We were in western Tennessee last week for an argument. We stayed at a beautiful and venerable hotel, most famous for twice-daily “march of the ducks.” Every morning, at 11 a.m. sharp (at least 30 minutes after guests have packed the lobby), an elevator door opens, and a uniformed “duck master” leads a perfect procession
On our office bulletin board, we keep a post-it listing the states we have not yet visited. We are down to ten, and we expected to cross Oregon off after a deposition last week. But our deponent moved from Bend, Oregon to St. George, Utah. We’ve been to Utah lots of times, and were annoyed
A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from the Northern District of New York. We have all suffered through opinions in
This post is from the non-Reed Smith side of the blog.
We post a lot about preemption. We post a lot about PMA preemption. That’s because thanks to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), almost all claims brought against pre-market approved medical devices are either expressly or impliedly preempted. What remains is a “narrow gap” through which a PMA medical device claim must fit in order to withstand a preemption challenge. And as demonstrated by our Device Preemption Scorecard which now has 336 entries – the gap just keeps getting narrower.
There are still a few claims that continue to squeeze by as “parallel violation” claims – misrepresentation claims come to mind – but they tend to fail on pleadings grounds and/or tend to be the more difficult of the claims to prove (with elements like reliance often being the sticking point). And a few courts have allowed some claims to slip through that we think should have crashed on the shoals. One word, Stengel. Even these, however, remain in the minority.
But all of this defense-friendly case law hasn’t stopped plaintiffs from still trying to thread the needle. We’ve seen some creative pleading in recent years and PMA complaints have become more upfront with allegations of alleged parallel violations. Fortunately most courts haven’t been persuaded by the use of “magic words” to create a parallel claim. It’s not enough to say the claim violates federal law. If we are talking about a duck, you better show that what you have looks like a duck, swims like a duck, and quacks like a duck. Otherwise, it’s no duck. It’s a preempted claim. Plaintiffs in Gates v. Medtronic, Inc., slip op., No. 1:15-cv-00726-RP (W.D. Tex. Jun. 29, 2016) didn’t have a duck.
For the second time in a week we are considering a former professor at our law school, though this occasion swims in sorrow. Before he became a Justice on the Supreme Court, before he became a Judge on the DC Circuit, Antonin Scalia taught at the University of Chicago Law School. Many of the eulogies we are hearing this week highlight things about Scalia that remind us of how well he fit in with that remarkable faculty: the relentless intellectual jousting, where arguments but not the arguers were skewered. There must not have been much lounging in a faculty lounge with Scalia, Posner, Epstein, Easterbrook, Sunstein, Stone, et al. (We cannot overstate our disappointment at reading Epstein’s complaint that when Barack Obama taught at the law school the future president displayed little enthusiasm for the robust intramural debates taking place all around him).
When the pundits discuss Scalia’s legacy, they usually emphasize his decisions on guns or flag-burning, or his sharp dissents in cases involving the death penalty or gay rights. Not all of those opinions were to our liking. But defense drug and device law nerds will always have a soft spot in our hearts for Justice Scalia’s opinion in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), where he held that most tort claims against PMA devices are expressly preempted by a federal statute. The decision is logical. The writing is clear. (It is not surprising that Scalia has co-authored books with Bryan Garner that urge lawyers to be more direct, concrete, and muscular in their writing.)
Let’s honor Scalia in a way he would have liked – by saluting his logic and his prose in the Riegel decision. But let’s first offer a prologue by way of considering Scalia’s concurrence/dissent in the Cipollone (1992) case. That case was about preemption of tort claims against cigarette manufacturers. The court’s opinion was authored by Justice Stevens and was a Brunswick stew. Some of it made sense and some of it was squirrelly. As with so many Stevens decisions, things that at first blush seem relatively sensible become muddy once you wrestle with the real-life consequences down the road. Stevens held some things preempted and some things not, but good luck figuring that out once you’re down to actual cases. By contrast, Scalia’s opinion in Cipollone is crisp and intelligible. One thing he was especially crisp on was the silliness of the presumption against preemption. As Scalia reasoned, the issue is what was the Congressional intent, as manifested by the plain words of the statute. There is no need to indulge in any presumption in making out that intent. Moreover, a presumption against application of a doctrine that can arise in the absence of any Congressional pronouncement whatsoever, such as conflict preemption, makes no sense.
Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers. Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what emerges is mostly correct and at least intermittently coherent. Some of us pretend to actually know Strunk & White by heart. Still, errors occasionally evade the dragnet of dorks. In honor of National Grammar Day, we have festooned today’s post with enough errors to keep all of you grammar cops busy. We do this as a matter of principal.
But there are no errors in the case under review. We have a rare favorable medical device decision out of the Seventh Circuit. The case is called Kallal v. Ciba Vision Corporation Inc., 2015 U.S. App. LEXIS 2987 (7th Cir. Feb. 24, 2015). Mind you, the Seventh Circuit is one court we think the world of. Any court that is home to legal luminaries like Posner, Easterbrook, Wood, et al. must be fairy formidable. But the Seventh Circuit is also home to the hideous Bausch precedent. Perhaps you remember Bausch. Its hard to forget. The Seventh Circuit permitted a plaintiff to vaguely state a parallel claim which lacked substance under both federal and state law. TwIqbal pleading requirements impacted the case not at all. Irregardless of the Supreme Court’s instruction that lame cases should be dismissed before subjecting defendants’ to expensive discovery, the Bausch court elevated the plaintiff’s desire for discovery into something sacramental.
But Kallal is much better than that is. The plaintiff claimed that defective contact lenses had hurt his eyes. The plaintiff did not have alot of evidence. The company had recalled some of it’s contact lenses. Courageously (after Bausch) the district court held that the plaintiff’s claims were preempted nonetheless, and that the parallel claim could not save the case. The plaintiff argued that his suite fit inside of the Riegel exception because the company failed to list ion permeability as a “material characteristic” in its premarket approval list. The company responded that the FDA did not require them to meet any ion permeability threshold. The plaintiff did not offer any evidence to the contrary. In any jurisdiction but Bausch-land, that argument would win the preemption day for the defendant. And mirabile dictum, it managed to win for the defendant in Kallal. At least at the lower court’s level.
Continue Reading An Error-free Seventh Circuit Medical Device Case
New Hampshire has always marched to its own flinty tune. It was the first colony to establish a government independent of British authority. It holds the first presidential primary every four years, insisting that candidates visit waffle shops and bloviate to the amused Yankee locals. You’ve probably seen New Hampshire license plates with the “Live Free or Die” motto. That motto supplied the title for episodes of both The Sopranos and Breaking Bad. What other state can make that boast? And what other state with such a small population can list among its offspring such eloquent luminaries as “Go West Young Man” editor Horace Greeley, “Liberty and Union, now and forever, one and inseparable” Senator Daniel Webster, “And miles to go before I sleep” poet Robert Frost, and we-can’t-think-of-a-quote President Franklin Pierce?
New Hampshire has played a significant role in American legal history. Daniel Webster won a case against the Devil. One of the early major U.S. Supreme Court cases involved Dartmouth College. We cannot remember what the case was about, though we think it had something to do with Delta House being put on double secret probation. The Bartlett v Mutual product liability case gave rise to some awful rulings in the New Hampshire federal court before the Supreme Court set things right in what might be our favorite case of the last five years.
In today’s case, Murray v. Hogan, #226-2013-CV-00600 (New Hampshire App. Ct. Feb. 2, 2015), a New Hampshire court addresses Riegel preemption, as well as the dreaded parallel claim exception. As far as we can tell, it is the first such decision from the Granite State. (We gratefully tip our cyber cap to David Ferrara at Nutter McClennen for sending the case our way.) The plaintiffs in Murray brought negligence and products liability claims claiming injuries from a knee replacement gone wrong. The plaintiffs sued several defendants, including the manufacturer of the artificial knee, as well as the sale rep who was in the operating room and assisted in preparing the artificial knee for insertion. The artificial knee was a class III medical device, so it comes as no shock that the company moved for summary judgment against all of the plaintiffs’ claims as being preempted by federal law. Even less of a surprise, the plaintiffs disagreed, arguing that federal preemption does not apply because: (1) the artificial knee did not meet federal regulations, (2) the plaintiffs would like to have some discovery, please, and (3) the company is vicariously liable for the conduct of the sales rep.
This is the time of year when our thoughts start migrating southward. We can see all those birds’ nests in our suddenly denuded poplar trees. The driveway is a skating rink of damp leaves. The baseboards in our home now gurgle from the operation of an ancient oil heating system.
Over the last two weeks our posts leaned against a pair of intemperate blasts from a Vermont federal court. The results were dreary and/or indecipherable. Thus, it is with some relief that we bask in the warm glow of a nice, straightforward decision from the happiest place on Earth, the federal court in Orlando. In Stanifer v. Corin USA Ltd, Inc., 2014 U.S. Dist. LEXIS 158587 (M.D. Fla. Nov. 10, 2014), a hip resurfacing system was implanted into the body of the plaintiff during a right hip arthroplasty procedure. Subsequent failure of the system allegedly caused the plaintiff to suffer a revision left total hip arthroplasty and surgical removal of the system. The plaintiff filed a lawsuit in state court seeking to recover “damages and losses” from the defendants based on state law strict liability claims for breach of warranty, manufacturing defect, and design defect. After removal of the action to federal court, the defendants moved to dismiss the claims based on federal preemption.
The hip system was a class III device, and therefore subject to the PMA process and the attendant federal preemption. After the Supreme Court’s decision in Reigel, a plaintiff injured due to use of a Class III PMA device can escape preemption only by asserting a “parallel” state law claim. As readers of this blog likely know, we think of the parallel claim exception as something crazy and made-up, like a fairy tale or a Johnny Depp movie. Luckily, the Stanifer case is governed by the law of the Eleventh Circuit, a place that knows how to deal with such things. The Stanifer court embraced Eleventh Circuit precedent to the effect that plaintiffs cannot effectively state a “parallel claim” absent allegations that the defendant violated a “particular federal specification.” Ah – we are far from the windy incoherence of Vermont (or Chicago – the Bausch case still stands as the babbling zenith of parallel claim doofus-prudence).
Continue Reading Far from Dumbo: M.D. Fla. Gets “Parallel Claim” Case Right
Time travel is on our mind today. We should hasten to add that it is not a topic that usually absorbs us – otherwise we might squander what little credibility we have with our serious-minded readers. But a trio of things prompted us to think about time-travel. First, we will (soon, we promise) be discussing
We like Riegel preemption because the oscillations of state tort juries should not supplant FDA regulation of medical devices. We like Twombly and Iqbal because plaintiffs should plead sensible facts before turning on the million dollar discovery machine. We do not much like the parallel claim exception to Riegel because its origin is muddy, its