This past Sunday, we, as Drug and Device Law Jews, celebrated Rosh Hashanah, the Jewish New Year.  Normally, we host dinner for 20 or so members of our extended family.   This year, the entire day before the holiday was occupied by the uber-wedding of the Drug and Device Law Rich Cousin’s daughter.  Because we had no time to prepare for the holiday dinner, we opted, for the first time ever, to go out for the meal.  We, along with several dozen relatives, descended upon a local (Italian!) restaurant that was hosting hundreds for what was billed as a “traditional” Rosh Hashanah feast.  As the courses arrived, our table rang with youthful cries of “that doesn’t look like our gefilte fish/brisket/kugel” answered with a chorus of “it’s close enough.”  Such is the case with today’s decision.  It does not involve a drug or a medical device, but it is a products case with a strong holding that bolsters arguments we make in the prescription drug context.  So it is “close enough” to be relevant for readers of this blog.

Regular readers know that we have blogged many times about the issue of ‘innovator liability” – whether the innovator and manufacturer of a branded drug can be liable for injuries to a plaintiff who took the generic version of the drug, which was not manufactured or sold by the innovator company.  Seven years ago, in Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), review denied (Cal. Jan. 21, 2009), the California Court of Appeal came up with the wrong answer to this question, holding that a plaintiff who used a generic drug could sue the manufacturer of the branded  version.  As Bexis likes to say, the Conte court took the “product” out of product liability and held a company potentially liable for injuries allegedly caused by a product that it did not make and did not sell.  In the months after Conte was decided, we criticized virtually every aspect of it here, here, here, and here.

n the ensuing years, we have posted about Conte and innovator liability numerous times – you can see all of our posts collected here — as we waited and watched to see which courts would adopt this poorly-reasoned holding that flew in the face of the foundations of product liability law.  As we have been happy to report (you can see our innovator liability scorecard here and our 50-state survey of innovator liability here) Conte is now an outlier, with the majority of courts holding that an innovator drug manufacturer cannot be liable for injuries allegedly caused by a generic drug it did not manufacture or sell.


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The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators.  We’ve given you the link, but it might be behind a paywall.

The article indicates that 3D printing of medical devices is already a reality.  3D printing is currently being used with implants where sizing is both critical and extremely patient specific – the article mentions tracheal splints, skull plates, hip cups, spinal cages, knee trays, and dental reconstruction devices. Here’s a cool slide show that we found on the FDA’s website showing some of them and discussing relevant 3D printing techniques.  Also according to the article, the FDA doesn’t have any specific 3D printing guidance available – which we confirmed on Westlaw (no mention of “3D printing” or “additive manufacturing” in any FDA guidance).


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