United States: In Re: Accutane

On the Basis of the Learned Intermediary Doctrine, New Jersey Superior Court Dismissed 160 of 162 Plaintiffs in the Accutane MDL

On October 12, 2016, in two separate orders, the New Jersey Superior Court overseeing the In re Accutane Litigation mass coordinated litigation dismissed 160 of the 162 remaining plaintiffs on the basis of the learned intermediary doctrine ("LID").37

As discussed in our Products Liability & Toxic Torts Spring 2016 Alert, in January 2016, the Court — after discussing the six public policy elements that support the LID — held that "[i]n prescription drug cases where the LID applies, it is the physician who is viewed as the user" and that, in such cases, "[t]he intended 'audience' of the labeling and warnings are medical doctors, not patients."38 The Court asked the parties for additional briefing on how the Court's ruling applied to out-of-state plaintiffs.

The Court dismissed 86 plaintiffs in its first October 2016 order, holding that they failed to satisfy their burden of proof because their physicians had either died or had not been located.39 While the plaintiffs argued that the Court should apply the "heeding presumption," under which "there is a rebuttable presumption that the recipient of an adequate warning in a failure-to-warn case would have heeded the warning,"40 the Court disagreed. Specifically, the Court found that the plaintiffs' "reasoning is flawed" because if the Court denied the defendants' motion for summary judgment,"[p]laintiffs' claims would go before a jury with testimony from [p]laintiff that she/ he ingested Accutane [with] no testimony from the prescribing physician[,] [and] [t]he jurors would be left to speculate as to what the prescribing physician considered of the warning(s)."41 Importantly, the Court noted that if a heeding presumption were applied to prescription drugs, "given that every prescription medication has associated risks, heeding those warnings would result in medications never being prescribed. While that may be Plaintiffs' counsels' hopes, it is not reality."42 Additionally, because the Court found it was unreasonable to believe that prescribing physicians would "cease to prescribe" Accutane,43 the Court held that, under New Jersey law, "[n]either policy nor reason warrant the extension of the heeding presumption to these cases."44 While the Court, citing its July 24, 2015 order, noted that New Jersey's proximate cause standard applied and dismissed the applicable plaintiffs under that standard, the Court nonetheless reviewed the proximate cause standard of outof- state plaintiffs from 19 and found the plaintiffs would be dismissed under those jurisdictions as well.45

In the second order, noting that the plaintiffs' counsel had "done their best to conflate the LID with the informed consent doctrine," the Court held that that was "simply not the law" and that "[w]hen a prescribing physician comprehends the fact that a given medicine is associated with certain potential risks, and exercises his/her medical judgment in deciding whether and how to address those risks with his/her patient, the manufacturer cannot be held responsible for the prescriber's decision."46 The Court found that the law in 15 states was consistent with New Jersey's LID statute and, on individual bases, dismissed the applicable plaintiffs when the defendants met their LID burden.47

The Court's orders demonstrate well considered arguments on the heeding presumption and the difference between the LID and the informed consent doctrine. Because of the growing application of the LID, plaintiffs continue to seek ways to bypass it. The New Jersey Superior Court saw past the plaintiffs' attempts on both counts. That said, these decisions do not mean defendants can rest easy – Defendants in mass tort cases will have their work cut out for them to depose the medical professionals (who are available). Indeed, as to the two remaining cases, the Court found that (1) the prescriber's testimony "demonstrate[d] substantial uncertainty" about whether a different warning would have changed the prescriber's decision and (2) the prescriber testified that he was "not sure" if he would have changed his decision based on a different warning. As such, defendants must be prepared to effectively challenge prescribers at deposition about whether he/she would have made a different decision with a different warning.


37. No. 271, 2016 WL 5958374 (N.J. Super. Ct. Law Div. Oct. 12, 2016); 2016 WL 5958375 (N. J. Super. Law Div. Oct. 12, 2016).

38.  In re Accutane Litigation, No. 271, 2016 WL 355843, at *4 (N.J. Super. Law Div. Jan. 29, 2016). The six elements discussed by the Court were that "(1) Prescription medications require far more precaution than an over-the-counter ("OTC") drug . . . (2) Prescription drugs are often complex medications . . . (3) . . . with a prescription drug, it is inconceivable that a manufacturer could fulfill its obligation of a warning sufficiently understandable by the average person . . . (4) The treating physician plays the role of the go-between to the full extent implied by that term . . . ." (5) patients would be unlikely to properly evaluate technical information; and "(6) Human nature is what it is, the common law acknowledges that, after the fact, upon diagnosis of a condition said to be associated with a medication, that the patient is likely to testify that she/he would never have taken the medication had they known then, what they know now." (Id.).

39.  2016 WL 5958374 at *3.

40. Id. at *4 (citing Coffman v. Keene Corp., 628 A.2d 710, 720-21 (N.J. 1993)).

41. Id. at *11.

42.  Id.

43.  Id. ("(1) the medical community issued statements urging continued use, (2) there is evidence that the learned intermediaries were otherwise aware of the risk of IBD, and (3) no evidence has been provided supporting the notion that one additional risk factor would lead the prescribing physicians to avoid this drug. Additionally, this is not a no-warning case. All prescribing physicians were aware of at least a risk of 'temporal association' with IBD. Sufficient evidence has been presented to rebut the heeding presumption, were it to apply in any of these cases.").

44.  Id. at *12.

45.  Id. at * 12-16.

46.  2016 WL 5958375, at *5. Here, the Court, found "[c]oursing through the deposition testimony. . . facts and instances revealing the 'condition' in which many Plaintiffs' [sic] found themselves prior to being prescribed Accutane . . . . In truth, Accutane was their only hope for relief . . . . It was prescribed as a last measure of treatment; many Plaintiffs were impatient to receive it." Id. at *6.

47. Id. at *8-48. Depending on the individual, the Court found the defendants had established that the LID applied because the prescriber: (1) was aware of the risk, (2) had not read the warning at all, (3) judged the risk was not severe, (4) affirmatively decided not to warn the patient, or (5) would not have changed his/her decision based on the information he/she subsequently learned.

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