Learned Intermediary Doctrine Causes Dismissal of New Jersey Accutane Suits

Accutane is linked to a series of serious side effects, including bowel diseases like Crohn’s disease, liver damage, depression, and miscarriage and birth defects if taken during pregnancy. Because of these injuries, more than 7,000 lawsuits have been filed against Roche Pharmaceuticals.

By James Beck of Reed Smith

31 more Accutane cases in the the New Jersey Accutane litigation were dismissed on Jan. 29 for failure to establish warning causation under the learned intermediary rule. Click to read the Memorandum Opinion.

This round of dismissals is all about the learned intermediary rule.  The court recites six bases for the rule:

(1) prescription drugs have risks that require a prescription in the first place;

(2) prescription drugs are complex, requiring a doctor to make patient-specific assessments;

(3) direct warnings to patients are ‘impracticable’

(4) medical ethics require the physician to act as intermediary;

(5) patients can’t be expected to 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.”

In re Accutane Litigation, No. 271, slip op. at 7 (N.J. Super. Law Div. Jan. 29, 2016).  In these 32 cases:

Doctor insulates manufacturer

In each claim, there was a “willing patient” who only thought differently upon acquiring new information via the litigation process.  Because the doctors, in each and every instance, testified that even with a different warning they still would have prescribed the medicine, the manufacturer’s duty is fulfilled.  Because the warning is directed to the prescribing physician, she/he is afforded the opportunity to engage in “hindsight” and opine on what they would have done had they known then what they knew at the time of their deposition, Plaintiffs are not afforded an opportunity at “hindsight.”

Slip op. at 9.  In only one case was summary judgment denied, without prejudice, because a deposition hadn’t been completed.  Id. at 11-12.
Choice of law was no obstacle.  These plaintiffs all chose to come to New Jersey and asked for New Jersey law, so they got what they asked for.  Id. at 9-10.  Ask for a New Jersey mass tort, and you get New Jersey law.  Next time, plaintiffs, be more careful what you ask for.  But since the learned intermediary rule is virtually universal, even under other states’ law (Kansas, Louisiana, California, Texas) the result is the same.  Page after page of the slip opinion (pp. 11-36) consist of minor variants on the theme of no change in prescribing behavior equals no causation.
Edited and Republished from JD Supra.

Larry Bodine

Attorney Larry Bodine is Editor of Mass Tort Nexus, and the Editor of The National Trial Lawyers. He is the former Editor in Chief of Lawyers.com and the American Bar Association Journal. He is a cum laude graduate of both Seton Hall University Law School and Amherst College.

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