California state court is not the place most products liability defendants want to end up.  Unfortunately, today’s case had to stay in state court because plaintiff sued the defendant’s device representatives who had direct contact with the plaintiff.  The reps, like plaintiff, were California residents and destroyed diversity jurisdiction. The decision, however, in James v. Medtronic, 2022 WL 6238373 (Cal. Sup. Ct. Sep. 16, 2022), is both clear and good.

Plaintiff suffered from chronic back pain.  He asked his doctor if he could undergo a spinal cord stimulator trial.  The stimulator is an implanted device that uses electrical pulses to interrupt pain signals.  Id. at *1.  Plaintiff’s doctor told him he “was not an ideal candidate” for the device due to his cardiac history and use of blood thinner medications.  Plaintiff wanted to proceed anyway.  Plaintiff spoke with one of defendant’s device representatives and claims the rep told him people with his cardiac history commonly use the defendant’s device.  Id. at *2.  A few days after the device was implanted, plaintiff met with another device rep to adjust the settings for the device, which is done via Bluetooth connection.  Plaintiff asked the rep if the adjustment had to be done in a doctor’s office and when the rep advised it did not, plaintiff suggested they meet at a nearby fast-food restaurant.  During the adjustments, plaintiff experienced complications which led to an epidural hematoma and leg paralysis.  Id. at *2. 

Plaintiff brought claims for strict liability failure to warn, negligence, and negligent misrepresentation.  There was no dispute that defendant warned about the risks of the surgery and implantation of the device in patients with cardiac conditions.  So, plaintiff limited his failure to warn claim to failure to warn about the increased risks associated with adjusting the stimulator in patients taking blood thinners.  Id. at *7.  Because the stimulator underwent Pre-Market Approval by the FDA, any failure to warn claim should be preempted.  So, defendant moved on that ground.  In opposing, plaintiff chose to ignore Riegel completely.  But the court did not.  Finding the first prong of Riegel satisfied by the PMA, the court looked at whether plaintiff’s claim would impose state law requirements on the device that are different from or in addition to those imposed by the FDA.  Id. at *8.  Medtronic produced evidence that the warning it gave was the one approved by the FDA.  Therefore, any different warning would impose additional requirements and therefore be preempted.  Id. at *9.

But this is California and plaintiff also alleged a failure to report claim which has been recognized as a parallel claim by the California Court of Appeals.  Id. at *8.  Therefore, at the summary judgment stage the burden was on defendant to demonstrate that it did not fail to report adverse events to the FDA.  That’s just what defendant did here via testimony from an employee about compliance with their reporting obligations.  In response, plaintiff argued only that defendant provided evidence that it’s employees maintain compliance with reporting obligations, not the company itself.   We’ll let you re-read that and give it a moment to sink in.  The employee was compliant but not the company.  Having presented no evidence to refute defendant’s, plaintiff’s failure to report claim also failed.  Id. at *9.

As to negligent misrepresentation, plaintiff pointed to his two conversations with defendant’s device reps.  The first rep made a statement about the frequency with which patient’s with similar cardiac conditions undergo stimulator implant.  The court reasoned that reasonable jurors could differ as to whether the rep was making a statement about the safety of the device.  But what plaintiff could not demonstrate was that the rep’s vague statement was material to plaintiff’s decision to undergo the surgery.  Plaintiff’s doctor advised against it and offered other alternatives which plaintiff rejected.  The evidence established that plaintiff had made up his mind to have the stimulator implanted well before he met with the device rep.  Id. at *13.  The court also found the statement “too vague for [plaintiff] to have reasonably attached importance to.”  Id. at *14.  It would be unreasonable to infer that plaintiff, who failed to heed the advice of his doctor, would make his decision based on a general comment by a device rep. 

As to the other rep’s statement that the adjustment did not need to take place in a doctor’s office, the court was unwilling to conclude that was a misrepresentation that the device was safe.  Id. at *13.  Therefore, the negligent misrepresentation claim was dismissed as to the manufacturer and the device reps. 

Defendant also moved to dismiss the negligence claim on causation grounds, but the court decided the experts could battle that out at trial.  Id. at *10-11.   Note, the negligence claim is based on the conduct of the device representative–demonstrating the perils (particularly in a PMA preemption case) of letting sales representatives have direct contact with patients, who can be expected to blame the rep for anything and everything.  Importantly, however, while the negligence claim survived summary judgment, the court held that the representative’s conduct failed to support punitive damages as a matter of law. As it turns out, the device rep suggested that the adjustment be done at a medical center, and it was plaintiff who wanted it done closer to his home and suggested the restaurant parking lot.  The reps accommodation of plaintiff’s preferred meeting location does not demonstrate a conscious disregard for plaintiff’s safety.  Id. at *15. 

Overall, the meat of plaintiff’s claims has been stripped away, leaving us with a little optimism about the Golden State.