However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn.  Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff of evidence that anything went wrong on the production line?  Seldom do we see the pharma equivalent of a mouse in the Coke bottle or, thinking of a more recent case, a bat in the salad.  Similarly, a design defect claim is often a make-weight claim.  How should the design have been improved?  Not selling the product at all is hardly a design improvement.  An entirely different product is not a safer alternative under the law of any enlightened state.  Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).  No, failure to warn is where the action is.  In the wake of Wyeth v. Levine, it seemed that preemption would be a tough row to hoe in such cases, but keep hoeing that row because the preemption defense might still be available – as a motion to dismiss, summary judgment motion, directed verdict, or argument to the jury.

 

The recent case of Amos v. Biogen Idec, Inc. et al., 2017 WL 1316968 (W.D.N.Y. April 10, 2017), makes every one of these points for us.  The court granted summary judgment to the defendants in that case, holding that all of the claims were fundamentally about failure to warn, the warning was adequate as a matter of law, and the FDA’s earlier rejection of proposed warnings meant that the plaintiff’s claims were preempted.  The facts of Amos present the sort of situation defendants encounter all too often, but which make for a hard sell to a jury: something very sad happened to an innocent patient, but it was nobody’s fault.  The patient had Multiple Sclerosis too severe to respond well to the usual treatments.  Her doctor recommended Tysabri.  That medicine came with a black box warning that it might increase the risk of Progressive Multifocal Leukoencephalopathy (“PML”), a viral infection of the brain that is as incurable as MS is.  The patient eventually contracted PML and died.  Her estate filed a lawsuit that included claims for negligence, negligent misrepresentation, strict liability, and breach of implied warranty. 

 

From the recital of facts in the Amos case, it appears that the manufacturer of Tysabri was quite diligent and proactive.  It also appears that the defense attorneys did an excellent job of mining the administrative record.  The manufacturer continued to perform clinical trials after initial approval, and promptly alerted the FDA of whatever risks it observed.  Among other things, the company asked the FDA to add information in the label about screening for certain virus antibodies that might increase the risk of PML.  The FDA rejected this proposal a couple of times, finding insufficient evidence at those times to support the label change.  The FDA ultimately relented and approved a label change in 2012 – after the plaintiff’s decedent died.

 

In considering the defense motion for summary judgment, the court concluded that all of the plaintiff’s claims turned on the sufficiency of the warnings.  New York law applied, and there was ample precedent under New York law that adequate warnings precluded claims for negligence, strict liability, breach of warranties, or fraud.  What’s more, the learned intermediary applied to claims regarding prescription drug warnings, and the record was replete with evidence that the prescribing doctor was well aware of the increased risk of  PMI.  It certainly helped the defense that the defendant, in collaboration with the FDA, had created a program called Tysabri Outreach: Unified Commitment to Health (“TOUCH”), which required that, prior to prescribing Tysabri, a physician had to acknowledge in writing that he/she understood the risks of PML and obtained a written acknowledgment from the patient that the patient understands the PML risk. The existence of the TOUCH program was one of several facts that made Amos a hard case for the plaintiff to win.

 

Even so, we all know that no matter how comprehensive and informative a warning label is, a good plaintiff lawyer can flyspeck it and find, or make up, some gaps.  The plaintiff lawyers in the Amos case are well known to us, and are very, very good.  They argued that the Tysabri warnings were inadequate because they failed to include information regarding the correlation between the virus antibodies and PML, and failed to inform doctors of the risks associated with duration of treatment and prior treatment with an immunosuppressant.  To our eyes, the plaintiff lawyers made the best arguments they could.  In too many courts, such an argument would furnish enough of a crutch for a plaintiff-leaning (or lazy-leaning) judge to mutter ‘factual dispute’ and deny the motion in a post-card ruling.  But not this court.  The judge analyzed New York law and held that even without the details regarding specific risk factors, “when read as a whole, the warnings unmistakably conveyed the seriousness of PML and its association with Tysabri treatment.”  That “read as a whole” point is important.  Do not let a court tell you that it is the jury’s duty to read the warnings as a whole.  It is the court’s job to assess whether the warning is adequate as a matter of law, and plaintiff post hoc fly-specking should not be enough to plant a case in front of twelve citizens good and true (and half-asleep and inflamed with sympathy and anti-corporate hatred).    

 

Even aside from the conclusion that the Tysabri warnings were adequate as a matter of law, the court offered an alternative basis for dismissing the case:  the claims were preempted as a matter of law.  Wyeth v. Levine ruled against preemption on the (at least partially specious) ground that drug companies can unilaterally ramp up warnings through the Changes Being Effected (“CBE”) process.  But the Amos court accurately observed that CBE is not available in all situations, and definitely is not available to add or change a black box warning, which is what was at issue in this Tysabri case.  Moreover, “the evidence of record leads inescapably to the conclusion that the FDA would not have approved a change to Tysabri’s label prior to 2012.”  With respect to Tysabri, there were two “smoking gun” rejections from the FDA. 

 

Also notable in Amos:  a second defendant in the case, a distributor of Tysabri, received summary judgment on preemption grounds.  The distributor did not own the drug’s New Drug Application, and thus had no power under the FDA scheme to alter warnings in any way.  The distributor’s inability to act independently to change warnings meant that, under the Mensing and Bartlett decisions, all claims against it were preempted.

 

There have been other cases around the country where courts arrived at similar rulings that Tysabri warnings were adequate as a matter of law and that failure to warn claims were preempted.  Perhaps plaintiff lawyers will do their best to distinguish these cases on their facts.  We will, doubtless, hear that “smoking gun” has become the standard for the Wyeth v. Levine “clear evidence” standard. We heard something nearly as silly from our home appellate court recently.  But reading the Amos case in the same way that the Amos court read the Tysabri label – as a whole – there is an awful lot of comfort in that case for drug and device defendants.

   

 

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted, under certain circumstances, non-manufacturers to be sued for failure to warn of a risk that the product they manufactured didn’t have (exposure to asbestos), where they “encourage[ed]” the use of products containing that risk with their products and thereby benefitted economically:

[A] manufacturer’s duty to warn of combined use of its product with another product depends in part on whether the manufacturer’s product can function without the other product, as it would be unfair to allow a manufacturer to avoid the minimal cost of including a warning about the perils of the joint use of the products when the manufacturer knows that the combined use is both necessary and dangerous. And, the justification for a duty to warn becomes particularly strong if the manufacturer intends that customers engage in the hazardous combined use of the products at issue.

*          *          *          *

[W]here a manufacturer creates a product that cannot be used without another product as a result of the design of the product, the mechanics of the product or the absence of economically feasible alternative means of enabling the product to function as intended, the manufacturer has a substantial, albeit indirect, role in placing the third-party product in the stream of commerce. . . .  Specifically, when the manufacturer produces a product that requires another product to function, the manufacturer naturally opens up a profitable market for that essential component, thereby encouraging the other company to make that related product and place it in the stream of commerce.

NYCAL, 2016 WL 3495191, at *__ (for some reason there is no Westlaw star paging at the moment).  This opinion is very bad news for the affected companies, who are now sucked into the maw of interminable asbestos litigation on the basis of products they didn’t even make, but it should not open the door to innovator liability type claims against our medical product manufacturer clients, and it’s good on causation, too.

Here’s why.

Continue Reading New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

This post comes from the Cozen O’Connor side of the blog.

Last week, the New York Appellate Division upheld a preemption decision in a medical device case involving alleged off-label promotion. Pitkow v. Lautin, 2016 WL 2746469 (N.Y. App. Div. May 12, 2016). While the Appellate Division’s opinion was only three-paragraphs long, it affirmed the trial court’s ruling in every respect, making the trial court’s lengthier opinion that much more important. We obtained a copy, and here it is.

The plaintiff’s claims were based on complications that arose after her use of an injectable product, Sculptra, for cosmetic purposes, which was an off-label use. Plaintiff sued the doctors who injected her and the manufacturers of Sculptra. Among other things, she alleged that the manufacturers had improperly promoted off-label use of Sculptra.

After discovery, the manufacturers moved for summary judgment, arguing that all of plaintiff’s claims were preempted. The trial court agreed and, quite effectively, walked through the manner in which both Riegel and Buckman preempted plaintiff’s claims as well as the deficiencies of plaintiff’s attempts at parallel violation claims.

First up was Riegel preemption, since Sculptra was approved under the FDA’s PMA process:

Sculptra is a Class III medical device that was undeniably approved through the PMA process. What is more, all of the plaintiff’s claims against the [manufacturers] regard the safety and effectiveness of the device or require a finding that Sculptra’s design, labeling, and/or manufacturing process should have differed from that approved by the FDA via the PMA process . . . . Thus, the claims are preempted by the federal law.

Slip. Op. at 8-9.

Continue Reading New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really should involve individualized proof. Like here, here and here. (This same dynamic plays out when governmental entities seek reimbursement for such products too.) Usually, though, the plaintiffs allege that the manufacturer’s fraud—under whatever particular statutes or headings it is pursued—was unknown to them during the time for which they seek damages for amounts paid for the product and that the damages stopped once they found out. In Teamsters Local 237 Welfare Fund v. Astra-Zeneca Pharms. LP, No. 415, 2015, 2016 Del. LEXIS 236 (Del. Apr. 12, 2016), the plaintiff payors were undone by their concession that they knew about the alleged fraud and kept paying for the drug at issue anyway. Based on its self-described common sense analysis, the Delaware Supreme Court affirmed the dismissal for lack of causation without weighing in on the Superior Court’s rejection of causation where individual physicians made individual decisions about what to prescribe. This is a good result, but we are concerned about the implications for the practices of payors who seem increasingly interested in signing up with contingency fee lawyers to sue medical product manufacturers. (In case you were wondering, that was a teaser, designed to get you to read all the way to the end of the post.)

The basic facts are that the plaintiff filed a purported nationwide class action on behalf of third-party payors in Delaware state court in 2004, alleging that the defendant violated state consumer fraud laws by falsely marketing Nexium as being more effective than Prilosec, an older product with allegedly one-half of the same active ingredient per dose. Adding some facts omitted in the opinion, the initial NDA for Prilosec had been approved in 1989 (under the name Losec) and lost exclusivity in 2001, around which time FDA approved the NDA for Nexium, which had an enantiomer (here, the left hand chiral image) of the Prilosec’s active ingredient as its active ingredient. The indications for both drugs were expanded through the years, with Prilosec going over-the-counter in 2015. These drugs together accounted for a large chunk of the prescriptions written for heartburn, gastroesophageal reflux disease, and related complaints. Plaintiffs claimed that the development of Nexium and the marketing campaign after its introduction were designed to get the defendant paid a high price for its newer branded product instead of money going to pay for cheaper generic versions of the older product. They claimed they had been harmed by paying for the Nexium prescribed by physicians for the patients participating in their plans. The same group of lawyers apparently filed other “essentially identical class actions” with different sets of named plaintiffs, including one in Delaware federal court that resulted in the dismissal of a New York consumer fraud claim. Ignoring some history and details much like the plaintiffs ignored the marketing for Prilosec over the last fifteen years and the difference between a racemic mixture and an enantiomer, the Delaware state court action woke up from a long slumber in 2014 with its second amended complaint asserting the same claims the federal court had disposed of a few years before.

The Superior Court first determined that the law of New York, where the named plaintiffs were based, applied instead of the law of Delaware, where the defendant was based, or the laws of thirteen other states. Id. at *9. The court found that plaintiffs had not alleged the causation required for a consumer fraud claim: the “purported chain of causation that runs from the allegedly deceptive advertisements that may have influenced the decisions of individual doctors to prescribe a drug to their patients to causally affect the payer unions in this case is simply too attenuated,” as the doctors would be “presumed to go beyond advertising medium and use their independent knowledge in making medical decisions.” Id. at **9-10. We certainly like this reasoning, which would apply to a bunch of these cases. We also like that the court did not give plaintiffs a fourth chance to frame a complaint that stated a claim.

Continue Reading TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

Every now and then even Bexis comes across a decision involving legal propositions he’d never heard of before. Such was the human tissue case Kennedy-McInnis v. Biomedical Tissue Services, Ltd., No. 13-CV-6545, slip op. (W.D.N.Y. April 12, 2016). Kennedy-McInnis introduced us to the common-law “right of sepulcher” – and more importantly to the defenses, including broad “good faith “ immunity, that limit this little known “right.”

First, why should anybody interested in drug/device product liability care? The answer is that a lot of products, particularly implantable medical devices, are used in conjunction with so-called “allograft bone.” As everyone knows, many other types of tissue are transplanted as well. Other medical devices, and some drugs, are typically used in conjunction with – or to support transplants of – various types of human tissue that doctors and hospitals typically obtain from tissue banks. Human tissue used in this manner can be extremely medically beneficial – and anything so beneficial is potentially worth a great deal.

Anything that’s worth a great deal creates a market for itself, and in our market-based society, there is always temptation for somebody in the chain of distribution to cut corners. When that happens, we’ve seen product manufacturers end up getting sued. Thus, we have blogged several times about litigation involving human tissue incorporated into certain medical devices, and allegations that fly-by-night (and convicted) intermediaries hadn’t bothered testing the tissue in question for communicable diseases. Ultimately, the litigation fizzled because, as bad as the intermediaries’ conduct had been, plaintiffs couldn’t prove that it actually caused anybody to get sick.

Continue Reading Learning Something New – Limits To Human Tissue Liability

Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined.  Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be.  There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had.  For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it.  As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively.  So definitively that it took our spot as top decision of 2015.  Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted.  It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.

We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug.  In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug.  One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. 2466, 2475.  Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks.  Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about.  There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.

Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims

Way back when – before Restatement (Second) of Torts §402A (1965) crystallized the concept of strict liability – courts around the country were poking around, trying to come up with viable theories of what we would now call “product liability.”  One method that gained some traction, prior to the advent of strict liability, was to strip contractual implied warranty of its historical requirement that the buyer and seller have been in “privity” (that is, that they dealt directly with each other).  New York was one of the states that started down that road.  In Goldberg v Kollsman Instrument Corp., 191 N.E.2d 81 (N.Y. 1963), the court held 4-3 that the manufacturer of a “thing of danger” (not otherwise defined, but in Goldberg, an airplane part that allegedly caused a crash) could be liable for breach of implied warranty without being in contractual privity with the plaintiff.  Id. at 83 (“at least where an article is of such a character that when used for the purpose for which it is made it is likely to be a source of danger to several or many people if not properly designed and fashioned, the manufacturer as well as the vendor is liable, for breach of law-implied warranties, to the persons  whose use is contemplated”).  This was problematic, because until §2-318 was amended in 1975, New York’s UCC hadn’t done away with privity in all personal injury cases.

But along came strict liability, and New York’s tentative steps down the road of privity-less implied warranty were largely forgotten.  Nobody paid much attention to warranty in the Empire State until the Court of Appeals held that strict liability and implied warranty were “not identical” in Denny v. Ford Motor Co., 662 N.E.2d 730, 739 (N.Y. 1995), in that strict liability utilized a risk/utility approach whereas implied warranty focused on consumer expectations.  Id. at 736.  While this distinction “may have little or no effect in most cases,” it can in some.  Id. at 738.

Continue Reading The Citadel Revisited – New York’s “Thing of Danger” Privity Exception Is Obsolete (and Another New York Note)

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.”  This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning can presume it will be heeded, a plaintiff should also be able to presume that an adequate warning, had it been granted, would have been heeded.  That’s false equivalence if we’ve ever seen it.  A defendant to such a warning claim needs no heeding presumption, since it wins on adequacy without ever getting to causation.  The comment j discussion really involves design defects (about which more below).  Plaintiffs, on the other hand, are getting a burden of proof shift on warning causation that simply has no basis in reality.  People disregard adequate warnings all the time.

So we fight the heeding presumption whenever it comes up.  Some states have good law on the issue.  N.C. G.S.A. §99B-5(a); Wis. Stat. §895.047(1)(e); Ford Motor Co. v. Boomer, 736 S.E.2d 724, 733 (Va. 2013); Rivera v. Philip Morris, Inc., 209 P.3d 271, 274 (Nev. 2009); Leaf v. Goodyear Tire & Rubber Co., 590 N.W.2d 525, 528-29 (Iowa 1999); Riley v. American Honda Motor Co., 856 P.2d 196, 199-200 (Mont. 1993); Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991); Huitt v. Southern California Gas Co., 116 Cal. Rptr.3d 453, 467-68 (Cal. App. 2010); Harris v. International Truck & Engine Corp., 912 So. 2d 1101, 1109 (Miss. App. 2005); McPike v. Enciso’s Cocina Mejicana, Inc., 762 P.2d 315, 319 (Or. App. 1988); DeJesus v. Craftsman Machinery Co., 548 A.2d 736 (Conn. App. 1988); Muilenberg v. Upjohn Co., 320 N.W.2d 358, 366 (Mich. App. 1982); Potthoff v. Alms, 583 P.2d 309, 311 (Colo. App. 1978); Payne v. Novartis Pharmaceuticals Corp., 767 F.3d 526 (6th Cir. 2014) (applying Tennessee law); Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (8th Cir. 2004) (applying Minnesota law); Wilson v. Bradlees of New England, Inc., 250 F.3d 10 (1st Cir. 2001) (applying New Hampshire law); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (applying Florida law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (applying South Carolina law); Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *13 (N.D.W. Va. Jan. 16, 2015); Luttrell v. Novartis Pharmaceuticals Corp., 894 F. Supp.2d 1324, 1345 n.16 (E.D. Wash. 2012).

Almost as many states are adverse.  House v. Armour, Inc., 929 P.2d 340, 347 (Utah 1996); Coffman v. Keene Corp., 628 A.2d 710, 717-19 (N.J. 1993); Eagle-Picher Industries, Inc. v. Balbos, 604 A.2d 445, 468-69 (Md. 1992); Bushong v. Garman Co., 843 S.W.2d 807, 811 (Ark. 1992); Arnold v. Ingersoll-Rand Co., 834 S.W.2d 192, 194 (Mo. 1992); Butz v. Werner, 438 N.W.2d 509, 517 (N.D. 1989); Harlow v. Chin, 545 N.E.2d 602, 606 (Mass. 1989); Bloxom v. Bloxom, 512 So.2d 839, 850 (La. 1987); Payne v. Soft Sheen Products, Inc., 486 A.2d 712, 725 (D.C. 1985); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057-58 (Kan. 1984); Seley v. G.D. Searle Co., 423 N.E.2d 831, 838 (Ohio 1981); Menard v. Newhall, 373 A.2d 505, 506 (Vt. 1977); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1382 (Okla. 1974); Dole Food Co. v. North Carolina Foam Industries, Inc., 935 P.2d 876, 883 (Ariz. App. 1996); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 555 (Ind. App. 1979).

Continue Reading Heedless Heeding Presumptions – How New York Law Became a Morass

 

Failure to warn cases remind us of sports talk radio and paleontology.  Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination.  The Iggles are terrible, their deficiencies are many and obvious, and the people running the team are dunderheads.  Mind you, the callers and radio hosts are the same people who a few short weeks ago anticipated Super Bowl glory.  But there is a reason for the phrase “Monday morning quarterback.”  There is also a reason why we DDL defense hacks worry about hindsight bias.  At first blush (though what plaintiff lawyer has ever blushed?) a failure to warn claim seems so reasonable and modest.  It does not ask for scientific innovation.  It asks only that the company tell the truth about its product.  Ah, but what truth?  The truth is that the company probably believed (and the FDA concurred) that the relevant risks had been adequately disclosed.  Sadly, reality in the form of an unfortunate, sympathetic plaintiff seems to disclose a new risk, or a risk that calls for a louder, brighter warning.  The reality also is that nobody hid anything.  Stuff happens.  Looking back, we all always wish we had done more and done better.

Hindsight is 20-20.  What it sees is corporate omniscience.  What it demands is perfection.  That’s when we start reflecting on paleontology – or, to be more precise, the debate between paleontology and creationism.  Creationist critics point to “gaps in the fossil evidence” as refutation of evolution.  Where is the missing link?  That ploy creates no end of frustration among actual scientists.  Produce a new piece fossil in the evolutionary chain, and the critics will now gleefully point to two new gaps in the evidence.  You cannot win, because you are dealing with people who care much more about the end result than the integrity of the process.  The same is true with drug or device warnings.  Whatever is warned about, it is all too easy after the fact to find something that was not warned about, or was not warned about with enough fury and poetry. It gets worse when the court admits evidence of subsequent warnings.  Not only is the perfect the enemy of the good, but so is the better.  What we wish courts (or legislators or regulators) would do is establish a bright line rule that when a label warns of the injury suffered in the case, the failure to warn claim (and all of the parasitic claims essentially alleging the selfsame thing) must be dismissed.  The court should not pass along to the jury as a bogus, hindsight fact-issue whether the warning could have been more robust.

Something like what we want – a rigorous, disciplined approach to warning adequacy – happened in Becker v. Cephalon, Inc., 2015 U.S. Dist. LEXIS 123670 (SDNY Sept.15, 2015).  The court’s clear-headedness is particularly impressive because it was a wrongful death case, and the claim was that the decedent had come down with the horrific burning and peeling skin condition known as Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TEN).  That dreadful injury would provoke sympathy in anyone.  The decedent had been diagnosed with leukemia in 2000.  He was treated with allopurinol in late 2010, and was also treated with the medicine at issue, Treanda, on multiple dates in late 2010 and early 2011.  Then came the SJS/TEN. Continue Reading SDNY Sacks Treanda Failure to Warn Claim

By all rights, it should be Sullivan writing about the Sullivan case.  But John is taking a well-deserved vacation.  We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes where one must dodge rattlesnakes and gila monsters, or if Sullivan is more like today’s correspondent, who is content to plop down in a BeNeLuxian cafe and down a couple of Chimays before staggering past museum walls adorned with Brueghel and van Ruisdael masterpieces.

Sullivan v. Aventis, Inc., 2015 WL 4879112 (S.D.N.Y. Aug. 13, 2015), is no masterpiece.  It offers a crabbed reading of Bartlett to support its stubborn refusal to expand that case’s generic preemption to brandeds, it conflates design defect and warning theories, and its reasoning often seems incomplete or incoherent. We’re not saying that the Sullivan case is a complete train-wreck, but it is not exactly pleasant beach reading either.

The Sullivan case was brought by a woman who claimed that she suffered birth defects because her mother had taken an allegedly defective fertility drug.  She alleged that the drug’s half-life was too long and that the manufacturer had failed to supply the requisite warnings.   The legal claims included design defect, manufacturing defect, failure to warn, misrepresentation, breach of express and implied warranties, and unjust enrichment.  New York law controlled.

Continue Reading SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest