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Untimely Accutane Product Liability Claims; Ulcerative Colitis


Accutane (isotretinoin) may cause inflammatory bowel disease (IBD), a chronic disease that primarily manifests as one of two diseases, Crohn’s disease or ulcerative colitis. Ulcerative colitis primarily involves inflammation of the lining of the colon (large intestine). The peak onset of IBD occurs during adolescence – the same period during which individuals are likely to take Accutane. Both forms of IBD share the same core symptoms including abdominal pain, frequent and often bloody bowel movements, and rectal bleeding. These symptoms, however, are also associated with other less serious and curable diseases. Although the cause of IBD remains largely unknown, several triggers are associated with a statistically increased rate of IBD, including family history, infections, antibiotics, smoking, and possibly the use of oral contraceptives and nonsteroidal anti-inflammatory drugs.

 

Four patients were prescribed Accutane. All four developed IBD.

 

More than two years after each patient was diagnosed with IBD, each of the four patients brought individual product liability claims against the manufacturers and distributers of Accutane.

 

The manufacturers and distributors of Accutane filed motions to dismiss each of these claims on statute of limitations grounds.

 

The first patient read the FDA-approved warnings that did not specifically refer to IBD or ulcerative colitis, but did state that Accutane’s side effects included abdominal pain, diarrhea, and rectal bleeding. The first patient experienced the first symptoms of IBD, including abdominal pain, diarrhea, and rectal bleeding, approximately two years after the first patient stopped the Accutane treatment. The first patient was diagnosed with ulcerative colitis approximately seven years before filing the complaint.

 

The second and third patients claimed that neither connected ulcerative colitis with Accutane until each patient’s mother told the patient about lawsuits against the makers of Accutane alleging it caused IBD. The second patient testified that the second patient made the connection when the second patients’ mother told the second patient about a lawyer’s advertisement the second patient’s mother saw in a publication. A discovery request was made for all the lawyers’ advertisements pertaining to Accutane and IBD in that publication within two years of when the second patient filed a claim. There were no advertisements that fit that description. The third patient testified that the third patient made the connection when the third patient’s mother told the third patient about a lawsuit the mother discovered online. The third patient’s mother testified that the mother conducted the online research connecting Accutane and ulcerative colitis when the third patient was first diagnosed with ulcerative colitis, more than two years before the third patient filed a claim.

 

When the fourth patient, a well-educated, twenty-three year old woman began taking Accutane, the fourth patient received a copy of the stronger FDA-approved warnings contained in the 2002 patient binder, unlike the first three patients. Also unlike the first three patients, the fourth patient’s symptoms, specifically rectal bleeding, began during the fourth patient’s treatment with Accutane. Approximately seven years before filing a complaint, the fourth patient told a primary care physician that the fourth patient suspected Accutane might have caused the rectal bleeding. The primary care physician diagnosed the fourth patient at that time with a rectal fissure. The fourth patient’s dermatologist continued the prescription for Accutane. The fourth patient continued to suffer from worsening rectal bleeding for approximately three years. The fourth patient was diagnosed with ulcerative colitis two years after the fourth patient stopped taking Accutane, four years before filing a complaint.

 

The Superior Court of New Jersey, Law Division, Atlantic County, dismissed each of the patients’ claims as time barred under New Jersey’s two year statute of limitations for product liability claims. A product liability action generally accrues on the date of injury. The trial court held that the discovery rule did not apply to toll the statute of limitations because a reasonable person exercising ordinary diligence would have been alerted by the facts presented more than two years prior to these patients filing complaints that the alleged injury was due to Accutane. The trial court concluded that the first patient had reason to know when the first patient was diagnosed with ulcerative colitis, at least seven years prior to filing a claim, that Accutane may have been involved, because the first patient’s symptoms were identical to the symptoms described in the FDA-approved warnings. The trial court concluded that the second and third patients had reason to know when the patients’ mothers told each patient about the connection, more than two years prior to filing each patient’s claim, that Accutane may have been involved in the patients’ ulcerative colitis. The trial court found the persistent symptoms that started while the fourth patient was taking Accutane would have led a reasonable person to conclude very early on that something was wrong and that the something may have been the fourth patient’s ingestion of Accutane.

 

The Appellate Division of the Superior Court of New Jersey affirmed. The court held that a reasonable person in the circumstances of the patients would have been aware, within two years, that the person had been injured by Accutane.

 

A reasonable person in the circumstances of the patients would have been aware, within two years, that the person had been injured by Accutane. In considering whether the discovery rule applies to toll the statute of limitations in a pharmaceutical case, a court must consider the nature of the injury; the availability of witnesses and written evidence; the elapsed time since the alleged wrongdoing; whether the delay was deliberate or intentional; whether the delay peculiarly or unusually prejudiced the defendant; and whether, despite the product’s FDA-approved warnings, a reasonable person in the plaintiff’s circumstances would have been aware, within the prescribed statutory period, that the plaintiff had been injured by the defendants’ product. Regarding the first patient, the court deferred to the trial court’s finding that the patient had reason to know when the first patient was diagnosed with ulcerative colitis, at least seven years prior to filing a claim, that Accutane may have been involved, because the first patient’s symptoms were identical to the symptoms described in the FDA-approved warnings the first patient had read. Regarding the second and third patients, the court deferred to the trial court’s determination that testimony that the patients did not connect IBD to Accutane until the patients’ mothers saw information about lawsuits against the manufacturers of Accutane by people with IBD within two years of filing claims lacked credibility. Regarding the fourth patient, the court found that the trial court’s finding that that the patient failed to sustain the burden of persuasion was supported by evidence that the fourth patient was a well-educated, twenty-three year old when the fourth patient began taking Accutane and suffered gastrointestinal symptoms during treatment. The fourth patient (unlike the other three patients) received a copy of the stronger warnings contained in the 2002 patient binder, which another court had found sufficient to alert a plaintiff of the connection between Accutane and ulcerative colitis. As early as seven years before the fourth patient filed a complaint, the fourth patient expressed to a primary care physician suspicion that Accutane may have caused the fourth patient’s rectal bleeding. The court concluded that that trial court’s findings that each of the patients had failed to sustain the burden of persuasion on the issue of whether a reasonable person in their circumstances would have been aware that the person had been injured by Accutane was entitled to the court’s deference.

 

The Appellate Division of the Superior Court of New Jersey affirmed the trial court’s dismissal of the patients’ claims on the grounds that they were time barred.

 

See: Brecke v. Hoffman-La Roche Inc., 2018 WL 619729 (N.J.Super.A.D., January 30, 2018) (not designated for publication).

 

See also Medical Law Perspectives Report: Gut-Wrenching Pain: Liability Risks Related to Gastrointestinal Disorders

 

See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives Report: Colonoscopy: Scoping the Risks and Liabilities

 

See the Medical Law Perspectives Blog: Jury Instruction in Product Liability Case That Violation of the FDCA is Negligence Per Se; Preemption Considerations

 

 

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