August 2016

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We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011); Thompson v. Western States Medical Center, 535 U.S. 357 (2002); United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); and Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), to name the most notable.  The FDA has promised action on a number of occasions, but has never delivered.  This stonewalling has even caused the Pharmaceutical Research & Manufacturers of America (“PhRMA”) to force the issue by filing amicus curiae briefs in litigation, as we discussed here a couple of years ago.

The longstanding disconnect remains. What the FDA purports to prohibit, and what the First Amendment actually allows, in terms of truthful communications by regulated manufacturers about off-label uses are two very different things.  So PhRMA, joined this time by the Biotechnology Innovation Organization (“BIO”), is charging once more unto the breach, this time with its own industry-practice “principles” concerning off-label communications.  Here’s a link to the document itself, which is called “Principles on Responsible Sharing of Truthful & Non-Misleading Information about Medicines with Health Care Professionals and Payers.”  That’s a mouthful, so we’ll just call it “Industry Principles” in this post.

Essentially, these industry organizations are drawing a line in the FDA’s regulatory sand – telling the Agency, and their own members, that they will fill the gap caused by administrative dithering themselves. Notably, since PhRMA has already shown its willingness to litigate First Amendment issues against the FDA, we would not be surprised to see these guidelines form the basis of industry’s First Amendment position in future court challenges.

The Principles’ introduction first states the reason off-label communication is needed: “Scientific knowledge and new findings go far beyond . . . clinical trials, often are outside the scope of [FDA] parameters . . ., and often outdate the FDA-approved labeling.”  Industry Principles, at 1.  The introduction then explains why the industry cares so much.  “Biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of [their] medications.” Id. Finally, it states what the industry is doing about it from this day forward.

These Principles are intended to form the basis for defining new and clear regulatory standards governing responsible, truthful and non-misleading communications to inform health care professionals about the safe and effective use of medicines.

Id. In other words, in default of FDA action, industry will set its own standards for off-label communications (including those that the FDA calls “promotion”), and will defend them in whatever fora are necessary, including in court.Continue Reading Off-Label Marketing – Industry Groups Step into the Breach

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

It’s been awhile since we’ve posted about PMA preemption in an Infusion case – but that litigation continues to make good law.  This time in Minnesota state court which fortunately took a lot of its cues from strong federal law.  In Stiltner v. Medtronic Inc., 2016 WL 4005471 (Minn.Dist.Ct. Jul. 25, 2016) the court dismissed all of plaintiffs’ claims as preempted and while the dismissal is without prejudice, the court laid down tough pleading standards for plaintiff to meet if he wants to try a comeback.

Plaintiff had an Infusion pain pump installed and that particular pump model was recalled about one year later.  Three years after the recall, plaintiff began experiencing complications which necessitated revision and re-implantation surgeries.  Id. at *1.   Plaintiff brought claims for manufacturing defects, failure to warn, negligence, breach of express and implied warranties, and violations of the Minnesota Consumer Fraud Act.  Id.  Because the Infusion pain pump was Pre-Marketed Approved (“PMA”) by the FDA, it is subject to both Riegel express preemption and Buckman implied preemption.  Therefore, in response to defendants’ motion to dismiss, plaintiff had to demonstrate that his claims fit within the “narrow gap” left open between Riegel and Buckman – emphasis on the “narrow” part.  To pass through, plaintiff needs to be suing for conduct that violates the FDCA (the state law claim must parallel device-specific regulations to survive express preemption) but not suing solely because the conduct violates the FDCA (such a claim would be impliedly preempted).  Id. at *4.

Plaintiff attempted to overcome preemption by relying on the recall and by citing to certain FDA actions such as warning letters issued to defendants to establish that defendants violated Current Good Manufacturing Practices (“CGMP”) regulations.  Id. at *1.  But in assessing the sufficiency of plaintiff’s pleadings, the court concluded that plaintiff simply surmised that “because of the [FDA warnings] and Defendants’ . . . recall of the Device, Defendants must have violated federal regulations which must have resulted in injury to Plaintiff.”  Id. at *6.  “Must have” is about on par with “would of, should of, could of.”  Not nearly enough.Continue Reading In Minnesota PMA Preemption Requires Plaintiffs to be Specific, Very Specific

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If a surgeon combines a PMA device with a 510k device, what does that do to federal preemption? We ask this question because one of the more fascinating aspects of the medical device world is modularity.  We have heard of modular furniture, modular homes, modular computers, and modular hamster cages—collections of components that can be matched together in different ways to form the desired end result.  The highest and best use of various components could be different for each user, depending on his or her particular needs and vision.  After all, why should two different families own the same three-seat sofa when one would prefer four seats, with a recliner, and perhaps a built-in cooler, and maybe add the matching foot stool?

When you look at it that way, many medical devices (and particularly orthopedic devices) would have to be modular to some extent to offer the greatest benefit to patients. A defining principle of healthcare—and the laws that govern it—is that different patients have different needs that require a physician’s best judgment and exercise of discretion.  That was the situation in Nagel v. Smith & Nephew, Inc., No. 3:15-cv-00927, 2016 U.S. Dist. LEXIS 98408 (D. Conn. July 28, 2016).  In Nagel, a surgeon treated his patient with a hip replacement system.  But instead of using the plastic cup liner that came with the system, the surgeon elected (with his patient’s consent) to use a metal liner from a similar system made by the same manufacturer, thus forming a “metal on metal” system.

The fascinating part arose because the FDA cleared the hip system under the 510k process as substantially equivalent to a predicate device. But the metal liner was approved under the FDA’s rigorous premarket approval process.  Faithful readers know where this is headed—express preemption, which is strongest when applied to PMA devices like the metal liner.

Turning back then to our introductory question, what do we do with an implanted device with “mixed levels of approval”?  The short answer is that the plaintiffs’ claims were all preempted, even though significant components used to treat the patient were 510k products.  Here is how the court came to that result.

The court first walked through the now-familiar dance between express and implied preemption. On the one hand, the FDCA expressly preempts any state law requirement that is different from or in addition to federal requirements. See Section 360k(a).  Thus, when suing over a PMA device, a plaintiff must allege the breach of a state-law duty that is the same as federal requirements—the so-called parallel claim exception.  On the other hand, the plaintiff’s claim must not rely only on a requirement already imposed under the FDCA, or else the claim is impliedly preempted under Buckman.  That’s the “narrow gap” through which a plaintiff must navigate. Id. at **10-11.Continue Reading Mixed and Matched Hip Components Equal Express Preemption

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We often lament, in our curmudgeonly way, that plaintiffs in obviously lacking cases get chance after chance to keep going, all the while imposing costs and risks on the defendants and a burdens on court dockets.  Plaintiffs tend to get three strikes on complaints that fail to plead cognizable claims or cannot help but plead right into a clear defense.  Plaintiffs are sometimes allowed to offer extra experts after Daubert wipes out their first wave or two.  Summary judgment is denied on the pretense that a jury could find for the plaintiff based on tenuous and speculative liability or causation arguments.  The reality, particularly in cases where hundreds or thousands of plaintiffs sue over the same drug or device, is that the calculus of the number of pending cases, the time they have been pending, and the proximity to trial plays into the likelihood of large settlements.  Even where the manufacturer has good reason to believe that the cases against it should not succeed, the cost of pursuing them to the bitter end can weigh in favor of paying to settle cases.  So, when we see a drug or device manufacturer take a litigation to its end (or the end for one of the major fronts), we applaud its determination.

For the In re Mirena IUD Products Liability Litigation MDL, the litigation looks to be fairly short-lived as far as such litigations go.  In April 2013, the JPML consolidated cases because of the common issues of “the alleged risks of uterine perforation and migration associated with Mirena and the adequacy of the product’s warning label.”  In less than three years, the parties did fact discovery, selected bellwether cases, did expert discovery, and filed dueling Daubert motions.  We discussed the lengthy ruling on those motions here, noting that the court “was not afraid to shut down entire theories on which the plaintiffs based their claims.”  All of the plaintiffs with pending cases after the Daubert decision apparently agreed that their cases required them to prove that the product can cause “secondary perforation”—definition discussed below—which was something the plaintiffs’ experts could not support with admissible opinions.  The plaintiffs also agreed that the product liability law of each of their home jurisdictions generally required admissible expert evidence on general causation.  In opposing defendant’s motion for summary judgment, plaintiffs offered two arguments:  1) the injury here makes general causation something that the jury can decide without supporting expert testimony from plaintiff despite the general requirement; and 2) a series of purported admissions from the product’s label and elsewhere can establish general causation.  In rejecting both arguments, the court was up front that it was doing so “reluctantly, knowing that it will doom hundreds of cases,” which showed as each proffered decision and statement was analyzed patiently. In re Mirena IUD Prods. Liab. Litig., Nos. 13-MD-2434 (CS), 13-MC-2434 (CS), 2016 U.S. Dist. LEXIS 99221, **67-68 (S.D.N.Y. July 28, 2016).  We, of course, have no such reluctance in seeing the decision as correct and the basis for bringing the cases as dubious from the start.Continue Reading Summary Judgment for All Pending Cases in The Mirena MDL

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A couple of weeks ago we reported on our visit to the Women’s Health Litigation Conference. One of the conference panels discussed the most interesting ongoing litigations involving women’s health products. Essure, a permanent contraception implant, was among those products. The standard claim is that the Essure implant can cause women to suffer pelvic pain, blood clots, and various other injuries. A plaintiff lawyer at the conference recounted (from a certain point of view) the Essure development and medical stories, concluding that Essure would be a “slam dunk … if not for the fact that it is a PMA product.”

Aye, there’s the rub. Essure is, indeed, a medical device that went through, and passed, the FDA’s rigorous Pre-Market Approval process. PMA approval means that almost all product liability theories are preempted by federal law. If state law, including jury verdicts, would impose any requirement different from, or in addition to, the FDCA, then such state law must yield. Consequently, tort claims against PMA products are difficult to sustain. Still, difficult is not the same as impossible. Plaintiff lawyers have tried all sorts of clever ways to circumvent PMA preemption. But clever is not the same as correct. Good for courts that can tell the difference.

Such a court issued the opinion in Norman v. Bayer Corp., 2016 U.S. Dist. LEXIS 96993 (D. Conn. July 26, 2016). As is typical, the complaint in that case covered the product liability waterfront, with claims for strict liability, negligent failure to warn, negligent training, negligent manufacturing, negligent misrepresentation, negligence per se, and breach of warranty. As is typical, the complaint devoted most of its girth to the generic development and medical stories alluded to above. In the 29 pages of the Norman complaint, “only four short paragraphs” related to the plaintiff and her experience with the product.Continue Reading Federal Court Dismisses Essure Complaint

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We’ve been remiss in updating our cheat sheet devoted to ediscovery for defendants.  Because of the broad nature of the topic – these cases can and do arise in a wide variety of non-drug/device contexts – we have to research them separately to find what we need.  It’s been two years since we last updated, and we just did it now.  The new decisions are below, and every one of them either allows access to a plaintiff’s social media activity or imposes sanctions on plaintiff for resisting such discovery.

Except for one. We’ve also included Facebook, Inc. v. Superior Court, 192 Cal. Rptr. 3d 443 (Cal. App. 2015), a third-party social media subpoena case. Facebook is included because the California Supreme Court granted review at the end of 2015 (so the opinion itself has been depublished), and whatever that court ultimately has to say about ediscovery of social media is likely to be very important.

We have a few other comments from just having reviewed a large number of social media discovery cases. Since this is a cheat sheet, we only collect the good cases – because we don’t believe in doing the other side’s research for them, these are comments primarily about cases that we haven’t included.  First, defendants would be well advised not to make broad requests for social media discovery without being able to back them up with something more solid than suspicions.  Increasingly, blanket social media discovery demands succeed only when based on a plaintiff’s contradictory public social media evidence or else indications of attempts to delete or otherwise hide social media activity.  Our word to the wise, “investigate.”  Evidence of plaintiff-side perfidy is often not hard to find.  Second, consider adding reasonable time, subject matter, and other limits to discovery requests suggested by the nature of the case.  If plaintiff’s business-related activities aren’t relevant, exclude them from the request.  We’d like your case to go on our cheat sheet.Continue Reading 2016 Updates to Ediscovery for Defendants Cheat Sheet

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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