Consumer Warnings Not Always Needed for Medications and Products

3/27/2013

Must a company always provide a warning label about hidden dangers in its product? The answer might surprise you. Despite being bombarded with hundreds of warning labels on almost every product we encounter, a company is not always required to warn. For example, when a drug company gives proper warnings about a medication to physicians, the company is not required to provide warnings to consumers. This forms the basis for the “learned intermediary” doctrine which provides a complete defense for failure to warn claims against companies.

Although originally developed in the pharmaceutical arena, other realms of tort law have successfully adopted the defense. Decisions stemming from pharmaceutical cases impact other types of claims.

Second Circuit Decision

The U.S. Court of Appeals for the Second Circuit has provided continued support to the learned intermediary doctrine as a defense for drug manufacturers in failure to warn claims. In McClamrock v. Eli Lilly and Co., 2012 WL 5951842 (2d. Cir. Nov. 29, 2012), the Court upheld the U.S. District Court for the Eastern District of New York’s grant of summary judgment to Defendant Eli Lilly and Company ("Lilly") in a case stemming from the Zyprexa multi-district products liability litigation.

Background

The plaintiff in this action brought claims for negligent failure to warn, strict liability, breach of warranty, and fraud in the USDC for the District of Columbia in 2002. The case was transferred to the Eastern District of New York by order of the Judicial Panel on Multidistrict Litigation. The plaintiff alleged that (1) Zyprexa caused plaintiff’s diabetes and his various diabetes-related complications, including the amputation of some body parts; (2) Lilly failed to warn of the dangers of Zyprexa; and (3) Zyprexa would not have been prescribed, and plaintiff’s injuries avoided, if Lilly had provided proper warnings.

Two of the plaintiff’s physicians prescribed Zyprexa starting in December 1998 to treat plaintiff’s schizoaffective disorder, bipolar type. The medication was continuously prescribed through November 1999. The plaintiff and his family concluded in 1999 that Zyprexa caused his diabetes and discontinued its use.

Zyprexa Litigation History

Zyprexa is an “atypical” antipsychotic drug used to treat psychiatric problems. The U.S. Food and Drug Administration (FDA) approved its use for treating schizophrenia and acute manic episodes in 1996 and bipolar disorders generally in 2004. In May 2000, the FDA began investigating rates of diabetes and hyperglycemia from atypical antipsychotics and requested safety information from Lilly. In September 2003, the FDA announced a requirement that package inserts for this category of drug include a warning about risks of diabetes and hyperglycemia and treating precautions. Lilly changed its label to include information for prescribing physicians on the studies related to the noted side effects, but the “warnings to patients” section did not mention diabetes or weight gain. In March 2004, Lilly also sent a “Dear Doctor” letter notifying physicians of its label change.

In November 2003, the American Diabetes Association and others held a consensus development conference and later concluded that Zyprexa posed an increased risk of diabetes and weight gain and that because of complications from these effects, physicians should weigh these risks when choosing a medication for a patient.

Approximately 30,000 cases have been brought against Lilly principally alleging that Zyprexa caused side effects including, excessive weight gain, hyperglycemia, and diabetes and that Lilly misled prescribers and their physicians about the possibility of side effects.

Through the course of this extensive litigation, the evidence suggests that it was widely known in the late 1990s among treating and prescribing physicians that weight gain could result from Zyprexa use. It was also “broadly recognized” by that time that weight gain carried a heightened risk of diabetes.

Learned Intermediary Defense

In 2011, Lilly filed a motion for summary judgment which argued that the plaintiff’s complaint should be dismissed because the learned intermediary doctrine shields Lilly from liability. After a choice of law analysis resulted in application of North Carolina law, the District Court held that North Carolina appears to have adopted the doctrine, which provides that (1) manufacturers of prescription drugs and medical devices discharge their duty of care to patients by providing adequate warnings to prescribing physicians and (2) that any failure to warn a patient cannot be considered a proximate cause of a subsequent injury if the physician was fully aware of the dangers that would have been included in an alternate warning. The District Court recognized that there is a “strong trend in prescription drug failure-to-warn cases to reiterate and apply this well-established doctrine.” The Court also cited to Souther v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 489 F.Supp.2d 230, 269 (E.D.N.Y. 2007) in acknowledging that “a manufacturer or seller of a prescription drug has no legal duty to warn a patient of the dangerous tendencies of its drugs, as long as sufficient warnings are provided the prescribing physician.”

One of the plaintiff’s physicians testified that he was aware of the risks of Zyprexa but thought the benefits outweighed the risks. Based on this evidence, the Court found that the doctor prescribed the medication as an “exercise of his discretion as a learned intermediary.” Therefore, Lilly satisfied its duty to warn under North Carolina law and was not the proximate cause of the plaintiff’s injuries. On appeal, the Second Circuit affirmed the lower court’s application of North Carolina law regarding the learned intermediary doctrine to the plaintiff’s case.

Implications

This case represents renewed support for the learned intermediary doctrine which continues to garner support in many jurisdictions. The Texas Supreme Court, in its first direct ruling on this issue, adopted the doctrine in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012). The doctrine has also been explicitly included in the Restatement (Third) of Torts: Products Liability (1998).

Not all jurisdictions, however, have adopted the doctrine. Recently both West Virginia and New Mexico declined to adopt the defense. See State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 906 (W. Va. 2007) (finding justifications for defense outdated and unpersuasive); Rimbert v. Eli Lilly & Co., 577 F.Supp. 2d 1174, 1222 (D.N.M. 2008) (explaining state court unlikely to adopt doctrine because of changing dynamics between doctor and patient, self-diagnosis, and direct-to-consumer advertising).

Some courts, while generally recognizing the doctrine, have still carved out exceptions. One of the more significant exceptions is the inapplicability of the doctrine when a case involves direct-to-consumer advertising. As the direct-to-consumer advertising for pharmaceuticals and medical devices markedly increased after the FDA relaxed advertising requirements in 1997, counsel began to question the applicability of the learned intermediary doctrine. In Perez v. Wyeth Labs., Inc., 734 A.2d 1245, 1256 (N.J. 1999), the New Jersey Supreme Court rationalized that direct-to-consumer advertising “belies each of the premises on which the learned intermediary doctrine rests” and erodes the justifications for relying on a physician when a drug is marketed directly to consumers.

The drafters of the Restatement (Third) of Torts considered carving out an exception which would not shelter manufacturers who directly advertised to consumers, but they did not include this exception in the final draft. In the comments, the drafters noted “the Institute leaves to developing case law whether exceptions to the learned intermediary rule in these or other situations should be recognized.” Restatement (Third) of Torts: Products Liability §6 cmt. e (1998).

The drafters’ comment seems to insightfully predict the current landscape for this issue, as developing case law does continue to decide the fate of the doctrine and any exceptions to its protection. Because application of the learned intermediary doctrine in other product liability fields has its roots in the pharmaceutical cases, practitioners in these other arenas also closely monitor these decisions. Continued support, as recently provided by the Second Circuit, may serve to bolster the defense in all areas of tort law.

For more information regarding defending failure to warn claims in products liability actions, please contact David Governo (dgoverno@governo.com) or Melissa Tarab (mtarab@governo.com).

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