Implied Malice Verdict May Hold Drugmakers Liable for Punitive Damages

Recently, a federal judge presiding over a Stevens-Johnson syndrome lawsuit ruled that drug makers may be held liable for punitive damages if evidence can prove that the manufacturer hid information from the FDA when seeking drug approval.

Senior U.S. District Court Judge Jan E. DuBois presided over the case of Wolfe v. McNeil-PPC Inc. and, in a 25-page briefing of his ruling, explained that the makers of Children’s Motrin, McNeil, hid data that linked the medication to Stevens-Johnson syndrome. When seeking approval for the popular pain reliever, the drug giant didn’t show that at least two patients taking the drug had developed the rare skin disease.

Lawyers for the plaintiff presented evidence that showed that McNeil, which is a pharmaceutical division of Johnson & Johnson, hid the information about the two patients developing SJS when they conducted a large study that addressed the safety of selling Children’s Motrin over the counter. While the pharmaceutical company did admit to hearing about the two cases, their study report didn’t mention the cases at all. (McNeil’s lawyers said that the FDA was told about the cases.)

In the end, the judge said that while it “may be true” that the FDA did get the reports, the judge concluded that “a reasonable jury viewing the evidence in the light most favorable to plaintiff could conclude otherwise.” This case will get to go to a jury. That wasn’t all the judge had to say on the matter. Judge DuBois also said that if the jury decides that the company purposely hid information from the FDA, “both to win FDA approval of over-the-counter Children’s Motrin and to avoid the need to warn of SJS or its symptoms — the jury could well find that plaintiff demonstrated, by clear and convincing evidence, the sort of outrageous conduct that would justify the imposition of punitive damages.”

If you or a loved one has suffered from Stevens-Johnson syndrome as a result of taking Children’s Motrin, you may be able to file a Stevens-Johnson syndrome lawsuit. Contact attorney Greg Jones today for a free consultation. I will work hard to help you recover any money that you may entitled to, including punitive damages.

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