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Today’s case is about a very unfortunate set of circumstances.  A woman who suffered from bipolar disorder and who was not trying to get pregnant did in fact become pregnant two months after being prescribed a mood stabilizer that carried a black box warning regarding birth defects. Fisher v. Abott Labs, 2023 U.S. Dist. LEXIS 194594 (C.D. Cal. Oct. 27, 2023).  Plaintiff was born with a pre-existing genetic condition unrelated to his mother’s use of the mood stabilizer, but sued the manufacturer alleging the drug may have exacerbated his symptoms.  Id. at *7. 

Plaintiff made many arguments to try to save his warnings claims.  He argued the warning provided by the manufacturer was inadequate.  He argued that there were other drugs on the market that were safer that could have been prescribed.  He argued the prescribing physician should have considered other options.  He argued that because the prescriber’s notes did not include a statement that he warned plaintiff’s mother about the risks of birth defects, it is an open question whether he did so warn her.  Finally, he argued that in recent years the prescriber stopped prescribing the drug to women in childbearing years, which is simply an inaccurate account.  The prescriber, having the same knowledge today that he had when he prescribed the drug to plaintiff’s mother, “tries to avoid” prescribing to women of childbearing age – which is precisely the same thing he did with plaintiff’s mother.  Id. at *14-18. 

None of those arguments, however, counters the fact that plaintiff had no evidence that if the prescriber had received a different warning, he would have opted not to prescribe the mood stabilizer to plaintiff’s mother.  Without that, plaintiff does not have causation.  Without causation, all his other arguments are irrelevant.

The prescriber’s testimony in this case is key.  He testified that when treating bipolar disorder, he prescribes mood stabilizers along with other medications.  At the time he treated plaintiff’s mother, he used three mood stabilizers.  His practice was to start with the one with the least side effects and move on to the second and third only if the prior drug was ineffective or could not be tolerated.  Defendant’s drug was his third line choice due to the black box warning.  Id. at *2-3.  Plaintiff’s mother could not tolerate the first line drug and so was prescribed the second line which seemed to be effective for several years.  Her condition worsened in 2021, causing her physician to switch her to defendants’ drug. Id. at *3-6.  The prescriber testified that he believed the prescription was necessary to treat plaintiff’s mother.  He also testified that he would have warned plaintiff’s mother about the serious risk of birth defects and advised her not to become pregnant without consulting with him first.  Id. at *6. 

It is well established California law that if plaintiff fails to adduce evidence that the prescribing physician would have acted differently if provided different warnings, defendant is entitled to summary judgment.  Id. at *11.  The uncontroverted evidence here is that the prescribing physician was well aware of the serious risk of birth defects, tried other medications before prescribing this one to plaintiff’s mother, and warned plaintiff’s mother against becoming pregnant.  Notably, plaintiff’s counsel never asked the key question to the prescriber—would you have done something differently?  So, the record is that the physician “stands by his prescription and believes it was necessary.”  Id. at *13.

So, adequacy does not matter.  Other options do not matter.  Causation matters.  Without it, plaintiff’s case does not survive.