Medical Device Daily Washington Editor

WASHINGTON — The pre-emption question hovers over industries regulated by FDA despite the outcome of the Riegel case (Medical Device Daily, April 3, 2008) and seems unlikely to go away, as yesterday's hearing in the House Oversight and Government Reform Committee makes clear.

The current majority of Democrats in Congress, which some observers think is likely to increase in November, foreshadows a reversal of pre-emption, especially if one of the candidates from the Democratic Party makes it into the White House.

In his opening remarks, Rep. Henry Waxman (D-California) described pre-emption as "a radical doctrine" under which "[p]atients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries."

"In most states, [consumers] can sue a manufacturer in state court," but pre-emption disallows some suits. "The result is that one of the most powerful incentives for safety, the threat of liability, would vanish."

Waxman claimed that "for decades, FDA believed that state law" helped its regulation of drugs and devices, but "under the Bush administration" that has been reversed. He said that given recent demonstrations of resource shortages at the agency, "[t]his is exactly the wrong time for FDA to say 'trust us.'"

"Some drug and device companies have hidden and manipulated important data" and "have hid known defects," Waxman said, adding that clinical trials will not detect small effects and "all the resources in the world [at FDA] will not fix" this dilemma.

"Today we will consider a fundamental question with high stakes for everyone in America," he said in reference to pre-emption.

Rep. Thomas Davis (R-Virginia), the ranking minority member, said of pre-emption that "framing the issue as an either/or proposition offers illusory solutions."

Davis said that Congress should attempt to "skirt around the horror stories on both sides of the debate," and said that Congress's function in this situation should be to "help patients and consumers too often caught between predatory trial lawyers" on the one hand, and drug and device companies "hiding behind the shield of pre-emption" on the other. Davis said "if either side wins, American loses."

Davis said that five former FDA general counsels, including those from both Democratic and Republican administrations, recently wrote that "[i]f every judge and jury could fashion their own regulatory environment," chaos would ensue. The bipartisan nature of the letter also rebuffs Waxman's allegations that pre-emption is a Bush policy, Davis said, stating further that pre-emption is "neither novel nor radical."

"The hard truth is that drugs and devices will always pose some risk," Davis said. "Striking a pose on one side of the debate is easy," he commented, but "striking a balance" is essential to make regulation sensible.

Actor Dennis Quaid appeared on the panel, noting that his twin children were hospitalized at Cedars Sinai Medical Center (Los Angeles) and treated for a staph infection. As is well known, the infants were made sicker when a nurse used a version of heparin that is 10 times the normal potency used to clean the intravenous lines through which antibiotics were infused.

Quaid said the nurse "mistakenly injected not once, but twice," the higher dose product. He said the labels of the products "are deadly similar in their labeling and size.

"If the bottles are slightly rotated, they are virtually indistinguishable," Quaid said, because the bottles of heparin for flush lock, made by Baxter Healthcare (Deerfield, Illinois), were labeled a light blue whereas the formulation for more intensive uses, at 1,000 times the potency, bore a dark blue label.

Quaid charged that the product, "due to its labeling, had already killed three infants" and acknowledged the role of the hospital, but asserted that "the first link in that chain was Baxter."

"Like many Americans, I often thought that one of the problems in this country was frivolous lawsuits," Quaid said. He also said of Baxter that "everybody's trying to do their job in the best way, but we're talking about business here."

Bill Maisel, MD, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center (Boston), told the committee that "FDA marketing clearance is not a guarantee of safety" and said "it is apparent that additional consumer safeguards are needed."

Maisel described FDA as "the pre-eminent safety agency in the world," but that companies are in a much better position to track the adverse events that arise in connection with their devices. He referred to the problems engendered by defibrillators made by Guidant as a demonstration of the fact that FDA is ill-equipped to track the volume of drugs and devices hitting the U.S. market.

"Device glitches have become modern diseases," Maisel asserted, adding that "additional consumer safeguards are needed if we are to protect patients."

Also on the first panel was former FDA chief David Kessler, MD, who said that his purpose for appearing on the panel was to explain why he thinks FDA's system "is not entirely adequate to protect public health."

Kessler said that in the case of drugs, that "a serious and life-threatening risk will only emerge" on the market if it is a one-in-10,000 event.

"Those who favor pre-emption focus on the pre-market," Kessler said, but added "I believe it is wrong to focus on pre-approval" to determine the validity of pre-emption.

"FDA's knowledge base of the risks of a drug is far from static," Kessler acknowledged, but asserted that pre-market data are limited. "The fact is that the companies will always have more and better data" than the agency, he said.

"Even if FDA's budget is doubled," it would be behind the sponsors in terms of data. "For that reason, the tort system has always had a role" in regulating devices and drugs, he said.

"My greatest concern with pre-emption is that it would dramatically reduce the manufacturer's" motivation to act on post-market safety data," Kessler said.

Davis asked Quaid why he and his wife decided not to sue the hospital. Quaid said that hospitals are peppered with letters about products that could pose a hazard. "Those letters that are sent out to hospitals, there are so many warnings sent out to hospitals."

Quaid acknowledged that "[w]e have eight years to sue the hospitals" and that "our twins survived with no apparent damage." He also said "I'm hesitant to sue people" rather than businesses.

"We don't want to bring down our medical institutions," he said.