Medical Device Daily Washington Editor

The Senate Health, Education, Labor and Pensions (HELP) Committee started the process of reviewing the Medical Device Safety Act of 2009 (S. 540), but little was heard from most of the committee's members, ostensibly due to a series of votes on the Senate floor. Hence, any hope of divining the bill's prospects in the committee was immediately dashed.

One thing was clear from the comments heard during the afternoon hearing; there is little middle ground to be found on the issue, suggesting a party-line vote should the HELP Committee ever get past the healthcare reform effort and vote on S. 540.

Sen. Tom Harkin (D-Iowa), who chaired the hearing, noted that HELP Committee chairman Ted Kennedy (D-Masschusetts) had championed the 1976 amendments that gave rise to pre-emption, but Harkin also made the case that the Supreme Court's decision in Riegel v. Medtronic "means complete immunity" for device makers and that "a negligent corporation cannot be held accountable" as a consequence. He also asserted that FDA's review of PMAs "is simply inadequate to replace the long-standing safety incentives and consumer protections provided by state tort law."

Harkin added that litigation offers a deeper probe into device development data than is often available to FDA. "Through discovery, litigation can help uncover previously unavailable information on adverse effects that might not have been caught during the regulatory process," he said. He noted that in the case of Wyeth v. Levine, the Supreme Court's majority opinion included the observation that state tort suits "provide incentives for drug manufacturers to disclose safety risks promptly," stating that the same should apply to medical devices.

Sen. Orrin Hatch (R-Utah), who is not the committee's ranking GOP member, said healthcare costs are a big issue on Capitol Hill at present and that anything that boosts the costs of medical devices – or prevents effective devices from getting to market – runs counter to the need to constrain healthcare inflation.

"FDA's premarket approval process ... is extremely rigorous," Hatch observed, adding post-market requirements mandate that firms "report any new and relevant clinical information ... that the manufacturer knows or should know" about the device's performance and that "FDA has the authority to revoke approval" or require a recall.

"Given the rigorous and costly nature of FDA's review process," Congress determined in 1976 that it would be best if states did not impose their own regulatory regimes, Hatch stated, adding that the Supreme Court decision in Riegel was "an 8-1 decision" and that some have "painted this as an unexpected decision" when the law prescribed the outcome.

The financial risk associated with device development will go up if pre-emption is overturned, Hatch said, and "inevitably we will see the cost of devices rise in an attempt to offset" the increased risk. "We all want to ensure that those who have been victimized" by faulty devices can obtain compensation, Hatch said, but he argued that the current legal state does not prevent patients who have been harmed by defective devices from suing. "If the manufacturer is at fault, they are not protected under the current law," he asserted.

The first witness to speak, Bill Maisel, MD, director of the Medical Device Safety Institute (Boston), said FDA's approval of a device "does not guarantee its safety" and said the Riegel decision "will lead to less safe medical devices and an increase in patient injuries."

Maisel said, "it is not uncommon for unanswered questions about a device's safety and effectiveness to remain at the time of approval," citing the Sprint Fidelis electrophysiology leads made by Medtronic (Minneapolis). He said that Medtronic was said to have refused to allow FDA to see certain documents related to the matter during the course of an inspection following reports of lead failures.

"Manufacturers often have an inherent financial conflict of interest" in announcing recalls, Maisel observed, adding that because of the Supreme Court decision in Riegel, "a vital consumer safeguard ... has been eliminated." He also described device malfunctions as "modern diseases that will continue to occur" under the current legal regime.

There were several glaring omissions from the event, including the fact that the committee included nobody from FDA on the witness list. For its part, the committee was missing its chairman, Ted Kennedy, due to illness, and the ranking GOP member Mike Enzi (R-Wyoming), but Sen. Al Franken (D-Minnesota) appeared, although he left before speaking on the issue, surely a thorny one for a junior senator whose home state represents manufacturers such as Medtronic and St. Jude Medical (St. Paul, Minnesota).

After the hearing, Brett Loper, director of government affairs at the Advanced Medical Technology Association (Washington), told Medical Device Daily that the bill's prospects in committee can be forecast "by looking at the co-sponsors of the bill," a list that as of May 8 includes 24 members of the Senate, including sponsor Ted Kennedy and Vermont independent Bernie Sanders.

The list of supporters for S. 540 suggests a distinct state-by-state orientation. Both senators from the states of New York, Rhode Island, California, Vermont, Illinois and New Mexico make up half the sponsors of the bill, while states such as Minnesota and Michigan are not represented.

Loper said he could not address the possibility of any defectors from the committee's Democratic Party members, but noted that "we continue to talk to a number of them" about the issue. He also said of the full Senate that the bill "hasn't been a pressing issue for most members of the Senate," and could not forecast what a full Senate vote on the bill might look like.

The House version of the bill, H.R. 1346, has been referred to the House Energy and Commerce Committee's health subcommittee, but as is likely the case with the Senate, the bill is expected to languish during the August congressional recess and will fall behind healthcare reform before moving into the full committee for a vote.

Franken's office had not returned calls for comment by the time Medical Device Daily went to press.