Court Opinion

ID: 7328611
Source: CourtListenerOpinion
Date Created: 2022-07-25 22:05:09.183802+00
Date Added: 2024-06-11T16:20:06.648167
License: Public Domain

Judge WEFING
(temporarily assigned), dissenting.
In New Jersey, actions for personal injuries must be commenced within two years of accrual of the cause of action. N.J.S.A. 2A:14-2. If the individual who wishes to commence such an action was a minor at the time the cause of action accrued, the period of limitations is extended until two years after the date the individual attains majority. N.J.S.A. 2A-.14-21; Green v. Auerbach Chevrolet Corp., 127 N.J. 591, 592-93, 606 A.2d 1093 (1992) (noting that although the Legislature did not amend N.J.S.A. 2A:14-21 at the time it reduced the age of majority from twenty-one to eighteen, the period of limitations within which to com*200menee suit for injuries received as a minor is computed from the individual’s eighteenth birthday).
Plaintiff Kamie Kendall was born on January 28, 1984. Her eighteenth birthday was on January 28, 2002. Her first course of Accutane treatment commenced in January 1997, and her last course commenced in September 2003. Pursuant to N.J.S.A. 2A:14-21, she had until January 28, 2004, to commence suit for any injuries she reasonably attributed to her use of Accutane while a minor.
My colleagues have determined, however, that her complaint, which was not filed until December 21, 2005, was timely. They reach this result by concluding that the various warnings included with Accutane over the period of her use, each of which was approved by the federal Food and Drug Administration (FDA), did not provide adequate warning to plaintiff of the risk of developing ulcerative colitis. Based upon what they perceive to be inadequate FDA-approved warnings, they conclude that plaintiff is entitled to a further tolling of the period of limitations under the discovery rule. See Lopez v. Swyer, 62 N.J. 267, 300 A.2d 563 (1973). I am unable to agree and therefore must dissent.
A review of the facts demonstrates that plaintiff had adequate notice of the risks of receiving Accutane. Plaintiff received her first prescription for Accutane from her treating dermatologist in January 1997 when she was twelve years old. At that time, the patient brochure that accompanied each prescription included the following warnings regarding side-effects of the treatment:
• YOU SHOULD BE AWARE THAT ACCUTANE MAY CAUSE SOME LESS COMMON, BUT MORE SERIOUS SIDE EFFECTS. BE ALERT FOR ANY OF THE FOLLOWING:
• HEADACHES, NAUSEA, VOMITING, BLURRED VISION
• CHANGES IN MOOD
• SEVERE STOMACH PAIN, DIARRHEA, RECTAL BLEEDING
• PERSISTENT FEELING OF DRYNESS OF THE EYES
• YELLOWING OF THE SKIN OR EYES AND/OR DARK URINE
IF YOU EXPERIENCE ANY OF THESE SYMPTOMS OR ANY OTHER UNUSUAL OR SEVERE PROBLEMS, DISCONTINUE TAKING ACCUTANE *201AND CHECK WITH YOUR DOCTOR IMMEDIATELY. THEY MAY BE THE EARLY SIGNS OF MORE SERIOUS SIDE EFFECTS WHICH, IF LEFT UNTREATED, COULD POSSIBLY RESULT IN PERMANENT EFFECTS.
Plaintiff’s physician testified that he gave plaintiff a copy of the brochure when he gave her the first Accutane prescription. Plaintiff signed a consent form acknowledging that she received and read the patient brochure. Those same warnings were repeated on the blister packaging that contained the individual Accutane pills that plaintiff received when she filled the prescription. In addition, the package insert for Accutane included the following statement:
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.
The FDA had approved the contents of the patient brochure, the blister packaging, and the package insert.1
Plaintiff’s treating dermatologist gave her three more prescriptions for Accutane. She took the drug for three separate three-month periods: July to September 1997, February to April 1998, and July to September 1998. On each occasion, when she received the prescription from her physician and when she had it filled at the pharmacy, she received the same FDA-approved warnings. On each of the visits, as she had been on her first, she was accompanied by her mother.
Plaintiff began to suffer abdominal pain in approximately April 1998. In April 1999 she was hospitalized after experiencing a severe ease of bloody diarrhea, abdominal pain, and cramping; and on April 14, 1999, her pediatric gastroenterologist diagnosed her as having severe ulcerative colitis. Thus, by 1999 plaintiff *202suffered symptoms, which were included in the FDA-approved warnings that accompanied her receipt and use of Accutane.
Inflammatory bowel disease is a condition marked by chronic idiopathic inflammation of the small bowel and colon. Stedman’s Medical Dictionary 414 (26th ed. 1995). It traditionally manifests itself as one of two diseases: Crohn’s disease or ulcerative colitis. David B. Sachar & Aaron E. Walfish, Overview of Inflammatory Bowel Disease, The Merck Manual Home Health Handbook, Aug. 2006, http://www.merckmanuals.com/home/digestive_disorders/ inflammatory_bowel_diseases_ibd/overview_of_inflammatory_ bowel_disease.html. The latter involves the chronic inflammation of the inner lining of the colon cells. Sachar & Walfish, Ulcerative Colitis, The Merck Manual, supra, http://www.merckmanuals.com/ home/digestive_disorders/inflammatory_bowel_diseases_ibd/ ulcerative_colitis.html. The symptoms of ulcerative colitis include frequent and often bloody bowel movements accompanied by cramping and abdominal pain, together with other symptoms. Ibid.
In October 2000, plaintiff returned to the physician who was treating her acne condition. He consulted with her pediatric gastroenterologist, who expressed no objection to plaintiff receiving another course of Accutane as long as plaintiffs liver enzymes were monitored. In December 2000, plaintiff began her fifth course of Accutane. By that time, the package insert that accompanied the pills stated:
Inflammatory Bowel Disease: Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately____
The only modification to that portion of the package insert from its previous iteration was the deletion of the word “temporally,” which had preceded the word “associated” in the earlier package inserts. She again received the patient brochure with its various warnings. The pills were again dispensed in a blister package *203that also restated the warnings. All of the warnings had been approved by the FDA.
In August 2003, more than a year and a half after turning eighteen, plaintiff again returned to her treating dermatologist for her acne. He decided to prescribe yet another course of Accutane treatment. By this time, the FDA had directed that the warnings that accompanied a prescription of Accutane be strengthened.
In connection with her 2003 prescription, plaintiff received an expanded patient booklet. It stated in pertinent part:
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 preseriber 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 Aecutane and call your preseriber 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.
Plaintiff signed an acknowledgement that she received and read the information.
In addition, when she went to the pharmacy to have the prescription filled, she received a medication guide for Accutane. It stated in pertinent part:
What are the possible side effects of Accutane?
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 (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your preseriber if you get severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine.
In addition to the various warnings delivered to plaintiff over the course of her Accutane treatment, defendants also delivered *204warnings to physicians prescribing the drug. For example, some years prior to plaintiffs initial prescription, defendants sent a “Dear Doctor” letter to physicians informing them that ten patients who had received Accutane treatment “experienced gastrointestinal disorders characteristic of inflammatory bowel disease.” The letter said that defendants would continue to monitor the matter. In 1998, defendants issued another “Dear Doctor” letter warning dermatologists of the importance of monitoring patients on Accutane for inflammatory bowel disease. Plaintiffs dermatologist received those letters.
Plaintiff suffered symptoms of ulcerative colitis with varying intensity from the time she was initially diagnosed with the disease in 1999. It is characteristic of ulcerative colitis that its symptoms will wax and wane over the course of time. The Merck Manual 307 (17th ed. 1999). She acknowledged that her symptoms intensified after completing a course of treatment with Accutane. Indeed, plaintiffs expert with respect to causation, David B. Sachar, M.D., relied on the fact that her symptoms worsened after several courses of treatment in opining that Accutane was a cause of plaintiffs ulcerative colitis. Plaintiff also acknowledged that her diarrhea worsened with the 2003 treatment. Her symptoms progressively worsened and led to her decision in January 2006 to undergo a proctocolectomy.
In the face of the repeated FDA-approved warnings provided to plaintiff, the warnings provided to her physician, and the intensification of her symptoms, my colleagues have concluded that plaintiff was reasonably unaware by December 21, 2003, two years prior to the filing of her complaint, of a potential link between her ulcerative colitis and her use of Accutane. My colleagues stress that the material she received in 2003 did not use the terms inflammatory bowel disease or ulcerative colitis.
I cannot find that reasoning persuasive for several reasons. The 2003 material, in an effort to be more informative, refrained from diagnostic terms but clearly stated that an individual’s intestines could be damaged and that an individual should stop *205taking the drug if he or she experienced diarrhea or rectal bleeding. Because plaintiff experienced both symptoms, she should have been aware of a potential link. See, e.g., Magistrini v. One Hour Martinizing Dry Cleaning, 109 F.Supp.2d 306, 315 (D.N.J.2000) (holding that manufacturer of dry cleaning solvent was required to warn that the substance was carcinogenic rather than to warn of the risk of contracting a specific form of cancer). Further, plaintiff testified at the Lopez hearing that after receiving the diagnosis of ulcerative colitis in 1999, she engaged in research on the topic and knew that ulcerative colitis was a particular form of inflammatory bowel disease and was a medical term for damage to the bowels.
Plaintiff testified that she “skimmed” the material she received in 2003. At the beginning of the medication guide she received from the pharmacy in 2003, it noted the importance of a patient reviewing the entire document, even if the patient had received an earlier prescription for Accutane because the information may have changed in the interim. Plaintiff should not be relieved of having the information contained in that material imputed to her because she chose not to review it.
Further, I am unable to agree, for purposes of determining whether a complaint has been timely filed, that the statutory presumption contained in N.J.S.A. 2A:58C-4, which presumes FDA-approved labels are adequate, can be overcome by plaintiffs election not to review the material in which the warnings are set forth. Nor can I discern an analytical justification for according the statutory presumption set forth in N.J.S.A. 2A:58C-4 a different weight when the issue is timeliness of the filing of the complaint as opposed to the merits of the claim.
This Court recently recognized that the Legislature enacted N.J.S.A. 2A:58C-4 to “re-balance the law ‘in favor of manufacturers.’ ” Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615, 623, 917 A.2d 767 (2007) (quoting William A. Dreier, N.J. Prods. Liab. & Toxic Torts Law § 15:4 (2007)). One of the underlying purposes of our product liability statute was “ ‘to establish clear rules with *206respect to specific matters as to which the decisions of the courts in New Jersey have created uncertainty.’ ” Id. at 624, 917 A.2d 767 (quoting Senate Judiciary Committee, Statement to Senate Committee Substitute for S.B. No. 2805 at 1 (Mar. 23, 1987)). In my judgment, the approach adopted here by my colleagues does not further either of those legislative objectives.
As I noted at the outset, a cause of action accrues when a plaintiff knows or should know of a state of facts that possibly equates to a cause of action. The determination of when a cause of action accrues is a question of law for the court. Baird v. Am. Med. Optics, 155 N.J. 54, 65, 713 A.2d 1019 (1998) (citing Fernandi v. Strully, 35 N.J. 434, 439, 173 A.2d 277 (1961)). “The discovery rule delays the accrual of a cause of action until ‘the injured party discovers, or by an exercise of reasonable diligence and intelligence should have discovered that he may have a basis for an actionable claim.’ ” Id. at 66, 713 A.2d 1019 (quoting Lopez, supra, 62 N.J. at 272, 300 A.2d 563). Medical certainty linking the harm and its cause is not the fulcrum for the analysis; rather, “reasonable medical information” suffices. Vispisiano v. Ashland Chem. Co., 107 N.J. 416, 435, 527 A.2d 66 (1987). Certainly, all of the FDA-approved material provided to plaintiff has to be considered “reasonable medical information.” Giving plaintiff the most generous reading of the material provided to her, I conclude that she knew or should have known, no later than her August 2003 receipt of yet another prescription for Accutane, of a potential link between her use of the medication and her continuing gastrointestinal problems.
I note that my colleagues “take no position” whether advertisements placed by lawyers in January and April 2004 “should have spurred Kendall to action.” See ante op. at 199, 36 A.3d at 557. Kendall testified that the advertisements caused her to think for the first time that there might be a link between her use of Accutane and her intestinal problems. My colleagues’ omission is entirely understandable in light of the fact that the advertisements *207contained less information than defendants had provided her over the years as she took the medication.
In my judgment, plaintiffs complaint was untimely and should have been dismissed.
For affirmance—Chief Justice RABNER and Justices LONG, LaVECCHIA, ALBIN, and HOENS—5.
For reversal—Judge WEFING (temporarily assigned)—1.
Not Participating—Justice PATTERSON—1.

 It is not immediately apparent from the record whether plaintiff received a package insert each time she had her prescriptions filled. There are two categories of package inserts: physician package inserts and patient package inserts. The examples conlained in the record are not identified as to which category they belong.