On certification from the Superior Court, Appellate Division.
The opinion of the court was delivered by: Justice Long
(This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for the convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please note that, in the interests of brevity, portions of any opinion may not have been summarized.)
Kamie S. Kendall v. Hoffman-LaRoche, Inc., et al.
Decided February 27, 2012
LONG, J., writing for a majority of the Court.
The Court considers whether plaintiff Kamie Kendall's lawsuit against the developers and marketers of the prescription drug Accutane (collectively, Hoffman-LaRoche), was barred by the two-year statute of limitations.
Accutane is used to treat nodular acne. Its many side effects include dry skin, lips and eyes and a high risk of birth defects if taken while pregnant. This case concerns Accutane's alleged propensity to cause inflammatory bowel disease (IBD), including ulcerative colitis, which is characterized by frequent and often bloody bowel movements, pain, and other symptoms. The symptoms wax and wane, but the condition is permanent. When the FDA approved Accutane in 1982, it did not require a warning of possible gastrointestinal side effects such as IBD.
Kendall was first prescribed Accutane in January 1997, when she was twelve years old. By that time, the information provided to physicians began to warn of a possible link between Accutane and IBD. The information provided to patients warned to stop taking the drug and consult a doctor if stomach pain, diarrhea and rectal bleeding occurred. In 1998 and 2000, the physician warnings were strengthened with regard to IBD. In 2003, the warnings provided to patients also were strengthened. These included a brochure that focused on the dangers relating to pregnancy, but also warned about "abdomen (stomach area) problems" and damages to the "liver, pancreas, bowels (intestines), and esophagus." It advised patients to stop taking the drug and call a physician if they developed symptoms that included stomach, chest or bowel pain or diarrhea. Patients also were required to sign a consent form and watch a video about contraception. The 2003 warnings did not mention IBD or ulcerative colitis by name.
When Kendall was first prescribed Accutane, her doctor did not mention the risk of IBD because he was not aware of it. Although the patient brochure Kendall was provided warned to be on the alert for stomach pain, diarrhea and rectal bleeding, she did not experience any gastrointestinal side effects. During three additional courses of Accutane--July to September 1997, February to April 1998, and July to September 1998-Kendall also had no gastrointestinal symptoms. However, in April 1999, at a time when she was not taking Accutane, Kendall was hospitalized for bloody diarrhea and abdominal pain and was diagnosed with ulcerative colitis. Although the doctor did not identify a cause, hospital records indicated that Kendall's grandmother also had the disease. Thereafter, Kendall took medication for the condition, and the symptoms disappeared and reappeared frequently, as is usual.
In December 2000, Kendall was again prescribed Accutane after her dermatologist consulted with her gastroenterologist, who had no objection. Kendall did not experience any gastrointestinal side effects. In September 2003, Kendall was prescribed her sixth course of Accutane, which she took until January 2004. She was given the 2003 warnings and signed the consent form agreeing that she had read and understood them and had watched the video on contraception. Kendall later testified that she skimmed over the warnings because she had taken the drug before. This time Kendall had increased diarrhea. In January 2004, Kendall saw a magazine advertisement that listed the risks associated with Accutane, including IBD, and began to think that it may have caused her IBD. In April 2004, Kendall's grandmother told her about a lawyer's advertisement linking Accutane to IBD.
On December 21, 2005, Kendall filed this lawsuit, alleging that Hoffman-LaRoche was liable because the warnings were inadequate by failing to disclose the risk of developing IBD. Hoffman-LaRoche moved to dismiss the lawsuit, asserting that the statute of limitations had expired. The trial court scheduled a hearing to determine whether Kendall had filed her complaint within the two-year statutory period for personal injury actions, pursuant to N.J.S.A. 2A:14-2(a). After the hearing, the judge denied the motion to dismiss. He noted Kendall's age at the time she began taking Accutane, the fact that her doctor prescribed it even after she was diagnosed with IBD, and the fact that the 2003 warnings focused primarily on preventing pregnancy and suicide. The judge concluded that by December 2003, Kendall did not know that her ulcerative colitis was caused by Accutane and that a reasonable person in her circumstances would not have known, therefore the suit was timely. After a trial, the jury found in favor of Kendall.
The Appellate Division panel remanded the case for a new trial on a different issue, but affirmed the trial court's decision on the statute of limitations. In ruling, the panel considered whether the presumption of adequacy of an FDA-approved warning, as provided in the Product Liability Act (PLA), N.J.S.A. 2A:58C-1 to -11, governs the statute of limitations issue. The panel concluded that if the warnings are presumed sufficient to place an adult consumer on reasonable notice of a drug's risks, they bear on what the consumer reasonably should have known about potential side effects for the purpose of contemplating filing a lawsuit. The panel determined, therefore, that to survive dismissal based on the statute of limitations, a trial court should find that the policies underlying the presumption of adequacy are outweighed by the particular circumstances presented and that the plaintiff has a reasonable basis for overcoming the presumption. The panel found that permitting Kendall's case to go forward did not undermine the policies underlying the presumption because her failure to file a lawsuit earlier was not unreasonable under the circumstances. The Supreme Court granted certification on the issue of the timeliness of Kendall's complaint. 205 N.J. 99 (2011).
HELD: Because a reasonable person in plaintiff Kamie Kendall's situation would not have known by December 2003 of the relationship between Accutane and ulcerative colitis, her December 2005 lawsuit against the defendant developers and marketers of the drug was timely.
1. Statutes of limitations place a time limit on when lawsuits may be filed to penalize dilatoriness and serve as a means of repose. The discovery rule balances the need to protect injured persons against the injustice of compelling a defendant to defend against a stale claim. It postpones the accrual date of a cause of action if the plaintiff is unaware either that he has been injured or that the injury is due to the fault of an identifiable individual or entity. Knowledge of fault and injury may occur simultaneously, but where the relationship between them is not self-evident, a plaintiff can invoke the discovery rule if he establishes that a reasonable person in those circumstances would not have been aware within the statutory period that he was injured through the fault of another. (pp. 19-25)
2. Under the common law, a product may be defective due to a failure to warn or an inadequate warning. In enacting the PLA, the Legislature intended to reduce the lawsuit-related burden on manufacturers of FDA-approved products. In part, the PLA provides that if a warning has been approved by the FDA, a presumption arises that the warning was adequate. Although nothing in the PLA suggests that the Legislature intended to alter New Jersey's long-standing discovery rule jurisprudence, it could be argued that the legislative desire to lessen a manufacturer's potential liability for using an FDA-sanctioned warning would extend to protecting it from defending belatedly-filed lawsuits. Therefore, a judge considering the timeliness of a lawsuit alleging a failure to warn may consider the PLA's presumption of adequacy, but the presumption is not conclusive and can be overcome by evidence. Ultimately, the burden remains on the plaintiff to show that a reasonable person in her circumstances would not have been aware, within the prescribed statutory period, that she had been injured by a defendant's product. (pp 25-31)
3. Kendall's lawsuit may proceed because the evidence overcame the presumption and established that Kendall reasonably was unaware that Hoffman-LaRoche caused her injury until after December 21, 2003. When Kendall was first prescribed Accutane, her dermatologist did not warn about IBD because he was not aware of the risk. Kendall took four courses of the drug from 1997 through 1998 with no gastrointestinal symptoms. When Kendall later developed ulcerative colitis, a disease that waxes and wanes, her gastroenterologist did not know of a connection between ulcerative colitis and Accutane. In 2000, her dermatologist consulted her gastroenterologist and they agreed she could be prescribed Accutane. Again, she did not experience gastrointestinal effects. While on her sixth course of Accutane, September 2003 to January 2004, she experienced some increased diarrhea. Kendall, who the trial judge found credible, said that her doctors never advised her not to take Accutane or of the risk of IBD or she would not have taken the drug. The 2003 warning focused on pregnancy and suicide and, although it advised to stop taking the drug if certain symptoms occurred, neither the warning nor the consent form mentioned IBD or colitis. In fact, Kendall never received a warning that specifically mentioned IBD or ulcerative colitis. In these circumstances, the warnings were not sufficient to cause Kendall to disregard six years of physician advice, particularly in light of the lack of a discernable link between her symptoms and her ingestion of the drug. (pp. 31-33)
The judgment of the Appellate Division is AFFIRMED.
JUDGE WEFING (temporarily assigned), DISSENTING, is of the opinion that the warnings sufficiently advised of the risk, but because Kendall was a minor when she was diagnosed with ulcerative colitis, she was permitted two years beyond her eighteenth birthday, which occurred on January 28, 2002, to file the complaint; therefore her December 2005 complaint was time barred.
CHIEF JUSTICE RABNER and JUSTICES LaVECCHIA, ALBIN, and HOENS join in JUSTICE LONG's opinion. JUDGE WEFING (temporarily assigned), filed a separate, dissenting opinion. JUSTICE PATTERSON did not participate.
JUSTICE LONG delivered the opinion of the Court.
On December 21, 2005, plaintiff Kamie Kendall filed suit against
Hoffman-LaRoche, Inc., Roche Laboratories, Inc., F. Hoffman-LaRoche
Ltd., and Roche Holding, Ltd. (defendants), for injuries that
allegedly resulted from her use of Accutane, a drug produced and
marketed by defendants. Defendants moved to dismiss the action as
untimely. The trial judge conducted a Lopez hearing*fn1
and ruled that Kendall's claim was not time-barred; her delay
was reasonable under the circumstances.
A subsequent jury trial resulted in a large award to Kendall. Defendants appealed, challenging a number of the evidential rulings at trial and again arguing that the suit was barred by the statute of limitations. The Appellate Division declared the action timely, but reversed the award on other grounds. On certification, the sole issue before us is whether Kendall's action is time-barred.
The case requires us to revisit our discovery rule jurisprudence and to assess the place, if any, of the Product Liability Act (PLA), N.J.S.A. 2A:58C-1 to -11, in determining whether to countenance a filing delay. In particular, we are asked to decide if the presumption of adequacy of a Food and Drug Administration (FDA)-approved warning, provided in N.J.S.A. 2A:58C-4, affects the application of the discovery rule.*fn2
Although that presumption is not a perfect fit for a statute of limitations analysis, we have concluded, as did the Appellate Division, that it cannot be totally ignored where the question is what a reasonable person knew or should have known about the risks of a product for discovery rule purposes. However, in the discovery rule setting, the presumption is not dispositive but may be overcome by evidence that tends to disprove the presumed fact.
With that consideration in place, we are satisfied, as were the trial judge and the Appellate Division, that Kendall reasonably did not appreciate by December 21, 2003, that Accutane had caused or exacerbated her condition and that, therefore, her filing on December 21, 2005, was timely.
The relevant facts are basically uncontroverted.
A. Accutane Accutane, the brand name for isotretinoin, is a prescription drug developed and marketed by defendants.*fn3
Physicians' Desk Reference 2848 (59th ed. 2005). The drug is a retinoid, derived from vitamin A, that is used to treat recalcitrant nodular acne that has not responded to other regimens. Id. at 2849. Nodular acne is a condition marked by an accumulation of sebum under the skin, which ultimately ruptures the follicle wall and forms an inflamed nodule. John S. Strauss & Diane M. Thiboutot, Diseases of the Sebaceous Glands, in Fitzpatrick's Dermatology in General Medicine 771-73 (Irwin M. Freedberg et al. eds., 5th ed. 1999). Although much remains unknown about how Accutane treats acne, the drug appears to reduce the production of oil and waxy material in the sebaceous glands. Physicians' Desk Reference, supra, at 2849.
Accutane has a number of known side effects, including dry lips, skin and eyes; conjunctivitis; decreased night vision; muscle and joint aches; elevated triglycerides; and a high risk of birth defects if a woman ingests the drug while pregnant. Id. at 2848-49. This case concerns the effect of Accutane on the digestive tract and, in particular, the alleged propensity of the drug to cause inflammatory bowel disease (IBD).
IBD includes several chronic incurable diseases characterized by inflammation of the intestine. Mark Feldman, Lawrence S. Friedman, & Marvin H. Sleisenger, Sleisenger & Fordtran's Gastrointestinal and Liver Disease 2005 (7th ed. 2002). It traditionally manifests as one of two diseases: Crohn's disease or ulcerative colitis. Ibid. Ulcerative colitis, Kendall's diagnosed condition, involves a chronic condition characterized by ulceration of the colon and rectum. Id. at 2039. Individuals suffering from ulcerative colitis experience frequent and often bloody bowel movements. Id. at 2046-47. Accompanying those bowel movements are fatigue, dehydration, anemia, cramping, abdominal pain, and bloating. Ibid.; William S. Haubrich, Fenton Schaffner, and J. Edward Berk, Bockus Gastroenterology 1338 (5th ed. 1995). The symptoms often wax and wane, but the condition is regarded as permanent. The Merck Manual 307 (17th ed. 1999).
The causes of IBD are unclear. Sleisenger & Fordtran's Gastrointestinal and Liver Disease, supra, at 2039. The peak onset of IBD is young adulthood. Id. at 2040. Statistically, it has been linked with family history, prior infections, frequent use of antibiotics, and possibly to use of contraceptives and nonsteroidal anti-inflammatory drugs. Id. at 2009, 2040, 2041; Bockus Gastroenterology, supra, at 1355.
By way of background, in 1982 the FDA approved the use of Accutane and did not require a label warning of possible gastrointestinal side effects. In 1983 and 1984, defendants revised the warnings on the Accutane label, provided to physicians, to indicate that "[t]he following reactions have been reported in less than 1% of patients and may bear no relationship to therapy . . . inflammatory bowel disease (including regional ileitis), [and] mild gastrointestinal bleeding. . . ."
In 1984, defendants issued a "Dear Doctor" letter to prescribing physicians, which explained that:
Ten Accutane patients have experienced gastrointestinal disorders characteristic of inflammatory bowel disease (including 4 ileitis and 6 colitis). While these disorders have been temporally associated with Accutane administration, i.e., they occurred while patients were taking the drug, a precise cause and effect relationship has not been shown. [Defendants are] . . . continuing to monitor adverse experiences in an effort to determine the relationship between Accutane . . . and these disorders. [(Emphasis added).]
At that time, defendants also amended the warning section of the Accutane package insert provided to physicians. Specifically, the revised physician's insert included:
Inflammatory Bowel Disease: Accutane has been temporally associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately. [(Emphasis added).]
That warning remained in effect until 2000.
In 1994, defendants issued a patient brochure that warned, among other things, that "ACCUTANE MAY CAUSE SOME LESS COMMON, BUT MORE SERIOUS SIDE EFFECTS" and that patients should "BE ALERT FOR . . . SEVERE STOMACH PAIN, DIARRHEA, [AND] RECTAL BLEEDING." Patients who experienced any of those symptoms were advised to "discontinue" Accutane and consult with a doctor. The brochure warned that those symptoms "MAY BE THE EARLY SIGNS OF MORE SERIOUS SIDE EFFECTS WHICH, IF LEFT UNTREATED, COULD POSSIBLY RESULT IN PERMANENT EFFECTS." That patient brochure remained in effect until 1999. The same warning was printed on the blister packaging, which contained the individual Accutane pills.
Defendants issued another "Dear Doctor" letter in August 1998 to board-certified dermatologists warning that patients taking Accutane should be monitored for several serious adverse events, including IBD. In 2000, defendants amended the warnings provided to physicians to remove "temporally" from the 1984 warning and added that the symptoms of IBD "have been reported to persist after Accutane treatment has stopped."
In 2003, defendants again strengthened the warnings accompanying Accutane. The written materials provided to Kendall included a patient brochure presented as a binder entitled "Be Smart, Be Safe, Be Sure." The binder materials primarily focused on the dangers of becoming pregnant while taking Accutane. The binder also contained a warning about gastrointestinal side effects:
You should be aware that certain SERIOUS SIDE EFFECTS have been reported in patients taking Accutane. Serious problems do not happen in most patients. If you experience any of the following side effects or any other unusual or severe problems, stop taking Accutane right away and call your prescriber because they may result in permanent effects.
Abdomen (stomach area) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus . . . . If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bowel pain; have trouble swallowing or painful swallowing; get new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine. [(Emphasis added).]
A similar warning was included on the medication guide provided to Kendall by the pharmacy and on the blister pack.
In addition to those warnings, patients were required to sign a "Patient Information/Consent" form, which stated that the patient had read and understood the written patient information and watched a video about contraception. A second "Informed Consent/Patient Agreement Form" listed several side effects of Accutane, including birth defects and the risk of depression and suicide. None of the 2003 patient warnings mentioned IBD ...