Thursday, May 9, 2013

Plaintiff group weighs in on FDA process for metal hip implants

5/7/2013     
By Terry Baynes

(Reuters) - The leading plaintiff trial lawyers association has asked the Food and Drug Administration to prevent the manufacturers of controversial all-metal hip implants from using a proposed change in the device-approval process to shield the companies from liability.

The implants were developed to be more durable than those made from a plastic socket and ceramic or metal ball, but studies have shown that the all-metal versions can shed debris, potentially damaging bone and soft tissue. Several makers have been inundated with lawsuits claiming injuries, and a number of the all-metal implants have been recalled.

In response, the FDA in January issued a proposed rule that would require the manufacturers to go through a more extensive safety review process in order to continue selling the devices or to bring new ones to market.

That would be a change from the current process, where manufacturers obtain approval by showing that their all-metal designs are similar enough to those on the market that they don't have to submit clinical studies.

In a letter submitted to the FDA on April 18, the American Association for Justice, a plaintiff lawyers' industry group, said it supported the agency's switch to the more intensive approval process for metal-on-metal hips.

However, the group expressed concern that when a device is approved through the alternative process, known as "premarket approval," consumers could lose the ability to sue the device maker in court over alleged injuries.

"It would be absolutely unfair ... if these claims all of a sudden were thrown into jeopardy solely because the government determined that the products needed additional safety testing before being marketed to consumers again," wrote Mary Alice McLarty, the president of the American Association for Justice, in the letter to the FDA.

The association said it was worried that manufacturers would be able to use to their advantage a 2008 Supreme Court case, Riegel v. Medtronic, which found that most personal injury claims against a device approved through the rigorous premarket approval process are barred by federal law.

'UNANSWERED QUESTIONS'

The plaintiff lawyers' group cautioned in the letter that a manufacturer could obtain premarket approval for an existing all-metal hip implant, and then use that to shield itself from liability - even for alleged injuries that occurred before the product met the heightened safety test.
The organization urged the FDA to include language in its final rule that would prevent manufacturers from attempting to use premarket approval retroactively to defeat personal injury claims that originated before the process changes.

Peter Goss, a lawyer at Blackwell Burke who represents medical device makers in product liability suits, said manufacturers could argue that if a product already on the market obtains heightened FDA clearance, then it has been proven safe, and past claims should be pre-empted.

"But that's going to be a very difficult argument to make from a legal standpoint, just because of the timing," Goss said.

Erica Jefferson, a spokeswoman for the FDA, declined to comment on the association's request or whether the agency would prevent manufacturers from using the new approval process to thwart past legal claims. She said the agency plans to finalize the proposed order within a year, at which point the manufacturers would have 90 days to submit clinical data showing their safety and effectiveness.
Spokeswomen for Johnson & Johnson unit DePuy and Wright Medical Group, both of which continue to make all-metal hip implants, declined to comment on whether they would undertake the expensive premarket approval process or simply stop selling the products.

Julie Tracy, the spokeswoman for Wright Medical Group, said sales of the all-metal products account for less than 0.5 percent of Wright's annual revenues.

Even if the plaintiffs' group does persuade the FDA to add language preventing manufacturers from using the rule change as a shield to deflect past legal claims, that language may not carry much legal weight, said Jeffrey Shapiro, a lawyer at Hyman Phelps & McNamara who represents medical device companies before the FDA.

"I don't know that the courts would defer to that" in deciding whether past claims are pre-empted, Shapiro said. "There are a lot of unanswered questions here." 

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