Wyeth case may redefine drug liability laws

December 17, 2008

A patient suit against Wyeth Pharmaceuticals may open brand name drug makers to liability for mishaps when patients take a generic product.

A patient suit against Wyeth Pharmaceuticals may open brand-name drug makers to liability for mishaps when patients take a generic product. A three-judge state appeals panel in California ruled that the originator company is responsible for product warnings and product information even when the patient is taking a generic.

“Manufacturers’ attorneys were aghast that a manufacturer could be held liable for a product the company didn’t even make,” William Fassett, pharmacist, attorney, and professor of pharmacy law at Washington State University College of Pharmacy in Spokane, WA told DT. “This is new territory.” The ruling overturns an earlier summary judgment that dismissed the suit against Wyeth and sends the case back to trial. The drug maker was sued over a neuromuscular disorder linked to long-term use of generic metoclopramide (Reglan, Wyeth).

Pharmacies that dispensed the product were not involved in the case. The American Pharmacists Association declined to comment on the decision, noting that it involves product liability and drug makers, not pharmacists. Fassett agreed that RPhs and even prescribers are probably not at risk here.

 He added that most observers are missing the most important implication of the case. It’s not about liability for drug products, it’s about liability for drug-product information. “People say this is about extending product liability for a generic back to the brand-name maker,” Fassett said. “It’s not.” That distinction between liability for a product and liability for information about a product is based in common law, he added.

That means the same theory could be used in other states or at the federal level. “The issue is that Wyeth is the only source of information and promotion for metoclopramide,” he said. “If Wyeth left prescribers with incomplete knowledge of long-term side effects of the drug they brought to market, Wyeth is responsible. This is about negligent misrepresentation of product safety, not product liability.”

The case, Conte v Wyeth, was brought by San Francisco resident Elizabeth Conte. Her physician prescribed metoclopramide in both its generic and brand-name form for nearly four years to treat gastrointestinal reflux disease (GERD). After taking several generic versions of drug between August 2000 and April 2004, Conte developed tardive dyskinesia.

Conte said in court documents that she took only generic versions of the product. She also sued generic metoclopramide makers Purepac, Teva, and Pliva. In its opinion, the appeals court noted that patients taking a generic medication could reasonably be expected to rely on drug information from the brand-name manufacturer.

Pharmacists in California and many other states are authorized to fill brand-name scripts with generic equivalents unless the prescriber specifically forbids a substitution. In practice, patients typically get generics even when prescribers write a brand-name Rx.

The plaintiff claimed that both Wyeth and the generic manufacturers knew or should have known that physicians tend to prescribe metoclopramide for periods of 12 months and longer even though the product is only approved for 12 weeks of use. Conte’s original complaint also claims that metoclopramide product information substantially understates the risks of serious side-effects from long-term use of the drug. In its opinion, the California Court of Appeal noted that brand-name manufacturers are generally responsible for writing product information, which is approved by the U.S. Food and Drug Administration. Information from product originators is included in monographs published by the FDA as well as in package inserts for brand-name and generic versions of the product, Physicians Desk Reference, and other compendia.

The three generic firms were granted summary judgment and relieved of any potential liability in the case. Neither Conte nor her physician relied on information from the generic firms in prescribing metoclopramide. Even if they had, Fassett noted, product information distributed by generic manufacturers originates from the brand-name company. Wyeth did not respond to multiple requests for comment on the ruling.

While the California ruling does not create any additional liability issues for pharmacists, Fassett warned that the case should not be ignored. If the appeals court theory holding manufacturers liable for faulty or incomplete information survives an eventual court trial and subsequent appeals, pharmacists could find themselves at risk.

“I can see pharmacists being sued for poor advice on OTCs, nutritional products, and especially on compounded products,” Fassett said. “Advice to patients could be held to be the kind of negligent communication that has traditionally been applied against publishers. Pharmacists have already been sued successfully for giving bad advice on products like muratic acid that dissolved a sandstone fireplace instead of cleaning it.”