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Justinian Lane

Wyeth loses; FDA preemption is not the law of the land.

Hooray for Civil Justice!  (And Clarence Thomas.)

March 4 (Bloomberg) -- The U.S. Supreme Court ruled that patents can sue drugmakers for failing to provide adequate safety warnings, upholding a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.

The justices, voting 6-3, said that pharmaceutical companies aren’t shielded from suit by the Food and Drug Administration’s approval of a treatment and its packaging information.

“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” Justice John Paul Stevens wrote for the court. 

Source: Bloomberg.com: Worldwide

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Posted at 12:15 PM, Mar 04, 2009 in Civil Justice | Federal Preemption | News | Product Liability | Supreme Court Rulings
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Comments

Rent Seeking Theory of Appellate Decisions trumps all ideology and political affiliation. This decision was predicted at the time of cert.

Posted by: Supremacy Claus | March 4, 2009 1:31 PM

Gosh, the dissent was a tough read. I give credit to Thomas for sticking to his states rights guns, while I find the dissenters to be hypocritical and don't terribly care to hear them argue in favor of states rights in the future.

Posted by: slulawstudent | March 4, 2009 6:55 PM

This case highlights an important issue. Pherergan has been around for used and is heavily used. It is also generically produced. The lawsuit started because of an improperly performed injection. So, why was the nurse who gave the medication not sued? Instead, the attorneys went after the deepest pockets, that being the drug company. Also interesting is that the incidence of this complication from phenergan is less than the incidence of getting struck by lightning. So, does that mean that the drug company should have on its label a warning that you could be stuck by lightning?

Posted by: throckmorton | March 4, 2009 9:48 PM

Oh, I forgot. Here are some of the facts. In the case in question, the medication(actually twice the recommended dosage) was injected in an atery instead of a vein. The medicaion already had a warning regarding fast push causing gangreen rarely if it were ingected into a vein. Inter arterial injections by themselves are a contradiction and are negligent. So, now we have a drug company sued for negligence on the part of a PA who gave the drug. This is what we call justice.

Posted by: throckmorton | March 4, 2009 9:58 PM

This is truly a victory for Diana Levine and consumers and patients everywhere!

Posted by: Kia | March 5, 2009 12:42 AM

This is truly a victory for land pirates.

Posted by: Supremacy Claus | March 5, 2009 9:14 AM