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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

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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.Continue Reading New Hampshire Applies Riegel Preemption

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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

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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…

Although trial court judges mostly get things right, every once in a while a trial court judge will issue an opinion that just plain stinks. We aren’t simply talking about any old decision in favor of a plaintiff suing a drug or device company. We recognize that some trial court decisions against our clients are…

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We had to comment on the most intriguing case of Hughes v. Boston Scientific Corp., 2009 WL 3817586 (S.D. Miss. Nov. 12, 2009). Hughes involved a PMA device, something called a “HydroTherm Ablator,” that allegedly malfunctioned and injured the plaintiff. Thereafter, the defendant (1) changed its adverse event reporting algorithm in response to FDA…

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Bexis’ Book

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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