New Act to Protect Patients Could Cripple Preemption - Pharmaceutical Executive

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New Act to Protect Patients Could Cripple Preemption


PharmExec Direct Marketing Edition

Last week, US Reps. Frank Pallone, Jr. (D-NJ) and Henry Waxman (D-CA) introduced a House bill that could reverse Riegel v. Medtronic, a case that barred citizens from suing medical device companies for faulty equipment if the device in question was approved FDA.

The decision relied on a provisions in the Medical Devices Amendment of 1976, which stated, in part:

Except as provided in subsection (b) of this section [which describes conditions under which the Secretary of Health and Human Services can make exceptions], no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement? (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

The Court held that this language preempted lawsuits on the state level for devices subject to FDA premarketing approval. Pallone and Waxman's legislation, dubbed the Medical Device Safety Act of 2008, basically voids the outcome of the Riegel and gives the power to assess liability back to the state courts.

"This bill reverses an unfortunate Supreme Court decision that denied victims any legal recourse, and gave medical device makers blanket immunity for the life of a product," Pallone said in a release. "Congress should pass this legislation so that we can protect patients from dangerous and defective medical devices."

The Congressman stated that FDA cannot be the final word in the safety of devices, and manufacturers should be responsible for their equipment even after it's been used. For preemption based on statutes, the decision to make a preemption ruling currently lies in Congress's hands. If Congress passes a statute that states that preemption should be law, then the bickering could end, but it's doubtful.

What effect would this pending legislation have on future drug cases—particularly the mammoth Wyeth v. Levine? According to Jones Day lawfirm partner Mark Herrman, not much. "In the drug context, you don't have an express preemption provision, so you're thinking a different way," Herrmann told Pharm Exec on Tuesday.

"There's policy interest—people that believe FDA should be passing judgment on drugs and devices versus people who think that juries should be doing it," Herrmann continues. "You also can't discount that there is economic interest behind that passion."

Now, everyone is watching and waiting for the outcome of Wyeth v. Levine, to see if preemption can win out in the pharma industry. In the case, patient Diana Levine lost her arm after being given Phenergan, an injectable nausea medication manufactured by Wyeth. Her lawyers argued that even though the drug was approved by FDA, Wyeth should have provided stronger safety labeling. The Vermont Supreme Court eventually awarded her $6 million, but Wyeth appealed the case to the US Supreme Court.

The case is slated to be reviewed early next year.

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