Generic Drugs Prove Resistant to Damage Claims - NYTimes.com

Generic Drugs Prove Resistant to Damage Claims - NYTimes.com:
by Katie Thomas

 "Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs."

Comment:
In Pliva v. Mensing the Supreme Court (5-4), in an opinion written by Justice Clarence Thomas, dismissed a drug product liability case, distinguishing it  from Levine v. Wyeth (2009).  The difference?  The drug at issue was a generic.  Despite strong arguments by AARP and Public Citizen in an amicus brief, the majority held that a copycat manufacturer had no right to change the drug warning label without FDA permission.  Thomas's interpretation of the Hatch Waxman Act (which eased the path to approval for generic manufacturers) has been a bonanza for generic drug makers - and a disaster for injured patients, as trial courts have swept cases from their dockets.  
Though Public Citizen has petitioned for a rule change, the FDA has not acted to change its rules, nor has the Congress.  Plaintiffs' only hope is for swift FDA reaction - and a Democratic President and Congressional majority because "tort reform" and hostility to product liability litigation has become a staple of the Republican Party platform.  
The underlying logic of change is a policy I called "product stewardship" in my 2007 article Punctuated Equilibrium.  As the Institute of Medicine said in its landmark report The Future of Drug Safety, little is known about safety until the drug is used in "real world" conditions.  Drug safety must be a priority for the entire "life cycle" of a drug - from its experimental phase to the post-marketing phase when large numbers of patients take the drug.   Even drugs long on the market are understood in new ways with experience.  Generic manufacturers are a big part of the market and they are obligated to stay current with developments in their industry, and to report what they learn.  All manufacturers should be compelled to gather and share that knowledge.  that is the logic of the expert standard of care we have imposed on product makers for the past 50 years since the American Law Institute promulgated its landmark strict product liability doctrine in Section 402A of the Second Restatement of Torts.
- GWC

'via Blog this'