2014

Photo of Michelle Yeary

We often report on cases that are dismissed at the pleadings stage but in which plaintiff is afforded an opportunity to “fix” his or her complaint.  And almost as often, we refer to this as plaintiff getting a “second bite at the apple.”  Not overly creative, but it conveys the point nicely.  In the InFuse cases, for instance, the large majority of plaintiffs’ claims have been dismissed as preempted.  Typically, the claims that survive preemption are for fraud and misrepresentation and more often than not those have been dismissed for pleading deficiencies. Less often do we see blogworthy decisions on the result of plaintiff’s second bite. So we were surprised to happen upon two such decisions in the InFuse litigation issued just days apart.  Plaintiff’s second attempt in one case was more well received by the court, but even that decision has some positive notes for defendants.

To start, we’ve posted a lot about the great success defendants have had in the InFuse litigation defeating off-label promotion claims.  So, we aren’t going to reiterate all the details.  You can check out all our posts on the InFuse cases here, including our post on Martin v. Medtronic which is one of our follow-up cases today.

In Martin, the court dismissed all of plaintiff’s claims.  The preempted claims (fraud based on the labeling, failure to warn based on off-label promotion, design defect, negligent failure to warn based on labeling, negligent design/manufacture, and negligence based on off-label promotion) were dismissed with prejudice.  Plaintiff was given leave to amend her remaining claims: fraud based on misrepresentations in off-label promotion, failure to report adverse events to the FDA, and breach of express warranty.  Martin v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 164980 at *8-9 (D. Ariz. Nov. 24, 2014).  She didn’t fare much better on the second go-round.  First, plaintiff re-pleaded all of her preempted claims and the court quickly dismissed them again.  Id. at *11-12.Continue Reading InFuse Update

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Any defendant that has litigated – and lost − remand motions has encountered plaintiffs with very flexible facts, particular in opposition to fraudulent joinder arguments.  By that we mean:  dates that change after remand, non-diverse defendants that suddenly had nothing to do with anything, damages shrinking below the jurisdictional minimum, product exposures that disappear, “yes” that becomes “no” (and vice versa) in plaintiff testimony.  That kind of thing.

But there’s nothing anybody can do about it, right?  After all, a federal statute, 28 U.S.C. §1447(d), bars federal review of remand orders, so no matter how outrageous a plaintiff’s fraud on the court during the remand process is, they skate, and the defendants are stuck in state court, right?

Wrong.  At least not now.  At least in the Fourth Circuit.  See Barlow v. Colgate Palmolive Co., ___ F.3d ___, 2014 WL 6661086 (4th Cir. Nov. 25, 2014).

In the first precedential decision to address this issue, last week the en banc Fourth Circuit held in Barlow that, when a plaintiff’s remand-related misrepresentations are bad enough, a remand order can be vacated under Fed. R. Civ. P. 60(b)(3), with the result being that the case retroactively returns to federal court.  It’s a matter of first impression (prior adverse appellate decisions were all non-precedential), so all defendants should study Barlow closely.Continue Reading Fraud on a Federal Court Allows Vacation of Remand Orders

Photo of Eric Alexander

OK, we made that up.  It is not true at all.  A complete lie, much like “The Dallas Cowboys are America’s Team.”  Or “Eating turkey makes you sleepy because of its high tryptophan content.”  Or “The pilgrims left England because of their desire to wear stylish hats.”  Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.”  If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today.  You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football.  Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.

The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator.  As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements.  21 U.S.C. §360k(a).  This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers.  Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject.    A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims.  We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer.  Like here.

We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is.  We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.Continue Reading Nothing Helps With Post-Thanksgiving Indigestion Quite Like A Heaping Helping Of Express Preemption

Photo of Stephen McConnell

“Our rural ancestors, with little blest,
Patient of labor when the end was rest,
Indulged the day that housed their annual grain,
With feasts, and off’rings, and a thankful strain.”

― Alexander Pope, Imitations of Horace

Today isn’t officially a holiday, but the preparations for Thanksgiving make it terribly difficult to put in a productive…

Photo of Michelle Yeary

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

This is the official week in the United States for giving thanks.  Counting your blessings.  Welcoming family and friends to your home.  Christmas might get top billing, but Thanksgiving is all about feeling warm and fuzzy.  And here at the Drug and Device Law Blog, we’ll get to what we are thankful for tomorrow. Today is a different story.  Today we feel more cold and hard.  And who is the unfortunate recipient of our negativity at this otherwise festive and lighthearted time – California.

And why is that we don’t want to share our turkey and pumpkin pie with California?  Three reasons:  negligence, Good Samaritan, and subsequent remedial measures.

Plaintiff Christine Scott sued manufacturer C.R. Bard, Inc. alleging injuries resulting from implantation of that company’s pelvic mesh device.  The case went to trial and the jury found the manufacturer negligent and awarded damages (reduced based on finding that surgeon was 40% at fault).  Scott v. C.R. Bard, Inc., 2014 Cal. App. LEXIS 1049, at *1 (Cal. App. Ct. Nov. 19, 2014).  On appeal, the defendant argued, among other things, that the trial court erroneously submitted the negligence theories of liability to the jury, including negligent training and erroneously admitted evidence of post-surgery events.  Id. at *1-2.  The court denied the appeal in its entirety.  We are blogging about this case because it demonstrates the potholes created by California’s recognition of negligence claims in pharma and medical device cases.Continue Reading Thanks for Nothing California

Photo of Bexis

We posted not too long ago about a Seventh Circuit decision by Chief Judge Posner that we thought had favorable implications for reining in the steadily metastasizing concept of “cy pres” in class action litigation.  That opinion, Redman v. RadioShack Corp., 768 F.3d 622 (7th Cir. 2014), prohibited any sum that did not “benefit the class” from being included in the calculation of attorneys’ fees in a class action settlement.  Although a cy pres award was not at issue in Redman, the implications (to us at least) seemed obvious.  Funds not paid to class members do not benefit the class.

Judge Posner made that explicit last week in Pearson v. NBTY, Inc., ___ F.3d ___, 2014 WL 6466128 (7th Cir. Nov. 19, 2014).  Indeed, he thought it was “obvious,” just like we did:

The [trial] judge excluded, however, both the cy pres award of $1.13 million in calculating the benefit to the class, for the obvious reason that the recipient of that award was not a member of the class, and the injunction, which he valued at zero, which was proper too.

Id. at *2.  So, in the Seventh Circuit at least, it’s improper to use funds paid to non-class members via cy pres to calculate the fee that class action plaintiff lawyers are allowed to receive under the “common fund” doctrine.

And there’s more.Continue Reading Judge Posner Drops the Other Shoe on Cy Pres

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Bexis is pretty pleased this morning.  Almost eighteen years ago, to the day, he filed his first brief with the Pennsylvania Supreme Court challenging the negligence/strict liability dichotomy adopted in Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978) (in a case called Spino).  Over twelve years ago, he filed his first outright “overrule Azzarello” brief (in a case called Phillips).  Well, yesterday the Pennsylvania Supreme Court did precisely that – it overruled Azzarello – unanimously in an opinion written by Chief Justice Castille.  In the end, even the most pro-plaintiff members of the Court (those remaining, anyway) could not stomach the travesty that Azzarello had become.  End of self-congratulatory gloat.

We learned of this development late yesterday afternoon and published a very brief “breaking news” post alerting our readership.  At that point we had not yet read the Court’s entire 137-page opinion, Tincher v. Omega Flex, Inc., No. 17 MAP, slip op. (Pa. Nov. 19, 2014).  Now we have.  While it’s clear that the most obnoxious aspects of the Azzarello regime − the bizarre pre-trial procedure for determining “unreasonably dangerous” as a matter of law, the absolutist negligence/strict liability dichotomy, and the “plaintiff wins” guarantor/any element jury instruction (for those of you not familiar with Pennsylvania law, this is what jurors are instructed: “The supplier of a product is the guarantor of its safety.  The product must, therefore, be provided with every element necessary to make it safe for its intended use, and without any condition that makes it unsafe for its intended use,” Azzarello, 391 A.2d at 559 n.12) – have been disapproved, what’s taken their place is less clear.

On the theory that you can’t beat something with nothing, ever since Phillips Bexis had been advocating the Third Restatement of Torts as an alternative, even though there were significant aspects of the Third Restatement that could hardly be called defense friendly.  Yes, Azzarello was that bad.  The Court, however, did not adopt the Third Restatement in Tincher.  Instead, it has adopted a more mainstream (compared to Azzarello) approach to Restatement Second §402A, that in places is also informed by Third Restatement principles.  We’ll be discussing that in more detail.Continue Reading Pennsylvania Product Liability – Azzarello Is Dead, Long Live…?

Photo of Bexis

This is as short as the Tincher majority opinion (137 pp.) is long.  Azzarello is overruled.  The preliminary judicial evaluation of “unreasonable danger” is abolished.  The jury considers it under a dual standard.  The negligence/strict liability dichotomy originating in Azzarello is gone.  The Third Restatement is not adopted.  Haven’t finished reading.  There will be more…

Photo of Steven Boranian

This is short – but very sweet.  Regular readers will recall the California appellate decision that we criticized in our “Hotel California” post back in August.  In that case, the court avoided the restrictions that Daimler AG v. Bauman, 134 S. Ct. 746 (2014), had imposed on “general” personal jurisdiction by transferring…

Photo of Stephen McConnell

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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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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