Kendall v. Hoffman-La Roche, Inc.

• Decision Date: 27 February 2012
• Citation: 209 N.J. 173,36 A.3d 541
• Parties: Kamie S. KENDALL, Plaintiff–Respondent, v. HOFFMAN–LA ROCHE, INC., Roche Laboratories, Inc., F. Hoffman–La Roche Ltd., and Roche Holding Ltd., Defendants–Appellants.
• Court: New Jersey Supreme Court

209 N.J. 173

36 A.3d 541

Kamie S. KENDALL, Plaintiff–Respondent,

v.HOFFMAN–LA ROCHE, INC., Roche Laboratories, Inc., F. Hoffman–La Roche Ltd., and Roche Holding Ltd., Defendants–Appellants.

Supreme Court of New Jersey.

Argued Oct. 24, 2011.Decided Feb. 27, 2012.

Paul W. Schmidt, a member of the District of Columbia bar, argued the cause for appellants (Gibbons, Dughi & Hewit, and Covington & Burling, attorneys; Mr. Schmidt, Michelle M. Bufano, Russell L. Hewit, Cranford, and Michael X. Imbroscio, a member of the District of Columbia bar, of counsel; Mr. Schmidt, Ms. Bufano, Mr. Hewit, Mr. Imbroscio and Natalie H. Mantell, Newark, on the briefs).

David R. Buchanan argued the cause for respondent (Seeger Weiss and Hook & Bolton, attorneys; Mr. Buchanan and Michael D. Hook, a member of the Florida bar, on the briefs).

John Zen Jackson, Morristown, submitted a brief on behalf of amicus curiae The Medical Society of New Jersey (McElroy, Deutsch, Mulvaney & Carpenter, attorneys).Michael A. Galpern, Cherry Hill, and Jonathan W. Miller submitted a brief on behalf of amicus curiae New Jersey Association for Justice (Locks Law Firm, attorneys).Stephen C. Matthews submitted a brief on behalf of amici curiae The New Jersey Business and Industry Association, The New Jersey State Chamber of Commerce, and The Commerce and Industry Association of New Jersey (Porzio, Bromberg & Newman, attorneys; Mr. Matthews and Brian P. Sharkey, Morristown, on the brief).Edward J. Fanning, Jr. submitted a brief on behalf of amici curiae The New Jersey Lawsuit Reform Alliance and The Healthcare Institute of New Jersey (McCarter & English, attorneys; Mr. Fanning and David R. Kott of counsel; Mr. Fanning, Mr. Kott and Maritza Braswell, Newark, on the brief).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 ¹ 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.²

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.

I.

The relevant facts are basically uncontroverted.

A. Accutane

Accutane, the brand name for isotretinoin, is a prescription drug developed and marketed by defendants.³ 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).

B. 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.

C. Accutane Labels ⁴

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...