This post comes from only the Dechert side of the blog, as Reed Smith is involved in this litigation.
The New Jersey NuvaRing litigation, which involves a combination hormonal contraceptive, recently produced an opinion that granted the defense summary judgment in seven separate cases. That’s a pretty big win for the defense. But a broader win can be found in the reasoning of the court. The defense didn’t win on one overarching argument. It won for a variety of reasons.
Failure to Warn
Two of the seven cases were dismissed because the court found that the NuvaRing label’s warning on venous thromboembolism (VTE), the alleged side effect, was adequate as a matter of law. The plaintiffs in these two particular cases were New Jersey residents, and so the court applied the New Jersey Product Liability Act (PLA). The PLA contains a presumption for adequacy of any FDA-approved warning:
If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration . . . a rebuttable presumption shall arise that the warning or instruction is inadequate.
Slip Op. at 31 (citing NJSA §2A:58C-4). New Jersey caselaw has established two types of evidence that can rebut this statutory presumption, both relate to post-approval actions by the defendant: (1) evidence that the defendant deliberately concealed or failed to disclose after-acquired knowledge of harmful effects of the drug (the Perez exception), or (2) evidence that the manufacturer engaged in an economically-driven manipulation of the post-market regulatory process (the McDarby exception). Id.
But presenting sufficient evidence of these two exceptions is by no means easy. This is no ordinary statutory presumption. It’s a “super-presumption.” Id. (citing Kendall v. Hoffmann-La Roche, Inc., 209 N.J. 173, 195 (2012)). What does that mean? Well, it means that the presumption is “virtually dispositive” of failure to warn claims. The term “virtually dispositive” is about as strong as it gets. If the court properly applies it, FDA approval of the warning makes it almost certain that the defense should win.
And this court applied it exactly that way. Right out of the box, the court rejected plaintiffs’ attacks on the adequacy of the label’s language on daily dosing and description of the VTE risk, holding that the PLA presumes that this FDA-approved language is adequate and that plaintiffs, once again, could only overcome that presumption through the Perez or McDarby exceptions. Slip op. at 41-42.
Plaintiffs did not have sufficient evidence to get to a jury as to either exception. The Perez exception didn’t apply because plaintiffs didn’t have sufficient evidence that the defendants failed to disclose information to the FDA. Plaintiffs tried to point to an internal report in which the defendants analyzed certain VTE data from clinical trials. But FDA regulations did not require defendants to give that document to the FDA. The regulations, instead, required that the defendants give the FDA the underlying data. The defendants did so in periodic adverse event reports. Id. at 43. Plaintiffs also pointed to VTE data that defendants allegedly did not give to the FDA fast enough. But defendants eventually provided that data. The alleged delay simply was not enough to overcome the “super-presumption” of the PLA. Id.
As to the McDarby exception, plaintiffs didn’t present sufficient evidence of defendants trying to manipulate the post-approval market. The court found it relevant that the defendants didn’t actually believe that there was an increased risk of VTE and that the FDA, with all the data, never required a warning change. And plaintiffs simply didn’t have sufficient evidence that defendants tried to hide information from prescribing doctors, and certainly not enough evidence to overcome the PLA’s super presumption. Id. at 45.
In the five remaining cases, which we’ll discuss next, the court did not hold that the label was adequate as a matter of law. That’s because those cases were decided under the law of states other than New Jersey. But the court’s application of New Jersey’s PLA presumption in the two case involving New Jersey residents is important. This is now the second of New Jersey’s three mass tort courts to grant summary judgment based on that presumption, meaning that it is becoming more and more difficult to bring failure to warn drug or device cases in New Jersey if you are a New Jersey resident.
Proximate Causation and the Plaintiffs’ Burden
The remaining five cases were dismissed on various proximate causation grounds. In a number of the cases, plaintiffs didn’t have sufficient evidence to satisfy the learned intermediary doctrine. An important aspect of the court’s reasoning was its recognition that plaintiffs had the burden. The defense didn’t have to disprove anything. The plaintiffs had to produce sufficient evidence that the prescriber would not have prescribed if she had received the warning that plaintiffs claim was appropriate. Time and again, the court found that plaintiffs hadn’t done this.
In one case, the evidence showed that the prescriber “was aware of the risk and prescribed NuvaRing to Plaintiff regardless.” Id. at 61. That same prescriber testified at his deposition that he continues to prescribe NuvaRing and wouldn’t have changed his prescribing decision, or in the least didn’t know whether he would have changed it, based on the information that the plaintiff’s attorney was giving him at the deposition. Id. at 61. With some courts, we could see such “I don’t know” testimony being enough to get the plaintiff passed summary judgment. Not here. And it shouldn’t have. The court understood that the plaintiff had the burden to show proximate causation: “This evidence does not sufficiently raise any issues of fact as to whether the physician would have changed his decision to prescribe NuvaRing®, therefore Plaintiff has not established issues of material fact.” Id.
The court saw another proximate cause problem. Other contraceptives on the market also carried a risk of VTE. Plaintiffs didn’t present sufficient evidence that, if the patients used contraceptives other than NuvaRing, they would not have suffered their injuries anyway.
Therefore, in applying the but-for test, the Court notes that Plaintiff did not present any evidence to show a material issue of fact as to whether Plaintiff would have suffered [her injury] “but for” using NuvaRing® — i.e. if she had not taken NuvaRing® and instead taken another CHC.
Id. at 69. In one case, plaintiffs’ own expert said that he would have attributed the plaintiff’s injury to whatever combination hormonal contraceptive she was using at the time, even if it wasn’t NuvaRing:
In addition, Plaintiff’s expert, Dr. Jaffe . . . testified at his deposition that he would have attributed Plaintiff s injury to whatever CHC, such as an oral CHC, she was taking at the time of her VTE. . . . Therefore, Plaintiff’s reliance on Dr. Jaffe’s expert report is insufficient to establish a genuine issue of material fact, because it does not make it more likely that Plaintiff only suffered a VTE because she was taking NuvaRing®.
Id. at 75-76.
Plaintiffs all brought breach of express warranty claims too and were still pressing them at the time of defendants’ summary judgment motion. The court quickly dismissed them. In most cases, plaintiffs were simply unable to articulate any particular warranty that became the basis of the bargain. The court dismissed those outright. Id. at 46-47, 56, 60, 67, 73-74 & 79. In one case, plaintiffs tried to argue that the statements by sales representatives to prescribing doctors were warranties that the doctors relied on. But plaintiffs ran into another evidence problem, one that typically comes out of prescriber depositions. While the prescriber recalled speaking to sales representatives and said that she trusted them, she did not recall any particular statements on which she relied. Id. at 47. The court, again understanding who has the burden of proof, dismissed plaintiffs’ claim. Id.
We suspect that plaintiffs will appeal and, if so, we’ll be posting about this case again. In the meantime, we recommend that you read this opinion. There’s more to it. For example, it dismisses design and manufacturing defect claims (Id. at 88-90). It also contains a lot of thoughtful reasoning and useful quotations if you can find a way to use them in your litigations.