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

It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two.  It is a tried and true metaphor, like its modern English counterpart — between a rock and a hard place.  But it is particularly fitting in products cases dealing with pre-market approved medical devices.  So, even though it is another favorable InFuse decision and we probably would have blogged about it anyway, the court’s clever turn of phrase was enough to reel us in:Continue Reading The Scylla and Charybdis of PMA Preemption

We start with some disclaimers.  Not the usual disclaimers about which of the Blog authors’ respective firms deny responsibility for the post.  We disclaim that we care much about the availability of cigarettes and vaping products, except insofar as litigation over them says something about litigation over medical products and the general interplay between state…

Medical device preemption should be straightforward.  The statute could not be clearer.  Federal regulation supplants state laws that would impose requirements that are different from or in addition to the federal requirements.  But the law has evolved into a bit of a mess, with misreadings of certain approval/clearance pathways and inventions of exceptions, such as…

We write a lot of briefs involving federal preemption and Class III medical devices with premarket approval (or “PMA”).  Many of those briefs are in support of motions to dismiss lawsuits brought by attorneys who don’t regularly practice in the pharmaceutical and medical device product liability space. 

The complaints filed by such attorneys often are…

Product liability litigation over Class III medical devices is an interesting creature.  Absent something unusual, cases and litigations should not get past motions to dismiss.  That is pretty clearly what Congress intended when an express preemption provision was added to the Medical Device Amendments of 1976.  We understand that each plaintiff may think her case is exceptional in that it should meet the exception to the rule of preemption.  (We do not really think the plaintiff lawyers think that, although they sure argue it enough.)  But the usual is more common than the unusual by definition.  When you hear hoof beats, you should look for a horse not a zebra, unless you happen to be in a part of the world where zebras are endemic or end up in a zebra enclosure in a zoo.  When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations.  An unfortunate fiction developed post-Buckman—particularly after Riegel v. Medtronic, Inc. 552 U.S. 312 (2008)—that plaintiffs could assert “parallel claims” that were neither expressly preempted by the provisions of the MDA nor impliedly preempted under Buckman.  We, and others, have described the purported path of a parallel claim as being like navigating between Scylla and Charybdis, a monster and whirlpool on opposite sides of a narrow strait per ancient Greek mythology.  Without claiming that mythology is the same as fiction—we are not touching that with a twenty foot sarissa—we can say that a true parallel claim is as rare as a striped unicorn or perhaps a flying horse.  The unfortunate fiction of which we spoke above has taken shape with particularly egregious appellate decisions like Bausch such that some trial courts are advised, when they hear the hoof beat of a Class III medical device product liability case, to expect Pegasus or his stripy, horned pal to gallop around the corner.

Viewed over the course of more than five years and many decisions, three of which have featured in prior posts (here, here, and here, which drew honorable mention honors in 2018), we think Bausch delayed the inevitable in Gravitt v. Mentor Worldwide, LLC, __ F.Supp.3d __, 2022 WL 17668486 (N.D. Ill. Dec. 14, 2022), by insisting that parallel claims for failure to report adverse events to FDA exist.  After an unnecessary odyssey, the manufacturer of a Class III breast implant won summary judgment on the last of plaintiffs’ claims, alleged failure to report adverse events to FDA.  (We say “plaintiffs,” but the decision referred to the plaintiff with the implant—who we will call the “plaintiff”—by her first name and the consortium plaintiff by his first name.  In terms of whether the last claim was supported, the court referred the female plaintiff only and somehow omitted any reference to “burden.”  These are usually signs that at least one claim will survive summary judgment.)  A shout out to Dustin Rawlin and his colleagues for sticking it out on this case and sending us this decision.Continue Reading Fallacious FDA Reporting Claim Finally Falls

We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options.  This…

We’ve blogged a number of times about the Dormant Commerce Clause (“DCC”) as an additional basis for bolstering both preemption and Due Process arguments.  Here’s another prescription drug-based example.

The state of New York decided to impose a special tax on opioid manufacturers to finance various responses to the so-called “opioid epidemic.”  The tax came…

We like bright lines in the law.  They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability.  Rear-end a car and you’re liable, even if the other guy stopped short.  Leave a sponge behind in a patient’s abdomen, and you and your…

When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along with the term “preemption.” That’s the constitutional doctrine most important to our medical device, generic drug, and (unfortunately to a lesser extent) innovator drug clients.  It’s also a doctrine more likely to get less attention in what promises to be the upcoming brouhaha.

By far the most important Gorsuch preemption decision is Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), cert. denied, 136 S. Ct. 796 (2016), the very favorable PMA medical device preemption decision that we discussed previously here and named as our #2 best case of the year for 2015.  We’re not reprising those posts here.  Rather, we’re examining Caplinger for what it might tell us about Judge Gorsuch’s broader views of FDCA preemption.  His dissatisfaction with the Supreme Court’s tortured approach to express preemption in medical device product liability cases is very clear.

Caplinger begins with the strong statement that, in enacting the Medical Device Amendments, Congress “[e]xercis[ed] its authority under the Supremacy Clause” in enacting 21 U.S.C. §360k(a). 784 F.3d at 1336.  Before looking at relevant Supreme Court authority, Caplinger comments:

At first glance the answer to this appeal might appear easy enough.  Section 360k(a) preempts “any requirement” imposed by states on manufacturers that differs from or adds to those found in the FDCA.  Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.  After all, a “requirement” usually means a request, need, want, or demand.  And an adverse tort judgment seems to involve just that: a demand that a defendant appear to answer for its conduct and pay damages for failing some state law duty.

Id. at 1337 (dictionary citation omitted).  A string citation about the lower courts’ “struggles” to make sense of medical device preemption followed.  Id. at 1337-38.

The problem was, when the Supreme Court got involved, rather than interpreting Congress’ “expansive” preemptive language according to its terms, the Court “issued a number of opinions that embody ‘divergent views’ about the proper role of the MDA’s preemption provision, a fact that has yielded considerable ‘uncertainty’ among the lower courts.”  Id. (citation omitted).Continue Reading Gorsuch Looks Pretty Good On Preemption

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