Medical Device Daily Washington Editor

WASHINGTON – The opening remarks of both Democrats and Republicans at Tuesday's hearing on PMA device pre-emption indicated that the battle lines are drawn along party lines for the most part, suggesting that opponents of the Medical Device Safety Act of 2009 (H.R. 1346) have their work cut out for them if they hope to cut the bill off in committee.

All forecasts aside, however, it seems unlikely that the bill will move onto the House floor before the end of summer. Wire service reports yesterday indicated that House speaker Nancy Pelosi (D-California) has promised she will shepherd a healthcare reform bill through the chamber before the August recess, and the House Energy and Commerce Committee will be part of that effort.

The health subcommittee chairman, Frank Pallone (D-New Jersey) confirmed that H.R. 1346 is not ready for a vote just yet. Pallone told Medical Device Daily that "with healthcare reform coming up, it's hard to predict" when the subcommittee would put the bill to a vote. However, he asserted, "I certainly intend to move it."

Still, there was an indication that at least one of the subcommittee's members from the Democratic Party might be wary of the bill. Rep. Jim Matheson (D-Utah), struck a cautious tone in remarking, "I don't think we should take this lightly. I don't think we should rush legislative action."

Matheson has almost certainly heard from his constituents on the issue, a group that includes device makers Zevex (Salt Lake City), Merit Medical (South Jordan, Utah), and Sonic Innovations (Salt Lake City), but which also includes a pioneering heart research institute, the University of Utah (Salt Lake City). Democrats outnumber Republicans by eight on the subcommittee, so device makers will have to hold the GOP and flip four members of the other party's representation to scotch the bill in the subcommittee.

Pallone said "we've made huge advances in medicine over the past few decades," but he cited pacemakers and implantable cardioverter defibrillators as problem areas, using the example of a 14-year old New Jersey girl whose defibrillator had shocked her numerous times inappropriately and who had to have the device explanted. "The medical costs of this family . . . are now tremendous," he said, adding that "the problem is that she and her parents have no opportunity for legal recourse."

Henry Waxman (D-California), the chairman of the full committee, cited the Supreme Court decision in Riegel v. Medtronic, claiming that "so long as FDA has approved a medical device, patients injured by that device could not seek compensation."

Also appearing was the previous chairman of the Energy and Commerce Committee John Dingell (D-Michigan), who stated that he was a co-sponsor of the original bill that gave pre-emption, the Medical Device Amendments of 1976. He said that the intent of that legislation was "to give FDA the power to regulate devices," and to pre-empt state law in a regulatory capacity. "We intended no other" effect, he said.

Dingell also observed that FDA "has been starved of resources for a number of years" and said "its laboratories are a joke."

Nathan Deal (R-Georgia), the committee's ranking GOP member, said "the U.S. is and should remain at the forefront of medical device innovation, which I believe would be undermined by this bill." He said "eliminating pre-emption will stifle innovation" and noted that "what seems to have been forgotten is that most state common-law claims are still available." He noted that PMA devices account for only 2% of all devices, adding, "it is also important to remember that if the device is improperly manufactured" or if the label carries incorrect information, pre-emption does not apply.

A celebrity also made the hearing in the person of journalist Michael Kinsley, who retired in 2002 because of an advancing case of Parkinson's disease. Kinsley said, "We have two completely independent systems for making the same decision of whether a drug or device should be approved," citing FDA and tort law as the two systems.

Kinsley stated that he has "written quite a bit about the damage done to our economy and to our country by excessive litigation in general and lawsuits over medical care in particular." He also observed, "I do believe that our society is overly risk averse" when it comes to medical products, a tendency he said that is liable to blunt the availability of needed devices. Kinsley's disease is managed in part, he said, by a device that provides deep brain stimulation.

Bill Maisel, MD, director of the Medical Device Safety Institute and a practicing cardiologist at Beth Israel Deaconess Medical Center (both Boston), said he intended to prove in his discussion that FDA approval "does not ensure absolute medical device safety." He noted that St. Jude Medical (St. Paul, Minnesota) continued to distribute pacemakers with known flaws in the battery two years after becoming aware of the problem.

The former chair of the circulatory systems advisory committee for FDA noted that the agency has a huge volume of safety notifications to sort through at any given time, and that "in a majority of cases, FDA relies" on manufacturers to track them. He also cited "an obvious financial incentive" for firms to under-report such events.

Rep. Michael Burgess, MD, (R-Texas), asserted that "pre-emption does not bar state common law torts" if a device maker violated its responsibility in manufacturing and designing a device. He also stated that if FDA is having difficulties "then let's do what's within our power and fix FDA." He described the Medical Device Safety Act as an example of tort law, remarking "this committee is not charged with fixing the legal system."

Pallone, who was involved in helping ReGen Biologics (Franklin Lakes, New Jersey) obtain its controversial 510(k) for the Menaflex, told MDD that a 510(k) hearing is not in the works. "I hate to sound like a broken record, but I don't know when I'm going to find time" for such a hearing, he said.