Tuesday, April 11, 2006

Merck Misled FDA According to NJ Jury

According to the Wall Street Journal, "Merck was ordered to pay $9 million in punitive damages to a man who had a heart attack while taking Vioxx. The verdict came after a jury in New Jersey concluded that the drug maker willfully and wantonly misled regulators about its troubled painkiller." (See "Vioxx Jury Adds $9 Million To Damages Merck Must Pay." Subscription required.)

"Under a 1995 New Jersey state law aimed at tort reform, plaintiffs generally can't get punitive damages for harm caused by an approved drug unless they can prove the drug maker knowingly withheld material information from the Food and Drug Administration."


Merck has always claimed that it was completely honest with the FDA and released all relevant risks regarding Vioxx to the FDA. The jury's decision obviously disputes that claim.


In a previous trial, according to the WSJ, "the jury voted unanimously at the time that Merck failed to warn doctors about the drug's cardiovascular risks, and that the company committed consumer fraud."


Merck has previously been accused of manipulating data released to physicians. See, for example, "
Merck's Hand in the Cookie Jar", regarding excising data from a peer-reviewed journal article. Also, it was accused of advising sales reps to "dodge" the issue of Vioxx cardiovascular risks when raised by physicians (see "Get a Load of Those Gams!").

Merck, juries and others have claimed, misled consumers, physicians, and the FDA. A perfect trifecta!

Rather than focusing on how many of these trials it is winning or losing, Merck should be more concerned about the damaging evidence or public opinion being raised by these trials. Each trial and jury decision drives another nail into Merck's reputation. The latest jury, for example, puts into question Merck's interaction with the FDA.


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