Returning to a Favorite Spot

            One member of our blogging team (we’ll let you guess who) recently returned from her (well, that narrows it down a bit) first real camping trip.  The kind with a tent, sleeping bags, no electricity.  You get the idea.  This wasn’t just a step, but rather a huge leap outside this blogger’s comfort zone – which runs more toward poolside bar service somewhere where the view is only obstructed by palm trees.  Before the trip images of big red welts from mosquito bites, spiders and ticks taking up residence in our hair, and critters of any size wandering around at night left us more than a little disconcerted.  An ample supply of wine was stowed with the gear.  A Google maps search had located nearby hotels.  And the iPhone car charger was packed.  We were ready for anything.

            Most importantly, as it turns out, we were ready for some fun.  The weather near the Appalachian Trail in Pennsylvania was almost perfect.  Sunny and warm during the day.  Just chilly enough at night to make you want to huddle around the camp fire.  Perfect weather for hiking, fishing, roasting marshmallows and hot dogs, and telling ghost stories.  The perfect environment for separating the kids from their DVD players, iPads and assorted other portable electronic devices – something we quickly realized was necessary when, as we drove into the mountains we heard from the back seat:  Wow, it’s like a real life 3D movie.  Yikes! (But don’t tell them about the car charger). 

            Perhaps best of all was the stillness of the early mornings.  No alarms going off.  No sounds of traffic congestion.  No being bombarded by streaming bad news from all over the world.  Just big, deep breaths of fresh air.  It made us think of …well, of camping again.  Much like the sandy beaches and umbrella drinks (which remain our top destination for relaxing) – when you discover a place you like, you find yourself wanting to return.  Even on the ride home, you start thinking about the next time.  Fun places are fun places.  So, we revisit them with fond memories of the last trip and anticipation that more fun is right around the corner.

            That’s sort of how we feel about the Aredia/Zometa litigation.  We’ve been there before, we generally like it, and so we go back again. 

            This week, the A/Z litigation added to its lengthy string of successes (see prior posts on A/Z cases here) with a Daubert (slip op.) and a summary judgment (slip op.) win all rolled into one in the case of Conklin v. Novartis Pharmaceuticals Corporation, No. 9:11-cv-00178-RC, (E.D. Tex. Sept. 19, 2012).  

While the case was pending in the Aredia/Zometa MDL, the court granted defendant’s motion for summary judgment on plaintiff’s (and 7 other TX residents’) failure to warn claims.  Daubert slip op. at 5.  Shortly after remand, in an attempt to avoid the implications of the MDL court’s ruling, plaintiff notified the remand court that the case would proceed on “design defect under Texas law.”  Id. at 8.  Plaintiff claimed that Dr. Robert Marx, an oral surgeon and one of plaintiffs’ leading MDL experts, had an alternative design theory that saved her remaining claims.  Id.   As Dr. Marx’s declaration was plaintiff’s sole support for those remaining design defect claims, the court first ruled on defendant’s motion to strike under Daubert.

Dr. Marx’s opinion was that a decreased dosage and/or frequency of Zometa administration would both reduce the risk of the side effect suffered by plaintiff (ONJ) and still efficaciously treat cancer-related bone damage.  Id. at 16.  Unfortunately for plaintiff, the court found both that Dr. Marx was unqualified to render such an opinion and that the opinion itself was unsupported.  First, the court noted that Dr. Marx is neither an oncologist nor pharmacologist and therefore not qualified to offer an opinion on what dosage of Zometa would effectively treat cancer-related bone damage.  Further, in disqualifying Dr. Marx, the court noted that he “had to rely on studies or opinions of other experts to opine of the efficacy or utility of his ‘safe alternative design.’”  Id.

But the court didn’t stop there.  Delving deeper into the shaky foundation of Dr. Marx’s opinion, the court stated:

The analytical gap, in Dr. Marx’s opinion is demonstrated by setting out his premises and conclusions:

Premise: Studies show that a certain regimen of Zometa helps treat cancer-related bone conditions, but may cause ONJ.  

Premise: Other studies show that less Zometa will result in less ONJ.

Conclusion: A regimen using less Zometa will help treat cancer-related bone conditions.

This is a classic logical fallacy—an irrelevant conclusion.

It is not helpful to the finder of fact for Dr. Marx to state that a drug used to fight cancer related diseases has a particular negative side effect, and that reducing the dosage and/or frequency of that drug will reduce the occurrence of the negative side effect. Rather, Dr. Marx must also provide some factual support that reducing the dosage and/or frequency of that drug will not only reduce the occurrence of the negative side effect, but will also be effective at fighting cancer-related diseases. Unfortunately, Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen . . .

Id. at 18.  Based upon Dr. Marx’s inability to show that a reduced dose or duration of Zometa treatment would be as efficacious as the FDA-approved dose or duration, Dr. Marx’s “alternative design” opinion was stricken.

          The court then turned to defendant’s motion for summary judgment.  The MDL court having done away with plaintiff’s failure to warn, and by extension her breach of express warranty claims, Summary judgment slip op. at 8, the remand court was left to consider strict liability design defect, negligence per se and breach of implied warranty.  First, the court quickly recognized that plaintiff’s negligence per se and breach of implied warranty claims were “re-packaged design defect or failure to warn claims.”  Id.   Since the MDL court had ruled that plaintiff’s failure-to-warn claims were foreclosed, and since plaintiff had offered no admissible evidence of a safer alternative design -- the court granted summary judgment for defendant.  Id. at 9-11.    Two wins, no waiting.

          As you know from our prior posts, the Conklin decision is just the latest in a string of defense wins in the Aredia/Zometa litigation.  But just like a good vacation – we don’t mind revisiting if the trip brings a smile to our face.

          As always congratulations and thanks to our friend Joe Hollingsworth for keeping us up to speed on this litigation.

Mixing Caffeine and Alcohol

In old movies, everybody seemed to use coffee to sober-up a friend who’d had too much to drink.  (The only other option, if our movie-memory is correct, was a bucket of ice water.)  Do you remember “Dead Men Don’t Wear Plaid” – an old movie about older movies?  Steve Martin played a Sam-Spade-like detective who made “a cup of my java” for anyone who was drunk.  Apparently it would sober them up.  But he didn’t brew it quickly enough to get Burt Lancaster up and moving in this scene. 

Now, we all likely understood that coffee really didn’t help.  That’s only in the movies.  In reality, the most it might do is turn a drunk into a suddenly wide-awake drunk. 

In the last few years, caffeine and alcohol have been mixed in a single drink, the recently popular alcoholic energy drinks.  And they have sparked litigation.  In Cook v. MillerCoors, LLC, 2012 U.S. Dist. LEXIS 73205 (M.D. Fla. May 25, 2012), the plaintiff was injured in a motorcycle accident in which the motorcyclist was drunk from alcoholic energy drinks.  The plaintiff sued the drink manufacturer, asserting design defect and failure to warn claims (a negligent manufacturing claim had been dismissed previously).  Id. at *1-5.

There isn’t much that is new in the decision.  But it is helpful because it reinforces a longstanding principle about private rights of action under the Food, Drug and Cosmetic Act (FDCA) – they don’t exist. 

The court dismissed plaintiff’s design defect claim because, in short, consumers understand the dangers of alcohol and so it’s not unreasonably dangerous, and the motorcyclist’s decision to drink, not the manufacturer’s actions, was the proximate cause of the plaintiff’s injuries.  Id. at *6-11. 

Plaintiff’s failure to warn claim is where the FDCA comes in.  The court determined that the manufacturer had no duty to warn because everybody already knows that consumption of alcohol can be dangerous:

Generally, however, a manufacturer does not have a duty to warn consumers of dangers which are obvious or commonly known. . . . Because the dangers associated with alcohol consumption are very well known, courts have usually found that alcohol manufacturers and retailers do not have a duty to warn consumers about the risks posed by the excessive  use, or prolonged use of alcohol because those risks are common knowledge.

Id. at *12-13.  The court was not convinced that the addition of caffeine to the drink somehow obscured this understanding.  Id. at *14. 

So plaintiff looked to the FDCA and FDA regulations to save her claim.  She alleged that adding caffeine (and guarana, another additive) to an alcoholic drink violated FDA regulations.  Id. at *14-15. 

The defendant denied this was true but, more important, argued that, even if it were true, it wouldn’t matter.   Id. at *15.  As we discussed in our recent post about pomegranate juice, only the FDA can enforce its regulations, not private citizens and attorneys in courtrooms.  The Cook court agreed:

Where the substance of a plaintiff’s claims seeks to assert a private right of action under the FDCA, they must be dismissed.  If a defendant's conduct would not expose it to liability but for the FDCA then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim).  Thus, [plaintiff’s] allegations regarding the FDCA are of no moment.

Id. at *15.  The court dismissed plaintiff’s complaint with prejudice.  Id. at *19. 

The moral of this story?  Nothing new really.  We know what we’ve always known.  Caffeine plus alcohol doesn’t equal sober.  But it doesn’t equal a private right of action under the FDCA either.

What Defect?

After a Memorial Day weekend filled with picnics, barbeques and full stomachs, we have a quick post for you. We recently read the opinion in Mattos v. Eli Lilly & Co., 2012 U.S. Dist. LEXIS 71519 (D. Ka. May 23, 2012), which, much like those barbeques and picnics, had a lot of good things to digest. But a portion of the ruling was like the extra hamburger that you shouldn’t have had. It’s just sitting there, feeling not right, and worrying you.

The Mattos plaintiff claimed that Cymbalta, a depression medication, caused her diagnosis of Stevens-Johnson Syndrome. She brought failure to warn and design defect claims under the Kansas Product Liability Act (KPLA), along with a Kansas Consumer Protection Act Claim and a host of common law negligence, warranty and misrepresentation claims. Id. at *1. The easily digestible portion of the opinion is the court’s decision to dismiss all the common law claims because, like with many states’ product liability statutes, they were merged into or subsumed by the KPLA. Id. at *4-9.

The portion that makes us a bit queasy – the part that sticks in our craw (or “sticks in our crow” if you believe this explanation of that old phrase) – is the court’s decision not to dismiss plaintiff’s design defect claim. The defense argued that, under TwIqbal, the plaintiff needed to plead an actual defect to state a design defect claim. Id. at *17-18. That seems reasonable. The court even agreed that TwIqbal requires plaintiff to plead supporting facts, not just conclusory or formulaic allegations. Id. at *19.

But then the court went on to accept a set of allegations that appear to be as formulaic as they come: plaintiff was injured; the drug had an unnamed defect that tended to cause that injury; due to the unnamed defect the drug’s risks outweighed its benefits, particularly when compared to alternative drugs; and it was somehow feasible to make an alternative drug without the unnamed defect. Id. *19-20. Those allegations can be made in just about any pharmaceutical case, with no particular supporting facts needed at all. It smacks of pleading by formula – find template, insert name of drug and injury, state claim – which is what TwIqbal does not allow.

Also, reference to other drugs on the market doesn’t help. As we’ve said before, other products are just that – other products. They are not alternative designs. They are merely a list of “completely different drugs that [plaintiff] could have taken.” Salvio v. Amgen, Inc., 2012 U.S. Dist. LEXIS 19009, *22 (W.D. Pa. Feb. 15, 2012).

Now, we understand that the plaintiff might have difficulty alleging a particular defect. As the court admitted in the Bartlett opinion that we recently criticized, drugs are often comprised of one-molecule and inactive ingredients, and therefore identifying a defect or alternative design is almost impossible. But that’s a reason to dismiss a claim, not allow it.

In any event, fortunately, the Mattos opinion is only on a motion to dismiss, not on a summary judgment motion like in Bartlett. There is still time for the court, presumably after some discovery, to re-address plaintiff’s design defect claim on summary judgment and dismiss it. Maybe that would alleviate that uneasy feeling in our stomachs.

Not A WIn, Not A Loss

The recent decision in Mims v. Wright Medical Technology, Inc., 2012 WL 1681810 (N.D. Ga. May 11, 2012), is really neither a win nor a loss.  Like Gaul, the decision contains three parts, and we have comments as to each.


Very briefly, the case involves a total hip implant constructed from titanium.  After being implanted for over three years, it broke.

Design Defect

The first part of the opinion denied summary judgment on design defect claims.  The plaintiff’s expert, as is common in such cases, alleged that instead of being made out of titanium it should have been made out of cobalt-chrome alloy (“CCA”).  Mims, 2012 WL 1681810, at *2.  Of course, if the defendant had used CCA, the expert would then have alleged it should have been made out of titanium − anything to claim a defect.

The defendant moved for summary judgment, arguing that merely claiming an alternative design was not enough.  Id. at *3. That struck us as a little odd, since defendants are usually the foremost advocates of a strong alternative design requirement. The court held that since alternative design was essential to design defect litigation, that was enough to survive summary judgment:

One factor consistently recognized as integral to the assessment of the utility of a design is the availability of alternative designs, in that the existence and feasibility of a safer and equally efficacious design diminishes the justification for using a challenged design. The alternative safer design factor reflects the reality that it often is not possible to determine whether a safer design would have averted a particular injury without considering whether an alternative design was feasible. The essential inquiry, therefore, is whether the design chosen was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. Alternative safe design factors include: the feasibility of an alternative design; the availability of an effective substitute for the product which meets the same need but is safer; the financial cost of the improved design; and the adverse effects from the alternative.

Id. at *2.

Frankly, we don’t mind that particular ruling too much.  We could even see using this quote in one of our cases.

The real problem in Mims was that the defendant hadn’t separately moved to exclude the plaintiffs’ expert under Daubert.  The court latched onto that and refused to “consider the reliability” of the expert testimony on summary judgment.  Id. at *3.  This procedural two-step is worrisome in that it allows an expert opinion that may well be inadmissible to defeat summary judgment.  The general rule has been that only admissible evidence counts on summary judgment, and the court’s wielding of a procedural fine-toothed comb undercuts that rule.  One take-away from Mims is to make sure to file Daubert motions separately and in advance of summary judgment, depending of course on the pre-trial schedule in any given case.

Another more unusual suggestion:  We’ve had some success using preemption against this type of claim, see Greenwood v. Pennsylvania Hospital, 1999 WL 1133313, at *2-3 (Pa. C.P. Philadelphia Co. June 9, 1999) (claim that implant should not have been made from stainless steel held preempted), but it depends on the classification regulation.  We’ll explain.  There’s usually no preemption in Class II metallic implants like hip implants under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), but there can be − if there’s a “device-specific” regulation, and the plaintiff’s particular claim is “different from or in addition to” something in that regulation under 21 U.S.C. §360k(a).

There are device-specific regulations for essentially all medical devices − but unfortunately they’re usually one-paragraph long and thus don’t cover many aspects of the device.  These are the FDA’s identification and classification regulations.  However, they do frequently say something about the metallic composition of implants. There are several hip implant I&C regs, see 21 C.F.R. §§888.3300-3350, and we don’t know which one applies specifically to Mims.  Most of them mention only “cobalt-chromium-molybdenum,” which was the plaintiff’s proposed design alternative in Mims, so the preemption argument wouldn’t fly.

However, if §888.3310 were applicable to this implant, or if some plaintiff’s expert offered the same opinion against the manufacturer of a §888.3310 implant, there’s a decent preemption argument.  That’s because this section states, as to composition, that such devices are “made of alloys, such as cobalt-chromium-molybdenum and titanium alloys.”  Emphasis added.  In this device-specific regulation, the FDA has expressly stated that “titanium alloys” are okay.  Thus, our preemption argument in such a situation would be that since a device specific regulation specifies “titanium” as acceptable composition, a common-law claim that titanium construction alone is a defect would be preempted even under Lohr.

Warning Defect

The second part of the Mims opinion also denied summary judgment as to the plaintiffs’ warning claim.  2012 WL 1681810, at *4.  The defendant moved based solely on the warning’s adequacy.  That’s hard to do unless the relevant part of the warning is really detailed.  The description of the warnings in Mims suggests otherwise in that case.

We find it much easier to win summary judgment in warning cases on causation − that the prescriber already knew the allegedly omitted information or that the information wouldn’t have changed what the prescriber did or the warnings.  Supporting facts would also include the prescriber continuing to utilize the device, with no change in procedure, after the plaintiff’s injury.

The lesson from Mims is that warning summary judgment motions ideally should have a double-barreled approach of both adequacy and causation.

The court in Mims seemed to assume, without any evidence (at least none was cited) that a different warning might have led to a different outcome.  Maybe the issue simply wasn’t raised in the Mims motion, but again the court’s willingness to rely on less than admissible evidence is troubling, since summary judgment can be sought on the grounds that the plaintiff has no evidence on an essential element where the plaintiff bears the burden of proof.

Punitive Damages

The final third of the Mims opinion dismissed punitive damages claims as a matter of law because the defendant demonstrated that the implant complied with FDA regulations:

[T]he Court concludes that the Plaintiffs would not be able to establish by clear and convincing evidence culpable tortious conduct that would authorize the imposition of punitive damages. Moreover, punitive damages are typically not appropriate where the manufacturer has complied with regulatory standards.

Mims, 2012 WL 1681810, at *5 (citing Stone Man, Inc. v. Green, 263 Ga. 470 (1993); Welch v. General Motors Corp., 949 F.Supp. 843 (N.D.Ga.1996)).

This part of Mims almost makes up for the rest of it.  Preclusion of punitive damages by regulatory compliance is something we’ve advocated before, here.  We prominently mentioned the Stone Man decision that the court followed in Mims.  So we take this opportunity to applaud the third part of Mims.

More Thoughts On Bartlett

Our initial post about Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012), was more or less a crie de coeur over what we saw as an essentially absurd result:  that while a simple warning claim involving a generic drug is indisputably preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a claim much more fundamentally in conflict with FDA approval of generic drugs – that state tort law can impose liability for not removing an FDA-approved product off the market entirely – supposedly is not.


Plain and simple, the preemption result in Bartlett makes no sense.

Today we take a closer look at the Bartlett opinion and the reasoning, if it can be called that, that brought the court to its highly questionable result.

Two fundamental facts underlie Bartlett:  First, the plaintiff had (at least in theory) lost her warning-based claim for lack of causation – the prescribing physician did not read or otherwise rely on the allegedly inadequate warning, rendering the warning non-causal.  Second, for whatever reason, the defendant at trial made the strategic decision (which with the benefit of 20-20 hindsight now seems disastrous) not to offer any affirmative defense at all.
The plaintiff’s lack of a warning claim itself had two effects.  One, plaintiff was damn lucky, because warning claims against generic drugs were precisely what the Supreme Court held to be preempted in Mensing.  A verdict in Bartlett based upon a warning claim – the most common theory – would undoubtedly have been overturned before the First Circuit ever saw the case.  Two, since both Mensing and Wyeth v. Levine, 555 U.S. 555 (2009), involved warning claims (again, they’re the most common), neither case was 100% on point.

Bartlett initially demonstrates why “design defect” simply doesn’t fit prescription drugs (some medical devices are different).  As the First Circuit mentioned, you can’t change the “design” of something that “is a one-molecule drug; and the variations in [it] as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects.”  2012 WL 1522004, at *2.  The ordinary constraint on design defect claims – that there be an alternative design – does not exist where the product is a chemical molecule, let alone one that would require FDA re-approval if it were changed in any way that affected its safety or efficacy.

“Design defect” in the absence of any available alternative design amounts to absolute liability.  It’s not a tort, but rather a judicially-imposed no-premium insurance policy.  For that reason, the Third Restatement and an increasing majority of states (Wisconsin and South Carolina, at least, have changed during the lifespan of this blog) require proof of an alternative design as an essential element of all design-based claims.

New Hampshire, however, isn’t one of those states.  In Vautour v. Body Masters Sports Industries, Inc., 784 A.2d 1178, 1183 (N.H.2001), the New Hampshire Supreme Court rejected the Third Restatement because of the alternative design issue.  See Bartlett, 2012 WL 1522004, at *3.  Vautour, however, involved exercise equipment, and the plaintiff offered alternative design evidence (albeit rather weak).  It was not a case where there was no alternative design possible, and thus an attempt to impose absolute liability.  Nor did Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir. 1981) – where the First Circuit allowed a design defect claim involving a prescription drug despite no state-court authority (contrary to proper Erie principles) – involve absolute liability, since that drug had two active ingredients, and the plaintiff argued that a better design would have had less of one of them.  Id. at 655.

The only New Hampshire precedent involving a design defect claim where no alternative design was possible is Buckingham v. R.J. Reynolds Tobacco Co., 713 A.2d 381 (N.H.1998), a tobacco case where the plaintiff sought to impose absolute liability.  The court rejected product liability for the design characteristics of a design that could not be changed.  “When the plaintiff cannot allege that something is ‘wrong’ with the product, strict liability should not be used as a tool of social engineering to mandate that manufacturers bear the entire risk and costs of injuries caused by their products.”  Id. at 384.

Bartlett, however, purported to follow Vautour because it was more recent than Buckingham. 2012 WL 1522004, at *3 (Vautour “followed after Buckingham”).  In reality, however, the court did something quite different.  For the first time under New Hampshire law, Bartlett permitted absolute liability – “design defect” liability for a design that the court admitted could not be changed.  Bartlett reached an unprecedented result by applying Vatour, which did not involve the impossibility of an alternative design, in an impossibility situation.  It did so, we would argue, in direct contravention of the holding in Buckingham rejecting “social engineering” through product liability litigation.

There was one final bulwark against absolute liability in Bartlett – Restatement (Second) of Torts §402A, comment k (1965), the “unavoidably unsafe product” doctrine, recognized in Brochu.  Comment k precludes liability for the “unavoidably unsafe” attributes of a product as long as it bears adequate warnings and isn’t contaminated in some way.  Here, however, the court ruled that the defendant slit its own throat by not putting on any defense.  Comment k is an affirmative defense in New Hampshire, so by not presenting a defense, waived it.  2012 WL 1522004, at *3 (defendant “could still have avoided liability by proving [the comment k defense, but] abandoned that defense on the eve of trial”).  To that extent, we can’t blame the court.

The First Circuit did something else unusual in Bartlett – applying a pure “consumer expectation” test to an alleged defect in a prescription medical product.  2012 WL 1522004, at *3 (“an ordinary consumer would hardly know without further warning that [the drug] or any other ordinary analgesic carries a risk of the kind of ill effects and suffering that [plaintiff] encountered”).  But that’s just not the law in most places, and Bartlett doesn’t cite anything to suggest that New Hampshire would choose this tangent.  Prescription only drugs simply aren’t available to “ordinary consumers.”  They require a physician’s prescription.  They’re the epitome of a “complex” product as to which an “ordinary consumer” would have no expectations.  In practically every other jurisdiction either the physician is considered the “ordinary consumer” (since they control use of the product) or “ordinary consumers” have no expectations other than what is stated in the product’s labeling, in which case plaintiffs are limited to warning defect claims.  As stated recently:

The consumer expectations test considers the same factors at issue in a failure-to-warn claim, and so its application is barred by Mensing. An ordinary consumer forms her expectations regarding the safety of drugs from her doctor or from the drug’s label. Thus, if [the drug] is dangerous beyond the expectations of the ordinary consumer, that can only be a symptom of [defendant’s] failure to update its label or communicate effectively with doctors.

Grinage v. Mylan Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2011 WL 6951962, at *6 (D. Md. Dec. 30, 2011).  Accord Carlin v. Superior Court, 920 P.2d 1347, 1355 (Cal. 1996); Craft v. Peebles, 893 P.2d 138,154-155 (Haw. 1995); Pittman v. Upjohn Co., 890 S.W.2d 425, 430 (Tenn. 1994); Shanks v. Upjohn Co., 835 P.2d 1189, 1195 (Alaska 1992); King v. Danek Medical, Inc., 37 S.W.3d 429, 445 (Tenn. App. 2000); Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 263 (Cal. App. 1999); Rosci v. Acromed Inc., 669 A.2d 959, 969 (Pa. Super. 1995); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987); Peterson v. Parke Davis & Co., 705 P.2d 1001, 1003 (Colo. App. 1985); Stilwell v. Smith & Nephew, Inc., 482 F.3d 1187, 1194 (9th Cir. 2007); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 302-303 (7th Cir. 1987); In re Zyprexa Products Liability Litigation v. Eli Lilly & Co., 489 F. Supp.2d 230, 267 (E.D.N.Y. 2007); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 751 (E.D. Pa. 2007); Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *6 n.6 (Mass. Super. Sept. 24, 2004). Bartlett did neither.  Rather, the court reached the singular conclusion that “ordinary consumers” have expectations about prescription drugs (which require a prescription precisely because they have risks) beyond those stated in the labeling.  That’s a unique and dangerous holding.

But none of the First Circuit’s mangling of New Hampshire law matters much any more – at least in Bartlett.  Those are all state-law issues, and if the defendant decides to “take it up” to the Supreme Court (as our prior post urged), there must be a federal question.

That question is preemption.

The First Circuit’s treatment of the preemption question is, if anything, even more peculiar than its flights of fancy under the guise of New Hampshire law.

Essentially, the Bartlett court thumbed its collective noses at the Mensing decision.  Instead the decision purports to follow Levine despite:  (1) Levine having nothing to do with generic drugs and (2) Levine having even less to do with design defect claims.  Indeed, in Levine the Supreme Court went through contortions specifically to avoid having to decide a “failure to contraindicate” claim:

[Plaintiff] also offered evidence that the [FDA-approved use] should be contraindicated and that [the drug] should never be administered [that way].  Perhaps for this reason, the dissent incorrectly assumes that the state-law duty at issue is the duty to contraindicate. . . .  But, as the Vermont Supreme Court explained, the jury verdict . . . did not mandate a particular replacement warning, nor did it require contraindicating [the use]. . . .  We therefore need not decide whether a state rule proscribing [the FDA-approved use] would be pre-empted.

555 U.S. at 564-65.

Pretty obviously, there was not a majority in Levine to allow state tort law to ban FDA-approved uses.  Bartlett is even more extreme – rather than simply banning one FDA-approved use of a drug, it allowed state tort claims predicated on banning an FDA-approved drug altogether.  We're not being hyperbolic defense lawyers here.  Take a look:

[Defendant] argues . . . that the generic maker also cannot alter the composition of the drug and so [Mensing]'s policy of encouraging generics by preempting state tort claims should extend to design defect as well as claims based on inadequate warning.  But although [defendant] cannot legally make [the drug] in another composition . . . it certainly can choose not to make the drug at all . . . . This is second-guessing the FDA (unless new information emerged known to the maker but not the FDA), but . . . while the generic maker has no choice as to label – the decision to make the drug and market it in New Hampshire is wholly its own.

2012 WL 1522004, at *4 (citations omitted) (emphasis added).

This is a startling result.  The claim Bartlett permits, that state tort law can penalize purportedly “unsafe” generic drugs simply for being on the market in the first place, has been raised on numerous occasions and universally rejected.  Indeed, it was rejected in Mensing itself.  The Eighth Circuit held, in the opinion that the Supreme Court later reversed:

The generic defendants were not compelled to market [their drug]. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product.

Mensing v. Wyeth, Inc., 588 F.3d 603, 611 (8th Cir. 2009), rev’d, 131 S. Ct. 2567 (2011).  The Supreme Court, of course, reversed Mensing in toto – finding preempted every claim that the plaintiffs raised.  Then, as other courts have described, plaintiffs highlighted the duty-to-withdraw theory in seeking reargument in Mensing and lost again:

The Supreme Court rejected this reasoning on appeal and denied a rehearing despite the contentions . . . “that the Petitioners could have ‘independently’ complied with both state and federal law simply by suspending sales. . . .”

Gross v. Pfizer, Inc., ___ F. Supp.2d ___, 2011 WL 5865267, at *3 (D. Md. Nov. 22, 2011) (quoting plaintiffs’ reconsideration brief in Mensing).  See also Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2012) (vacating portion of opinion that permitted failure-to-withdraw argument).

Moreover, as a regulatory matter, the FDCA requires generic drugs to be bioequivalent to the branded ("reference listed") drug.  As the Court noted in Mensing, a “generic drug” must be “identical in active ingredients, safety, and efficacy.  131 S.Ct. at 2574 n.2 (emphasis added).  The statute requires “that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug.”  21 U.S.C. § 355(j)(2)(A)(iv).  The FDA’s regulations are similar, mandating rejection of an abbreviated new drug application (what an application for generic approval is called) if the ANDA “is insufficient to show that the active ingredient is the same as that of the reference listed drug. 21 C.F.R. §314.127(a)(3)(i); see 21 C.F.R. §314.127(a)(3)(ii) (identical language for products with multiple active ingredients)

There’s that word again – “same.”  Seems like we’ve seen that somewhere before.  Where does Bartlett get the idea that the “sameness” requirement for design is less exacting than the “sameness” requirement for warnings held preemptive in Mensing?  Nowhere.  The opinion offers nothing but rank speculation:

[T]he FDCA might permit states to tell [defendant] it ought not be doing so [selling a generic drug] if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context.

Bartlett, 2012 WL 1522004, at *4.  The mind boggles.  In Mensing the plaintiffs also offered speculation about what the FDA might have done.  The Court flat out rejected such hypotheses – derisively calling them a “mouse trap game.”  Preemption is simply not affected by speculation that the FDA “might” do something different:

Accepting [plaintiffs’] argument would render conflict pre-emption largely meaningless because it would make most conflicts between state and federal law illusory.  We can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law. . . .  If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express pre-emption, the Supremacy Clause would have any force.  We do not read the Supremacy Clause to permit an approach to pre-emption that renders conflict pre-emption all but meaningless.

Mensing, 131 S. Ct. 2578-79 (emphasis original).  Bartlett’s speculation that the identical word, “same,” might for some unknown and unarticulated reason be interpreted (presumably by the FDA) differently in the design context than it has been in the warning context is precisely the kind of speculation that Mensing rejected.  Anybody could always avoid liability by not selling any products at all – but that would make preemption "illusory," and also totally defeat the purpose of the Hatch-Waxman Amendments to encourage production of generic drugs.  Sooner or later, one plaintiff or another will argue that every generic drug ever approved should be removed from the market.

Not surprisingly, before Bartlett the post-Mensing precedents had universally rejected arguments that supposed state-law duties (no state high court has ever recognized such a duty) to remove generic drugs from the market altogether could survive preemption.

[A] state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce . . . would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.

Gross, 2011 WL 5865267, at *3.  “Finding that state law prohibits [defendant] from doing what federal law explicitly requires [it] to do would be tantamount to conferring supremacy upon the state law.”  Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, at *5 (S.D. Ga. Jan. 19, 2012) (rejecting failure-to-withdraw claim).  See also Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817, at *6 (S.D. Tex. April 30, 2012) (“a state law requirement that the drug be completely withdrawn from the market . . . would also impermissibly conflict with federal law and be preempted”); Fulgenzi v. PLIVA, Inc., 2012 WL 1110009, at *7 n.5 (N.D. Ohio March 31, 2012) (“reject[ing] Plaintiff's argument that . . . [defendant] could have complied with both state and federal law by choosing to stop selling [the drug]”); Metz v. Wyeth LLC, ___ F. Supp.2d ___, 2012 WL 1058870, at *4 (M.D. Fla. March 28, 2012) (“[t]o the extent Plaintiffs contend that [defendant] should have pulled the generic version . . . from the market, such claim is also preempted”); Cooper v. Wyeth, Inc., 2012 WL 733846, at *6 (M.D. La. March 6, 2012) (“[i]f state law could require a generic drug manufacturer to wholly withdraw from the market . . . it necessarily must repudiate the label approved by the FDA”); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 718618, at *3 (E.D. Ky. March 5, 2012) (“the idea that [defendants] should have simply stopped selling [the drug] is an oversimplified solution that could apply anytime the issue of impossibility preemption arises: avoid a conflict between state and federal law by withdrawing from the regulated conduct altogether”); Bowman v. Wyeth, LLC, 2012 WL 684116, at *6 (D. Minn. March 2, 2012) (“reject[ing] th[e] argument” that “manufacturers could have complied with state and federal law by suspending sales”); Moretti v. Mutual Pharmaceutical Co., ___ F. Supp.2d ___, 2012 WL 465867, at *5 (D. Minn. Feb. 13, 2012) (failure-to-withdraw “reject[ed]” as an “additional attempt to recast [plaintiff’s] failure to warn claims”); Lyman v. Pfizer, Inc., 2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012) (the “’federal duty of sameness,’ . . . applies to the design or composition of the drug as well as to its labeling”); Fullington v. PLIVA, Inc., 2011 WL 6153608, at *6 (E.D. Ark. Dec. 12, 2011) (argument that “generic manufacturers could have complied with both state and federal law by simply pulling the drug off the market entirely” has been “overruled”).

Basically, the court in Bartlett decided it liked the outcome in Levine better than it liked the result in Mensing, even though Mensing dealt specifically with generic drugs, the product involved in Bartlett.  Thus the court tried to minimize Mensing as merely “carv[ing] out an exception" to Levine.  Bartlett, 2012 WL 1522004, at *4.  That’s just result-oriented sophistry.  The First Circuit’s claim that, in Levine, “the Court adopted a general no-preemption rule, 2012 WL 1522004, at *5, is simply wrong – an attempt to resurrect a presumption against preemption that the Mensing court refused to apply to generic drugs, and that four justices would abolish altogether in all cases.  131 S. Ct. at 2579-80.

Actually, both Levine and Mensing, being implied preemption cases, set forth generally applicable rules.  The rule in Levine, as much as we strongly believe otherwise, was that “the manufacturer bears responsibility for the content of its label at all times.”  555 U.S. at 570-71.  Note the word "label."  Levine was conspicuously silent about drug design (having deliberately avoided failure to contraindicate), let alone generic drug design.  The general principle established by Mensing was “when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”  131 S. Ct. at 2581.  That test is met for all drug designs, generic or branded.  The notion that Levine was based on some general principle was rejected in Mensing, which recognized that Levine turned on what the FDA allowed branded manufacturers (unlike generics) to do:

[Levine] is not to the contrary.  In that case, as here, the plaintiff contended that a drug manufacturer had breached a state tort-law duty to provide an adequate warning label.  The Court held that the lawsuit was not pre-empted because it was possible for . . . a brand-name drug manufacturer, to comply with both state and federal law.  Thus, the federal regulations applicable [in Levine] allowed the company, of its own volition, to strengthen its label in compliance with its state tort duty.

Mensing, 131 S. Ct. at 2581.  The FDA's regulations governing generic drugs do not confer this ability.  Id. at 2575-76.

Thus, having now thoroughly examined the substantive holdings in Bartlett (its evidentiary aspects, a rather tautological discussion of adverse event reports, must await another day), we remain convinced that the First Circuit decided that it would affirm no matter what, and in the process gave the back (or possibly some other part) of the hand to the Supreme Court’s Mensing decision.  Not only does that make Bartlett an excellent candidate for review and reversal by the High Court, but we would not be at all surprised if a such a reversal were ordered summarily.

All We Want are the Facts, Ma’am

            “The story you are about to hear is true; the names have been changed to protect the innocent.”  Well, not exactly, we don’t change the names but we try to give you the facts.  Just like Sgt. Joe Friday, we seek facts (note that our title is the phrase actually used by Jack Webb in the series Dragnet, whereas the more well known “just the facts, ma’am” was popularized by a spoof performed on Ed Sullivan’s Talk of the Town).  As defense lawyers, we immerse ourselves in facts.  We learn all the details of the plaintiff’s medical history, employment history, education.  We learn all the details of the alleged injury or disease – we know the risk factors, other potential causes, treatments and projections.  We particularly like it when courts are as interested in the facts as we are.  As were the courts in two cases decided last week; one on a motion to dismiss and the other on a motion for summary judgment.  But, both centered on design defect and so we thought we’d look at them together.

            First up is Tilden v. General Electric Company, 2012 U.S. Dist. LEXIS 40773 (E.D. Tenn. Mar. 26, 2012) which involved an allegedly defective MRI machine.  According to the complaint, while undergoing an MRI, a piece of the machine broke and fractured the plaintiff’s arm which had to be surgically repaired.  Plaintiff died approximately two months later allegedly as a result of “illness and the fracture to his forearm.”  Id. at *2-3.  All of plaintiff’s product liability claims were subsumed under the Tennessee Products Liability Act which requires that plaintiff prove that the “product was defective and unreasonably dangerous at the time the product left the control of the manufacturer.”  Id. at *8 (citation omitted).  And, of course, plaintiff bears the burden on proximate cause too.

            At the motion to dismiss phase, the court wasn’t looking to see if plaintiff had proven his case, but rather whether the plaintiff had alleged sufficient facts for the court to infer the existence of a defect and proximate cause.  Id. at *10.  Plaintiff’s facts were – the machine broke and plaintiff was injured.  Not nearly enough.  Even Sgt. Friday couldn’t build a case with that little to go on.  As the court found:  “[E]ven if a plaintiff allegedly suffered an injury from a product, it does not necessarily follow that the product was defective.”  Id. at *13.  Nor does it follow that because an injury was sustained, it was caused by the alleged defect.  Plaintiff’s allegations must trace the alleged injury to the specific defect, not just the product as a whole. 

While plaintiff alleges that the MRI machine caused [his] injury . . . and expedited his death, plaintiff has not alleged any facts indicating how the alleged defect--whether it was in the design or in the manufacturing of the MRI machine--caused [his] injuries. . . . [t]he relevant question is not whether the [the product] caused [the plaintiff] pain; the issue is whether the alleged defective design or manufacturing of the [the product] caused [the plaintiff] pain. . . . Plaintiff's complaint contains no factual allegations regarding this issue of causation.

Id. at *15-16 (citation and quotation marks omitted).  Without the facts, the court’s decision was clear – conclusory allegations and legal conclusions don’t satisfy the requirements of Twiqbal – case dismissed. 

            The second case is Sosnowski v. Wright Medical Technology, Inc., 2012 U.S. Dist. LEXIS 41303 (N.D. Ill. Mar. 27, 2012).  Being at the summary judgment stage, this case was much farther along than Tilden and therefore, the court was looking at many more facts. But, the facts stacked heavily in favor of defendant.  The product was a hip prosthesis.  Plaintiff, who then weighed 340 pounds, underwent hip replacement surgery in 2006.  At that time, plaintiff signed an informed consent form that included the risk of device failure.  Six weeks after surgery, plaintiff reported being pain-free and for about one year in 2007-2008 he was able to work as a school custodian.  Then, in 2010, the hip prosthesis fractured due to fretting and fatigue.  At that time, plaintiff weighed 438 pounds.  Id. at *1-2. 

            So, in summary – plaintiff had his hip replaced; the surgery was a success to the point of plaintiff being able to work in a physically demanding job.  Then, four years later, plaintiff, already obese, gained another 100 pounds and the implant fractured.  Dum-de-dum-dum.  It doesn’t take a detective to figure out what happened here.

But, let’s look at the court’s analysis anyway.  It applied the risk-utility test to determine whether plaintiff had met his burden on design defect.    First, utility.  No question that hip implants are useful to the population as a whole and clearly, this one was useful to plaintiff for at least four years.  Id. at *6.  Based on the facts, utility goes to the defendant.  Second, likelihood of injury.  Here, the facts were that after 10 years on the market, the highest fracture rate reported for this device was 0.36% -- similar or lower than most reported in the medical literature.  Id. at *8-9.  Advantage defendant. 

Next, compliance with industry standards.   Defendant’s facts were that it had complied with ISO standards and that the fatigue testing it provided to the FDA as part of the 510(k) clearance process was “consistent with normal industry practices.”  Id. at *9-10.  Plaintiff pointed to data in the medical literature regarding how much weight the prostheses are subject to.  To which the court responded:

Nor does plaintiff offer evidence that the medical literature he cites represented an industry standard, an authoritative voluntary organization's design guidelines, or design criteria set by legislation or governmental regulation.

Id. at *10.  Moving on to warnings, the device contained a warning regarding the exact risk at issue:  “An overweight or obese patient can produce high loads on the prosthesis which can lead to failure of the prosthesis.”  Id. at *11.   Two more for the defendant’s column.

            The court next had to consider the availability and feasibility of an alternative design.  The prosthesis at issue was made of titanium.  Plaintiff argued that it could have been made of cobalt chromium, a stronger alloy.  Plaintiff’s expert stated that cobalt chromium “appears to be a valid substitution.”  Id. at *11-12.  Plaintiff’s expert, however, failed to address the down sides of using cobalt chromium.  Facts pointed out by defendant’s experts -- such as, increased stiffness, less biocompatibility, and allergenic/carcinogenic properties.  Id. at *12-13.  Therefore, the court concluded:

that plaintiff has not shown that a prosthesis made from cobalt chromium is a better alternative to titanium. It is not sufficient that the alternative design would have reduced or prevented the harm suffered by the plaintiff if it would also introduce into the product other dangers of equal or greater magnitude.

Id. at *13-14 (citation and quotation marks omitted). 

            Finally, the court considered the consumer’s expectations.  Here, the facts are that everyone was aware of the potential for product failure, but “[w]hile the risk of plaintiff’s type of injury was foreseeable, . . . plaintiff has not offered evidence showing that these risks outweighed the benefits.”  Id. at *15.  Putting all of the facts together, the court found:

Because plaintiff has not offered evidence that the risks of defendant's prosthesis outweighed its benefits, the court concludes that no reasonable jury could find in plaintiff's favor on his strict products liability claim based on a design defect theory.

Id. at *16.  For all the same reasons, the court also dismissed plaintiff’s negligent design claim.  And, because the defendant “warned of the precise risk that plaintiff now complains of” and that warning was not inaccurate or misleading, plaintiff’s failure to warn claim also failed.  Id. at *18-20.

            So, those are the facts.  You’ve got to plead facts to start a case and you’ve got to prove facts to get to a jury.  Without that, plaintiff’s claims are more likely to get caught in a dragnet than see the inside of a courtroom.

The Plaintiff and The Known Risk

            As we are sure you can tell from many of our posts – we are television junkies (well, most of us).  We watch it all – comedies, dramas, news, sports, movies, documentaries, and yes, we’ll even admit to some knowledge of reality TV.  And while we are sitting on the couch taking in all that our high definition television can throw at us, we are at fairly low risk of injury – carpal tunnel remote control syndrome?  But, once we stand up and start moving around, all of that changes.  There is a risk we’ll stub our toe on the coffee table as we head to the kitchen to refill the popcorn bowl.  There is a risk of getting into a car accident driving to the movie theater (to again sit and become lost in another visual story).  There is a risk of choking on our hamburger at dinner following the movie.   

            Sometimes, like the examples above, the risks are things we just inherently know exist.  Other times, we need some additional warning.  Like the sign on our ride to work that warns of fog ahead or caution tape around a broken sidewalk.  How about a food label that says the product contains nuts – a warning to someone with a peanut allergy to avoid that food.    Bottom line -- we are surrounded by risks.  And in our everyday lives, we make decisions about how risk averse we want to be.  Will we walk around the broken sidewalk or jump over the caution tape?  But, if we decide to walk through rather than around, maybe because going around requires us to step into the street, presenting its own risks, we have to accept the fact that we might trip and fall on the broken concrete. 

            The same is every bit as true in the context of prescription drugs.  We don’t need to belabor the point that all prescription drugs contain risks.  All prescription drugs have side effects, that’s why they require a doctor’s prescription in the first place.  Where we rely on our own knowledge and experience in deciding whether the broken sidewalk or the street present the greater risk of injury, with prescription drugs we rely on our physicians.  When the drug label warns of a risk and the doctors are aware of the risk but decide that it is in the patient’s best interest to administer the drug in light of the risk and then the patient develops the very risk warned about – it is unfortunate but it is not a basis for liability against the drug manufacturer.

            So said the Connecticut Superior Court in Zelle v. Bayer Healthcare, LLC, 2012 Conn. Super. LEXIS 481 (Feb. 16, 2012).  Plaintiff was admitted to the hospital with symptoms that caused doctors to believe she was having a stroke.  The doctors ordered two MRIs, one with and one without contrast agent.  The contrast agent contains a known and warned of risk of anaphylactoid allergic reaction.  After administration of the agent, plaintiff did exhibit signs of an allergic reaction including respiratory arrest and hypotensive shock.  Plaintiff was treated for this reaction and released from the hospital.  Id. at *2-3.  Plaintiff alleged both failure to warn and design defect under the Connecticut Product Liability Statute and both claims were dismissed on summary judgment.

            First, failure to warn fell based on the learned intermediary doctrine.  The evidence of warning in this case was abundant.  It was documented in the label under the warnings, precautions and adverse reaction sections.  Id. at *13 n.4.  It was well-known by the doctors and nurses:

     The deposition testimony of each of the physicians and the MRI technician leave no doubt that they were well aware of the possibility of adverse effects as noted in the FDA approved warnings and had for years been well aware of the specific risk of an anaphylactic reaction to the contrast agent. Each confirmed that they had considered the risks versus the necessity to diagnose and treat a possible stroke and determined that the MRI with the contrast agent should be ordered.

Id. at *15.  In other words, the doctors decided to walk through the broken concrete (use contrast agent) because the risk of stepping into a busy street (the stroke) was greater.  Indeed, precisely due to this potentially fatal risk with the contrast agent, the doctors at the facility kept a “crash cart” in the MRI room.  Id. at *22.   

          The court also found that the “plaintiff [did] not present evidence or testimony that contradicts the adequacy of the warning, the nature of the warning, the approval by the FDA or the knowledge and understanding of the warnings by the treating physicians.”  Id. at *15-16.  In fact, apparently, plaintiff’s only “proof” was an unsigned consent form which the court found not only irrelevant, but detrimental to plaintiff’s argument:

the [learned intermediary] doctrine is applicable to the warnings being provided to the physicians and health care professionals and it is not relevant for purposes of this action whether the defendants provided specific warnings directly to the plaintiff.  What the testimony and existence of the Consent Form does confirm is that the health care professionals had specific information concerning the adverse reactions as evidenced by the inclusion of these reactions within a form created by the hospital. Therefore, the plaintiff's reliance upon the unsigned form to create a genuine issue of facts is misplaced. 

Id. at *12-13. 

            The court then turned to the design defect claim.  In dismissing the claim, the court made two good points.  First, plaintiff needed an expert to establish both the alleged design defect and proximate causation: 

     In an action involving the complications of prescription medication . . . where the claims are either scientific or medical, an expert opinion is required to discuss the development, manufacture, testing, handling and marketing of the product alleged to be defective.  Id. at *19-20.

. . . .

A finding of a defect in the drug is not within the common knowledge of an ordinary person. Without an expert as to the allegations that the product was in some manner defective causing serious unexpected and unforeseen physical injuries, the plaintiff has not been able to forge a sufficient link in the causal chain that would assist a jury in reaching an educated finding that the injuries were caused by a defect in the [drug] which was administered to her.  Id. at *23.

That was enough to grant the defendants’ motion for summary judgment.  But the court also had this to say about design defect in the context of a warned about risk:

[T]he plaintiff's allegations about the adverse effect of the drug which is noted in the product labeling information approved by the FDA does not, by itself, rise to the level of a defective product. Many courts have recognized that prescription drugs can cause adverse effects but do not create liability in every instance where there is an adverse effect. This is especially relevant for an action in which the plaintiff alleges she has suffered the adverse effects noted in the product labeling. This recognition impacts the plaintiff's obligation to prove not only that there are adverse impacts but that the plaintiff suffered because the drug was defective and the defect caused other adverse impacts or heightened in some manner the adverse impacts already recognized and addressed through precautions or warnings.

Id. at *21-22 (emphasis added).  Suffering from a warned about risk isn’t enough.  Even if the allergic reaction was connected to the injection of the contrast agent, that by itself does not create a defect.  Id. at *22.  As the court noted, “the product labeling . . . recognized the possibility of this exact reaction from a non-defective drug.”  Id. at *24.  Therefore, without expert testimony of a particular defect in the product, all plaintiff has proven is that she suffered from one of the potential, known, warned about side effects of the drug.  She tripped on the broken concrete.  Unfortunate, yes. A basis for liability, no. 

Doctor’s Negligence is Reasonably Anticipated Use

            Today we bring you a split decision tossing out a failure to warn claim because the doctor didn’t read the warnings at all, but allowing the plaintiff to continue on his design defect claim despite the doctor having done exactly what the warning warned against.  Makes us think of that song from Mary Poppins – a spoon full of sugar makes the medicine go down.  Well, we’re still gagging a bit on the design defect decision, but at least the dismissal of the failure to warn claim is helping to satisfy our sweet tooth. 

            Johnson v. Medtronic, Inc., 2012 Mo. App. LEXIS 294 (Mar. 6, 2012) involved an allegedly defective defibrillator and a doctor who everyone agrees acted well-below the standard of care.  But before we get to the doctor, a quick tutorial on defibrillators.  Most of us associate defibrillators with shocking a patient suffering from cardiac arrest (picture almost any episode from any medical drama that has ever been on television) – a life threatening emergency situation.  That patient would be suffering from ventricular fibrillation and a defibrillator would be used to administer a nonsynchronized shock.  On the other hand, plaintiff here suffered from recurring atrial fibrillation, a non-emergent heart rhythm disorder.  During an acute episode of atrial fibrillation, a defibrillator is sometimes used to shock the heart back into normal rhythm.  This is accomplished by administering a synchronized shock.  Id. at *4-5. 

            Now let’s turn to some of the factual highlights (or lowlights) of this case.  Plaintiff presented to the emergency room in atrial fibrillation which the attending cardiologist decided to treat with electric cardioversion.  Id. at *3.  Plaintiff, based on his knowledge of his recurrent condition, confirmed with the cardiologist that he would use a biphasic defibrillator and the cardiologist agreed.  Id. at *3-4.  The cardiologist then proceeded to use a monophasic defibrillator.  Id. at *4.  For the initial shock, the cardiologist selected the synchronous mode on the defibrillator to administer a synchronized shock.  When the initial shock was unsuccessful, the cardiologist administered a second shock, but this time he did not select the synchronous mode on the defibrillator.  Because the defibrillator had automatically re-set itself to asynchronous mode, the second shock was a nonsynchronized shock that sent the plaintiff into cardiac arrest.   The cardiologist applied 12 more unsuccessful shocks from the monophasic defibrillator before switching to a biphasic defibrillator which successfully cardioverted the plaintiff’s heart on the first attempt.  Id. at *7-8. 

            The alleged defect was the fact that the defibrillator “automatically reverted to the asynchronous mode after each synchronized shock and required the user to then select the synchronous mode for each synchronized shock.”  Id. at *10.  Presumably, this is so the device is ready to be used in emergency, cardiac arrest situations.  So, if that’s the defect, let’s look at the warnings.  The defibrillator came with an instruction manual that stated:  “If synchronized cardioversion needs to be reattempted, press sync again, device automatically returns to the asynchronous mode after each synchronized discharge.”  Id. at *5.  There was also a label on the device itself which specifically stated:  “Push SYNC for each synchronized attempt.”  Id. at *6.  In addition, when the device was in synchronous mode, its monitor displayed a green light reading “SYNCH.”  Id.  We think the failure to warn inquiry could have ended here, but the doctor’s testimony went even further:

• He admitted he’d never read the instruction manual or the instructions affixed to the device;

• He admitted that had he read them, he would have understood them and could have followed them;

• He admitted that had he read them, he presumably would have followed them.  Id. at *9. 

The court sums it up nicely:

With this backdrop, then, it is undisputed that [the cardiologist] used the [defibrillator] without regard to the instruction manual and the instruction label on the machine and, thus, [defendant’s] alleged failure to warn or alleged inadequate warning was not the proximate cause of [plaintiff’s] injuries.

Id. at *20.   That was the sweet part of the decision.

Unfortunately, we have to swallow a little castor oil too.  To recap, we have a doctor who not only used the wrong device, but used it incorrectly because he failed to read any of the warnings or instructions accompanying the device and plaintiff’s alleged injury was supposedly caused by the very danger about which defendant warned.   Given these facts, we have to say we are much more enamored of the trial court’s decision on design defect – defendant “was not required to manufacture and market a fool-proof device.”  Id. at *11 (quotation marks omitted).  While the Missouri Court of Appeals said it agreed with that statement, it didn’t agree with the trial court’s conclusion that “the use of the [defibrillator] by a trained medical practitioner in violation of the standard of care could not constitute a reasonably anticipated use by [defendant].”  Id. (quotation marks omitted).  Rather, the appellate court reasoned:

We recognize that [the cardiologist’s] actions in this case were contrary to the instructions provided by [defendant], both on a label on the defibrillator and in its instruction manual. However, the fact that a particular use of a product is contrary to the manufacturer’s instructions does not, per se, establish that the use could not be anticipated.

Id. at *32-33.  But it was anticipated and that’s why it was warned about.  The court’s reasoning and conclusion seem to fly in the face of the learned intermediary doctrine, which it clearly relies on to dismiss the failure to warn claim.  It seems undisputed that a defibrillator is an unavoidably unsafe product – it uses electricity to shock the heart into rhythm.  For that reason, it is only to be used by trained professionals – professionals who know about the difference between and consequences of administering the wrong type of shock.  Professionals who are warned, in more than one way, about how to properly use the defibrillator. 

            While we agree with the court that there are instances where perhaps a design defect claim is viable where a manufacturer “chooses to warn of the danger (even admittedly adequately warn) rather than preclude the danger by design.”  Id. at *34.  We also agree that such a claim is more appropriate in the context of the court’s stated example of a “lawn mower designed without a guard or deflector plate,” id., and not a medical device used incorrectly by a negligent physician who ignored every warning and instruction offered by the manufacturer.

Enbrel, Part 2 – A Sequel Within A Sequel

            As promised, we have a second Enbrel case from last week to report on.  So we teased it as a sequel.  And, as it turns out, this case is itself a sequel.  We reported on the first dismissal of plaintiff’s complaint in Salvio v. Amgen Inc., 2011 U.S. Dist. LEXIS 92558 (W.D. Pa. Aug. 18, 2011) here.  The court gave plaintiff a chance to try again and like with so many sequels – plaintiff should have left it alone.  So, that got us thinking about the worst ever movie sequels.  Unlike yesterday’s list, this one could go on for pages.  Generally speaking, sequels are never as good as the original.  For instance, we can start at the same place we started yesterday, The Godfather.  While there is ample ammunition for either side of the debate over whether Godfather 1 or Godfather 2 is better, nobody disputes that Godfather 3 is the quintessential franchise killer.  While most critics like to attack Sofia Coppola, she is far from the worst thing about that movie. 

            Here is just a short-list (consider it a sampling), in no particular order, of sequels that are so bad, they might even make you forget what you loved about the original (we’re sure you can all add to the list):

The Sting II – with all due deference to Jackie Gleason’s comic genius, he and Mac Davis were no match for Redford and Newman.

The Matrix Reloaded and Revolutions – too long, too tedious, just a complete let down in every way.

Legally Blonde 2:  Red, White and Blonde – In the original a ditzy blonde takes the legal profession by storm in a funny and charming way.  In the sequel she goes looking for her pet Chihuahua's birth mother.  Huh?

Dumb and Dumberer:  When Harry Met Lloyd – only good thing was a fairly spot-on impersonation of Jim Carey.

Jaws the Revenge – The original is one of the best horror movies ever made.   In this one, as if the plot – a shark that has already been blown to bits seeks revenge on the widow of the man who killed it – isn’t bad enough, the shark also roars.   

Dirty Dancing:  Havana Nights – somebody should definitely have put this movie in a corner.

Speed 2: Cruise Control – Isn’t Keanu supposed to be the not too bright one?  So, what was Sandra’s excuse?

Blues Brothers 2000 – Where was Jim?  Not that having a Belushi in it would have saved it.  We are just happy brother John wasn’t around to witness this travesty.

Caddyshack II – who ever thought Jackie Mason and Robert Stack could fill the shoes of Dangerfield, Murray, Chase and Knight?  They headed in the right direction by casting Akroyd, but that’s about it.

Staying Alive – In this sequel to the unforgettable Saturday Night Fever, Sylvester Stallone directs John Travolta in a movie about a Broadway musical featuring the music of his brother Frank Stallone.  Need we say more? 

Now for Salvio II.  Unlike the movies listed above that had their origins in greatness, Salvio II suffers from all the same plot pitfalls as the original.  As described in Scream 2 – there are rules to making a successful sequel (at least a horror sequel) – “Number one: the body count is always bigger. Number two: the death scenes are always much more elaborate - more blood, more gore - carnage candy. And number three: never, ever, under any circumstances, assume the killer is dead.”  Salvio II breaks all the rules.

Plaintiff took Enbrel to treat her rheumatoid arthritis.  She allegedly contracted a fungal infection of the sinuses, brain, and lungs, and died from complications related to her infection.  Salvio v. Amgen, Inc., 2012 U.S. Dist. LEXIS 19009, *2-3 (W.D. Pa. Feb. 15, 2012).  After the dismissal of her first complaint and being afforded an opportunity to amend, plaintiff filed an amended complaint alleging claims for negligent failure to warn, negligent design/manufacture, and punitive damages.  Id. at *4. 

Rule Number 1 – A bigger body count.  In this case, that meant plaintiff needed to identify feasible, safer alternatives to maintain her negligent design claim.  Putting aside our dislike of the fact that Pennsylvania law even allows a negligent design claim in a prescription pharmaceutical case (see prior comments on Lance v. Wyeth, 4 A.3d 160 (Pa. Super. 2010) here), the Salvio II decision correctly identifies the key question for this claim:  whether “an alternative, feasible, safer design would have lessened or eliminated the injury plaintiff suffered.”  Salvio II, 2012 U.S. Dist. LEXIS 19009, *21 (citation omitted).  Plaintiff thought she’d get there by pointing to other antirheumatic drugs that were on the market and which could have been prescribed to plaintiff. 

But other products are just that – other products.  They are not alternative designs of the product at issue.  Pennsylvania hasn’t yet addressed this issue, but the court found plenty of precedent from other federal courts which all agree that “an alternative design must not be an altogether essentially different product.”  Id. (citations omitted).  What plaintiff did here was essentially list a series of other drugs that that the plaintiff could feasibly have taken, “an allegation that is immaterial for the purpose of a negligent design/manufacture claim.”  Id. at *22.  Even if they could be “alternatives,” those products were made by other companies, and thus were not alternatives that this defendant could use.  Id.  So, without the bodies – here the feasible alternative safer designs – the plaintiff’s negligent design claim was dismissed.

Rule Number 2 – More, More More.  In a horror movie, that means more gore.  In a complaint that’s already been dismissed once, it means more facts.  Or any facts, as the case might be.  Salvio II is full of phrases such as:  “Plaintiff does not aver specific facts to show” or “Plaintiff has not pleaded any facts tending to” or “Plaintiff has failed to allege.”  So Salvio II violates the rules for a successful sequel and the rules of Twiqbal.

For instance, in trying once again to state a claim for punitive damages, the plaintiff made a boilerplate allegation that the defendant acted with reckless disregard and then recited the elements of a claim for punitive damages.  Id.at *23.  Plaintiff “again failed to allege any conduct that would rise to the level of seriousness necessary for imposing punitive damages and to satisfy the pleading standard of Twombly, Fowler, and Phillips.”  Id. at *24.  Definitely not more elaborate.  As for punitive damages, the court also went on to state that

claims for punitive damages are unfounded where a manufacturer-defendant warns of the potential danger that resulted in injury to a plaintiff. . . . [E]ven if Plaintiff could show that "[m]ore could have been done or said," the Defendants did not display indifference toward the public's safety and therefore punitive damages are not warranted.” 

Id. at *24-25 (citations omitted).  That’s a good standard to follow.

We now need to depart briefly from our discussion of the sequel rules, because we can’t quite fit a discussion of plaintiff’s failure to warn claim into the formula.  The court recognized that the only failure to warn claim is for failure to warn the prescriber.  Id. at *9.  But Enbrel was accompanied by a large, bold-faced warning of the risk of serious infections, including fatalities.  Id. at *12.  Plaintiff’s first attempt to circumvent the package insert was to argue that “that there is no evidence that [the] prescribing doctors actually received the Enbrel Package Insert.”  Id. at *9.  So, defendant has to prove the doctor did get the warning?  The court didn’t buy it:

This argument is not persuasive. Contrary to Plaintiff's contention, he -- not the Defendants -- has the burden of pleading sufficient factual matter to show that the claim is facially plausible. Plaintiff has not pleaded any facts tending to make it plausible that the particular packages of Enbrel sent to Decedent's doctors did not have a Package Insert, which Plaintiff concedes typically accompanied Enbrel during the period in which Decedent took the drug. To the contrary, he merely alleges that Plaintiff's medical records make no mention of a warning and therefore baldly concludes that Decedent's doctors must not have received such an insert.

Id. at *10.  Thus, plaintiff’s package insert argument is unlikely to warrant a sequel.

            Plaintiff’s next attempt is the more recognizable “the warning wasn’t good enough” argument.  Under Pennsylvania law, “a prescription drug manufacturer has a duty to exercise reasonable care to inform those for whose use the article [was] supplied of the facts which make [the product] likely to be dangerous."  Id. at *13.  So what was unreasonable about defendant’s Enbrel warning?  According to the plaintiff, it was the fact that while the package insert warned about infections generally, it did not warn about fungal infections specifically.  According to the court, such specificity was unnecessary to an adequate warning:

[T]he manufacturers of Enbrel issued a broad warning of the risk of infection and highlighted some specific risks, i.e. sepsis and tuberculosis. Furthermore, the warning specifically informed prescribing doctors of the risk of prescribing Enbrel to patients who, like the Decedent, had diabetes . . . . Therefore, the Court finds that the Enbrel Package Insert in effect when Decedent was prescribed the drug adequately warned doctors of the risk of serious infections, such as the one which allegedly led to Decedent's death.

Id. at *17 (citation omitted).  The court took judicial notice of the warning, and held it adequate as a matter of law.

            Finally, plaintiff argued that the warning was inadequate because five months after plaintiff stopped using Enbrel, the defendant changed the warning to include a "black box" warning for invasive fungal infections.  “However, it is well established that such a revision cannot be relied on to establish the inadequacy of Defendants' warning.”  Id. at *18.  A subsequent remedial measure could not prevent dismissal of the plaintiff’s failure to warn claim. 

            Rule Number 3 – never assume the killer is dead.  In a horror movie this is what allows for the type of jump-out-of-your seat moment like when Glenn Close pops out of the tub at the end of Fatal Attraction.  Or, it is what leaves open the option for movies such as Halloween 2, 4 and 5 (Michael Myers isn’t the killer in Halloween 3 so we’ll leave that one out).   But, again that rule doesn’t apply to Salvio II, because having given plaintiff two tries to get it right, the court didn’t allow a third.  Plaintiff’s motion to again amend her complaint was denied.  Id. at *26-27.  

            If Salvio II broke all the rules for making a successful sequel, it adhered to the one rule for making a horrible sequel – do a follow-up to a movie that was bad to begin with (hmmm, Wrath of the Titans is due out next month).