We love the unexpected. We loved standing up after what we thought was the finale of the fireworks show last night only to be left breathless by a stunning and unexpected encore.  We loved walking in to a “quiet family dinner” for our recent advanced birthday to find the room filled with dear relatives and friends shouting “surprise.”  But sometimes it is nice when things happen just as they are supposed to (which, in the jurisprudential world, may actually be unexpected!), like they did in today’s case, a terrific summary judgment decision out of the Eastern District of New York.  (A shout out to Tom Kurland of Patterson, Belknap for the victory and for sending us the decision before it was available online.)

In Chandler v. Janssen Pharms. Inc., et al., — F.Supp. 3d —,  2018 WL 3212422 (E.D.N.Y June 29,  2018), the plaintiff, placed in foster care in 1996 when he was six years old,  began taking Risperdal the next year after displaying aggression at school.  He continued to have serious psychiatric and behavioral problems and to take Risperdal in gradually increasing doses, until 2009.  That year, during a visit with his psychiatrist, the plaintiff complained that his breasts were enlarged.  The psychiatrist recommended that the plaintiff stop taking Risperdal, which he observed was “probably responsible for the breast enlargement,” and noted that he had been aware of the correlation between the drug and breast enlargement for several years. The plaintiff continued to see psychiatrists, and to take antipsychotic medications, until late 2012.   In April 2014, he underwent bilateral mastectomies to remove his enlarged breast tissue.  In March 2015, he filed suit alleging that the defendants failed adequately to wan about rate of incidence of gynecomastia (breast enlargement) in pediatric users of Risperdal.  Specifically, although the label at all relevant times, had always included a Precaution about gynecomastia, the plaintiff alleged that gynecomastia should have been listed in the “Warnings” or “Adverse Reaction” section, and that gynecomastia rates were two to five times higher than the 2.3% rate listed in the label after October 2006, when Risperdal was approved for pediatric use.  He alleged that his doctor would not have prescribed Risperdal if he had known about the higher incidence rate.

The defendants moved for summary judgment, arguing that the plaintiff had not produced admissible evidence that the Risperdal gynecomastia warning was inadequate.   The defendants argued that the only “evidence” supporting the plaintiff’s warnings claim was the two cherry-picked clinical studies that ostensibly demonstrated the higher incidence rate, a “contention that [was] inadmissible without expert testimony.” Chandler, 2018 WL 3212422 at *6.

The court explained that, under the learned intermediary doctrine, a drug warning is “adequate as a matter of law if it clearly and unambiguously notifies the prescribing physician of the particular adverse reaction that forms the basis of the plaintiff’s complaint.” Id. (citations omitted).  Because the Risperdal label always warned that the product could cause gynecomastia, the plaintiff could not prove that the label was inadequate.   The court also rejected the argument that the label should have included an incidence rate for gynecomastia before the drug was approved for use in children, noting that the defendants “were clearly keeping abreast of knowledge” of the drug through available methods and were “taking steps to bring that knowledge to the attention of the medical profession.”   Id. (internal punctuation and citation omitted).  Finally, the court held that the plaintiff had not produced admissible evidence that the gynecomastia incidence rate in the 2006 and 2007 labels was inadequate.  The plaintiff relied on two studies (of eighteen conducted around the same time)  that allegedly showed higher incidence rates, but the plaintiff “introduce[d] no  expert testimony on the validity of [those]  studies, either standing alone or  compared to the other sixteen studies, or [on]  the regulatory requirements of labeling.” Id, at *8.  Without an expert, the court held, the plaintiff could not opine on the “statistical or methodological differences between the studies or why the two studies he cited were correctly decided in comparison to the other sixteen.” Id.  Concluding, “To be clear, while the two studies could be evidence of higher incidence rates, the absence of an expert to interpret and validate them precludes their admission,” id, the court held that Risperdal’s gynecomastia warnings were adequate as a matter of law at all relevant times.

Warnings Causation

Though the defendants were entitled to summary judgment based on the adequacy of the warning, the court went on to consider the issue of warnings causation; in other words, whether a different warning would have changed the plaintiff’s doctors’ decisions to prescribe the drug. The court added, “if the treating physician is aware of the risks of a drug, independent of any warning by the manufacturer, such knowledge constitutes an intervening event relieving the manufacturer of any liability to a patient under a failure to warn theory.” Id. at *10 (internal punctuation and citations omitted).   In this case, both of the plaintiff’s prescribing physicians knew of the possible correlation between Risperdal and gynecomastia “both before and during the time that they prescribed the drug” for the plaintiff. Id.  One of the doctors testified that he wasn’t sure he would have changed his prescribing decisions even if he knew the risk was higher.  The other  testified that, although he knew of the gynecomastia risk from other  sources, he didn’t read the label or advise the plaintiff of the risk, both of which constituted intervening causes, “severing the causal connection between Defendants’ alleged failure  to warn and Plaintiffs’ injury.” Id. (citation omitted).  Finally, the court disregarded the plaintiff’s guardian’s affirmation to the effect that she would not have consented to the Risperdal prescription if the plaintiff’s doctor had advised her of the gynecomastia risk.  The court explained, “A failure to obtain informed consent might be a viable theory of liability against [a] physician or … hospital,” but neither was a party to the lawsuit.  Because the plaintiff could not establish specific (warnings) causation, the court held that the defendants were entitled to summary judgment on that basis as well.

We love a good warnings decision, and we are delighted that we had the chance to bring this one to you.   We hope you all had a great holiday.

We’re now into the New Year but aren’t completely done with the old one.  The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways.  (We say “conventionally” because some sources report that January is actually named after its tutelary deity, Juno.) Janus, like some of our opponents, is two-faced.  Janus looks both forward and backward.  Bexis last month took a couple of long looks backward at 2017’s best and worst cases.  We’re still scrolling through the various Ten Best of 2017 culture lists for ideas, confirmations, and occasional outrages.  An in-house lawyer we endlessly respect pointed us to The New Yorker’s  list of top tv programs.  It’s hard to quarrel with Emily Nussbaum’s choice of The Leftovers, a fever-dream about love and loss (and a lion sex boat) as the best drama.  She was also right to praise American Vandal, the show that made us laugh out loud the most.  (The Good Place came in second on that score.)  Nussbaum also gave honorable mention to Halt and Catch Fire, an AMC show that really did seem to catch fire after its first, flawed season.  HACF stopped acting like a Mad Men, difficult-guy retread, shifted focus to the female protagonists,  and successfully steered us through the digital revolution – from PC clones to gaming to community chat boards to security to the web to PayPal to Yahoo to something even sexier than a lion sex boat: the Next Idea.  In seasons 2-4, HACF managed to show us (rather than merely tell us) how “computers aren’t the thing; they are the thing that gets us to the thing.”  That ‘thing’ is human connection. But you already knew that, right? There is an episode after the death of a major character that is the best depiction of grief and its clumsy toggling between the transcendent and the quotidian that we’ve seen.  The dead leave a lot behind.  Some of it goes to Goodwill.  Some of it survives in silly stories.  Some of it gets caught in our throats and some of it squeezes our tear ducts hard.  If you are looking for something to binge, consider The Leftovers, American Vandal, and Halt and Catch Fire (and maybe Patriot, The Americans, and Mindhunter).  You might also want to set aside an hour to take in episode 8 of Twin Peaks: The Return because you need to relive your college experience of attending a midnight showing of something arresting and supremely weird. 

Today’s post takes us back to 2017 for a case that is neither particularly arresting nor even a little bit weird.  Rather, the result seems inevitable.  In Siddoway v. GlaxoSmithKline LLC (In re Avandia Mktg., Sales Practices & Prods. Liab. Litig.), 2017 U.S. Dist. LEXIS 203885 (E.D. Pa. December 12, 2007), the plaintiff alleged that he sustained a heart attack from taking Avandia, and that the label did not warn him adequately.  The facts here, both regarding the plaintiff’s use and the regulatory backdrop, lead ineluctably to the defendant’s victory on summary judgment.   The plaintiff was initially prescribed Avandia from 2001 through 2002. In 2003, the plaintiff suffered two heart attacks, and ultimately underwent a successful heart transplant operation. He blamed Avandia for those heart attacks.  Following the heart transplant, a different doctor prescribed Avandia to the plaintiff. The plaintiff continued to take Avandia from December 2003 through June 2007, and did not experience any other adverse cardiovascular condition.

Let’s go backward for a moment.  When Avandia was initially approved by the FDA in 1999 to treat Type II diabetes, the drug’s label contained no warning of an increased risk of heart attack. But in 2007 – four years after the plaintiff’s heart transplant — the FDA issued a safety alert for Avandia, notifying consumers that “data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”  The FDA directed that a boxed cardio warning be added to the Avandia label.  So there’s your lawsuit, right?

Not quite.  Now let’s go forward.  After the label change and after the plaintiff filed his lawsuit, the manufacturer and the FDA conducted extensive research on Avandia’s safety. In 2013, the FDA ultimately concluded that there was no increased risk of heart attack associated with Avandia use compared to alternative diabetes medications. Thus, in 2014, the FDA approved an updated Avandia label that removed the boxed warning for a potential increased risk of heart attack.  Good science led to good news for patients, but not such good news for this particular patient’s lawsuit.  All of the plaintiff’s nine causes of actions essentially boiled down to failure to warn theories, and the facts on the ground had removed all support for that theory.  Even putting aside the question of whether the original label was inadequate because it lacked a warning that had now been repudiated by the FDA, the plaintiff’s case failed for inability to show that the alleged failure to warn was the proximate cause of the plaintiff’s injuries.  To the extent that specific claims bumped against the learned intermediary doctrine (Utah law governed, so the learned intermediary doctrine was alive and well), the plaintiff faced a huge problem when it came to posing the usual question to the prescriber:  knowing what you know today, would you still have prescribed this medicine to the plaintiff?  From his deposition testimony, it is clear that the prescriber’s “understanding of Avandia’s risk profile today is the same as it was when he prescribed Avandia to [the plaintiff]—that Avandia is not associated with an increased cardiovascular risk compared to other diabetes drugs.  He also testified that, if the current package insert were in place when he was prescribing Avandia to [the plaintiff], he still would have prescribed it.”  That is pretty inescapable logic.  John Adams once said that “facts are stubborn things.”  So is science.  So are label changes. 

But the plaintiff did try to escape the facts, the science, and the label changes.  He pointed to the prescriber’s testimony that he “quit using” Avandia for patients after 2007.  But that same prescriber’s testimony made clear that even when the 2007 data on which the plaintiff based his claims is considered along with the other Avandia risk data available today, he would still prescribe Avandia to the plaintiff, just as he had in 2001 and 2002, when there was no heart attack risk warning in the Avandia label. It is as if the plaintiff tried to preserve his case by seizing upon one favorable moment in time and excluding any other, subsequent facts that might prove inconvenient.  Don’t look forward, and don’t look backward.  Just look at the evidence in that nanosecond that might support a claim.  But no decent doctor would do that.  Nor would any sensible court.  Hence, the Siddoway court held that the plaintiff had failed to establish a genuine issue of material fact as to whether the prayed-for warning would have deterred the doctor from prescribing Avandia to the plaintiff before he suffered the 2003 heart attacks.  The court looked at all the evidence, forward and backward, and saw its way clearly towards complete dismissal of the case.