(Note that this post comes from the Cozen O’Connor side of the blog.)
Good morning. Do you have your coffee? If so, start sipping it. You will need it. Because this morning we’re going to discuss leads for implantable cardiac defibrillators (“ICD”), Riata Leads to be precise. Now, while this may not be the most thrilling subject, you have to admit that Riata Leads is a solid name. It sounds like something important, like rock-solid leads for selling real estate, the type of game-changing leads that Shelly “the Machine” Levene would plot to steal from his boss’s office. Like the Glengarry leads. But these are not the Glengarry leads. They truly are ICD leads, ones that detect a patient’s abnormal heartbeat and deliver an electric shock to restore a normal heartbeat. So take another sip of your coffee.
Plaintiff Richard Connelly alleges that in 2003 his doctors surgically connected Riata Leads to his heart but that, in 2010, the leads improperly shocked him 16 to 20 times while he slept, causing damage to his heart and requiring surgery to replace them. Connelly v. St. Jude Med., Inc., 2018 WL 732734, at *2 (N.D. Cal. Feb. 6, 2018). Plaintiff hired a lawyer and sued, claiming that St. Jude, the manufacturer, failed to file adverse event reports about the Riata Leads and that, if it had, plaintiff’s doctor would not have implanted them or, in the least, would have removed them after he did implant them. Id. at *1-2.
As you can probably tell already, this is another parallel violation claim. So take another sip. Plaintiffs file a lot of these claims. We write about them often. And they often fail, for many reasons. This one failed because plaintiff didn’t adequately allege causation. In particular, his complaint didn’t connect the defendant’s alleged failure to file adverse event reports about the Riata Leads to his doctor’s decision to implant them or leave them in.
In this respect, the allegations had a number of problems. They had a timing problem. The allegations did not plausibly suggest that the defendants failed to file adverse reports about the Riata Leads before they were implanted in plaintiff, which happened in 2003. Id. at 3. The allegations had regulatory problems. While the FDA issued a 483 Report covering the years 2002 to 2009 noting that the defendant failed to file adverse event reports on Riata Leads, plaintiff did not identify a single failure to file a report before the Riata Leads were implanted in him in 2003. Id. The allegations had defect identification problems. The FDA inspection that resulted in the 483 Report focused on malfunctions in the Riata Leads due to perforation, but the defect alleged by plaintiff had to do with improper abrasion. Id. OK, take one last sip of coffee. We’re almost there.
Finally, plaintiff claimed that defendant’s failed to file adverse event reports about Riata Leads after they were implanted in him, resulting in his doctor not removing them. This theory failed as a matter of California law, which does not allow such claims:
[T]o the extent Connelly’s claim is premised on a theory that St. Jude had a post-distribution (i.e., post-implantation) duty to warn, this fails as a matter of law. Under California law, a defendant may be held strictly liable for a failure to warn only if “the defendant did not adequately warn of a particular risk that was known or knowable…at the time of manufacture and distribution.” Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549, 558 (Cal. 1991).
Id. at 4.
Having already dismissed plaintiff’s complaint once before, this time the Court dismissed it with prejudice.
Ok, all done. Now “Put . . . that . . . coffee . . . down! (I’m here from downtown. . . . I’m here from Mitch and Murray.)