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We are just back from a lovely long weekend in Mexico.   We were delighted to find, on our DVR, a show we’d forgotten we set to record:  a special interviewing the cast and director of Love, Actually on the 20th anniversary of that film’s release.  This is our all-time favorite holiday film, and pretty close to our favorite film of any genre.  We love how it has crept into popular culture (the SNL parody of the flip cards scene, featuring Kate McKinnon as Hillary Clinton is nothing short of brilliant), and we find the film endlessly charming and restorative, no matter how many times we watch it.   Take a look at the special, if you missed it

Speaking of all-time favorites, today’s case deals with warnings causation, our all-time favorite doctrine.  (Along with our co-blogger, Mr. McConnell, we just presented a CLE on this topic.)  This is the doctrine:  to prevail on a failure-to-warn claim in a prescription drug or medical device case, a plaintiff must prove both that the products warnings were inadequate and that the inadequate warning proximately caused the plaintiff’s injuries. Subject to variations of local law, the general rule is that, to prove the warnings causation piece, a plaintiff must adduce evidence that a different or stronger warning would have altered her physician’s decision to prescribe the drug or device. 

In Brennan v. Johnson & Johnson, et al., 2022 WL 17219513 (C.D. Cal. Nov. 18, 2022), the plaintiff alleged that the warnings provided with her pelvic mesh devices were inadequate.  She asserted failure-to-warn claims sounding in negligence and strict liability, and the defendant moved to dismiss both, arguing that the plaintiff could not prove that any inadequacy of the warnings proximately caused her injuries because her prescribing physician had not testified that she would have acted differently in the face of a different warning. 

And the court agreed, finding that “the undisputed facts reflected that [the doctor] testified she read the IFU, relied on the warnings provided by [the defendant], believed she had a comprehensive informed consent process, and would have passed on a warning about the risk of severe and chronic pain to patients.  However, the undisputed facts also reflect that [the doctor] never testified she would have changed her prescribing decision or given a different warning.”  Brennan, 2022 WL 17219513 at *12.   Note that “she would have passed on the warning” did not necessarily equate to “she would have changed her decision” in the court’s mind.   This is the key to a correct warnings causation decision, in our view, and it is where so many warnings causation decisions go off the rails.  It is also akin to an issue currently before the California Supreme Court on a question certified by the Ninth Circuit; namely, does the plaintiff have to show that a stronger warning would have altered the physician’s prescribing diction, or can the plaintiff establish causation by showing that the physician would have informed the plaintiff of the stronger warning and that a prudent person in the patient’s position would have declined treatment.

Here, the court confronted the question directly, turning for guidance to one of our all-time favorite warnings causation decisions, Motus v. Pfizer, Inc ,196 F. Supp. 2d 984 (C.D. Cal. 2001), aff’d sub nom. Motus v. Pfizer Inc. (Roerig Div.) 358 F.3d 659 (9th Cir. 2004). In Motus, as the court explained, the plaintiff’s attorney never asked the treating physician the ultimate question − whether he would have behaved differently if the manufacturer had provided a different warning; instead, he asked only whether the doctor would have passed the information along to the plaintiff.   The court found that there was no question of fact for the jury because the testimony “[did] not establish that if that warning had been provided, [the doctor] would not have prescribed [the product] or would have told Mr. Motus something other than what he did say.  Based on that record and the lack of affirmative deposition testimony, the district court granted summary judgment for the manufacturer because there was no evidence establishing that [the physician] would have acted differently.”  Id. at *13 (internal punctuation and citation to Motus omitted).  Note that this is just a little murky:  what the doctor would have told the patient does seem to be on the table in the court’s analysis.  But the Ninth Circuit cleared it up a bit, affirming the grant of summary judgment because the plaintiff “failed to establish proof that stronger warnings would have changed her husband’s medical treatment or averted” his injuries.  Id. (citation omitted). 

And the Brennan court, applying Motus, further closed the gap, holding that the plaintiff could not prove warnings causation, even in the face of the doctor’s “I would have passed on the information” testimony, because she “ha[d] not put forth evidence that [the doctor] would have altered her prescribing decision.”  Id.  And, in the absence of any direct causation evidence, the court held that the plaintiff did “not adequately cite to any additional circumstantial evidence . . . .”  Here’s the best part:  the court emphasized, “[T]he relevant inquiry is not whether Plaintiff would have withdrawn consent given a different warning—instead, it is whether . . . the treating physician would have altered her prescribing decision.”  Id. (emphasis in original, citation omitted.).  We are tempted to have this tattooed on our forearm. If every court heeded this directive, dockets would be wiped clean of thousands of meritless failure-to-warn claims. 

Beyond warnings causation, Brennan also includes a great punitive damages holding. The court explained that, in California, punitive damages are awarded in product liability actions “where it is proven by clear and convincing evidence that the defendant has been guilty of oppression, fraud, or malice.”  Id. at *17 (citation omitted).  The court found that the defendant had met its initial burden of identifying the absence of evidence supporting the punitive damages claim, so the burden shifted to the plaintiff to adduce affirmative evidence creating an issue of material fact.  The plaintiff argued that punitive damages were warranted because the lack of warnings listing the full range of complications associated with the mesh devices “gave rise to a strong inference that these IFUs were likely to deceive doctors.”  Id. (citation omitted). For this proposition, the plaintiff’s “evidence” was an excerpt from the report of her case-specific expert, the redoubtable Dr. Bruce Rosenzweig. The court held that the plaintiff  “[could not] properly rely on Dr. Rosenzweig’s opinion as evidence on the motives of Defendants to create a genuine issue of material fact on their shifted burden, because “[i]nferences about the intent or motive of parties or others lie outside the bounds of expert testimony.”  Id. at *18 (citations omitted). “Accordingly,” the court concluded “the opinion of Dr. Rosenzweig does not demonstrate a genuine issue of material fact that Defendants acted with ‘malice, oppression or fraud’ under California Civil Code § 3294.”  Id.   Summary judgment for the defendant on the punitive damages claim.

Brennan is a terrific decision, giving the back of its figurative hand to several varieties of familiar (and often successful) plaintiff nonsense.   Further evidence that “love, actually, is all around.”   We are officially in the holiday spirit.  Stay safe out there.