Bush tort reform: Protects all FDA drugs and devices - LIABILITY LAWSUITS

[Guest guest]

Repost to group - from Aug. 12, 2004

 

 

, Frank

<califpacific> wrote:

>

> > [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.

[Guest guest]

--- califpacific <califpacific wrote:

> Repost to group - from Aug. 12, 2004

 

Thank you Frank. Somehow I completely missed this post.

 

Cheers,

Cara

 

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