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Cardiologist Conclusions Insufficient for Phen/Fen Benefits


A class member under the Diet Drug Nationwide Class Action Settlement Agreement with Wyeth sought benefits from the settlement trust. To qualify for benefits from the trust, a claimant had to demonstrate a reasonable medical basis to support the claim. To demonstrate a reasonable basis supporting his claim, the man provided a statement from his cardiologist that, based on echocardiograms dated April 1, 1999, and May 25, 1999, he suffered from moderate mitral regurgitation, an abnormal left atrial dimension, and a reduced ejection fraction in the range of 50% to 60%. 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”). Based on these findings, a claimant would be entitled to benefits in the amount of $518,044.

 

Another cardiologist reviewed the claimant’s cardiologist’s findings. The reviewing cardiologist did not specify a percentage as to the claimant's level of mitral regurgitation in either the April 1, 1999 echocardiogram or the May 25, 1999 echocardiogram. He concluded that Doppler analysis demonstrated moderate mitral regurgitation.

 

The trust sent the claim to an auditing cardiologist. The auditing cardiologist concluded that there was no reasonable medical basis for the claimant’s cardiologist’s finding that the claimant had moderate mitral regurgitation because his May 25, 1999 echocardiogram demonstrated only mild mitral regurgitation. Based on the auditing cardiologist's finding that the claimant did not have moderate mitral regurgitation, the trust issued a post-audit determination denying the claim.

 

Pursuant to the settlement agreement, the claimant contested this adverse determination. The claimant submitted reports prepared by another cardiologist based on the two 1999 echocardiograms and a February 14, 2003 echocardiogram. The cardiologist found that the claimant had moderate mitral insufficiency with an RJA/LAA ratio of 23%.

 

The trust forwarded the claim to the auditing cardiologist for a second review. He affirmed his previous conclusion that there was no reasonable medical basis for claimant’s cardiologist’s finding that he had moderate mitral regurgitation because the claimant only had mild mitral regurgitation. Specifically, the auditing cardiologist detailed exactly how he measured and calculated the regurgitant jet area/left atrial area ratio. Based on these measurements and calculations, the man’s RJA/LAA ratio was 14.5%, which did not meet the definition of moderate or greater mitral regurgitation set forth in the settlement agreement.

 

The trust then issued a final post-audit determination, again denying the claim. The claimant disputed this final determination and requested that the claim proceed to the show cause process established in the settlement agreement. A technical advisor was assigned to review the documents submitted by the trust and claimant and to prepare a report for the court.

 

The technical advisor stated, with respect to each echocardiogram, that an echocardiographer could not reasonably conclude that moderate mitral regurgitation was present on this study even taking into account inter-reader variability. The technical advisor detailed the claimant’s cardiologist’s erroneous measurements in the May 25, 1999 echocardiogram. The technical advisor also determined that the largest representative jet on claimant's April 1, 1999 echocardiogram revealed only mild regurgitation of 9%. Based on these findings, the technical advisor determined that there was no reasonable medical basis for the claimant’s cardiologist’s representation of moderate mitral regurgitation.

 

The United States District Court for the Eastern District of Pennsylvania affirmed the trust's denial of the man's claim for benefits. The court held that the claimant had not met his burden of proving that there was a reasonable medical basis for the attesting physician's finding that he had moderate mitral regurgitation, for the following three reasons.

 

First, the claimant did not adequately refute the specific conclusions of the auditing cardiologist or the technical advisor as to his level of mitral regurgitation. The court held that mere disagreement with the auditing cardiologist or the technical advisor without identifying any specific errors by them is insufficient to meet a claimant's burden of proof. Here, neither the claimant nor his attesting physician identified any particular error with the findings of the auditing cardiologist and the technical advisor.

 

Second, the claimant's reliance on inter-reader variability to establish a reasonable medical basis for the attesting physician's representation that he had moderate mitral regurgitation was misplaced. The reasonable medical basis standard applicable to claims under the Settlement Agreement already encompassed the concept of inter-reader variability. In this instance, the attesting physician's opinion could not be medically reasonable where the claimant did not adequately rebut the conclusions of the auditing cardiologist and the technical advisor that his RJA/LAA ratios were all less than 20%. The court also noted that the technical advisor took into account the concept of inter-reader variability as reflected in his statements, with respect to each echocardiogram, that an echocardiographer could not reasonably conclude that moderate mitral regurgitation was present on this study even taking into account inter-reader variability.

 

Finally, the court rejected the claimant's assertion that the technical advisor did not aid the court and was just another cardiologist's opinion among several. Specifically, the technical advisor detailed the claimant’s cardiologist’s erroneous measurements in the May 25, 1999 echocardiogram. The technical advisor also determined that the largest representative jet on claimant's April 1, 1999 echocardiogram revealed only mild regurgitation of 9%. Based on these findings, the technical advisor determined that there was no reasonable medical basis for the claimant’s cardiologist’s representation of moderate mitral regurgitation.

 

The court affirmed the trust's denial of the claim for benefits.

 

See: In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation, 2013 WL 5567445 (E.D.Pa., October 9, 2013) (not designated for publication).

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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