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 against the decision as you might expect us to. We aren’t going to laud it either. Rather, we are taking the decision for what it is – the narrowest of preemption escapes based on the unusually detailed nature of what the manufacturer actually said in the alleged warranty. Good luck to plaintiffs trying to use this decision elsewhere. For 99.9% of express warranty cases, this case’s rationale actually is a positive result.

The facts of the case are straightforward. Plaintiff alleged that a neurostimulator implanted in his spine stopped working after one and a half years, had to be explanted, and that he suffered complications from the revision surgery. Wildman v. Medtronic, Inc., 2017 U.S. App. LEXIS 21655 at *2-3 (5th Cir. Oct. 31, 2017). Plaintiff’s only claim was that the defendant breached its express warranty guaranteeing the device for 9 years. The alleged warranty language is important. The defendant’s website said that in addition to battery life, “many other factors and components are involved in determining the overall longevity of an implanted medical device.” And that based on extensive testing of many components, not just the battery, defendant had “confidence that [its] device is reliable for 9 years.” Id. at *4. Plaintiff alleged these statements were not reviewed or approved by the FDA. The device’s reference manual did undergo FDA review and approval as part of the PMA process. The manual contains an approved FDA statement that the device’s “battery life” was 9 years. Id. at *5. It is the distinction between “battery life” and “device life” that is at the crux of the court’s decision.

Why is that so important? Because that Fifth Circuit stated definitively that “when a claim challenges a representation the FDA blessed in the approval process, it is preempted.” Id. at *8. Could not be any clearer. Hence the reason this decision is probably more beneficial to defendants generally than to plaintiffs. Because the manufacturer’s website drew a distinction between the battery and the rest of the components, the court found the language was guaranteeing the reliability of the latter but that the FDA had only evaluated the former. Id. at *9. A verdict that the defendant’s representation was misleading or untruthful would therefore not run counter to any safety finding by the FDA. Instead, it would parallel federal regulations prohibiting false or misleading statements about medical devices.  Id. at *10-12.

The Fifth Circuit goes on to point out that where an express warranty claim survives preemption, it also still has to meet the TwIqbal pleadings standards. Therefore, an express warranty claim based on “vague allegations about representations . . . made to doctors or consumers” isn’t enough. Id. at *13. Another defense-favorable holding emphasizing that Wildman is an aberration.

Even though the case is being remanded, plaintiff hasn’t proven anything yet. Far from it. As the court points out, to prove his express warranty claim under Texas law is going to require both reliance and notice. Id. at *8n.3. It’s also going to require proof that something other than the battery caused the device to fail. Id. at *13-14. Plaintiff already amended his complaint to change from his more specific allegation that the device failed due to the battery to a more general allegation that the “neurostimulator did not conform to a nine-year device life.” Id. at *5. But does that general allegation meet the mark on the TwIqbal yardstick? The only claim that escapes preemption is a narrow one – did defendant breach a warranty about the longevity of some component other than the battery. On remand, the first issue for the district court is to determine whether plaintiff’s complaint sufficiently alleges facts to support such a claim. Again we say good luck on that.

The case may be, for the moment, revitalized, but the opinion bringing it back to life had enough juice worth the squeeze for defendants.

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 not, lawyers get tired of repeating themselves – especially those (like our adversaries) who don’t bill by the hour.  Thus, in complaints, we usually see each cause of action in multi-count complaints begin with a paragraph “incorporating by reference” facts that were pleaded earlier in the document.

That can be fatal to express warranty claims – because the warranty must be “express” – whereas other claims, such as failure to warn, can be maintained on the basis of allegedly omitted facts.  Thus, incorporation by reference (or pleaded facts) that only incorporates allegations of omitted facts isn’t enough to plead express warranty.  This is one more way to make express warranty claims go bye-bye (see our TwIqbal cheat sheet for others), and it appears that, increasingly, plaintiffs have been called out for this failing.

The only appellate prescription medical product case that we’ve seen on this point is Rite Aid Corp. v. Levy-Gray, 876 A.2d 115 (Md. App. 2005), aff’d on other grounds, 894 A.2d 563 (Md. 2006).  In Levy-Gray, an omission by the defendant pharmacist of a statement in the manufacturer’s labeling didn’t cut it as a basis for express warranty:

[I]n order to have an express warranty there must be an affirmative statement of fact by the seller about the goods.  A claim that there is a warranty by omission is at odds with the UCC definition of an express warranty.  Here, the manufacturer’s package insert . . . contained, inter alia, the following statement:  [statement omitted]  The omission of this statement, which was relevant to the negligence claim asserted by Plaintiff, and is of some relevance to the medical causation issues, is not relevant to the creation of an express warranty.

Id. at 126 (citation omitted) (emphasis added).

Several federal district courts have made the same point.  The issue arose in the Testosterone MDL, where the “plaintiffs have pointed to no statement that constitutes an express warranty.”  In re Testosterone Replacement Therapy Products Liability Litigation, 2014 WL 7365872, at *8 (N.D. Ill. Dec. 23, 2014).  “[P]laintiffs must plead more than misstatements and omissions to state a claim for breach of express warranty.”  Rather, plaintiff “must point to a specific affirmation or promise.”  Id.  In Young v. Bristol-Myers Squibb Co., 2017 WL 706320 (N.D. Miss. Feb. 22, 2017), the court raised the issue sua sponte (meaning “on its own”), pointing out:

[T]he Court notes that, while not raised by the defendants, [plaintiff’s] breach of express warranty claim must fail to the extent it is based on alleged omissions in [the drug’s] prescribing information. An omission is neither an affirmation of fact nor a promise.

Id. at *15 n.10 (citation omitted).

Non-express “express” warranty claims also failed in House v. Bristol-Myers Squibb Co., 2017 WL 55876 (W.D. Ky. Jan. 4, 2017), because allegations of omissions were insufficient:

[Plaintiff] cannot base her express warranty claim on allegations that the Prescribing Information fails to include the “true risks” of the drugs and does not contain “adequate information[.]”  An express warranty is created by an “affirmation of fact or promise,” not an omission.

Id. at *6 (citations omitted).  In Vakil v. Merck & Co., 2016 WL 7175638 (D.N.J. Dec. 7, 2016), the court disposed of a warranty claim under Virginia law (significant because Virginia doesn’t have strict liability) observing that “during oral argument” plaintiff “indicated that his theory was more akin to an omission. Therefore, summary judgment is granted to Defendants as to the breach of express warranty claim.”  Id. at *5.

We also looked outside the drug/device sphere, and were surprised by the relative paucity of precedent.  Either plaintiffs aren’t pleading omissions in express warranty claims or defendants are letting them get away with it.  There’s one citable appellate decision, and it’s almost 30 years old.  Sidco Products Marketing, Inc. v. Gulf Oil Corp., 858 F.2d 1095, 1099 (5th Cir. 1988) (“Omissions, however, are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.”) (applying Texas law).  Young cited Sidco.  So did the next two cases – coincidentally, both from Missouri:

Plaintiffs repeatedly allege that the press releases and advertisements all failed to disclose the defect, so, to the extent their express warranty claims are based on advertisements and promotional materials, these claims are based on omissions. A breach of express warranty claim, however, cannot be premised on an omission.

In re General Motors Corp. Anti-Lock Brake Products Liability Litigation, 966 F. Supp. 1525, 1531 (E.D. Mo. 1997), aff’d on other grounds, 172 F.3d 623 (8th Cir. 1999)

Plaintiff, therefore, bases liability not on what the documents provide, but on what they do not provide.  The law is clear that [plaintiff] may not recover under this theory because omissions are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.

Cambridge Engineering, Inc. v. Robertshaw Controls Co., 966 F. Supp. 1509, 1524 (E.D. Mo. 1997) (quoting Sidco).

Likewise, defendants in tobacco product liability cases have not allowed plaintiffs to pass off “warranty by omission” as an “express warranty.”  Witherspoon v. Philip Morris, Inc., 964 F. Supp. 455, 465 (D.D.C. 1997).  Omissions of this and that are “at odds with the definition of express warranty.  Plaintiff has not pleaded an express promise on the part of Defendant.”  Id.  Accord Hughes v. Tobacco Institute, 2000 WL 34004261, at *10 (E.D. Tex. May 5, 2000) (“nondisclosure . . . does not create an express warranty”), aff’d on other grounds, 278 F.3d 417 (5th Cir. 2001).

Another appellate decision actually exists, but it’s non-citable:

Essentially, [plaintiff] bases his claim not upon an express affirmation of fact or description of the goods, but instead, upon the omission of language such as simulated or imitation.  [Plaintiff] has presented no authority that an omission of fact can create an express warranty.

Pocino v. Jostens, Inc., 2006 WL 1163785, at *5 (Cal. App. May 3, 2006).

Finally, we found one other case, on point, not citing anything beyond the relevant UCC section, but reaching the same result:  “[A] failure to include information in the specification sheet is the exact opposite of an express warranty.”  “[O]missions . . . are simply insufficient to support a breach of warranty.”  Cannon Technologies, Inc. v. Sensus Metering Systems, Inc., 734 F. Supp.2d 753, 769-70 (D. Minn. 2010).

Express warranty claims deserve attention in prescription medical product liability litigation.  Some courts allow such claims to escape preemption.  Others give express warranty claims a longer (or at least different) statute of limitations.  Such claims should not be allowed to persist when there is no basis for them, so any express warranty claim based on omissions should be challenged at the first opportunity.

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.

Continue Reading Express Warranty Claim Preempted

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.

Continue Reading Still No Duty To Supply Drugs – In 22 States

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

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.

Continue Reading Third Circuit: “Safe and Effective” Isn’t an Express Warranty

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.

Continue Reading Express Warranty Claim Survives Summary Judgment under West Virginia Law in Mesh Litigation

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 wish we were coming to you today with another dismissal order, thus completing a weekly trifecta.  Regrettably, today’s post more resembles the children’s game duck, duck, goose.  And today’s case is the goose—an order denying the manufacturer’s motion to dismiss as “premature” even though the plaintiff alleged treatment with a PMA device.

In Frederick v. Smith & Nephew, Inc., No. 1:13 CV 1220, 2013 U.S. Dist. LEXIS 170938 (N.D. Ohio Dec. 4, 2013), the plaintiff attempted to allege state-law tort claims over a PMA-approved prosthetic hip device known as the Birmingham Hip Resurfacing System (“BHR”), which the plaintiff identified in his Third Amended Complaint by name.  From our point of view, this means express preemption under the Medical Device Amendments, but the district court saw it differently in an order that raises more questions than answers.

We do not know what the plaintiff’s first three complaints said, but by the time the plaintiff got around to his third amendment, there appears to have been no doubt on which device was used and who manufactured it.  The BHR System’s manufacturer therefore moved to dismiss the complaint on the basis that the plaintiff’s state-law claims were expressly preempted, and also because the plaintiff did not adequately plead his claims under Twombly and Iqbal.  Id. at *4.  The district court correctly observed that federal law preempts state-law claims regarding PMA devices to the extent that state law imposes requirements different from or in addition to FDA requirements.  Id. at *5.  The court also recognized that the first step in express preemption analysis is to determine whether the federal government has established requirements or regulation applicable to the medical devices in question.  Id. at *6.

From this point, however, the district court took a wrong turn and ruled that it was “premature” to apply express preemption because discovery was not complete.  According to the court,

[D]iscovery is not complete and the defendant conceded to the Court that it has not examined the device and any component parts utilized in plaintiff’s original surgery.  [The plaintiff’s doctor’s] letter does not specifically identify the . . . device and any component’s used in plaintiff’s surgery.  Devices and
component parts for which the FDA has not established regulations or requirements are not preempted by the MDA.  It is premature to conclude at this stage of the lawsuit that the PMA letter issued by the FDA for the [device] preempts all of plaintiff’s claims.

Id. at **6-7.

So the Court could not apply preemption because it could not tell which device was used to treat the plaintiff, which for us raises several questions.  To begin with, we know the identity of the device at issue because the plaintiff identified it in his complaint.  And this was the Third Amended Complaint.  Maybe there really was a genuine question regarding the identity of the device, or maybe the plaintiff’s lawyers re-used an old complaint and forgot to change the name of the device.  We don’t know, but we think it is more likely that on their fourth try the attorneys took some care in identifying the most basic and elemental fact in the lawsuit.  We do not understand why the district court would not accept the complaint at face value, especially when a motion to dismiss is supposed to be determined on the facts as pleaded and the plaintiff had already taken numerous opportunities to amend.

We also do not understand the district court’s reasoning in permitting further discovery and why it mattered that the defendant had not examined the explanted device. The purpose of a motion to dismiss is to dispose of claims that fail on the pleadings before engaging in unnecessary and very expensive discovery.  Sure, the defendant had not examined the device, and the plaintiff’s doctor was not specific in his letter, but so what?  It is not the defendant’s burden to verify the complaint’s well-pleaded facts with extrinsic evidence when it moves to dismiss, and what about cases where the device is not available for inspection, such as when it was discarded or where it has not been explanted from the patient’s body? It cannot be that the defendant cannot assert federal preemption in cases involving implantable devices without first physically inspecting them.

The district court also held back because “the specific details, extent and scope of the federal requirements and/or regulations imposed by the PMA for the [device] are not yet fully developed in the record, and some areas may be specifically excluded from regulation.”  Id. at *11.  Maybe there is more to this than meets the eye, but we cannot understand why the “extent and scope” of federal regulation was not clear.  This again was a PMA device for which the FDA reviewed and approved the device’s design and instructions for use.  Moreover, the plaintiff was alleging garden variety claims—design defect, failure to adequately warn, and breach of warrant.

A final signal that something is not quite correct about this order is that the district court denied the defendant’s motion to dismiss also because the plaintiff pleaded his claims with sufficient detail under Twombly and Iqbal.  In doing so the court created a “Catch 22,” holding that the Third Amended Complaint was too vague to tell the identity of the device for purposes of preemption, but clear enough to plead claims under state law.  It seems to us the plaintiff cannot have it both ways:  If the Third Amended Complaint was clear enough to state a claim under state law, it was also clear enough to determine that federal law preempted those claims.  This result is contrary to the purpose of Twombly and Iqbal.

The district court denied the motion without prejudice to the defendant filing a motion for summary judgment “if following the completion of discovery, it appears that the device and any component parts are entirely regulated by the FDA, and that plaintiff cannot sustain a claim under state requirements that parallel federal requirements.”  Id. at *8.  Perhaps the defendant will move for summary judgment, and perhaps the district court will grant it.  But if that proceeding has to await “the completion of discovery,” this defendant has a legitimate reason to be disappointed.  Federal preemption is a powerful defense, as Bexis frequently reminds us, and where express preemption appears on the face of the complaint, the defendant should be able to put an end to litigation.  And when the plaintiff has already amended his complaint three times the dismissal should be without leave to amend.

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.

Continue Reading Recurring Intermittent Headache

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.

Continue Reading Pleading Defect