US bill to shield drug companies from product liability

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[sSRI-Research] US bill to shield drug companies from product

liability

 

 

 

http://bmj.bmjjournals.com/cgi/content/full/330/7482/62-a

 

BMJ 2005;330:62 (8 January), doi:10.1136/bmj.330.7482.62-a

 

News extra

 

US bill to shield drug companies from product liability

 

New York Jeanne Lenzer

 

US federal legislation that could shield drug companies from product

liability lawsuits will be reintroduced in the Senate within two

months, says Jack Finn, spokesperson for Senator John Ensign of Nevada

state.

 

Senator Ensign sponsored an earlier version of the planned bill

(S11) that would prohibit product liability awards for drugs or

medical devices that " comply with Food and Drug Administration standards. "

 

The provision, known as the " FDA compliance " or " pre-emption "

defence, does not apply if FDA officials were bribed or if the

manufacturer withheld information about product safety.

 

Proponents of the legislation say that rising drug costs and threats

to the financial stability of drug manufacturers make the provision

necessary as lawsuits create expenses that are passed along to

consumers and, in the case of some current drug liability cases, could

actually threaten manufacturers with bankruptcy.

 

In a highly controversial move, the FDA joined with industry in

support of the pre-emption defence (BMJ 2004;329:189) when Daniel

Troy, then FDA’s chief counsel, filed " friend of the court " briefs

in several cases, including the Dusek v Pfizer case.

 

In the Dusek case, a federal trial court dismissed a case against

Pfizer in which the plaintiff, Alma Dusek, sued Pfizer in the suicide

of Cyril Dusek, who was using the antidepressant sertraline (Zoloft)

before his death. Ms Dusek argued that Pfizer failed to warn patients

and physicians that sertraline could induce suicidal behaviour. But

Pfizer and the FDA argued successfully that such a warning would have

conflicted with the FDA’s decision not to require a warning about

increased suicidality as, in the FDA’s estimation, causation had not

been proved. The case was dismissed on the grounds of pre-emption.

 

The pre-emption defence represents a radical departure from earlier

years when Margaret Jane Porter, FDA’s chief counsel in the Clinton

era, said the FDA’s view was that FDA product approval and product

liability suits " operate independently, each providing a significant,

yet distinct, layer of consumer protection. " Her viewpoint was

published recently in a white paper issued by the Center for

Progressive Regulation, a non-profit research and educational

organisation based in Riderwood, Maryland.

 

Robert Reich, labour secretary under President Clinton, speaking on

National Public Radio, told listeners that regulatory agencies across

the board are understaffed and have had their budgets " whacked " while

" many of them are in the pockets of the very companies and industries

they are supposed to regulate. " It is the wrong time to shield

industry from lawsuits, said Mr Reich, when the FDA is " failing in its

core mission to protect consumers from harm. "

 

" You can’t have it both ways, " he said. " Either regulatory

agencies have to be made tougher and more independent, and given the

resources they need to protect the public, or we’ve got to rely on

courts and private lawsuits to make sure companies have every

financial incentive to protect the public. "

 

 

 

Other related articles in BMJ:

News

FDA's counsel accused of being too close to drug industry.

Jeanne Lenzer

BMJ 2004 329: 189. [Extract] [Full text]