argument that, in a borderline case such as this, the measurement of a single frame in an echocardiogram, without evidence showing that the
depicted jet is a true regurgitant jet, i.e., representative of the claimant’s actual level of mitral regurgitation, constitutes a reasonable medical basis for recovering Matrix compensation. To hold otherwise would permit claimants whose echocardiograms show an aberrant jet in a single frame to recover payment from the Trust.

Further, the court found that a physician's "eyeball" assessment is proper when an echocardiogram clearly indicates that the claimant's level of valve leakage is consistent with that of the general population.

The settlement fund resulted from class-action litigation [case backgrounder] against the company now known as Wyeth Pharmaceuticals [corporate website], which pulled its diet drugs Pondimin (fenfluramine) and Redux (dexfenflura) off the market [FDA press release] in 1997. Earlier that year, a Mayo Clinic study [text] linked fen-phen, a combination of the Wyeth drugs with the medication phentermine, to a rare heart-valve condition. The Judicial Panel on Multidistrict Litigation later transferred all diet-drug cases in federal court to Pennsylvania's Eastern District. The court approved [order text] a settle agreement [materials] in 2000, leading to the establishment of the trust.

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