Medical Device Daily Washington Editor
The Supreme Court case of Riegel v. Medtronic ruffled a lot of feathers on Capitol Hill, so much so that the rallying cry is that Riegel gives device makers blanket immunity for products despite the fact that the case turned on a device for which there was no evidence of device malfunction.
All the same, Rep. Frank Pallone (D-New Jersey), chairman of the House Energy and Commerce Committee's health subcommittee almost immediately penned a bill to overturn federal pre-emption (Medical Device Daily, April 3, 2008), and that bill, the Medical Device Safety Act of 2008, has now been formally introduced to the subcommittee.
"This bill reverses an unfortunate Supreme Court decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product," Pallone said in a statement.
The tight legislative calendar suggests there is little chance the 110th Congress will act on the proposal, however.
Senate Democrats are said to be at work on a companion bill. In a June 27 news release, Melissa Wagoner, a spokeswoman for Ted Kennedy (D-Massachusetts) said the Senate version "will be about protecting patients from dangerous medical products," alleging that pre-emption gives companies "blanket immunity."
Pat Leahy, chairman of the Senate Judiciary Committee, said in the statement that liability law "should not be left to the discretion of bureaucrats or the political appointees in the executive branch," adding that he "look[s] forward to the Senate's consideration of legislation to protect consumers and patients in the future."
Proponents of the bill have only until the end of July as a realistic timeline for passage, given that the August recess will be followed by the biennial electoral scramble. Furthermore, a comprehensive pre-emption strategy might suggest that opponents of pre-emption await the outcome of the case of Wyeth v. Levine, a pharmaceutical pre-emption case that the Supreme Court will not hear until at least October.
Mark Leahy, executive director of the Medical Device Manufacturers Association (Washington), told Medical Device Daily "this is an issue we will have to deal with this year and if action isn't taken in this Congress, it may be an issue that has to be addressed again in the 111th Congress." Leahy also said that should such a bill pass, the regulatory landscape will change radically.
"If you are a company that abides by all the rules and regulations, and somehow a state court says that's not enough, you may as well have each state start its own FDA," Leahy said, which "would be hugely detrimental, especially to small companies."
Leahy dismissed talk of blanket immunity, noting for example "if a company withheld information about a product [in its regulatory filings], pre-emption would not attach." Riegel also did not address pre-emption in the context of a device with known design or manufacturing flaws.
Still, Leahy said manufacturers should take nothing for granted. "We understand there's an interest [on the part of Congress] to do something, and our job is to go out there and educate legislators" about the impact.
Brett Loper, senior VP for government affairs at the Advanced Medical Technology Association (Washington), told MDD that any such bill has to clamber past other congressional priorities to get out of the House. "With only a few weeks left, you're looking at a Medicare bill," Loper said, adding that the recent draft of healthcare information technology legislation, H.R. 6357, is another item on Congress's plate.
Unfortunately, Loper was speaking from a cell phone and the signal was lost before he could address further questions.
Senate fails on Medicare funding vote
The House of Representatives passed a bill for Medicare funding last week by a 355-59 landslide (MDD, June 27), but the companion bill came up two votes short Friday in the Senate, leaving Congress with a very short deadline.
Failing congressional action, doctors face a cut of 10.6% for fees under Part B, but the rhetoric surrounding the vote shows that some Republicans are of the opinion that they were shut out of the process of writing the bill.
Mitch McConnell (R-Kentucky) said the GOP "offered to negotiate" and "to extend current law," apparently to no avail. Dick Durbin (D-Illinois) went on record as saying: "Who supports this bill? Doctors, consumer groups, pharmacists, hospitals. Who opposes this bill? The health insurance industry and the White House." The reference to the White House addresses a veto threat based on the bill's cuts to Medicare Advantage plans to finance fees for doctors under Part B.
The vote came to 58-40, with the absences of presidential candidate John McCain (R-Arizona), and Ted Kennedy (D-Massachusetts), who is still recovering from surgery to remove a brain tumor.
Senate letter says keep DME bids
Competitive bidding for durable medical equipment may not be dead despite opposition in the House, if a June 24 letter from a bipartisan group of senators is any indication. The letter urges the body's majority and minority leaders to allow the competitive bidding program for durable medical equipment to go forward per the schedule set by the Centers for Medicare & Medicaid Services.
GOP support for the program comes as no surprise, but the two Republicans, Tom Coburn (Oklahoma) and Larry Craig (Idaho), found unlikely-seeming bedfellows in Democrats John Rockefeller (West Virginia), John Kerry (Massachusetts) and Dianne Feinstein (California) in support of competitive bidding.
The letter, which surfaced last Friday, states that "while we understand that there have been some problems with implementation, we believe these can be addressed without legislatively delaying both rounds" of the bidding program. The letter notes that "competitive bidding has long enjoyed significant bipartisan support" as far back as the Clinton administration and that the language behind the idea "was based on bipartisan legislation."
The signers urged the recipients of the letter, Sen. Harry Reid (D-Nevada) and Kentucky's McConnell, "to work with us to develop meaningful solutions to the small number of creditable problems" so that both the first and second rounds of bidding can move forward as planned.