Preemption Makes Waves in Two More Cases

It looks like preemption is not going to be the crutch that device manufacturers and pharma companies had originally expected. As noted by Pharmalot, a federal court ruled last week in Purcel v. Advanced Bionics and Astro Seal that a suit involving a pair of faulty hearing implants could continue in Texas, and that preemption could not be used to excuse the case. The medical device companies attempted to apply the Riegel v. Medtronic verdict to another Class III pre-market approval device, but failed.

In Riegel, the device manufacturer triumphed in court on the grounds that it could not be sued at the state level for a product that received FDA approval. In Purcel, the lawsuit was allowed to continue because the judge felt that the argument was based on manufacturing defect claims—not a working product approved by FDA.

"Some people think that the Riegel vs. Medtronic decision would not bar claims based on a manufacturer defect," Jones Day partner Mark Herrmann told Pharm Exec. "If a particular component was supposed to be made with two-inch wire and the company made it with three-inch wire instead, then perhaps the claim would not be preempted."

And that wasn't the only preemption case in the last week. On Monday in Minnesota, Medtronics scored another win for preemption when Judge James Rosenbaumruled that a plaintiff could not sue the over a faulty defribrillator.

"Plaintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe," the judge cited from Riegel. "As the Supreme Court aptly recognized, the premarket approval process is ultimately a cost/benefit analysis in which the potential health benefits are weighed against the potential risks."

So what can pharma glean from these cases?

"Purcel case be compared to a pharma company putting a contaminant into one batch of the product, and someone was hurt as a result of that," Herrmann said. "That's a slightly different exception to run-of-the-mill preemption, where the drug was made according to specifications and then it had a side effect."

Sounds familiar? Parallels could be drawn to the heparin debacle, where a manufactured contaminant somehow landed in an ingredient at a Chinese plant. Herrmann expects preemption to play a part in future heparin litigation, particularly whether the drug was made to proper specifications.

However, the 300-pound gorilla in the room is Wyeth v. Levine, scheduled for early next year. In that case, Wyeth contends that it shouldn't be responsible for bodily harm caused to Diana Levine, who was improperly injected with nausea drug Phenergan. The dosage was injected into her artery leading to gangrene and partial amputation of her arm. Wyeth argues that the drug worked as approved by FDA, relieving the drug manufacturer from wrongdoing.