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Health News/Science News Thursday, August 12, 2004
Can FDA seal be broken?
A fight is raging on whether agency's approval of medical devices or drugs can prevent litigation

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August 11, 2004

His soft Mississippi drawl almost masks his angry tone. But it's clear oilman Gary Murphree has a bone to pick with the Bush administration.

What has him so riled up?



The Justice Department and Food and Drug Administration recently filed court papers to block Murphree's lawsuit against Pacesetter Inc., a company that made two pacemakers he says damaged his heart.

The Murphree v. Pacesetter case is just one of several in which the Justice Department has intervened recently on behalf of the FDA, seeking to prevent lawsuits against medical device and drug makers.

Some legal experts say the government is using a back-door approach to achieve tort reform - a move to reduce huge payments to plaintiffs in liability cases.

Murphree, 46, says the two pacemakers he received - both recalled - left him with serious heart rhythm problems. He says he suffered third-degree heart block - failure of the heart's electrical signals which can lead to cardiac arrest.

"I had emergency surgery," Murphree said in an interview from his Jackson, Miss., Dutch Lubricants office, where he is a partner in an oil marketing business. "For a year I couldn't pick up my daughter." He eventually received a third pacemaker from a different company.

Since 2001, the FDA, represented by the Justice Department, has been trying to block liability lawsuits, usually by filing friend-of-the-court briefs or other legal documents.

A range of products

The cases have all involved FDA-approved products - with plaintiffs alleging either injuries or death. Products range from a heart pump to an antidepressant to a nicotine patch.

In one case, Motus v. Pfizer, a woman alleged that her husband killed himself after taking the company's antidepressant Zoloft. The government said she could not challenge Zoloft's safety because the FDA had approved it. The court dismissed the case, though not on the government's grounds.

Government lawyers have not wavered in their argument: Once the FDA approves the product, they say, allowing injured consumers to sue manufacturers would sabotage the agency's authority.

But this position is a tactic adopted by the Bush administration to accomplish tort reform, some legal experts say.

A tort is a legal term meaning a "wrong" - causing injury to people or property. Tort reform refers to efforts to reduce large - some say excessive - payments by insurance companies in liability cases. The Bush administration has advocated tort reform but not received needed support from Congress.

As a result of the government's intervention in his pacemaker lawsuit, Murphree, a Republican contributor, says he will vote for John Kerry in November or sit out the election.

A Justice Department "statement of interest" filed in connection with Murphree's suit states: "Relying on its scientific expertise, FDA determines the proper regulatory pathway for medical devices. If juries were to make this determination in the first instance, rather than the FDA, it would result in an unworkable, chaotic system that Congress sought to avoid by charging FDA with the responsibility for regulating medical devices."

Justice Department spokesman Charles Miller said he could not comment on Murphree's case or the department's shift toward preventing lawsuits for injuries stemming from FDA-approved products.

'Dramatic change of policy'

Jim O'Reilly, a visiting law professor at the University of Cincinnati and an expert in food and drug law, disputes the government's position. "It is a dramatic change of policy for the current Bush administration to take the pre-emption issue as a weapon against private plaintiffs," said O'Reilly, who filed a friend-of-the-court brief in the Murphree case.

The FDA position on product liability differs from the Clinton era viewpoint that states could provide consumer protection to supplement FDA safety standards. In the past, the FDA intervened in liability cases - but typically not without being asked to do so by a court or other government entity, O'Reilly said.

In 1997, Margaret Jane Porter, Clinton administration's chief FDA counsel, wrote: "FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."

FDA officials did not respond to interview requests. However, acting FDA Commissioner Lester Crawford said in a prepared statement: "When state courts call into question the FDA's global gold-standard determinations, FDA has an obligation to act."

In July, a Pennsylvania federal appeals court threw out a lawsuit brought by a Pennsylvania woman who alleged her husband died because of a defective heart pump. The Justice Department had intervened, arguing the FDA had approved the pump and its authority could not be challenged.

Allison Zieve, an attorney with Public Citizen, a Washington watchdog group, represented the widow, and said the administration's interest in liability cases "certainly seems like tort reform by the back door."

"The main issue for us is the FDA is taking a position that is bad for consumers, bad for patients and bad for public health," Zieve said.

The administration's interventions have all occurred since Daniel Troy, an attorney who previously represented drug companies, became the FDA's chief counsel in 2001.

In July, five former FDA counsels - excluding Porter - wrote to Congress defending Troy, who had been attacked by Rep. Maurice Hinchey (D-Saugerties) for cracking down on liability suits involving FDA-approved products.

Peter Hutt, FDA counsel during the Nixon administration and now a practicing attorney, said he didn't ask Porter to sign the letter because she now works for the government. Porter could not be reached.

Hinchey recently persuaded the House of Representatives to transfer $500,000 from Troy's budget to another FDA office. It's unclear if the Senate will back that move.

The five former FDA counsels urged a restoration of funding, saying: "... Mr. Troy is establishing a sound policy of national decisions that promote the public health and, thus, the public interest."

Hinchey, a member of the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, disagrees. He said Troy's previous work on behalf of drug companies conflicts with his current actions. Troy did not return calls for comment.

"They are saying under federal law, when the feds give approval to a drug, that means the manufacturer can sell it - and if people use it and get harmed by it, there is no state tort remedy," said Susan Low Bloch, a constitutional law professor at Georgetown Law Center.

In Mississippi, Gary Murphree just celebrated his son's wedding and is waiting to see whether his lawsuit moves forward. "I'm for tort reform," he said. "I'm just not for taking everybody's rights away."

Copyright 2004, Newsday, Inc.

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