The Govt. Looking Out For Your Health Dept.: LIABILITY LAWSUITS

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> SSRI-Research

> Wed, 11 Aug 2004 15:27:24 -0400

 

> [sSRI-Research] Newsday.com - Health

> News-Science News.htm

>

>

> Wednesday, August 11, 2004

>

> LIABILITY LAWSUITS

> Can FDA seal be broken?

> A fight is raging on whether agency's approval of

> medical devices or drugs can prevent litigation

>

>

> KATHLEEN KERR

> STAFF WRITER

>

> 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. "

>

> 2004, Newsday, Inc.