United States: WDNY Holds That Tysabri Warnings Are Adequate As Matter Of Law And That Product Liability Claims Are Preempted

Last Updated: April 21 2017
Article by Stephen J. McConnell

Most Read Contributor in United States, May 2017

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.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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