Conte vs. Wyeth

Conte vs. Wyeth, INC

Court of Appeal, First District, Division 3

Decided: November 7, 2008

http://caselaw.findlaw.com/ca-court-of-appeal/1114587.html

Plaintiff Elizabeth Conte developed a serious and irreversible neurological condition. She alleges her condition is due to her long-term consumption of a generic prescription drug, and that the warnings provided by the manufacturers of the drug failed to adequately warn of known dangers resulting from its long-term use.

The trial court granted summary judgment in favor of all the manufacturers. Judgment was entered in favor of Wyeth, Inc. (Wyeth), the name-brand manufacturer of the drug, on two grounds:  (1) Conte could not show that she or her physician relied upon warnings or product labeling disseminated by Wyeth;  and (2) a name-brand pharmaceutical manufacturer owes no duty to individuals who take only generic versions of its product. The court granted summary judgment in favor of three generic manufacturers on grounds of federal preemption and Conte's lack of reliance on their warnings or product labeling.

We hold that the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product, but also to those whose doctors foreseeably rely on the name-brand manufacturer's product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug. We further conclude that Conte has shown there is a material factual dispute as to whether her doctor relied on Wyeth's product information, but that she is unable to show he relied on any information supplied by the generic manufacturer defendants.  

Accordingly, we reverse the judgment in favor of Wyeth and affirm the summary judgment in favor of each of the three generic manufacturers. In light of our disposition of this appeal, it is unnecessary for us to reach the generic defendants' further contention that federal law preempts state tort claims based upon allegedly inadequate drug labeling.

The defendants in these consolidated appeals manufacture and market metoclopramide, which Conte's physician prescribed in its generic and name brand form, Reglan, to treat her gastro esophageal reflux disease. Wyeth manufactures and markets Reglan. Defendants Pure Pac Pharmaceutical Company (Pure Pac), Teva Pharmaceutical USA, Inc. (Teva), and Pliva, Inc. (Pliva) manufacture generic versions of metoclopramide.

Conte developed tardive dyskinesia, a debilitating and incurable neurological disorder.   She alleges she developed her condition as a result of taking metoclopramide for almost four years between August 2000 and April 2004. It is undisputed that Conte took only the generic version of the medication, not Reglan. She claims that defendants knew or should have known of a widespread tendency among physicians to misprescribe Reglan and generic metoclopramide for periods of 12 months or longer, even though the medication is only approved for 12 weeks of use, because the drugs labeling substantially understates the risks of serious side-effects from extended use.

Her complaint, after various pretrial amendments, asserts claims for fraud, fraud by concealment and negligent misrepresentation 1 against Wyeth;  negligence, strict products liability, negligence per se, and breach of express and implied warranties against the generic manufacturers;  and medical negligence against her doctor, Robert Elsen, M.D. The crux of Conte's claims against all of the drug company defendants is that she was injuriously overexposed to metoclopramide due to their dissemination of false, misleading and/or incomplete warnings about the drug's side effects.

Purepac successfully moved for summary judgment on the ground that Conte's claims against it are preempted by the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.) and its implementing regulations.  

Pliva and Teva subsequently filed a joint motion for summary judgment on the same basis. While the Pliva/Teva motion was pending, Wyeth moved separately for summary judgment arguing its product information had no causal relationship to Conte's injuries and it owed her no duty of care. Unlike the generic manufacturers, it did not assert that Conte's claims were preempted by federal law. Pliva (but not Purepac or Teva) joined in Wyeth's motion asserting a lack of causation, and argued Conte could not prove any alleged inadequacies in its own labeling 2 caused her injuries because neither she nor her doctor relied on it.

The court granted Wyeth's motion on both grounds. The court found that neither Conte nor her doctor relied on drug information provided by Wyeth, and that as a name-brand manufacturer; Wyeth owes no duty of care to the users of generic versions of its name-brand drug. The court subsequently granted the Pliva/Teva summary judgment motion on the ground that Conte's state tort claims were preempted by federal law.

Conte timely appealed the judgments in favor of each company. We granted her unopposed motion to consolidate the appeals for purposes of briefing, oral argument, and decision.

Similar to Pliva vs. Mensing, it is said that generic brand drugs are not at fault for the injury that happens to the patient, but rather it is the name brand’s liability. The court decided that "those whose doctors foreseeably rely on the name-brand manufacturer's product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug." Thus making name brands to be held accountable since generic brands are using the same ingredients and warnings as the name brands. In this specific case, because the court found it foreseeable that physician would prescribe a generic version in reliance on Wyeth’s representations about Raglan  the court allowed the negligence claims against Wyeth.