Court Holds That Manufacturer's Post-April 2002 Labeling Is Adequate as a Matter of Law

In an opinion issued on April 2, 2015, the Honorable Nelson C. Johnson, JSC, granted the motion of defendants Hoffmann-LaRoche, Inc. and Roche Laboratories, Inc. for summary judgment in the In re Accutane Multicounty (mass tort) Litigation (MCL) on the grounds that the defendants' post-April 2002 warnings for the prescription medication Accutane (isotretinoin) are adequate as a matter of law. The ruling, based on the New Jersey Products Liability Act, N.J.S.A. § 2A-58C (NJPLA), is dispositive of hundreds of Accutane products liability cases filed by New Jersey plaintiffs who started taking the medication after April 2002, and will also likely impact thousands of Accutane plaintiffs from other states with products liability laws similar to New Jersey's. Additionally, the decision reinforces and clarifies existing New Jersey products liability law with respect to the presumption of adequacy of FDA-approved labeling of prescription drugs under the NJPLA.

The court framed the question presented under the NJPLA as "taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician," regarding whether the warnings communicated adequate information that inflammatory bowel disease (IBD) was a risk associated with Accutane use. Before addressing the merits, the court reviewed the pertinent procedural history, in which the prior mass tort judge assigned to these consolidated cases had considered the adequacy of post-April 10, 2002 warnings.

After reviewing the five prior motions in which the adequacy of the warnings previously had been addressed, Judge Johnson determined that the law-of-the-case doctrine did not control disposition of Roche's current motion because "new facts and law eclipse the record on which prior rulings were based." As Judge Johnson noted in his decision, the prior judge did not have the benefit of Bailey v. Wyeth, Inc., 424 N.J. Super. 278 (Law Div. 2008), which granted summary judgment on plaintiffs' NJPLA claims because plaintiffs did not provide specific evidence necessary to overcome the rebuttable presumption of adequacy under the NJPLA of the FDA-approved labeling on the hormone replacement therapy products at issue. Specifically, the Bailey court found that N.J.R.E. 301 (which governs presumptions under the law of evidence) does not address the plaintiffs' substantive burden for overcoming the rebuttable presumption under the NJPLA, and was affirmed on appeal as "legally unassailable" in DeBoard v. Wyeth, Inc., 422 N.J. Super. 360, 362 (App. Div. 2011) certif. denied, 211 N.J. 274 (2012). Bailey and DeBoard are "new controlling authority" in the case, as Judge Johnson concluded.

Moving to the merits, the court reviewed the standard for liability for failure to warn by a prescription drug manufacturer under the NJPLA. A manufacturer that communicates adequate information on the risks of a prescription drug, "taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician," is not liable under the NJPLA on a failure-to-warn claim. Further, a rebuttable presumption arises under the NJPLA that the warning or instruction is adequate where the warning or instruction provided has been approved or required by the U.S. Food and Drug Administration (FDA). While the adequacy of a product warning is typically a jury issue, the court explained that this principle "is not a rigid mantra, to be applied inexorably in all situations and contexts," and that adequacy may be determined as a matter of law.

The court then reviewed the warnings contained in the Accutane documentation provided to prescribing physicians, pharmacists and to patients also in January 2002, including a "Guide to Best Practices" (provided to prescribing physicians); the package insert (also provided to prescribing physicians); the medication guide (provided by pharmacists to patients each time an Accutane prescription was dispensed); patient brochures (provided to physicians for distribution to patients); and the blister packaging (from which patients removed their Accutane pills). The court found that this extensive labeling—no less than five separate documents associated with the product—warned of the precise risk of harm alleged in the case: inflammatory bowel disease (IBD).

Following its findings of facts, the court's legal analysis started with a discussion of the roles of the FDA and manufacturers in crafting appropriate prescription drug labels, and the learned intermediary doctrine. The court explained that "under the statutory and regulatory scheme by which new pharmaceutical products enter the marketplace, the FDA is the gatekeeper … empowered to initially assess all new medications," and alone is given authority to approve the labels by which medications are presented to consumers. Under the learned intermediary doctrine, prescribing physicians are considered those to whom the drug's warnings need to be addressed.

Given its unique and significant role in the approval of prescription medicines, the court found that the FDA's review and ultimate approval of prescription drug labeling is entitled to a strong presumption of adequacy. This is the public policy in New Jersey, which has expressed in the NJPLA its "special concern for an industry with significant relationship to New Jersey's economy and public health." Therefore, as a matter of New Jersey substantive law, where the FDA has approved product labeling, it will be deemed presumptively valid and not subject to attack in a products liability lawsuit without specific evidence of conduct by the defendant pharmaceutical manufacturer that, in effect, undermines the FDA's regulatory process.

The court further explained that New Jersey courts have recognized two narrow exceptions to the NJPLA's statutory presumption of adequacy—both of which require specific types of evidence, and neither of which was presented in the case. Under Perez v. Wyeth, 161 N.J. 1, 24 (1999), and Rowe v. Hoffmann-LaRoche, 189 N.J. 615, 626 (2007), the presumption may be overcome by evidence of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects of the drug. Under McDarby v Merck, 401 N.J. Super. 10, 63 (2008), the presumption may also be overcome by the defendant's "economically-driven manipulation of the post-market regulatory process." Judge Johnson ruled that based upon the PLA's express language and the New Jersey precedent, a drug's FDA approved warnings will not be rebutted without this kind of evidence.

Judge Johnson held that such evidence was completely absent in the Accutane cases. Rather, all of the literature and documents relating to the drug conveyed what the court described as "a very forceful seriousness of purpose" and an "unmistakable" message about the potential risks and consequences of prescribing the drug. Summarizing, the court stated:

"It is inconceivable to this court that the reasonable dermatologist (or any physician, generally) of ordinary education, training and experience could examine the materials comprising the warning literature and not immediately conclude that Accutane has been associated with life-altering side effects, including IBD."

Not only did all of the product packaging and labeling warn of the risk of IBD, but the court also found it relevant that FDA approval of the same labeling continues to this day, pointing to the Absorica label, an isotretinoin product that was approved by the FDA in May 2012 with the identical warning language on the package insert regarding IBD.

In sum, Judge Johnson's ruling appears to strike a stiff blow to the Accutane plaintiffs. It immediately impacts all of the New Jersey cases involving post-April 2002 warnings, and will likely impact most of the cases filed by plaintiffs from other states. The court requested submissions regarding: (1) all of the cases involving post-April 2002 warnings and identification of the state of the plaintiff involved in each case; (2) those jurisdictions that recognize the learned intermediary doctrine and permit the adequacy of drug labeling to be determined as a matter of law; and (3) those jurisdictions with a heavier burden of proof than New Jersey. Similar to New Jersey law, virtually all states recognize the learned intermediary doctrine in prescription drug products liability cases and some have statutes as demanding as the NJPLA for FDA-approved drugs. As a result, it appears likely that this ruling will result in the dismissal of a substantial number of the approximately 6,700 pending Accutane cases in the New Jersey Accutane MCL.

The court's ruling that the post-April 2002 Accutane labeling is adequate as a matter of law is entirely consistent with a decision several years ago of a federal district judge in the Middle District of Florida supervising the Accutane/Isotretinoin Multi-District Litigation, or MDL, who also concluded that Accutane's post-2000 warnings are adequate as a matter of law.

Accutane (isotretinoin) is among the most highly regulated drugs in the United States. Its labeling is extensive, as the court found in its careful analysis of the record before it. The ruling in In re Accutane is consistent with the express language and legislative history underlying the NJPLA, which was to provide substantive protection to pharmaceutical manufacturers that comply with applicable FDA requirements regarding product labeling. This is accomplished by interpreting the NJPLA's presumption of adequacy as a substantive—and not merely procedural—requirement of New Jersey law, and mandating that a plaintiff demonstrate by a preponderance of the evidence the factors articulated in Perez, Rowe and McDarby in order to rebut and overcome the statutory presumption of adequacy given to FDA-approved drug labeling in New Jersey.