Products Liability Law Daily Makers of Accutane® successfully assert learned intermediary defense in 32 defective drug warnings cases
News
Monday, February 1, 2016

Makers of Accutane® successfully assert learned intermediary defense in 32 defective drug warnings cases

By Pamela C. Maloney, J.D.

Finding that treating physicians would have prescribed the acne medication Accutane® to their patients even had the warning label had been changed, a New Jersey trial court granted the drug manufacturers’ motions for summary judgment based on lack of proximate cause in 32 product liability claims filed by California, Kansas, Louisiana, and Texas patients who had alleged that ingestion of the drug caused them to develop inflammatory bowel disease (IBD). The court also stay the drug makers’ motions for summary judgment based on Florida and North Carolina’s statutes of repose and on the statutes of limitations in Alabama, Idaho, Maine, and Virginia pending the outcome of New Jersey Supreme Court’s decision in McCarrell v. Hoffman-LaRouche (Docket No. A-28-15; cert. granted November 20, 2015) (In re: Accutane® Litigation, January 29, 2016, Johnson, N.).

Learned Intermediary Doctrine. Under New Jersey common law, state courts routinely held that a warning about a prescription drug need be given only to the physician who prescribed the drug. This holding, which has come to be known as the learned intermediary doctrine (LID), was incorporated into prescription drug cases by way of the New Jersey Products Liability Act. Accordingly, the trial court explained, because the warning is issued to the physician, the adequacy of the warning must be assessed from the treating physician's perspective, not that of the patient’s.

In applying the LID to the patient’s claims in this case, the trial court referred to the Appellate Division’s unpublished decision in Gaghan v. Hoffman-La Roche Inc. [see Products Liability Law Daily’s August 5, 2014 analysis], in which the court focused squarely on a state trial court’s view that “the proximate cause question ... [is] tied to the patient's decision to accept or decline Accutane, not just to the doctor’s decision to recommend and prescribe it or not to do so[,]” and rejected such an application of the LID. Instead, the court found that a prescription drug manufacturer fulfilled its duty to warn if it provided adequate warnings to the prescribing physician, and it owed no duty to ensure that the warning ever reached the patient. Noting that the court in Gaghan applied California law, the trial court in this case was satisfied that its statement of the law on the LID is the law of New Jersey, not merely that of California.

After considering the deposition testimony of the various treating physicians of the many plaintiffs involved in this MDL, the trial court determined that either: (a) a different warning would not have altered each physician’s decision to prescribe Accutane®, nor the way in which the drug was prescribed; or (b) although a different warning likely would have altered their discussions with patients, the physician still would have prescribed the medication to a “willing patient.” According to the trial court, in each case there had been a “willing patient” who only thought differently about taking the drug after acquiring new information through the litigation process. Because the doctors, in each and every instance, testified that even with a different warning they still would have prescribed the medication, the manufacturer’s duty to warn was fulfilled and summary judgment was appropriate. The court added that while it was mindful of the fact that a lay person could view the lack of the patient’s perspective into the process as harsh, to rule otherwise would eviscerate the statutory immunity granted to drug manufacturers by NJPLA and would vitiate the common law.

Conflict of law. The court rejected attempts by both sides to convince it to apply the substantive law of the place of injury to the motions presented, reminding them that in ruling on the plaintiff’s petition for MDL designation, the court had concluded that all of the drug manufacturers’ motions relating to the learned intermediary doctrine would be considered under the NJPLA and New Jersey case law.

Statute of repose and limitations. In deciding to stay the drug makers’ motions for summary judgment on the basis of relevant state statutes of repose and statutes of limitations, the trial court clarified that if the state supreme court reverses the Appellate Division’s decision in McCarrell, which allowed equitable tolling of statutes of limitations under “discovery rule” principles [see Products Liability Law Daily’s August 11, 2015 analysis], and instead rules that New Jersey law applies for statute-of-limitations purposes, the motions would be denied, without prejudice to manufacturers’ rights to argue that the affected causes of action were barred under New Jersey law in Alabama, Idaho, Maine, and Virginia.

The question presented before the state supreme court is: “Should the timeliness of plaintiff’s products liability claim be assessed under New Jersey law, which allows for the equitable tolling of statutes of limitations under ‘discovery rule’ principles, or the law of plaintiff’s state of residence, which disallows such tolling?”

The case is No. 271.

Attorneys: Michael L. Rosenberg (Seeger Weiss LLP), Mary Jane Bass (Beggs & Lane LLP), Stephen F. Bolton (Hook & Bolton PA), William F. Cash III (Levin Papantonio Thomas Mitchell Rafferty & Proctor PA), Kevin Haverty (Williams Cuker Berezofsky LLC), and William T. Jones, Jr. (Clark, Love & Hutson GP) for plaintiffs. Michelle M. Bufano (Gibbons PC), Matthew John Griffin (Peabody & Arnold LLP), Paul W. Schmidt (Covington & Burling LLP), and Mark A. Dreher (Butler Snow LLP) for Hoffmann-La Roche Inc. and Roche Laboratories Inc.

Companies: Hoffmann-La Roche Inc.; Roche Laboratories Inc.

MainStory: TopStory WarningsNews SofLReposeNews DrugsNews NewJerseyNews

Back to Top

Interested in submitting an article?

Submit your information to us today!

Learn More