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This post is from the non-Winston & Strawn side of the blog.

As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before.  We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see

Photo of Rachel B. Weil

As we write this, our firm’s “return to office” date is less than two weeks away.  We will be delighted to see, hug, and collaborate in person with colleagues we’ve missed for two long years (computer visages notwithstanding), though we confess to panic at the prospect of “real clothes.” And shoes.  It’s all a bit

Photo of Rachel B. Weil

Before we turn to today’s case, a quick update:  when last we spoke, we were about to board a plane for Peoria – our first work trip in sixteen months.  We were excited about it.  We regret to report that we stepped out of the plane into something resembling a weird post-apocalyptic Mad Max movie. 

Photo of Rachel B. Weil

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

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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.Continue Reading Post-Recall Negligence Claims Preempted

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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.Continue Reading Remembering Scalia, Remembering Riegel

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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