Sort of like hail in Alabama.  It happens, but when it does it’s an event.  Not like say picking a perfect NCAA March Madness bracket (1 in 2.4 trillion).  Maybe more like the chance of getting struck by lightning in a lifetime (1 in 13,000).  In any case, a California trial court decision finding no warning causation under the learned intermediary doctrine caught our attention as newsworthy.  The case is one of the coordinated Pradaxa Cases, Case No. CJC-16-004863 (Cal. Super. Nov. 8, 2019) (Lawson, CGC-17-559611), slip op.

Plaintiff was prescribed Pradaxa in late 2010 to treat her atrial fibrillation.  Id. at 2-3.  Her prescribing physician testified that at the time he prescribed Pradaxa to plaintiff he was aware that it carried a risk of significant bleeding, which risk was increased in female patients over the age of 75, which plaintiff was.  Id.  The prescriber also testified that he informed plaintiff of these risks.  In 2016, plaintiff suffered an intracranial hemorrhage.  She was administered the Pradaxa reversal agent and was stabilized.  Id. at 4.    Defendant moved for summary judgment on plaintiff’s claims for failure to warn, fraud, and misrepresentation.

We’ve seen these cases elsewhere before – no warning causation where doctor knew of the very risk (and in this case warned of the risk) that materialized.  But, again this is California.  The court pointed out that neither party cited any California cases to support their arguments on warning causation.  There was no binding precedent.  Id. at 8n.9.  What the court did find persuasive in this instance is the level of speculation needed on all sides to find causation – a level to which the court was unwilling to go.

First, plaintiff could not testify that she definitely would have changed her mind if provided additional risk information.  At best she said she “probably” would have refused or “might” have said no.  That’s not enough.  Id. at 4n.5.

Second, the prescribing physician, after being shown “various medical literature, references to [manufacturer] company documents, and regulatory documents,” testified that he stood by his prescribing decision.  The additional information would not have changed either his decision to prescribe Pradaxa to plaintiff or his informed consent discussion.  Id. at 5.  “This evidence is sufficient to demonstrate that Defendant’s alleged failure to warn did not proximately cause Plaintiff’s injury.”  Id. at 9.

What plaintiff clung to was her physician’s testimony that he would have liked to have known if there was a mechanism to monitor/measure a patient’s Pradaxa levels and that he would have measured the levels to see if there was a risk of a major bleed.  Id. at 5.  Plaintiff used this testimony to attempt a factual leap of causation.  If the doctor had known he could measure Pradaxa levels, he would have.  And if he did, he would have discovered her elevated levels and reduced her Pradaxa dosage or changed her medication to a different anticoagulant.  Id. at 9.  But the prescriber’s testimony only supports that he would have measured plaintiff’s levels, not whether those measurements would have caused him to alter courses.  In other words, [p]laintiff’s theory for proximate causation is speculative.”  Id.

The speculation could not be saved by a retained expert’s opinion.  Plaintiff’s expert testified that the elevated levels of Pradaxa in plaintiff’s blood “more likely than not caused her intracranial bleed.”  Id. at 11.  But warning causation is about the learned intermediary, not an outside expert:

However, regardless of [plaintiff’s expert’s] opinions, what matters to the causation inquiry in this case is [the prescriber’s] opinion, that is, as the learned intermediary, whether [the prescriber] would have changed his course of treatment or provided different warnings to Plaintiff.

Id. That evidence simply did not exist and that “absence of evidence” was fatal to plaintiff’s case.  Id. at 12.

Plaintiff’s last effort to save her case was to argue that because her prescribing physician testified that he may have changed some of his conduct if provided different information she had met her burden of proof.  But plaintiff did not frame the legal question correctly.

Upon a review of the case, the legal inquiry on causation is not, as Plaintiff suggests, whether the prescribing physician would have changed his conduct of the manner in which his [sic] would have prescribed the drug if he had received the warning or risk information of which he was unaware at the time.  Such a standard is too broad.  Rather, the change in a physician’s conduct or prescription procedures must have sufficiently prevented the Plaintiff’s injury, and/or be sufficiently connected to the injury.

Id. at 14 (citations and quotation marks omitted).  In other words, to defeat summary judgment, any change in the prescribing physician’s conduct must have been causally related to the alleged injury.  All doctor’s want to know more.  That is not enough to create a triable issue of fact.  Id. at 15-16.  Doctors get new information all the time that has no impact on their prescribing decisions.  To establish causation, the doctor must testify that he would have wanted to know and he would have done something differently that is related to the actual injury plaintiff suffered.  A possibility of a change in conduct is likewise insufficient – “might” or “may” are not enough.  Id.

The lack of warning causation was fatal to all of plaintiff’s warning-based claims and summary judgment was granted.  This might not be a blue moon (1 every 2.7 years) or a shark attack on a human (1 in 3.7 million).  It may not even be the only favorable California trial court decision we blog about this week.  But just because you find more than one four leaf clover in the same field doesn’t make it any less remarkable.  Who knows when the next one will come along?