This post is from the non-Reed Smith side of the blog.
This is the official week in the United States for giving thanks. Counting your blessings. Welcoming family and friends to your home. Christmas might get top billing, but Thanksgiving is all about feeling warm and fuzzy. And here at the Drug and Device Law Blog, we’ll get to what we are thankful for tomorrow. Today is a different story. Today we feel more cold and hard. And who is the unfortunate recipient of our negativity at this otherwise festive and lighthearted time – California.
And why is that we don’t want to share our turkey and pumpkin pie with California? Three reasons: negligence, Good Samaritan, and subsequent remedial measures.
Plaintiff Christine Scott sued manufacturer C.R. Bard, Inc. alleging injuries resulting from implantation of that company’s pelvic mesh device. The case went to trial and the jury found the manufacturer negligent and awarded damages (reduced based on finding that surgeon was 40% at fault). Scott v. C.R. Bard, Inc., 2014 Cal. App. LEXIS 1049, at *1 (Cal. App. Ct. Nov. 19, 2014). On appeal, the defendant argued, among other things, that the trial court erroneously submitted the negligence theories of liability to the jury, including negligent training and erroneously admitted evidence of post-surgery events. Id. at *1-2. The court denied the appeal in its entirety. We are blogging about this case because it demonstrates the potholes created by California’s recognition of negligence claims in pharma and medical device cases.
When California rejected strict liability for pharmaceuticals and then medical devices, it did so on the ground that public policy favored bringing new beneficial drugs/devices to market even though they were accompanied by risks. Therefore, a medical device manufacturer cannot be held strictly liable if its device was properly prepared and accompanied by an appropriate warning. Id. at *13 (citing Brown v Superior Court, 751 P.2d 470 (Cal. 1988)). Our reading of this is that a medical device manufacturer can still be liable for a manufacturing defect claim and/or for a failure to warn claim. Bard argued that interpretation to the court – they disagreed. This is the quote from a footnote in Brown that the Scott court chose to focus on instead:
[Drug and device manufacturers] are subject to liability for manufacturing defects, as well as under general principles of negligence, and for failure to warn of known or reasonably knowable side effects.
Scott, at *15. And therein lies the foundation for negligent design claims in California. Seems pretty thin when pitted against the justification for removing strict liability from drug and device litigation, but it’s been enough for some California courts, like this one.
Next, plaintiff got creative. Without strict liability, and having apparently been unable to maintain either a manufacturing defect or a failure to warn claim (directed verdict on the former, defense verdict on the latter, id. at *9-10), plaintiff asserted a negligent training claim. As many device manufacturers do, Bard offered educational opportunities to surgeons. Specifically, surgeons could attend classes, labs or surgery observations related to its pelvic mesh device. Id. at *5. Plaintiff Scott’s surgeon attended one of these sessions, after which her overall impression of the product was that it was safe and superior to other products. Id.
Using this as the hook, plaintiff’s negligent training claim is what is often referred to as “Good Samaritan” liability or “negligent undertaking” liability. We don’t think highly of it no matter what you call it. This concept holds that a person who undertakes to render services necessary to protect another is subject to liability resulting from a failure to exercise reasonable care. First, if manufacturers are going to be exposed to liability for offering training, what’s the alternative? No training. Why risk offering training, if the result is that it will be held against you. Second, California courts have further defined the “undertaking” part of the theory as “to render services to another that the defendant should recognize as necessary for the protection of third persons.” Id. at *17 (emphasis added). It is extremely difficult to comprehend that a one-day class on a medical device is necessary to protect a surgeon’s patients. Medical school, internships, residencies, fellowships – those are necessary. And third, isn’t the court essentially using training to get around the learned intermediary doctrine. They seem to be saying that by attending this class, the surgeon’s independent medical judgment (all those years of necessary medical training) goes out the window. Shouldn’t this really just be part of the failure to warn claim? What information was provided to the surgeon? What information did she independently possess? Was she adequately warned? That last question was answered in the affirmative by the jury – a decision that should have swept away the negligent training claim as well.
Finally, the appellate court upheld the trial court’s decision to admit evidence of subsequent remedial measures (post-surgery FDA regulatory actions). For various reasons, chiefly not to deter defendants from making things safer, the prevailing rule is that subsequent remedial measures aren’t admissible to prove that the defendant was negligent before, for not having done what it later did. That’s California’s rule too. Id. at *28-29. The post-1997 version of Fed. R. Evid. 407 (the relevant federal rule) explicitly states that post-accident changes to a product are not evidence that an earlier version of the product was defective. In other words, the federal rule was amended to make it clear that the exclusion of subsequent remedial measures applies to strict liability cases as well. That’s not the rule in California. According to California, “[w]hen the context is transformed from a typical negligence setting to modern products liability, the public policy assumptions justifying this evidentiary rule are no longer valid.” Id. at *29. So, California is practically the only jurisdiction that still allows admission of subsequent remedial measures because “strict liability” is different than “negligence.” That rule is simply nonsensical as we’ve previously discussed here.
But wasn’t this a negligence case? Well, the court got around that by arguing that the post-surgery actions were actually taken by the FDA, a third-party, and that therefore the policy reasons for exclusion didn’t apply in this case. Id. at *29-30. We’ve got posts on that too (here and here) – identifying dozens of cases excluding FDA-mandated label changes and recalls. The fact that the subsequent measure was directed by the FDA doesn’t justify admitting it as evidence.
We want to stop feeling stern and critical now, and slide into the holiday spirit. So, as a prelude to tomorrow’s post and on a personal note, the thing this blogger is most thankful for today is a husband who is willing to brave the supermarket — 2 days before Thanksgiving and on the eve of the first predicted snowfall — for ginger and nutmeg.