Plaintiff in Gurule v. Boston Scientific Corp., 2023 Cal. Super. LEXIS 49321 (Cal. Super. Jul. 18, 2023), tried to pull off a little magic through misdirection, but couldn’t fool the court. Plaintiff tried to distract the court from the complete lack of sufficient allegations to satisfy even notice pleading requirements by alleging an elaborate conspiracy among the manufacturer, the prescribing surgeon, and apparently a group of urologists at USC. The “conspiracy” was based on the surgeons doing things like attending manufacturer sponsored events, consulting for the manufacturer, and receiving grants and sponsorships. Essentially, all the things doctors and medical device manufacturers do – collaborate on product development and education. Comes as little surprise that that was not enough to keep the case alive.
Plaintiff underwent surgery to implant a penile prosthesis and alleges that he has suffered complications since the surgery. The device is a Class III, Pre-Market Approved prescription medical device. Which means plaintiff had to allege claims that were not expressly preempted by Riegel v. Medtronic, Inc., 552, U.S. 312 (2008). Something they did not do for failure to warn. Plaintiff’s only failure to warn allegations were that defendant needed to include warnings that were different from or in addition to those approved by the FDA. While plaintiff stated that he was asserting a parallel claim – saying it and doing it are two different things. Gurule, at *17-18. The court also found that plaintiff’s allegations “hinge entirely on FDA and PMA violations.” Id. at *18. Since they were based on the FDCA rather than California state law, the claims were also impliedly preempted.
But that was not the only problem with plaintiff’s failure to warn claim. California adheres to the learned intermediary doctrine and plaintiff failed to allege that his physician was not adequately warned. Id. at *20. And while a failure to report adverse events to the FDA is not preempted in California, plaintiff failed to include any of the necessary allegations to sustain such a claim – that any adverse events were not reported; that the FDA would have made them public; or that his surgeon relied on the FDA database. Id.
None of plaintiff’s remaining claims fared any better. His manufacturing defect claim was dismissed as entirely conclusory. No defect, no malfunction, no causation. Id. at *21-22. Negligent misrepresentation was done in by the learned intermediary doctrine because defendant’s duty ran to the implanting surgeon, not plaintiff. Id. at *23. Plaintiff’s breach of express warranty claim was unsupported by any allegations that defendant made any representations to plaintiff’s surgeon that formed the basis of the bargain. Id. at *25. Finally, California’s Unfair Competition Law provides only a derivative claim. With no other viable claim, plaintiff’s UCL claim also failed. Id. at *24.
If plaintiff is going to try to pull a rabbit out of a hat, they better have more up their sleeve than a quasi-conspiracy.