Breaking news. This just in. Prescriber’s testimony linchpin in manufacturer’s victory over failure to warn claims. And the crowd gasped at this startling news. Actually, this news might be more the equivalent of an announcement that a 13 year-old boy made a snarky comment to his parents (current daily experience for this blogger). Not exactly a revelation. But we will say that the opinion entered by the magistrate in Harper v. Janssen Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 58298 (M.D. Ala. Apr. 4, 2018) is strong and well-reasoned. A good addition to any learned intermediary library.

Plaintiff is the mother of a boy who was diagnosed with autism at the age of 4. From the age of around 5 or 6 until he was 10, plaintiff’s son was prescribed Risperdal among other medications. During that time he began gaining weight and experienced high prolactin levels. At the age of 16, plaintiff’s son was diagnosed with gynecomastia, an abnormal development of breasts in males. Id. at *5-8. Plaintiff filed suit alleging claims for failure to warn under common law and under the Alabama Extended Manufacturer’s Liability Doctrine (“AEMLD”), negligence, wanton misconduct, breach of implied warranty of merchantability, fraud, and negligent misrepresentation. Id. at *5.

At the core of all of plaintiff’s claims is an allegation that the manufacturer failed to provide accurate or complete information about the risk of gynecomastia with the use of Risperdal. So, there are two key areas of inquiry – what information did the manufacturer provide and what did the prescribing physician know. Starting with the Risperdal label, throughout the time plaintiff’s son was taking Risperdal, elevated prolactin levels and gynecomastia were included in the precautions section of the label. Further, at all relevant times, the label included a warning that “safety and effectiveness in children have not been established.” Id. at *9-10. Plaintiff focuses on studies done by the manufacturer that allegedly show that Risperdal had a greater risk of increasing prolactin levels than other anti-psychotic drugs in the same class and argue that this information was available to defendant at the time plaintiff’s son was prescribed the drug and it should have been part of the warning. Id. at *12-14.

Moving on to the prescribers – the first doctor to prescribe Risperdal to plaintiff’s son testified that at the time he prescribed he knew that safety and effectiveness had not been established for children, that he took that into consideration when prescribing, and that it was his practice to discuss with the parents of child patients that this was an off-label use. Id. at *15. He was also aware that the label called for periodic re-evaluations if the drug was used long-term and again it was his practice to do so and that he only continued patients on medications if he felt the benefits outweighed the risks. Id. at *16. And, the prescriber was aware that Risperdal was associated with weight gain and was also aware that prolactin-elevating compounds could lead to gynecomastia. He took both into account when prescribing Risperdal. Id. at *16-17. The second prescriber was likewise aware that Risperdal was not approved as safe and effective for use in children and would have considered that at the time he prescribed to plaintiff’s son. Id. at *19.

Before jumping into its legal analysis, the court made a few astute observations about the intersection between science and the law and in particular the uncertainty of medicine that are uncommon in legal opinions and so we decided to provide for you directly here:

To a significant degree, this case epitomizes the limitations of medical science, the law, and their interaction. The course of human history has seen profound improvements in our understanding of health, disease, and other afflictions. Recent advances in diagnosis and treatment of medical conditions, both physical and mental, are often little short of miraculous. Despite these advances, our understanding of maladies and their safe and effective treatment remains incomplete and imperfect. This is especially and poignantly true with respect to the broad category of mental health conditions. Doctors and the pharmaceutical industry have developed any number of powerful medicines for treatment of many of those conditions, with varying levels of effectiveness. All these medicines carry the burden of potential side effects for some or all users. Determining the origin of adverse conditions associated with certain drugs is often difficult.

Measuring the breadth and fixing the limits of legal liability for adverse drug reaction requires development and application of legal principles in an area of great medical uncertainty and conflicting economic and societal goals. Through federal and state legislation, administrative regulation and approvals, and the common law, we establish standards for patients, doctors, and pharmaceutical companies to govern their affairs. Legal concepts of proof and causation are often not readily applied where scientific knowledge is incomplete and uncertain. The twin aims of providing appropriate compensation to individuals injured by others while encouraging doctors and drug companies to advance the field of medicine frequently conflict, as in this case.

Id. at *21-22. We’ve blogged on occasion about the pitfalls of the law getting too far ahead of science and how making the two fields meet can be quite tricky – nice to see it in an opinion.

So, faced with a label that warned of the risk, and prescribers who knew and considered the risk, and imperfect scientific knowledge – what was left for the judge was to enter summary judgment. Plaintiff argued that while the Risperdal label contained some warnings, those warnings were incomplete or misleading about the extent of the risk (the studies noted above). However, the label was “not intended to be a risk profile for adolescents.” Id. at *28. The label explicitly stated the drug’s safety and effectiveness had not been established for pediatric patients and also went on to include both increased prolactin and gynecomastia in the precautions. More importantly, as noted above, the prescribers were aware of the risks. “The prescribing decisions of [plaintiff’s son’s] health care providers were made after weighing the risks and benefits of the medication. Critical to a plaintiff avoiding the learned-intermediary doctrine is a demonstration that the manufacturer failed to warn the physician of a risk not otherwise known to the physician.” Id. at *30 (citation and quotation marks omitted).

Further, as to the studies showing increased risk upon which plaintiff relies, plaintiff’s initial prescriber testified “that until a study is completed and the data analyzed, it is not available to him to rely upon in making his prescribing decision.” Id. at *29. Great support from the prescriber for keeping out science that post-dates prescription and usage of the drug. If the studies weren’t published until after the doctor stopped prescribing, they couldn’t factor into his prescribing decision and they shouldn’t factor into the court’s failure to warn analysis.  Putting all this together, the court concluded both that the defendant provided adequate warnings and that the “prescribing physicians knew use of Risperdal in children was an “off-label” use, independently knew of the risks associated with the medication or researched them prior to prescribing the medication, and chose to prescribe it anyway.” Id. at *31. Learned intermediary doctrine bars any failure to warn claim.

Plaintiff’s remaining claims fell away quickly as well. Wanton disregard requires a showing of recklessness or conscious disregard for the safety of others. Again plaintiff’s pointed to the label and argued it wasn’t enough. “The fact that the warnings could have been broader or stronger does not equate to reckless disregard or an indifference toward safety.” Id. at *33.  The label contained a warning of the very risk at issue, therefore, defendant was not indifferent to safety. Breach of implied warranty failed because (a) Alabama doesn’t recognize it for inherently dangerous products and (b) the drug served its purpose of treating mental health. Id. at *35-36. Finally, plaintiff’s fraud and misrepresentation claims fail because even if you assume all facts in the favor of plaintiff, she hasn’t established reliance by her son’s treaters or causation where the treaters knew of the risk and prescribed anyway. Id. at *38.

Learned intermediary may not be a hot new topic, but this testimony and the analysis by the court is pretty top-notch.