Can a New Jersey trial court, applying the law of another jurisdiction, disregard an intermediate appellate decision from that other jurisdiction that is directly on point? Apparently yes. We present two interesting decisions arising from the Accutane® litigation – the fi rst, a Florida appellate opinion, and the second, a New Jersey trial court decision that declined to follow precedent and permitted the plaintiffs to reargue the Florida appellate ruling.  

The Florida Appellate Case

Hundreds of cases are pending against Hoffmann-La Roche, Inc. (“Roche”) alleging that its prescription medication, Accutane, causes gastro-intestinal disorders, including infl ammatory bowel disease (“IBD”). One Florida trial against Roche resulted in a $7 million jury verdict in favor of plaintiff Adam Mason based on a failure to warn claim. Roche, however, was able to obtain a reversal of the judgment from the Florida District Court of Appeal, First District. Hoffmann-La Roche, Inc. v. Mason, 27 So. 3d 75 (Fla. Dist. Ct. App. 1st Dist. 2009), review denied, 2010 Fla. LEXIS 815 (Fla. May 24, 2010).  

In reversing the judgment, the Florida appellate court agreed with Roche that it had discharged its obligation to warn (i.e., provided adequate and appropriate information) to the plaintiff’s treating physicians. Although the plaintiff’s expert testifi ed that Roche’s label advising that Accutane was “temporally associated” with IBD was inadequate, one of plaintiff’s prescribing physicians testifi ed that he understood this meant that there was at least a possibility of a causal relationship between the medication and IBD, and that he would have prescribed Accutane even had Roche specifi cally warned that it could cause IBD. Plaintiff’s other physician did not rely on the label in prescribing Accutane to the plaintiff, so the content of the label was irrelevant to him.  

Applying Florida’s learned intermediary doctrine, the appellate court determined that the trial court erred and should have granted Roche a directed verdict. In so holding, the Florida appellate court noted that a drug manufacturer’s duty to warn is satisfi ed upon showing that it gave an adequate warning to the prescribing physician that enabled the prescribing physician to make an informed judgment. Id. at 823. Indeed, the learned intermediary doctrine – which is universally applied throughout the country – is premised on the theory that a physician acts as a fi lter in determining which prescription drug manufacturer instructions and information are communicated to the patient. See Buckner v. Allergan Pharm., Inc., 400 So. 2d 820, 822 (Fla. Dist. Ct. App. 5th Dist. 1981). Because one of plaintiff’s prescribing physicians understood that there was at least the possibility of a causal relationship between the medication and IBD and still would have prescribed it to the plaintiff even had the warning been stronger, the Florida appellate court found that plaintiff failed to establish proximate cause on the failure to warn claim and that the trial court erred in denying Roche’s motion for a directed verdict should have been granted.  

The New Jersey Trial Case

While Mason was still pending appeal in Florida, the consolidated trial of three Florida plaintiffs, who similarly claimed that they developed IBD from Accutane use, commenced in New Jersey before the Honorable Carol E. Higbee. The court applied Florida law. After the jury awarded three plaintiffs’ verdicts totaling in excess of $12 million, Roche moved for JNOV which was denied. Shortly thereafter, the Mason appeal was decided in Florida. Armed with the new Florida decision, Roche moved for reconsideration. Mace v. Hoffmann-La Roche, Inc., Docket No. ATL-L-199-05, slip op. (N.J. Sup. Ct. Law Div. Mar. 16, 2010).

Roche presented Judge Higbee with the testimony of plaintiffs’ prescribing physicians showing that they were aware of the potential risk of IBD from Accutane use, but nevertheless would still have prescribed the medication to each plaintiff. Roche argued that given these facts, and the recent Mason decision in Florida, plaintiffs could not demonstrate proximate cause, and therefore a directed verdict in Roche’s favor was warranted under Florida law.

The New Jersey trial court rejected Roche’s arguments, fi nding the Mason appellate decision inapplicable and non-binding for several reasons. First, Judge Higbee observed that the adequacy of a warning to a prescribing physician was a jury issue (and the court noted that every jury deciding the issue found Roche’s warning inadequate). Id. at 5. Second, the Mason decision did not address the informed consent aspect of proximate causation – the patient, after receiving the prescribing physician’s warning, would have the right to refuse taking the medication. Id. at 6.  

The New Jersey trial court also went beyond the four corners of the Mason decision to support its denial of Roche’s JNOV motion. It cited trial testimony suggesting that the prescribing physician did not believe that the Accutane label advising of a temporal association between Accutane and IBD meant that Accutane caused IBD, that the prescribing physician did not dispute plaintiff’s testimony that he was never informed about IBD risks, and that had the prescribing physician known about Accutane potentially causing IBD, he would have informed the plaintiff of such risk. Id. at 7-8.  

The New Jersey trial court then addressed its obligation to follow the law enunciated by the Florida appellate court, which it was presumably bound to follow. Judge Higbee concluded that the Mason decision was not binding because it was an abrogation of Florida law and in confl ict with other Florida appellate decisions that recognized a patient’s right to make an informed decision. Id. at 10. Judge Higbee also noted that the Florida appellate judges erred by failing to review all of the trial evidence, which was required in a de novo review of a denial of a motion for directed verdict. Id. at 12. Judge Higbee further indicated that because proximate cause is always a fact sensitive analysis, the Florida appellate decision could not be used to upset the fi ndings of the New Jersey jury that Roche’s warnings were inadequate. Id. at 13. Finally, the New Jersey trial court speculated that in light of the importance of proximate cause, and the brevity of the per curiam appellate decision, the Florida appellate judges likely did not intend their decision to have precedential value. Id. at 12.  

What Does This Mean?

Although Roche has appealed the New Jersey trial court’s decision, pharmaceutical manufacturers trying cases in Florida and New Jersey, particularly when it comes to the application of the learned intermediary doctrine, may be faced with drastically different results.  

To succeed in Florida, pursuant to Mason, a pharmaceutical manufacturer defendant need only show that either: (i) it provided an adequate warning to the prescribing physician; or (ii) notwithstanding the warning provided (or the warning proposed by plaintiffs’ experts), the doctor would have prescribed the medication to the plaintiff anyway. Put another way, if the prescribing physician testifi es that he would prescribe the medication regardless of the strength of the manufacturer’s warning, a defendant will be able to move for a directed verdict because any alleged inadequate warning was not a substantial factor or proximate cause of plaintiff’s injury. Mason, 20 So. 3d at 77-78.  

By contrast, in New Jersey, pharmaceutical manufacturer defendants may face a much higher standard. While the Mace decision arguably only interpreted Florida law, one cannot help but wonder whether Judge Higbee will apply her analysis to cases governed by New Jersey law since the learned intermediary doctrines of New Jersey and Florida are the same. The Mace decision confl ates a pharmaceutical manufacturer’s duty to adequately warn physicians, as opposed to patients, with the physician’s independent duty to obtain the informed consent of patients. Under the Mace decision, a pharmaceutical manufacturer’s duty to provide adequate warnings is only discharged if the physician understands the seriousness of the risks communicated by the warnings and relays those risks to the patient in such a way that enables the patient to make an informed decision whether to take the medication. Thus, pharmaceutical manufacturers may not be able to rely on the learned intermediary doctrine in cases where physicians understood and considered the potential risks, but did not adequately obtain the informed consent of their patients.

Because Roche, joined by amicus fi lings of the generic Accutane manufacturers, has appealed the Mace decision, the fi nal word on New Jersey’s learned intermediary doctrine has not yet been spoken. It remains to be seen whether Judge Higbee’s interpretation and application of the learned intermediary doctrine becomes the new law in New Jersey.