A couple of weeks ago we compared New Jersey litigation with New Jersey food and decided we liked the food better. No aspersions were intended. After all, we grew up in New Jersey and still worship at the altars of Seton Hall Prep, Bruce Springsteen, and the New York football Giants. Anyway, we might need

Today’s post is an update to our post from just a few weeks ago regarding McWilliams v. Novartis AG, No. 2:17-CV-14302 (S.D. Fla.). At that time, the court denied summary judgment on plaintiff’s failure to warn claims, but applying New Jersey law dismissed plaintiff’s claim for punitive damages. Since the case involves an FDA-approved

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while

When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that

This post is from the non-Reed Smith side of the blog.

It can be difficult to have a completely consistent position on choice of law issues.  That’s because state law varies and sometimes you’ll find you are better served by the law of the forum state, other times by the law of the plaintiff’s home state, and sometimes by the law of the defendant’s home state. The issue, the facts, and the law all drive the parties’ preferences.

Typically, however, we tend to favor the notion that liability issues should be governed by the law of the plaintiff’s residence.  That is where the alleged treatment and injury occurred, and those factors are important in any choice of law analysis.  Such a rule also imposes some limit on blatant forum-shopping by plaintiffs.  But what law should apply to punitive damages?  This is where things can get a little fuzzy.  On punitive damages, the balance of interest between plaintiff’s residence and defendant’s residence is more even – making the analysis trickier and also affording more opportunity to craft an argument for the law of the state that is more defense-friendly.Continue Reading Role Reversal – Plaintiff Asks for New Jersey Punitive Damages Law

Without pulling back the curtain all the way on how we find out about new decisions worth a pithy post, we occasionally re-learn about decisions when they are published or added to an electronic reporting service a few months later. When there is a slow week, this dynamic may prompt us to talk about an older decision, even if has already been the subject of a breaking news post. The summary judgment decision in In re Accutane Litigation, No. 271 (MCL), 2015 N.J. Super. Unpub. LEXIS 1216 (N.J. Super. Law Div. Apr. 2, 2015) was the subject of a breaking news post two months ago, but deserves another look, more for the story it tells about drug litigation than for its direct precedential value.

We have posted through the years about the tortured course of Accutane litigation over the risk of inflammatory bowel disease (“IBD”). (There have also been cases about birth defect and suicidality, but we are not focusing on those here.) In general, the news out of the MDL proceeding has been good for years, both on expert issues and the substance of plaintiffs’ claims.   For years, the news from the coordinated proceeding in New Jersey has been very bad, including a few large plaintiff verdicts. Issues with the judge who had overseen the New Jersey proceedings were highly publicized (but not by us), and it is easy to say that her assignment to a new post explained the sea change.

We can guess that the new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. There has also, though, been development in the case law on the New Jersey Product Liability Act (NJPLA) that undercut the legal basis for old (bad) decisions. The persistence of the defendant and willingness of the new judge to consider broad issues late in the life of the litigation bring us to the decision finding the IBD warnings since April 2002 to be adequate as a matter of law under the NJPLA, which sets up a potential adoption for cases where other state law may control.

The history of Accutane’s IBD warnings from the approval of the drug in 1984 through the discontinuation of its sale in 2009 is so extensive that we wonder how warnings claims—the only claims we think should be typically available for a prescription drug—ever could have had legs. As discussed below, we also wonder about other reasons why warnings claims should not have been viable. The court provides detailed findings of fact about the warnings for IBD, which included mechanisms for providing warnings not seen with most prescription drugs. Id. at **15-26. We assume the extra measures were driven by concerns about suicidality in teenage patients and birth defects in their offspring, but IBD was also described in the warnings accompanying blister packs (the only means of distribution since 1990), a guide that physicians had to acknowledge receiving in order to prescribe the drug, a guide that pharmacists had to provide to patients while filling their prescriptions, and brochure that physicians were encouraged to give to patients. Combined with a paragraph in the Warnings section of the package insert, the information provided to physicians warned them up, down, and side to side about the risk of IBD. That sounds a lot like an adequate IBD warning as a matter of law under any state’s law on prescription drug warnings.
Continue Reading Deeper Dive on New Jersey Accutane Summary Judgment Decision

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).Continue Reading Some Ideas About 3D Printing

In a post Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), world – plaintiffs most often attempt to avoid preemption of products liability suits involving PMA (Premarket Approval) medical devices by alleging a parallel violation.  While they’ve had some success in getting past the pleadings stage on this theory, to the extent any PMA medical device case survives preemption, what survives is only a small slice of the usual panoply of products claims.  Further, proving a state law claim for violation of a federal regulation is far from a slam dunk.

So, what’s a better way to avoid PMA preemption?  Claim the product at issue isn’t actually a PMA medical device.  But if the device actually did go through the PMA process, how do you claim it didn’t?  By taking the device apart.  Well, at least that’s what plaintiffs have tried to make courts believe.  But so far, no takers.

And, just yesterday, a New Jersey court said no to both – rejecting plaintiffs’ component theory of liability and casting serious doubt on the viability of parallel violation claims in PMA medical device cases.  The case is Smith v. Depuy Orthopaedics, Inc., No. 11-4139 (JAP), slip op. (D.N.J. Mar. 18, 2013).  To start, if you aren’t versed in the PMA process, the decision contains a thoughtful recitation of the process and of the defendant’s compliance with FDA requirements at every turn.  See slip op. at 2-9.  It also explains the difference between the rigorous PMA process, during which the FDA determines whether the device is safe and effective for its intended purpose, and the 510k premarket approval process, which has to do with a finding of substantial equivalence rather than safety and efficacy.  Id. at 7.  It was this distinction that led to Riegel and PMA preemption. And, it is what has plaintiffs attempting to strip medical devices like a mechanic disassembling a junker for its parts.  Sometimes that’s all an old car is good for.  Sometimes, the whole – say a 1967 Mustang GT 500 – even with scratches and dents, is worth significantly more than the sum of its parts.

The same is true for medical devices.  When determining whether state law claims are preempted, you look at the device as a whole.  “[A] device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption.”  Slip op. at 21 (citations omitted).    It doesn’t matter if some of its components were originally cleared through the 510k process.  Once those components are made part of a medical device that gets submitted to the FDA for PMA, then those components go through the PMA process too.  Id. Continue Reading New Jersey Court Finds No Parallel Claim and No Component Liability