Medical Device Daily Washington Editor
WASHINGTON – The Medical Device Safety Act of 2008 has morphed into the Medical Device Safety Act of 2009, and the Advanced Medical Technology Association (AdvaMed; Washington) held a session Wednesday to address the legislation, which industry sees as a game-stopper for many would-be investors in new med-tech.
While some observers see passage as a virtual certainty, the association's officials indicated a belief that passage "is not a slam-dunk."
Chris White, AdvaMed's general counsel, reminded attendees that the bill responds to more than just last year's Supreme Court decision in the case of Riegel v. Medtronic (Medical Device Daily, Feb. 21, 2008), which ended in favor the Minneapolis-based device maker.
White noted that the device involved in the suit, the Evergreen catheter, was contraindicated for patients with calcified coronary arteries, which the plaintiff had. The Evergreen in this instance was inflated outside the pressure indicated on the product label. "The court noted in particular FDA's authority" to determine whether a device's efficacy profile was adequate to justify any inherent risk, White said.
"We have a decision that is not a sea change in the law," White remarked, and which is "not a decision that provides blanket immunity" because it does not preclude 510(k) lawsuits in any event or lawsuits dealing with defective PMA devices.
"If a manufacturer makes a device that is inconsistent with FDA approval," he said, the manufacturer is legally liable under any state law.
Steve Ubl, the association's president, said of the pending legislation that "one would think this is simply a matter of giving patients access to courts," given the rhetoric, but noted that such a law "would upend 30 years" of legal precedent and "puts patients and innovation at risk."
Ubl noted that "only about 2% of device approvals are PMAs," and warned that "patients could lose access to the most promising medical technologies" because of blunted investor interest.
He also made the case that such a law would create problems for those most in need of lifesaving devices because "PMA devices are often the last resort" for profoundly ill patients, and investors would find such a law another disincentive, which is then "compounded by the current economic environment."
Ubl also noted that the end of PMA pre-emption could lead to "overwarning of the device label" which would in turn lead to "less clear information" and ambiguity for patients. He stated that the Medical Device Amendments of 1976 "set the stage for world-leading "innovations" and that the end of pre-emption would add uncertainty to the investment argument for innovative devices. "Nothing chases away investment in medical technology more than uncertainty," Ubl said, adding "we could lose a generation of our best ideas."
Rob Weiner, a partner at the firm of Arnold & Porter (Washington), said he was no fan of the Bush administration's handling of things at FDA, but said he attended the briefing in order to "make the progressive case for pre-emption." He said he had also presented on the subject at the liberal think tank, the Center for American Progress (Washington).
Weiner remarked that regulations dealing with new drugs and devices are intended to deal with "a trade-off between type I and type II errors." Type I errors are those which result in a device making it to market that should not be on the market, whereas a type II error results in a device that is not available, but which should be.
The question, Weiner said, is whether FDA or state courts should deal with balancing the relative probabilities of these two outcomes. "Litigation is only about type I errors, so you're going to overcorrect," he said.
Bret Loper, AdvaMed's director of government affairs, said the effect of the Medical Device Safety Act of 2009 on the new device pipeline would be tantamount to "driving your car down the interstate and throwing it in reverse."
Loper said that the current head count finds that the Senate version of the bill has zero support from the GOP and 19 supporters among Democrats. In the House, two Republicans had signed on as of Wednesday and 71 Democrats have indicated support.
However, he also pointed out that neither of the full committees that has jurisdiction in the House or Senate got around to holding hearings on the legislation last year, an observation he said holds true for this year to date. He indicated that the House Energy and Commerce Committee's health subcommittee may do so in the next several weeks.
When asked whether a Senate filibuster is the only backstop against passage, Loper said, "not necessarily.
"We have been out educating members on both sides of the aisle in both chambers," he said, taking the position that the House bill might not get the attention needed to pass, thanks in part to higher priorities in the House Energy and Commerce Committee, such as climate change legislation and healthcare reform.
Ubl remarked that in conversations with freshmen Democrats and their "Blue Dog" colleagues, "we've found they're asking a lot of questions and are very concerned." As for the physician specialty societies, Ubl said, "I've heard from a number of individual specialists who are concerned in a macro sort of way," but he said there appears to be no systemic chatter on the subject from the specialty societies or the American Medical Association (Chicago).
Loper pointed out, however, that doctors have typically been in favor of limiting litigation, so any physician support of the bill "runs counter to their position on an historical basis."
He reiterated: "We haven't given up on the House," and pointed out that a crowded legislative agenda "gives us time and room" to lobby on the issue, and that in order to pass the legislation, "they have to overturn an 8-1 court decision and that's not easily done."