2016

Photo of Eric Alexander

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the decision making of the learned intermediary and that proximate cause matters.  One implication is that heeding presumptions typically make little sense for claims about these products.  It is one thing to say that a plaintiff should be allowed to proceed with a warnings claim when a prescriber is truly unavailable to provide testimony—like by dying before the plaintiff knew he had a claim—and the alleged missing warning would have clearly contraindicated the plaintiff from receiving the prescription product.  In such a case, it might make sense to presume, absent contrary evidence, that the physician would have heeded the warning and not prescribed the product to the plaintiff.  In just about every other prescription drug and device case we can imagine, the heeding presumption does not make sense.

We feel the same way about a post-sale duty to warn.  Not only do such duties run contrary to the typical focus in warnings cases on the notice to the manufacturer of potential risks before the product leaves its control (or is prescribed to plaintiff), but the proximate cause inquiry can quickly become an exercise in layered speculation.  Cases acknowledging such a post-sale duty have typically involved situations where the seller had a continuing relationship with the purchaser, with an obvious route for relaying additional information about the product in a way that allows a jury to evaluate whether injury would have been avoided.  In prescription drug and device cases, there tends not to be any direct relationship at any time and the manufacturer does not know the names or addresses of patients using its products.  Over time, patients move, change their physicians, and even see physicians for reasons unrelated to the reason they were prescribed a drug or device in the past.  Over time, manufacturers also stop selling specific products or product lines and may even go out of business.  When it comes to drugs with alleged remote effects or devices that are implanted for many years, these real world considerations make potentially unlimited post-sale duties to warn a folly.  We could go on, but we will not.Continue Reading Heeding Presumption Only Goes So Far In Post-Sale Warning Case

Photo of Steven Boranian

We don’t write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem.  The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you.  We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.

Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices.  The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect:  “A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.”  (emphasis added).

Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design.  Or it might not.  The point is that the plaintiff has to prove it.  Take also the example we discussed in Bexis’ aptly named post “On Alternative Design.”  That case involved hernia mesh, not pelvic mesh, and the plaintiffs’ claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer.  Consider hormone-based contraceptives.  Cholesterol drugs.  We could go on and on.  All these products bear known and unavoidable risks, and those risks should not be labeled “defects” and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them.  And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all.  As we observed in the aforementioned post, that would convert strict liability into absolute liability.  As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer?  You get the point.Continue Reading A Gem on Alternative Design from a Pelvic Mesh MDL

Photo of Stephen McConnell

It is bad enough that the mass tort system in our country approximates a system of jackpot justice that, if it ever does justice among the parties, does so accidentally. But its wild inefficiencies and inconsistencies also have macro adverse effects on things like consumer choice and the overall healthcare system.

A recent law review article offers further support for our scurvy view of mass torts by explaining how the long, inglorious history of lawsuits against contraceptives has hurt consumers and society. The article is by Eric Lindenfeld, is entitled “The Unintended Pregnancy Crisis: A No-Fault Fix,” and it appears in the Spring 2016 issue of the Marquette Benefits & Social Welfare Law Review.

The article begins by outlining the unintended pregnancy crisis, which is caused at least in part by dissatisfaction with current methods of contraceptives. The article argues that the less-than-robust portfolio of available contraceptives is attributable to a stagnant research and development milieu for new contraceptives. That stagnant milieu is attributable, in turn, to the frenzy of mass torts against contraceptives. The article recites the history of litigation against the birth control pill, Dalkon Shield, Norplant, as well as more recent litigations, such Yaz/Yasmin, Mirena, and Essure. Not all of those litigations were particularly successful for plaintiffs. Not all possessed any merit. For example, the article cites evidence that Norplant turned out to be safe and efficacious – but the expense of the litigation and the enormous adverse publicity drove the product from the market. The real losers were consumers.Continue Reading Law Review Article Argues that Contraception Mass Torts Injured Consumers

Photo of Rachel B. Weil

Last week, along with many of you, we attended the ACI Drug and Medical Device Conference in New York City. The quality of the presentations was uniformly high, and the collegiality and camaraderie were welcome, refreshing, and a lot of fun.  There was plenty to drink.  There was lots of food.  Oh, and we got to see Hamilton!  We should preface our comments by pointing out that we were skeptics – we knew how pricey (really, really pricey) tickets are, and we weren’t even positive we would enjoy this immensely innovative rap musical.  To wit, one of our best beloved musicals of recent years was the wonderful, if short-lived, revival of Finian’s Rainbow that played the Great White Way a couple of years ago.  We go for the traditional stuff, and had neither resources nor plans to spring for Hamilton.

But we got very lucky. A generous friend had bought four tickets a full year earlier in anticipation of the annual conference.  And there was a last-minute cancellation.  And we got to go.  And it was worth all of the hype (and all of the money, if you have it).   We enjoyed it so much that we came home and researched ticket availability to return with the Drug and Device Law Long-Suffering Companion.  Tickets are on sale for next year, and we thought that we could avoid the crazy street prices by planning way ahead.   Not so – even this far in advance, tickets (from official ticket sources, not ticket agencies) are way out of the reach of normal consumers.  Sometimes, the early bird does not get the worm (or the greatest financial benefit).

And, with just a bit of creativity, we can glean the same message (among others) from today’s case. Dobbs v. DePuy Orthopedics, — F.3d —, 2016 WL 7015648 (Seventh Cir. Dec. 1, 2016), is an appeal of an attorney’s fee decision from the United States District Court for the Northern District of Illinois.  (We’ll explain how it got there in a minute.)  The plaintiff/appellant had direct-filed a product liability claim in the Hip Implant MDL in the Northern District of Ohio.  Believing that the promised compensation was too low, he opted out of the global settlement and fired his lawyers, who had advised him to accept the global settlement, which included a 35% attorneys’ fee.   (The global settlement provided one level of payment for unrepresented plaintiffs, and a second level, 35% higher, for represented plaintiffs.)

Less than two months after his lawyers withdrew their appearance, the plaintiff accepted the global settlement. Because he was considered “represented” for purposes of the settlement, he was paid the larger amount.  (Not clear why he was considered “represented” when his lawyers had been fired.)  His former lawyers asserted a lien on the award and sought to recover attorney’s fees.  The MDL judge tried unsuccessfully to mediate the fee dispute in the Northern District of Ohio then transferred the case to the Northern District of Illinois, where the case would have been filed if the MDL had not been pending.Continue Reading Court of Appeals Applies Law of Would-Be Filing Court in Fee Dispute in Hip Implant Case Filed Directly Into MDL

Photo of Bexis

The Reed Smith blogging team has just returned from this year’s annual ACI Drug & Medical Device Litigation conference.  In addition to excessive amounts of eating, drinking, and socializing (now called “networking”), we kept our eyes open for new and interesting topics to blog about.  We were not disappointed.  We learned a lot more regarding preemption of claims involving non-prescription, over-the-counter (“OTC”) drugs, particularly those governed by parts of the FDA’s monograph system that we haven’t considered much before.

We knew, of course, that OTC drug preemption is governed by 21 U.S.C. §379r, which contains not only an express preemption clause, but also a savings clause. Under the preemption clause, tort claims demanding warnings or other information that is “different from,” “addition[al] to,” or “otherwise not identical with” federal labeling requirements are preempted.  However – and it’s a great big however – the savings clause exempts “product liability” claims from preemption. Id. §379r(e).  That doesn’t mean that preemption covers nothing of interest to us.  We’ve discussed at some length how many courts have considered non-personal injury claims to be outside the scope of the “product liability” saving language, and therefore precluded by express preemption.  Most recently, we described a 2014 New Jersey case involving mouthwash that refused to apply a presumption against preemption to the express preemption clause, finding the presumption precedent “confused” and inapplicable.  Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371, 374 & n.17 (S.D.N.Y. 2014).

But what about implied preemption by reason of conflict – specifically the impossibility preemption rationale adopted in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2468, (2013)?  What we heard at the ACI conference sounded good enough to us that we thought we’d investigate it pass along what we found.Continue Reading Implied Preemption and Monograph Drugs

Photo of Steven Boranian

It took us a long time to understand how off-label promotion of prescription drugs had anything to do with the False Claims Act, and we’re still not so sure that the two are a fit. The FCA penalizes anyone who presents, or causes to be presented, to the federal government “a false or fraudulent claim for payment or approval.”  31 U.S.C. § 3729(a)(1).  Easy, right?  As we explained just last month in this quick primer on the FCA, Congress enacted the FCA after the Civil War to curb abuses in government procurement.  That part we get.  If you sell the Army 1,000 horses and send them a bill for 2,000 horses, that’s a false claim.

We’re writing about this today because the First Circuit issued an opinion last month that comes to the correct result and also illustrates how FCA claims are alleged in connection with off-label promotion—and how they fail. In Lawton v. Takeda Pharmaceuticals Co., No. 16-1382, 2016 U.S. App. LEXIS 20943 (11th Cir. Nov. 22, 2016), a patent lawyer filed a qui tam action against the manufacturer of a prescription diabetes medication.  He did not actually use the medication, nor did he buy or sell it.  So what did he allege?  He alleged that the manufacturer engaged in an elaborate scheme to promote the drug for un-approved uses—off-label promotion—and that the manufacturer thereby induced medical providers to make allegedly false claims for reimbursement to Medicare and Medicaid. Id. at **4-7.

It’s a two-step process. The manufacturer did not itself make a false claim, but rather engaged in alleged conduct that induced someone else to make a claim, whether the claimant knew it was false or not.  The problem for the plaintiff (or more accurately, the “relator”) is that he alleged neither falseness nor a claim.  We call that a double whammy.  Or maybe it’s a double fault.Continue Reading This Is How A False Claims Act Case Works—And Fails

Photo of John Sullivan

Well that was something. When we left you last Thursday, the jury for the third bellwether trial in the Pinnacle Hip Implant MDL had just started its deliberations, and we once again expressed concern over the trial’s evidentiary and procedural rulings and the effect they might have on the verdict. Our concern-level was high. Last time, amidst similar concerns, the jury came back with a half-billion dollar verdict.

Apparently that was chump change. Everything is bigger in Texas. And this time it was over one billion. Let that sink in. Over one billion. That’s a massive amount of money. Has anyone even ever won that in a lottery? It’s 1,000 winners of Who Wants to Be A Millionaire. And then you have to add about 40 more winners because the actual verdict was about $1.04 billion.Continue Reading The One-Billion-Dollar Verdict

Photo of Stephen McConnell

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?

In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.Continue Reading 11th Circuit Upholds Stent Defense Verdict

Photo of Michelle Yeary

It’s been two years since we applauded the downfall of Azzarello in Pennsylvania. Two years since the Pennsylvania Supreme Court ruling in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014). Two years since we opined that we didn’t think Tincher changed Pennsylvania law applicable to prescription medical products much at all. After all, Hahn v. Richter, 673 A.2d 888 excluded prescription medical products entirely from Azzarello strict liability twenty years ago, so Tincher’s reworking of strict liability shouldn’t be of much consequence. And, our prediction has largely held true. We really haven’t mentioned Tincher much since here on the DDL blog, other than to point out the serious flaws in plaintiffs’ attempts to argue that Tincher somehow altered Pennsylvania’s negligence-only standard for prescription medical product litigation and that plaintiffs’ theory had been rejected by the first courts to consider it.

Now, two years later, we have to report that a Pennsylvania federal court used Tincher to allow a strict liability manufacturing defect claim to proceed in a medical device case – in what we view as a misconstruction of both Tincher specifically and Pennsylvania products liability law (especially post-Lance) generally.

The case is Wagner v. Kimberly-Clark Corp., slip op., No. 16-4209 (E.D. Pa. Dec. 1, 2016). During the installation of a feeding tube, a piece of the tube came off in plaintiff’s stomach and she had to undergo several procedures to have to have it removed. Wagner, slip op. at 2-3. Plaintiff’s complaint brings claims for negligence, strict liability, and breach of warranty. Defendant moved to dismiss the latter two claims. Id. at 1. Plaintiff did not oppose dismissal of the breach of warranty claim. Id. at 13. As for strict liability, the court dismissed strict liability design defect and failure to warn on the ground that neither is allowed under Pennsylvania law for prescription medical products. Id. at 6 n.3. But the court was unwilling to find the same was true as to plaintiff’s strict liability manufacturing defect claim.Continue Reading Pennsylvania Federal Court Uses Tincher to Find Claim for Strict Liability Manufacturing Defect in Medical Device Case

Photo of Bexis

We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long.  In true congressional fashion, it’s now twice as long and loaded up with enough goodies (mostly of the $$$ variety) that it just passed the House of Representatives by a 392 to 26 margin.  It thus seems poised to become law.  Given the prospects for imminent passage, we decided to revisit this monster and see if there’s anything more of interest to product liability defendants.  We aren’t interested in the spending-related aspects of this bill, which are what’s really greasing its skids.

So here goes.

Preemption

The first thing we wanted to see is if there is any preemption of civil lawsuits, so we searched the text of the bill for the word “state.” More than 100 matches.Continue Reading Anything Worthwhile For Product Liability Defendants In The 21st Century Cures Act?

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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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