US State Liability Ruling "Protects Drug Firms"

The California State Supreme Court has ruled that drugmakers sued forproviding inadequate strict warnings are subject to strict liability, not just a standard of reasonableness. However, the law firm Crosby, Heafey, Roach & May feels that the ruling, involving Pharmacia &Upjohn, also provides protection to firms facing lawsuits over their warnings.

The ruling, on Carlin v Superior Court (P&U), had reaffirmed that medicines are unique products that the law should treat differently. Warnings on drugs are subject to the same standards as those on other products, but there are differences in that the Food and Drug Administration is involved, determining risks and drafting warnings, and that warnings on prescription drugs are most effective in communicating to a doctor or other "learned intermediary," who then helps a patient evaluate the medication's benefits and risks. From these two differences come two major limitations on the "strict" liability imposed by Carlin, notes the law firm; a manufacturer cannot be liable for failing to give warning if the FDA has rejected it, nor does it have to provide a warning about a risk "generally known" to the medical community.

In the Carlin case, P&U and other drug firms argued that liability for failure to warn of a product's risks should be governed by true negligence standards. The reasonableness of the manufacturer's testing, not an absolute "knowable" standard, should apply, the lawyers say, and plaintiffs should be required to show that a decision not to provide a particular warning was unreasonable in light of all the circumstances which include, said the manufacturers, the FDA's involvement and evaluation of available information.