United States: This Is How It Is Supposed To Work: Summary Judgment On Claims About The Adequacy Of Extensive, FDA-Approved Warnings

Last Updated: May 11 2018
Article by Eric Alexander

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while taking a drug, but sometimes there is no fault even if there is a significant injury related to the use of the drug. If the drug's manufacturer warned about the risk of plaintiff's ultimate injury consistent with the available evidence, which it examined and shared with FDA appropriately in connection with approval and after approval, and the prescribing physician(s) gave due consideration to the risk in treating the patient, then the manufacturer did what it was supposed to do and the patient might suppress the urge to sue someone. Often, of course, such patients become plaintiffs and courts are faced with deciding summary judgment in cases with a real injury, related in some way to the use of the drug, but no real claim against the manufacturer. In those situations, the courts often get it wrong and allow some claim to get past summary judgment. Nelson v. Biogen Idec, No. 12-7317 (JMV) (MF), 2018 WL 1960441 (D.N.J. Apr. 25, 2018), got it right. Joe Blute and Yalonda Howze of Mintz Levin, who defended the case and told us about it, deserve some credit for that.

The facts of Nelson do not exactly scream failure to warn, even with the severity of the injury claimed by the plaintiff, who received Tysabri, a prescription medication for his multiple sclerosis. He claimed to have developed progressive multifocal leukoencephalopathy ("PML"), a condition about which the drug's labeling contained black box warning, multiple other warnings in physician labeling, and warnings in a medication guide that the drug's Risk Evaluation and Management Strategy ("REMS") program required the patient acknowledge when receiving the drug through infusion provided by a healthcare provider. With such extensive warnings also comes the expected developed record of interacting with FDA about PML, which we will attempt to summarize. The medication was approved in 2004, but withdrawn because of PML cases the next year. PML results from exposure to the JC virus, which is prevalent in humans but only causes PML in vulnerable patients. Before seeking to bring the drug back to market, the manufacturer conducted FDA-requested research on testing for the JC virus. After taking an advisory committee recommendation, FDA re-approved the drug in 2006 with a slew of robust warnings on PML and a REMS program that essentially documented understanding and/or acceptance of the PML risk at each step of the prescribing chain every time the patient received the drug. The label was updated in August 2008, November 2009, and July 2010 to provide more information on the PML risk. Meanwhile, the manufacturer worked to develop a better assay to detect exposure to the JC virus. After years of research and interaction with FDA, in 2012, a new assay was approved and the label was amended to reference it.

Meanwhile, plaintiff was prescribed the drug for his MS in April 2008 after being advised of the PML risk. Plaintiff moved and continued on the drug when prescribed by two other physicians, each of whom also warned him of the risk of PML. Plaintiff was negative for the JC virus in 2009, but started demonstrating signs of PML in 2010, which was confirmed later that year by brain biopsy. Plaintiff sued and was on the fifth version of his complaint when the court considered summary judgment on plaintiff's remaining claim for failure to warn under the New Jersey Product Liability Act (along with a Daubert motion that was denied as moot).

The court started its analysis with a discussion of three prior decisions on similar claims with the same drug. We will skip that, partly because we have discussed these cases before. Because this was under the NJPLA, the first issue was whether the "super-presumption" of the adequacy of the PML warnings would apply given plaintiff's argument about post-approval compliance. The presumption did not look to be dispositive, as the court noted that the substance of the warnings to both the prescribing physicians and the patient were clear, strong, and effective. Yet, the court found that there was no evidence of "manipulation of the post-market regulatory process," the basis of the so-called "McDarby exception," noting the interaction between the manufacturer and FDA on an assay that could be used to detect the JC virus in connection with the use of the drug. (The court also assumed without deciding that the McDarby exception could apply.) In the face of this presumption, plaintiff relied on proposed expert testimony that only indirectly addressed the adequacy of warnings. His expert claimed a better assay could have been developed and approved in time to affect the various physicians' decision to prescribe the drug to plaintiff. Even if his testimony were admissible and if he took the next step of connecting a new assay to the content of the drug's label—which he did not and could not as a non-physician—there were still obvious issues with relying on this testimony to establish an inadequate label and proximate cause for failure to warn, including that the prescribing physicians were aware of the PML risk and discussed it with the plaintiff on multiple occasions. Put it all together and there was no evidence to carry a failure to warn claim, with or without a presumption of adequacy

As a bit of overkill, the court went ahead and considered the manufacturer's preemption defense, which argued that the proposed changes to the drug's label would have been impossible to make during the relevant time. The prior decisions that we elided above also found impossibility preemption, but they were not decided in the Third Circuit after the Fosamax decision tried to make the application of Levine's once-novel "clear evidence" standard just a question for juries. Even acknowledging the high standard and the decision in Fosamax (albeit with a recurring, and surely unintentional, misspelling), the court still found "There is clear evidence that FDA would not have approved an earlier change to the Tysabri label or have approved the JC Virus assay." FDA specifically rejected similar proposals twice in 2010, before approving the assay and corresponding labeling change in 2012 after additional research had been committed. That was pretty clear evidence of impossibility back when plaintiff was taking the drug.

So, the manufacturer won summary judgment thrice over. The co-developer also won because it had no ability to change the label, a useful nugget as innovator liability and other theories to impose liability on other defendants continue to get raised when the logical defendant is not liable. In Nelson, no defendant was liable to an injury that, while unfortunate and serious, was warned of about as thoroughly as is possible with a prescription drug. We would prefer such a case never to have been brought or to have been dismissed for failure to state a claim, but summary judgment is still the right result.

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

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