For at least forty years we’ve been hearing that soccer is going to supplant baseball, basketball, or football among America’s top three sports.  It hasn’t happened.  Maybe we heirs of Washington, Jefferson, Ruth, Rice, and Chamberlain have limited enthusiasm for one-nil scores and players diving and mimicking death throes in a cheap effort to extract a penalty kick.


Meanwhile, we have seen boxing subside in the country’s consciousness, bullied out of the way by mixed martial arts (MMA). It’s hard to believe one of those M’s does not stand for mayhem.  Forget about the Marquis of Queensbury’s niceties.  In MMA, the contestants are free to kick, choke, and elbow each other.  Hit a man when he’s down?  That’s not forbidden in MMA. Nope, that’s when the action is just getting started.  Pretty much anything goes in MMA.  
But you cannot use anabolic steroids.  If you test positive, you get suspended.  Rules are rules.  

The plaintiff in In re Lyman Good Dietary Supplements Litigation, 2018 U.S. Dist. LEXIS 131668 (SDNY Aug. 6, 2018), was an MMA fighter who was suspended because he tested positive for a banned substance.  The court employs the short-hand reference “andro” for the banned substance, and so shall we.  The plaintiff claimed that he had unknowingly ingested andro that was present in two dietary supplements that had been labeled to be free of any banned substances. The plaintiff alleged that the manufacturers and sellers of the dietary supplements promised that the products were “safe,” “without the use of banned substances,” “banned substance free,” and in compliance with “strict quality assurance procedures.”  The presence of andro broke such promises, and the plaintiff’s career had suffered a serious bruise. The plaintiff sued the manufacturers, high ranking executives at the manufacturers, and the retailer. The causes of action were interesting, including some you’d expect (breach of warranties, fraud, deceptive practices, false advertising, negligence, and strict liability) and some you wouldn’t (intentional infliction of emotional distress, assault and battery).  The defendants moved to dismiss and ended up winning more than they lost.

The court dismissed the claims for fraud, assault and battery, and intentional infliction of emotional distress.  Fraud claims are subject to heightened pleading requirements, which the complaint didn’t come within a puncher’s chance of satisfying. All we get are general allegations of fraudulent intent, along with generalized motive to earn profits.  That isn’t nearly enough.  The court applied a rear naked choke to the fraud claim and counted it out.  The assault and battery claim was a wild swing and miss.  The plaintiff’s theory was that putting a substance in someone’s body without consent is battery, but there was no case support for that, plus the plaintiff never alleged the requisite intention to inflict injury.  Here comes a reverse guillotine, and watch the court slice off the assault and battery claims.  Lack of intent is also what doomed the claim for intentional (or reckless) infliction of emotional distress.  The court also could identify no alleged outrageous conduct that went “beyond all possible bounds of decency.”  (To be sure, when one is dealing with MMA, it might seem difficult to meet that standard.) 

The court dismissed the claims against the executives, both on the merits and for want of personal jurisdiction.  Suing executives is fairly rare, and there are reasons for that.  Piercing the corporate veil requires a showing that the executives exercised compete domination and disregarded corporate formalities, including use of corporate funds for personal purposes.  At most, the complaint alleged that the individual defendants were high-level officers with wide-ranging authority, but an officer or director is not personally liable for the torts of a corporation merely by reason of occupying an important office.  The complaint utterly failed to allege that the executives used corporate domination to perpetrate a fraud.  In any event, there was no personal jurisdiction over the individuals.  They all had general authority over their corporations, but were not the primary drivers of the particular transactions in New York that gave rise to the litigation.  Hello sleeper hold, and good-bye claims against the individual defendants.  

The retailer prevailed on most of its motions to dismiss.  The claims for implied warranty of fitness for particular purpose, express warranty, and false advertising were carried out of the ring, but the claim of implied warranty of merchantability emerged unscathed.   The only express warranty by the retailer listed in the complaint was a statement in its 10-K annual report that the company used quality control procedures and that it refused to sell products that did not comply with law or were unsafe.  Those representations are pretty general, and the plaintiff did not even claim to have read them or relied upon them prior to purchase.  Nor did the annual report constitute a form of advertisement.  The court granted the plaintiff leave to amend the claim for implied warranty of fitness for particular purpose because, even though the complaint was bereft of any assertions that the plaintiff and the store had any conversations about how the plaintiff would use the supplements to prepare for MMA combat, the plaintiff wanted to add six paragraphs alleging precisely such conversations.  If such conversations did take place, it would not be “outside the realm of reasonable knowledge” that professional competitions require drug testing.   Thus, the particular purpose warranty claim might live to fight again.

The opinion in Lyman Good is solid and clear.  It goes through the different causes of action and defendants one-by one, jab by jab.  It reminds us that MMA is not the only place where rules are rules.

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

It may be post Mardi Gras season, but we don’t think there is ever a bad time to embrace the motto – “Laissez les bons temps rouler.” Quite literally – “Let the good times roll.” However, don’t try this with your high school French teacher, because after her gasp of horror, she will tell you that the grammatically correct way to get a party started in France is “Prenons du bons temps.” Of course, the Louisiana version is really Cajun French as opposed to France French and with both having so many good things to offer it’s really a matter of preference in a given moment. Like deciding if you’re in the mood for bouillabaisse or crawfish etouffee; a beignet or a croissant; a Hurricane or a Cabernet Franc.

Now that we’ve got you thinking about what’s for dinner, we can narrow our Louisiana focus to just the Louisiana Products Liability Act (“LPLA”) – hoping to whet your legal appetite now. In the case of Pierre v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 67773 (E.D. Lous. April 23, 2018), plaintiff alleged she was injured as a result of defendant’s self-fixating mesh that was used in plaintiff’s abdominal surgery. Plaintiff alleges she suffered an infection and pain following her surgery. Id. at *2. We are jumping to the end of the decision to immediately lop off several of plaintiff’s claims. The court dismissed claims for breach of warranty of fitness for ordinary use, negligence, breach of implied warranty, negligent misrepresentation, and negligent design all on the grounds that they exceed the scope of the LPLA and the LPLA “sets forth the exclusive theories of liability for manufacturers for damage caused by their products.” Id. at *15.

So, what claims does the LPLA allow? Manufacturing defect, design defect, failure to warn, and express warranty. Id. at *5. And on defendant’s motion to dismiss, only half those claims survived. The first claim to survive, unusual for a drug/device case, is for manufacturing defect. That’s because here plaintiff had a specific allegation that the mesh used in her surgery was improperly sterilized which led to her development of an infection. Because plaintiff is challenging a deviation from the standard procedures for this product, she’s stated a claim for a manufacturing defect. But the court was clear that what plaintiff could not do is attack the defendant’s sterilization process generally, only this particular alleged deviation. Id. at *7-8.

Next plaintiff alleged two design defects. First plaintiff alleged that the mesh was defective in that it was made of polyester, a weaker material than used in other mesh products, and that the weaker material required a different method of being secured which ultimately led to causing plaintiff more pain than she would have suffered with a different method of attachment. Id. at *8-9. Since plaintiff alleged a design defect, alleged that that defect was the cause of one of her injuries (pain), and that alternative designs existed, she passed TwIqbal on this claim. Her second design claim, however, did not meet that standard. Plaintiff alleged that the design of the mesh caused her infection by lowering her pH. But missing from this claim is any suggestion of “the existence of a feasible alternative design that would prevent the alleged injury.” Id. at *10.

There was no splitting the baby on plaintiff’s failure to warn claim. It was dismissed in its entirety. As to the alleged failure to warn about infection, plaintiff relies exclusively on a single marketing document. However, plaintiff failed to allege any facts “to plausibly suggest that [plaintiff’s] surgeon relied, or any competent surgeon would rely, on this marketing document when deciding whether to perform surgery.” Id. at *11. A pretty demanding standard when you infer, and we think the court was so implying, that no competent surgeon relies on marketing material to make medical decisions. Moreover, the court pointed out several ways in which the marketing document cites to other documents, most importantly to the “Instructions for Use” of the mesh demonstrating that “Defendants did not rely solely, if at all, on the marketing document to warn users of the risks.” Id. at *12. Not to mention that the risk of infection is a “common surgical complication” most likely already known to plaintiff’s surgeon. Id.

Plaintiff’s second failure to warn claim was based on a failure to warn that the mesh might contract after surgery causing pain. Id. Here plaintiff failed to allege any facts about what warning was provided to plaintiff’s surgeon relying only on a boilerplate statement that defendant didn’t warn. Id. But such an “allegation is too broad to state a claim because it does not identify (1) which aspects of the product warranted a warning and (2) what injuries resulted from the failure to warn.” Id. at *13. Too vague to withstand dismissal.

So too was plaintiff’s breach of express warranty claim. Plaintiff only alleged that defendant warranted the product was safe and fit for its intended use, merchantable, adequately tested, and did not have dangerous side effects. Id. at *14. But a claim that a product is “safe” or “effective” is only a “general opinion” or “general praise,” insufficient to form the basis for an express warranty under the LPLA.

Of the 6 claims brought that were permissible under the LPLA, only 2 survived the motion to dismiss. Not a complete win, but good enough to put in the “good times” category. And if you don’t want to get embroiled in the French debate, we recommend following the lead of Shirley & Lee from 1956 or The Cars from 1978 and just let the good times roll (in English).

Aren’t we all guilty of having that drawer, that shelf, that cabinet, maybe even a whole closet where things just get dumped. And as new stuff gets dumped, the old stuff gets pushed to the back. Then one day the space simply can’t hold anymore and you reach to the back to see just what’s there. What do you find? Old empty checkbooks. Gift card to a restaurant that closed two years ago. Any variety of expired items from coupons to salad dressing to cough medicine. And of course that half-eaten bag of cookies that are so stale you can use them as coasters. But, sometimes you also find a hidden gem. Like the cord to charge your radio that you haven’t been able to use for the last 6 months. Or the great family photo from Aunt Susie’s 80th birthday. Or your favorite pair of socks. How did they get there?

Well cases, just like socks and salad dressing, can get pushed to the back of the shelf – where they too get stale. And if courts still used paper dockets, the file in Beswick v. Sun Pharmaceutical Industries, Ltd., 2018 U.S. Dist. LEXIS 15012 (W.D.N.Y. Jan. 30, 2018) would be covered in an inch of dust with discolored pages stuck together from sitting at the bottom of a pile in a basement storeroom. The decision rendered just last week is on a motion that was filed in June 2012 on the basis of the Supreme Court’s ruling in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). A 5 ½ year old motion based on a 6 ½ year old ruling. Fortunately, the decision is to dismiss the case, but it’s a decision that could have been entered a long time ago. We imagine the delay has not been without some financial consequences to the defendant. Indeed, plaintiff’s counsel withdrew back in 2015, likely recognizing the folly of pursuing what is essentially a failure to warn case against a generic drug manufacturer. But still the case sat.

The complaint, alleging plaintiff suffered from Stevens Johnson Syndrome as a result of using defendant’s generic anticonvulsant drug to treat his epilepsy, was filed in 2010. Id. at *1, *4-5. In early 2011, the court granted defendant’s motion to dismiss all claims except those alleging breach of express and implied warranty. Id. at *2. The case was then stayed pending the Supreme Court’s decision in Mensing. Id. A year after Mensing, defendant file a motion for judgement on the pleadings on the two remaining claims and the motion was fully briefed by August 2012. Defendant then filed supplemental declarations in support of its motion in November 2012 and again in August 2013. In 2015, defendant formally requested that the stay be lifted and filed yet another supplemental declaration in support of its motion. Id. at *3-4. The supplements we assume necessitated by the development of the law over the years the motion was pending. And finally, three years later the motion was ruled on.

It should come as little surprise that the warranty claims, premised on a failure to warn, were found to be preempted.  Plaintiff alleged that defendant breached its express warranty that the drug was safe and effective by failing to disclose known risks of side effects including SJS. Id. at *6-7. Plaintiff similarly alleged that defendant breached the implied warranties of merchantability and fitness for the drug’s intended use by failing to warn about the drug’s side effects and risks. Id. at *7-8.

The court then analyzed both claims in light of Mensing and Bartlett (5 years old itself) which we know held that because generic drug manufacturers are prohibited from making any unilateral change to the drug’s label, federal law “preempts any duty the generic drug manufacturer otherwise would have under state law to provide additional warnings.” Id. at *18. Therefore, because plaintiff’s warranty claims are essentially “state law tort claims attacking a drug label warning as insufficient” they are preempted. Regardless of the theory, if the claim is premised on a failure to warn, it is preempted. See id. at *22.

Plaintiff attempted to advance two arguments to avoid preemption. First, plaintiff argued that defendant didn’t have to change its label but rather could have sent out Dear Doctor letters containing additional warnings. The Supreme Court deferred to the FDA that such letters would be misleading because they would imply a “therapeutic difference” between the brand and generic drugs. Id. Second, plaintiff argued that defendant should have pulled the drug off the market. This too has been rejected by the Supreme Court. When faced with a conflict between federal and state law, the manufacturer is not obligated to stop selling. If that were the case, “impossibility preemption would be all but meaningless.” Id. at *23 (citing Mensing).

There is nothing new or novel about the court’s decision other than the amount of time it took to be entered. The case simply hung around for way too long and could have been disposed of five years ago. Like the receipt for the gloves you bought your mom for Christmas 2014.

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.