The pharmaceutical industry will be watching the Supreme Court today to see if drugmakers will be given similar protection from lawsuits recently handed to medical-device makers, theAssociated Press reminds us.
The court ruled Wednesday in a case involving Medtronic that FDA regulation of advanced medical devices preempts lawsuits in state courts against manufacturers. But today's case probably won't provide as broad a shield against lawsuits as the Medtronic case, the AP notes, because it won't apply to all pharmaceutical suits. Instead, it focuses on a specific issue: whether state courts can consider allegations that a drugmaker misled the FDA to win approval for its med.
The justices will hear oral arguments today in the dispute, which stems from lawsuits against Warner-Lambert over its Rezulin diabetes drug, which was yanked in 2000 after links to nearly 400 deaths and hundreds of cases of liver failure. Warner-Lambert, of course, is now owned by Pfizer.
A group of 27 Michigan plaintiffs, including relatives of six Rezulin patients who died from liver damage, sued the drugmaker in 2000 for negligence and defects in the design and manufacture of the drug. Michigan law, however, prohibits product-liability suits against meds approved by the FDA. But it allows the suits to proceed if plaintiffs can show that a drugmaker misrepresented or withheld info from the FDA that would have prevented the agency from approving the drug.
The plaintiffs, led by Kimberly Kent, charge that Warner-Lambert misled the FDA about the extent of liver damage among patients in its clinical trials. Kent's relative died from liver damage. Lawyers for the drugmaker argue state courts shouldn't decide such claims, because that would "intrude upon an exclusively federal domain" and "inevitably conflict with FDA's authority" to police fraud against it, the AP writes.
Seven other states, including Texas and New Jersey, have similar laws that may be affected by the court's ruling, the AP notes.
In court papers, the PhRMA trade group wrote that decisions about drug safety should be left to the FDA. Judges and juries are not "in a position to make complex scientific decisions with consequences that could have a significant effect on public health for millions of Americans."
But the American Association for Justice, a group of trial lawyers, said in its filing that the FDA "is underfunded and overburdened" and noted its enforcement actions dropping by 66 percent between 2000 and 2005. As a result, product liability suits are necessary to help ensure that pharmaceuticals are safe and effective, the group argued.
Solicitor General Paul Clement, the Bush administration's lawyer, sided with Warner-Lambert. The administration has supported federal preemption of state laws in several cases before the court this term. A decision is expected by July. The larger preemption involving drugmakers will be heard later this year in a case pitting Wyeth against a Vermont woman, who claims she lost an arm due to the drugmaker's failure to properly warn consumers about the proper administration of an injectable medication. You can read about that here.