Manufacturers supervising medical doctors? In two words, they don’t. Yet plaintiffs, particularly in cases where preemption forecloses more normal product liability claims, try to get courts to impose such duties. We took a look at that issue back during the early days of the blog, when it was still a Bexis/Herrmann operation, in our September
This post is from the non-Reed Smith side of the blog.
In Glennen v. Allergan, Inc., — Cal. Rptr.3d –, 2016 WL 1732243 (Cal. Ct. App. Apr. 29, 2016), plaintiff brought one cause of action – negligent failure to adequately train physicians in the use of a medical device. Id. at *1. That’s it. Not that the product was defectively designed. Not that the defendant erred in the manufacturing process. Not that the device came with inadequate warnings. The plaintiff made none of those allegations. Instead she asserted only that she was injured as a result of implantation of the device done poorly by her physician. But rather than lay that blame at the foot of the physician, plaintiff sued the manufacturer claiming it was the manufacturer’s fault for not properly training the physician.
Quick sidebar: Plaintiff’s pronounced focus on the doctor’s alleged negligence made use stop and think. Plaintiff filed her lawsuit nine years after her surgery and alleged injury. California has a 1-year statute of limitations for medical malpractice, and while the products liability statute is only 2 years, plaintiff probably saw more leeway in arguing when she “discovered” her claim against the manufacturer then against her surgeon. Just a little supposition on how this essentially med-mal claim turned into a products liability claim.
This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week. In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013). In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here). Things didn’t go as well with the in limine motions. It was more of a mixed bag. Here are a few of the issues addressed by the court.
FDA 510(k) Clearance
This was plaintiffs’ motion. They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process. Id. at *4-6. Seems pretty relevant, doesn’t it? It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market. Yet the court granted plaintiffs’ motion.
We’ve posted about the purported “duty to train” before. It’s another of those supposed torts (like duty to test) that’s really little more than duty to warn dressed up in different garb. Fortunately, as we pointed out in our prior post, the notion of an independent “duty to train” prescribers hasn’t really caught…
Today’s post is by a guest blogger, Reed Smith’s own Jobina Jones-McDonnell.
She gets all the credit, and you can just blame Bexis.
This post discusses a recent Minnesota Supreme Court opinion rejecting a “duty to train” claim in a non-drug/device case. The Court held that a manufacturer doesn’t have a duty to train persons how to use its products, even where the manufacturer undertook to provide training as part of the purchase price of the product at issue.
The case, Glorvigen v. Cirrus Design Corp., ___ N.W.2d ___, 2012 WL 2913203 (Minn. 2012), decided on July 18, 2012, involved an airplane crash where the pilot/owner and his passenger died. The estates of the pilot and passenger filed suit against (guess who?) the manufacturer and seller of the plane. The Minnesota Supreme Court was reviewing the appellate court’s reversal of the jury’s special verdict in plaintiffs’ favor. That procedural posture meant that, if the defendant was going to win on appeal, it essentially had to do it as a matter of law, and that’s just what happened.
The pilot purchased the plane about a month prior to the crash. As part of the purchase price, the manufacturer defendant provided a 2-day on the ground and in-flight transition training course. Transition training is standard in the aviation industry. It builds on the pilot’s previous experience and gives the pilot individualized training in the new plane. We’ve seen similar programmes offered by makers of complex medical devices.