Friday, April 17, 2009

Device Industry: Stop Bill to Overturn Riegel v Medtronic

Device Industry Says Anti-Preemption Bill Would Hurt Innovation
Apr 16, 2009 Inside Health Policy

As the debate over FDA preemption for medical devices shifts from the courts to Congress, the device industry is arguing that revoking preemption would undermine innovation and have a disproportionate effect on small businesses. Manufacturers are also casting the U.S. Supreme Court's pro-preemption decision on devices as an affirmation of long-standing policy that they say Congress should leave alone.

The Advanced Medical Technology Association is hoping to defeat a bill that would overturn the Supreme Court's 8-1 decision in Riegel v. Medtronic, in which the court held that federal law blocks state tort suits involving devices with premarket approval from FDA. AdvaMed officials said this week that lobbying on the bill has fallen along the traditional battle lines for tort issues -- a framework that would appear to work in the Riegel bill's favor but has historically failed to produce results even when one party controls the House, the Senate and the presidency.

AdvaMed President and CEO Stephen Ubl told reporters that members of the conservative Blue Dog and New Democrat coalitions have been receptive to AdvaMed's concerns. Only 14 members from either group have cosponsored the bill to overturn Riegel. And with the number of other issues, including health care reform, already facing the House Energy and Commerce Committee and Senate health committee, AdvaMed government affairs director Brett Loper said, it's ?not outside the realm of possibility? that the legislation won't get off the ground. It didn't last year.

The AdvaMed officials discussed the bill during a meeting with reporters Wednesday (April 15). The American Association for Justice, one of the bill's leading supporters, declined to discuss its legislative strategy or identify the members or coalitions it has targeted.

Ubl said passage of the Riegel bill would be a major setback for innovation. Venture capital is already difficult to find, he said, and the threat of expensive litigation would only make the situation worse. And because the Riegel decision only applies to products with premarket approval, overturning it could open up litigation involving the most innovative types of devices, he said. Most products go through the less rigorous 510(k) clearance process, and those devices are still subject to tort suits under a previous Supreme Court decision.

?This flawed legislation contemplates a regulatory scheme that would undermine the safety and effectiveness determinations of the FDA with respect to complex medical devices -- for reasons that may or may not be medically and scientifically sound,? AdvaMed and 17 other industry groups stated in a March 31 letter to both parties' House and Senate leadership.

Officials said the adverse effects of the Riegel bill would fall largely on small businesses -- an argument that might not have made much difference to the Supreme Court justices but could be much more salient with members of Congress. Industry has also sought to downplay the level of protection afforded by Riegel. Ubl said the case's impact has been exaggerated through ?so many myths being propagated by the other side.?

AdvaMed chief counsel Christopher White said the Riegel decision was not ?a sea change in the law,? an argument the industry has made before. Although Riegel was only decided last year, AdvaMed says overturning it would effectively reverse 30 years of regulatory and legal precedent. Robert Weiner, a partner at Arnold & Porter, said the trend picked up after 1996, when the Supreme Court issued its 510(k) ruling. That decision hinged on the differences between the PMA and 510(k) processes, and Weiner said it hinted at support for preemption in the former context even though it didn't address the issue directly.

The Supreme Court only agreed to hear Riegel because of a division among lower courts, but White said it was a ?minimal split.? Only three courts -- two state Supreme Courts and the 11th U.S. Circuit Court of Appeals -- came down against preemption, he said.

The plaintiffs' bar disputes AdvaMed's claim of a long pro-preemption history. Sue Steinman, policy director at the American Association for Justice, was unfamiliar with the extent of circuit-court divisions but said the Supreme Court read into medical device law a restriction that Congress never intended to impose. The law prohibits state ?requirements? that go above and beyond FDA regulations, and the court said in Riegel that damages in tort suits count as a ?requirement.?

Lawmakers who helped write the statute in question filed a brief in Riegel stating that they only intended to preempt state statutes, not product liability actions. Justice Antonin Scalia, who wrote the majority opinion, was dismissive of that brief in a speech about the case (see related story, March 31, 2008). Steinman, however, said the stated intent of lawmakers who wrote the bill ought to carry more weight with colleagues deciding whether to accept the Supreme Court's interpretation.

Steinman said AdvaMed is overstating the effects of preemption on innovation. PMA devices on the market today were developed before Riegel and therefore before the issue was fully resolved. She also said the Riegel decision gives medical devices a stronger legal shield than almost any other industry.

?Why are they so special?? she said.

The AdvaMed officials, however, emphasized during the media briefing that only about 2 percent of all devices are PMA rather than 510(k) products. They also noted that manufacturers can still be sued over PMA devices if the products are manufactured improperly. State courts can also continue to hear parallel claims, or suits in which the state law mirrors a federal regulation. AdvaMed has made the same points about the scope of the Riegel decision in its meetings on Capitol Hill. -- Sam Baker

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