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Merck's grounds for appeal in Cona/McDarby Vioxx case

From the Merck press release:

Merck is examining various bases for appeal, which include:
  • Improper restrictions on Merck's ability to present relevant evidence to the jury, including orders that:
    • prevented Merck regulatory experts from talking about FDA rules and Merck's compliance with FDA regulatory requirements;
    • limited Merck's ability to discuss the FDA's most recent findings;
    • forbade Merck witnesses to state that they personally used VIOXX in the face of false allegations that they believed the medicine was unsafe;
    • stopped witnesses from testifying about scientific studies performed by Merck regarding the cardiovascular safety of VIOXX;
  • Allowing unsubstantiated conclusions that were irrelevant and/or inflammatory to be presented to the jury by plaintiff witnesses.
  • Allowing opinion testimony to be given to the jury by witnesses lacking subject matter expertise.
  • Allowing opinion testimony that was not based on a reliable scientific basis as required by law.

Soundest to me is the argument that the $9 million punitive damages award was unsupported by New Jersey law, which allows punitive damages only where there is clear and convincing evidence that (1) Merck knowingly withheld or misrepresented (2) information required to be submitted to the FDA under the FDA regulations (3) which information was material and relevant to the harm in question. The Shapiro analysis on which plaintiffs rely flunks all three requirements; only the slimmest of evidence (a deposition slip by Edward Skolnick) supports the first prong, and the other two prongs are completely naked. Perhaps Higbee let the claim go to the jury out of an abundance of caution with the intent to overrule the jury only if they came to the wrong conclusion, but I don't see how an honest court allows the punitive damages to stand.

A platonically perfect court would toss the failure to warn and consumer-fraud claims as a matter of law. Merck's warnings were presumptively appropriate under the law because they were FDA-approved. Both plaintiffs' heart attacks occurred over a year after Merck changed the warning label, so any causal argument appears inappropriate.



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.