Medical Device Daily Washington Editor

FDA's pre-emption of state liability law for PMA devices has generated almost as much anxiety and coverage as the 510(k) program, especially in the aftermath of the Supreme Court's decision in Riegel v. Medtronic (Medical Device Daily, Feb. 21, 2008) and legislation has been proposed to remove the exemption of PMA devices from state liability laws.

A recent study funded by the Advanced Medical Technology Association (AdvaMed; Washington) raises an alarm as to the prospects for a consequent further deterioration of investment in med-tech, which already is dropping substantially in the current economic climate.

The authors of the April 28 study, Ernst Berndt, PhD, and Mark Trusheim, both currently working at the Sloan School of Management at the Massachusetts Institute of Technology (Cambridge, Massachusetts), gave an overview of their report yesterday, and painted a grim picture for the device industry should the Medical Device Safety Act of 2009 make its way into law. In his opening remarks on the conference call, Berndt said the law "will reduce and in some cases eliminate patient access," and exert "a very substantial impact on innovation."

A congressional staffer for Rep. Henry Waxman (D-California), chairman of the House Energy and Commerce Committee, said at this year's edition of the FDA/FDLI annual conference that Waxman sees the bill as "a very high priority" for this year's legislative agenda, although the bill has been conspicuously absent from the news of late.

Congress is getting backing for the idea from at least some of the medical community as an editorial in the April 9 edition of the New England Journal of Medicine makes clear. The editorial, penned by a group of three including NEJM"s executive editor, Gregory Curfman, MD, states that pre-emption has a deleterious effect on "the disclosure of risks and thus the safety of the nation's supply of medical devices and drugs" is purportedly called into question.

Berndt went on during the conference call to assert, "if this legislation becomes law, it will profoundly change the environment in which device manufacturers" work to bring new products to market, and may increase the practice of defensive medicine, already seen as a bane in the effort to control healthcare costs.

Trusheim said the impact of the bill would be widespread and that the spectrum of effects would carry "uniformly negative consequences" on inventors, who "will invent less" as a result.

"Many products that are in the pipeline today or which would have been invented" will never get to market under a cessation of pre-emption, Trusheim said, adding that "the impact on patients is likely to vary because of state regulations" and the unpredictability of jury verdicts. This could, in turn, lead to intranational medical tourism, he said. "Patients with the means to travel will move from state to state" to get a device, he stated.

Trusheim said doctors would "increase their already substantial levels of defensive medical practices," including unnecessary tests. "The impact on both patients and medical innovation is not going to be whether it happens, but to what extent," thanks in large part to the cost of either paying directly for lawsuits or for purchasing increasingly expensive liability insurance, he said.

The 29-page report makes the case that the market for product liability insurance is liable to tighten up should Congress pass the bill. The report draws a parallel between liability insurance for device makers and the sharp contraction in catastrophic insurance following Hurricane Andrew's strike on the state of Florida in 1992.

The report draws another parallel, mentioning the effect of lawsuits on the availability of vaccines. According to the report, the number of firms making this class of product fell from 26 to three between 1967 and 2004. Berndt noted specifically that "a number of years ago, GlaxoSmithKline (London) put out a vaccine for Lyme disease and then removed the product entirely" due to plummeting demand, a phenomenon fed by allegations that the vaccine was producing side effects similar to the symptoms of Lyme disease.

Glaxo dropped production of the vaccine LYMErix in 2002 despite the fact that FDA never established a connection between the product and the reported adverse events.

Pre-emption was provided by the Medical Device Amendments of 1967 and initially applied to 510(k) devices as well, but the provision for 510(k) devices fell in a lawsuit that also involved Medtronic (Minneapolis).

In the case of Medtronic v. Lohr, the Supreme Court ruled in a decision dated June 1996 that a lawsuit filed over defective leads in a 510(k) pacemaker was not pre-empted. Voting in part or in whole for the majority decision written by Justice John Paul Stevens were Justices Anthony Kennedy, David Souter, Ruth Ginsburg and Stephen Breyer

Of the five, only Ginsburg voted wholly against Medtronic's argument in the Riegel case. Souter has announced his intent to retire, leaving the Obama administration and congressional Democrats with an opening to fill.

Medical Device Daily asked how many states have both the financial resources to set up the infrastructure and to staff drug and device regulatory bodies, and whether such expertise is liable to exist in sufficient numbers. Trusheim acknowledged that he did not know, but remarked that "in environmental protection, state regulatory authorities account for about 50,000 employees and spend about 50% of what [the U.S. Environmental Protection Agency] spends."

As for whether a specialty court for drug and device liability might tamp down the effects of pre-emption's demise the way the Court of Appeals for the Federal Circuit provides judicial expertise for patents, Berndt said he had "thought about it briefly, but it's such a wide area" that he opted not to include such an analysis in his and Trusheim's paper.

In a May 6 statement, AdvaMed President Stephen Ubl said the report "should serve as an alarm bell to those who are pushing" an end to pre-emption. Ubl decried an environment in which "the safety and efficacy of life-saving medical devices [are decided] state-by-state, court-by-court and jury-by-jury," adding that such a "patchwork of inconsistent and confusing guidance . . . will not protect patients, doctors, or the public health."