Products Liability Law Daily Heart patient’s failure-to-warn claim against Plavix® maker precluded by learned intermediary doctrine
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Friday, August 18, 2017

Heart patient’s failure-to-warn claim against Plavix® maker precluded by learned intermediary doctrine

By Susan Engstrom

In a multi-district litigation involving the prescription blood thinner Plavix®, a patient who allegedly was injured after taking the medication for eight years could not sustain a failure-to-warn claim against the drug’s manufacturer, the federal court in New Jersey ruled in an unpublished decision. The patient’s physician testified that he was aware of the risks of bleeding but that Plavix was the best therapy for the patient’s condition. Because the patient presented no evidence putting the physician’s credibility into doubt, and because the physician was not a defendant, the learned intermediary doctrine barred the patient’s claim. The patient’s design defect claim also failed, as it was based solely on the alleged inadequacy of Plavix’s warning. Thus, the manufacturer’s motion for summary judgment was granted (In re: Plavix Marketing, Sales Practices and Products Liability Litigation (No. II) (Armantrout v. Bristol-Myers Squibb), August 17, 2017, Wolfson, F.).

After suffering from unstable angina on three separate occasions, the patient, a 69-year-old man, received a stent. As a result of the particular type of stent that was used, his physician put him on double antiplatelet therapy, which included aspirin and Plavix. After taking Plavix for eight years, the patient was hospitalized with gastrointestinal bleeding, and was found to have two ulcers. Asserting that the excessive bleeding was due to taking Plavix, the patient filed failure-to-warn and design defect claims against the drug’s manufacturer, Bristol-Myers Squibb.

Failure to warn. New York courts have recognized that a prescription drug manufacturer’s duty to warn extends to a patient’s doctor (and not to the patient himself) pursuant to the "learned intermediary" rule. The logic underlying this rule is that the physician acts as an "informed intermediary" between the manufacturer and the patient, evaluating the patient’s needs, assessing the risks and benefits of available drugs, and prescribing and supervising their use. Thus, if a defendant fails to adequately warn a patient’s physician of a drug’s dangers and the patient suffers an injury as a result, a failure-to-warn claim may lie. In sum, the learned intermediary doctrine provides that: (1) manufacturers of prescription drugs discharge their duty of care to patients by providing adequate warnings to prescribing physicians; and (2) any failure to warn 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 alternative warning.

In this case, it was clear from the treating physician’s testimony that he was aware of the serious risks of bleeding when he placed the patient on a dual therapy regime of Plavix and aspirin. Moreover, the doctor testified that having reviewed all of the relevant studies regarding Plavix, he believed that prescribing it to the patient was the most appropriate medical therapy. In response, the patient produced no evidence—testimonial or otherwise—to suggest that a different warning would have led his doctor to alter his treatment. More importantly, the doctor represented that he would not have changed the prescriptions for the patient even understanding the additional risks or questions of efficacy raised by the patient in this litigation.

The patient argued that because his physician’s testimony was not "self-disserving," his statements must be presented to the factfinder. The court agreed that when a treating physician is a defendant in a case brought by the patient, the physician’s testimony, in the context of the learned intermediary doctrine, must be self-disserving—i.e., against the physician’s self-interest—before the testimony can be a sufficient basis to grant summary judgment. However, when the treating doctor is not a defendant but is merely a third-party witness, his or her testimony, without any evidence of credibility issues, is a sufficient basis to grant summary judgment.

In this case, because the treating physician was not a defendant and the patient had not brought claims against him in other forums, his testimony did not, on its face, raise any credibility issues. The patient’s assertion that the physician did not have long-term studies on which to rely when he prescribed Plavix was rejected because the patient’s counsel never questioned the doctor at his deposition on this issue. Moreover, the doctor was well aware of the lack of any studies with prolonged and extended use of Plavix. Even knowing these facts, the physician still asserted that he believed Plavix to be the best medical therapy.

Under New York law, a treating physician’s independent knowledge of a risk associated with a prescription drug is sufficient to preclude a drug maker’s liability to an injured plaintiff, even if the drug’s warnings were inadequate. Here, the patient failed to present any conflicting evidence to create doubt regarding his physician’s credibility and, thus, the learned intermediary doctrine applied to defeat his failure-to-warn claim against the manufacturer.

Design defect. With respect to the patient’s design defect claim, the court first found that comment k to §402(a) of the Restatement (Second) of Torts—which states that when an unavoidably unsafe product such as a prescription drug is accompanied by proper warnings it is not defective—was not available to the manufacturer as a defense because the question of whether Plavix’s warning was adequate was not raised by the manufacturer in its motion for summary judgment.

Next, the court observed that the patient’s theory of design defect was based on the inadequacy of Plavix’s warnings. However, the court found no case, and the patient pointed to no authority, that permitted a design defect claim to proceed based on a theory of inadequate warning. Under New York law, courts use two multifactor balancing tests to assess design defect claims: (1) a seven-factor evaluation of the risk and utility of the product to society; and (2) a three-factor test to determine whether the product was a proximate cause or "substantial factor" of the plaintiff’s injury. None of these factors relate to an assessment of warnings on a product. Thus, under New York law, the patient could not bring a design defect claim based on inadequate warnings alone. Even if he could do so, he would fail to meet his burden of proof, as he did not proffer any alternative, safer design for Plavix or show that the product could have been designed more safely. Therefore, the manufacturer was entitled to summary judgment on this claim as well.

The case is No. 13-4521 (FLW) (MDL No. 2418).

Attorneys: Diane Marie Coffeyn (Marc J. Bern & Partners LLP) for Gary Armantrout. Gavin J. Rooney (Lowenstein Sandler LLP) for Bristol-Myers Squibb Co.

Companies: Bristol-Myers Squibb Co.

MainStory: TopStory WarningsNews DesignManufacturingNews DrugsNews NewJerseyNews NewYorkNews

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