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

Way back at the start of this year, we posted about a great preemption win on express warranty. Well, that case has worked its way through the appellate process and the Fifth Circuit unfortunately has reversed the decision. But, we aren’t going to rage

The warranty is “express.”

Before you say, “Well, duh,” this sometimes actually does matter. Here’s how.

Most complaints in product liability actions involving prescription medical products that include express warranty counts do so as one of a bunch of different causes of action, all pleaded seriatim (“one after another,” in non-lawyer speak).  Believe it or

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

We use products with warranties every day. There are warranties on frying pans, on light bulbs, on computers. We once saw a warranty on a pair of nail clippers that cost $1.49 that allowed the owner to send them in for repair or replacement as long as you included $3.00 for return shipping. What a bustling warranty department that company must have had. Generally speaking, we don’t pay much attention to warranties unless they are on big ticket items. If something goes wrong with your car, you’re scrambling to see whether it’s covered by a warranty. If a light bulb that’s supposed to last five years burns out in three, you most likely just toss it out and screw in a new one. You probably forgot how long it’s been since you last changed it anyway (speaking for this blogger at least).

Medical devices such as implantable spinal neurostimulators (guess what today’s case is about) don’t come with warranties of the kind alluded to above. You’re not going to see a provision on the labeling that says should this device break or malfunction within 3 years of implant, just send it back for a new one. There are many reasons for this, the most obvious of which is the device is inside someone’s body. Returning the device it isn’t always an option, because revision surgeries aren’t always the best option. Moreover, most product warranties talk about normal wear and tear or under normal conditions. There is no such thing as “normal” or “typical” when you are talking about inside the human body. There are simply too many unknowns for medical device manufacturers to guarantee their products.

But that doesn’t stop plaintiffs from including express warranty claims in their complaints. Typically the allegations in express warranty claims in drug and device cases are general statements that the manufacturer’s labeling and advertising represented that the product would be safe, effective, fit, proper, etc. When pressed for the actual representations that constitute the express warranty or for proof of reliance on such statements – well, that’s when plaintiffs’ express warranty claims often fall away. That’s because they don’t exist. And, that’s usually the focus of our discussion on express warranty. Occasionally, however, plaintiffs come armed with a little more specificity.


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Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we  usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not  the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.


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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.


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Express warranty is one of those claims that is often raised in prescription medical product liability actions, but seldom pursued with any intensity.  A lot of express warranty claims drop out right away because most courts, under TwIqbal or equivalent state pleading rules, require plaintiffs to plead the precise language of the purported warranty.  As a bunch of cases from our TwIqbal Cheat Sheet establish, most plaintiffs can’t even do that – demonstrating that the majority of express warranty claims are patently bogus.

Express warranty can assume greater importance in preemption cases. Some courts view “express warranty” as based on voluntarily-made statements that aren’t governed by the FDA and thus don’t involve preemptive “requirements” when made by manufacturers of PMA medical devices.  That sentiment is particularly strong in the Third Circuit.  See Horn v. Thoratec Corp., 376 F.3d 163, 168 n.7 (3d Cir. 2004); Michael v. Shiley, Inc., 46 F.3d 1316, 1325 (3d Cir. 1995). Also, a number of states have tort reform statutes that abolish just about all pre-existing common-law causes of action.  Express warranty is often one of the few exceptions allowed in addition to the statutory cause(s) of action.

The latter scenario was the occasion of the Third Circuit’s excellent smack down of an exclusively express warranty class action in In re Avandia Marketing, Sales Practices & Products Liability Litigation (D’Apuzzo), ___ F. Appx. ___, 2014 WL 5334729 (3d Cir. Oct. 21, 2014).  Plaintiff D’Apuzzo, a New Jersey resident, sought to bring a no-damages class action for purely economic loss to recover “for the higher cost, including co-payments” that he allegedly suffered because the drug in question was more expensive but purportedly no better.  Id. at *1.  New Jersey, however, has a comprehensive product liability statute that both abolishes common-law causes of action and prohibits actions for purely economic loss.  Id. at *1 & nn.7-8.  The statute was clear, and New Jersey authority controlling, so plaintiff appealed only the dismissal of his express warranty claims.


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Today we have two summary judgment decisions recently issued out of one of the pelvic mesh litigation MDLs – the West Virginia federal court managing consolidated cases related to Boston Scientific’s mesh product.  See Tyree v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 148271 (S.D.W. Va. Oct. 17, 2014); Tyree v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 148371 (S.D.W. Va. Oct. 17, 2014).  The opinions are close to identical.  In each instance, with limited discussion, the court disposed of a number of the plaintiffs’ claims – e.g., manufacturing defect and fitness for a particular purpose – and allowed others to go forward to trial – e.g., failure to warn (remember, West Virginia has no learned intermediary doctrine) and implied warranty of merchantability.

But it’s the court’s decisions on plaintiffs’ express warranty claims that merit discussion.  The defendant argued – convincingly, you would think – that it was entitled to summary judgment on these warranty claims because the plaintiffs admitted that they never received or read the written materials (the Directions for Use) in which the warranty was allegedly made.  2014 U.S. Dist. LEXIS 148271, at *14-15; 2014 U.S. Dist. LEXIS 148371, at *13.  That argument sounds pretty good.


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Today we bring you a third case in one week regarding prosthetic hip implants.  Here and here we reported on courts correctly ruling that plaintiffs had not adequately pleaded product liability claims involving their hip prostheses and/or that federal law expressly preempted claims involving devices approved through the FDA’s rigorous Premarket Approval (“PMA”) process.  We

Do you remember way back yesterday when we posted on Daubert rulings from an OTC pediatric ibuprofen SJS case?  The rulings were in March but just popped up on Lexis last week.  We led in with a discussion of video games as a clever segue to the games some experts play. Really, no glimmer of recognition?  Well, the same case had summary judgment rulings that have now been “published,” so we are giving you a double dose.  See Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013).  As with the expert rulings, there is a mix of good and bad, but the bad gets stuck in our throat.  Dispensing with the lame medication jokes, on to the rulings, the good ones first.

Plaintiffs asserted a claim under the Illinois Consumer Fraud Act premised on “standby statements” from 2003 and 2005 concerning separate reports of SJS/TEN in children using defendants’ ibuprofen products.  This claim failed both because the statements were not deceptive—an obvious element of the claim—and because the defendants established the applicability of the Act’s regulatory compliance defense.  (The Act did not require that the plaintiff rely on the deceptive statement, only that the defendants intended that there be reliance, or there would have been another obvious basis where plaintiffs and their parents surely never saw the statements before using the product.)  As anyone who has ever participated in drafting any statements on adverse events knows, the line between saying something that will later be called an admission of causation and saying something that will later be called minimizing is a fine one.  The statements at issue described the particular cases as “allegedly associated” with the defendants’ product and noted that SJS and/or TEN, in general, “are associated” or “reported to be associated” with ibuprofen and other medications.  The FDA-approved label from 2009, when the plaintiffs used the product, included the warning that “[i]buprofen may cause a severe allergic reaction . . . .”  Under these circumstances, the statements were held consistent with the label and not “so misleading or deceptive in the context that federal law itself might not regard [it] as adequate.”  Id. at *19 (quoting Bober v. Glaxo Wellcome PLC, 246 F.ed 934, 941 (7th Cir. 2001)).  It was very sensible to not read “associated with” as deceptive simply because the label later said “may cause.”

The sensible approach continued in the evaluation of the evidence offered on the regulatory compliance defense—an unnecessary analysis given the lack of an otherwise actionable deceptive statement.  Without rehashing the discussion, which overlaps with the Daubert analysis at issue in yesterday’s post, the part that interested us was the use of statements from FDA in light of the inevitable allegations that defendants had underreported adverse events and generally kept FDA in the dark about the SJS risk of ibuprofen.  Defendants here were able to rely both on a 2006 denial of a citizen’s petition call for withdrawal of all OTC ibuprofen products—for once, not made by Public Citizen, at least openly—and deposition testimony of an FDA official.  The denial included the statement that “we have no evidence that there is additional undisclosed safety information that was withheld by ibuprofen manufacturers” and the FDA official did not suggest that defendants failed to perform any required analysis of adverse events.  Id. at **23-26.  With this back drop, the plaintiffs’ “slight, at best,” evidence of noncompliance could not be assumed to have “affected . . . FDA’s decision making.”  Id. at **26-27.  Placing the burden on plaintiffs to come forward with evidence that alleged noncompliance with regulatory requirements somehow invalidated FDA’s authorization of defendants’ statements was predictably fatal to plaintiff’s claim.


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We have all heard that bad facts make bad law.  We have also heard that discretion is the better part of valor.  Sometimes, faced with bad alleged facts, a bad decision may be the predictable result of a motion to dismiss.  We are all for knocking out non-existent claims and making plaintiffs plead properly, but it is important when deciding to file 12(b)(6) to keep an eye on the relief being sought and how that relief would affect the case.  Although we do not have any knowledge of the considerations that went into the filing of this motion to dismiss, sitting here with our retrospectoscope, we see Williamson v. Stryker Corp., No. 12 Civ. 7083 (CM), 2013 U.S. Dist. LEXIS 104445 (S.D.N.Y. July 23, 2013), as a predictably bad decision.  We also feel a little like the venerable plaintiffs’ expert from whom we first heard the term “retrospectoscope,” smug, in our office, blathering on about something with which we were not involved.  Unlike him, however, we will resist the temptation to ascribe motive to why the court ruled as it did, as we believe motive is a subject for juries/readers to decide not for experts/blawgers to opine.

When testing the adequacy of a complaint, the “facts” at issue are those plaintiff chooses to include in the complaint, how she chooses to include them.  As such, it is not surprising that the facts analyzed in Williamson seem incomplete to anyone who knows medical device product liability cases.  It seems likely that a knee replacement plaintiff with at least four prior failed replacement surgeries, who was told her only treatment options were amputation or surgery with defendants’ product, had something else going on besides her basic allegation that:  1) the product broke not long after an uneventful implant, 2) then she was assured by defendants’ representative that there had been no prior reports of such breaks, 3) then she proceeded to have the broken product explanted and replaced with another of the same product, and 4) then the second implant also broke.  The court cannot assume additional facts to help direct its analysis to a different result, though.  (Hint, hint.)  So, the court analyzed a motion to dismiss every count other than failure to warn and loss of consortium.  The central allegations were of “manufacturing defect and/or design defect”:

(1) it relies exclusively on “the fixation in place of the femur and tibia bones”; (2) the knee revision system “is not properly designed or constructed to constrain motion between the femur and tibia bones so as to promote fusion by compression of the bones”; and (3) motion by the bones causes excess force on the device, leading to breakage and injury.

Id. at **6-7.  Plus, plaintiff’s review of defendants’ website before the first surgery and discussions with their representatives before the second allegedly created liability under theories of fraud, warranty, negligent misrepresentation, and deceptive business practice.  As you might expect from this lead in, defendants’ motion was denied across the board, although the court directed plaintiff to flesh out her fraud and negligent misrepresentation counts.


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