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Monday, December 23, 2024

California District Court Punts on Learned Intermediary Causation Post-Himes


We posted earlier this yr concerning the failure to warn causation resolution from the California Supreme Courtroom in Himes v. Somatics, 549 P.3d 916 (Cal. 2024), and the potential parade of horribles that may ensue.  Right here comes the grand marshal of the parade.

The choice we report at this time is on remand from Himes itself (although the case caption, Riera v. Mecta, 2024 U.S. Dist. LEXIS 194654 (C.D. Cal. Oct. 24, 2024), may not appear like it).  To recap, in answering a licensed query from the Ninth Circuit in Himes, the California Supreme Courtroom held {that a} plaintiff can set up failure to warn causation with proof that (1) the prescribing doctor would have handed on a stronger warning to the affected person, and (2) “an objectively prudent particular person within the affected person’s place” would have declined the remedy.  Himes, 549 P.3d at 921.  After receiving the reply to the licensed query, the Ninth Circuit remanded to the district court docket.  Making use of the info to the Himes normal, the district court docket punted to the jury.

Plaintiffs’ claims come up from the usage of electroconvulsive remedy (“ECT”) with Somatics’s units.  Plaintiff Himes started ECT after repeated hospitalizations for melancholy and suicidal ideation over a multi-year interval and after unsuccessfully making an attempt 9 completely different medication.  In her lawsuit, she alleged the ECT precipitated extreme physiological, psychological, and emotional accidents, together with cognitive impairment and reminiscence loss.

When the prescribing doctor was requested whether or not he would talk the danger that the ECT gadget may trigger the lack of potential to formulate new recollections, he “responded that he would ‘should see it’ himself, however acknowledged he would inform the affected person of the danger.”  Riera, 2024 U.S. Dist. LEXIS 194654, *4.  He additionally acknowledged that “any warnings acquired from Somatics relating to everlasting reminiscence loss, mind damage, or the shortcoming to formulate new recollections could be included within the knowledgeable consent kind he provides his sufferers.”  Id.  This was ample for the district court docket to disclaim abstract judgment on prong one of many Himes causation evaluation.

The court docket additionally discovered a problem of truth on prong two. To find out what an “objectively prudent particular person within the affected person’s place” would do, the Himes court docket listed a variety of components to contemplate, together with:

[W]hether the doctor weighed and assessed the dangers and advantages of the remedy and, after discussing these dangers and advantages with the affected person, continued to suggest the remedy; whether or not the remedy was novel or was as a substitute a longtime methodology for addressing the affected person’s situation; the supply and utility of other therapies and the diploma to which they’ve beforehand been tried in an effort to handle the affected person’s situation; the severity of the affected person’s situation; and the probability that the remedy would have resulted in additional than marginal advantages to the affected person. [¶]  As well as, private traits of the affected person or circumstances distinctive to the affected person must be taken into consideration when making use of the objectively prudent particular person within the affected person’s place normal.

Himes, 549 P.3d at 931.

Though the district court docket acknowledged that Somatics successfully argued {that a} affordable particular person in Himes’s place wouldn’t have declined ECT remedy given the severity of her situation, that also was not sufficient.  Plaintiff obtained to the jury with proof “that different, unexplored therapies like particular person remedy have been obtainable to her” and “proof disputing the long-term security and effectiveness of ECT.”  Riera, 2024 U.S. Dist. LEXIS 194654 at *7.

This resolution wrongly applies the Himes normal not solely as a result of it fails to contemplate the Himes components, however as a result of it neglects a important piece of the Himes goal causation evaluation.  The query isn’t merely what an objectively prudent particular person typically would do.  It’s what an objectively prudent particular person in the affected person’s place would do.  Proof of “different, unexplored therapies like particular person remedy” mustn’t have created a problem of truth right here as a result of it was undisputed that “Himes was by no means supplied or given particular person remedy.”  Id. at *7, *3.  Neither is there any indication within the opinion that Plaintiff would have been supplied “proof disputing the long-term security and effectiveness of ECT.”  Id. 

How may an objectively prudent particular person within the affected person’s place decline remedy when she wouldn’t have had any of this data?  This resolution merely will get it fallacious.  Hopefully others is not going to be a part of this misguided parade.

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