Accutane Lawsuits: The Importance of the Statute of Limitations

Newark, NJWhen it comes to lawsuits involving Accutane side effects, which include a risk of Accutane inflammatory bowel disease, the statute of limitations is a highly-contentious issue. One lawsuit, however, recently dealt with the issue of Accutane acne medication statute of limitations, opening the door for more Accutane medication lawsuits to be filed.

The plaintiff was a 12-year-old girl who started taking Accutane in 1997 for cystic and scarring acne that did not resolve after treatment with antibiotics. At the time she was prescribed Accutane, she was reportedly not warned about the risk of developing inflammatory bowel disease but she was given a copy of the patient brochure, which included a warning that patients should be aware of severe stomach pain, diarrhea and rectal bleeding. Furthermore, the warning stated that patients should discontinue Accutane if they experience those symptoms.

According to court documents, the patient took four courses of Accutane treatment from January 13, 1997 through September 1998. Around April 1998, the patient began experiencing abdominal pain and in April 1999, she was hospitalized for severe bloody diarrhea, abdominal pain and cramping. The plaintiff was then diagnosed with severe ulcerative colitis.

On December 11, 2000, the plaintiff was again put on a course of Accutane treatment, with no warnings from the doctors involved that Accutane could have caused her IBD (the doctor testified that he did not believe there was a significant risk of developing IBD from use of Accutane). At that time, she did not suffer further gastrointestinal effects.

After one more course of treatment with Accutane, the patient's gastrointestinal problems grew worse, to the point that she often had "fifteen to twenty bloody bowel movements a day." At the age of 21, she underwent a proctocolectomy to remove her entire colon and rectum. Six weeks later, her intestine was placed back in her abdominal cavity, but she continued to suffer serious side effects, including having 30 to 40 bowel movements some days.

In her lawsuit, the plaintiff alleged that if she had known Accutane could cause or worsen her IBD, she would not have taken it. Furthermore, she alleged that although the materials regarding Accutane listed symptoms of IBD, such as rectal bleeding, it did not reference IBD directly and none of her physicians warned her of the risk.

In January 2004, the patient reportedly learned about the link between Accutane and IBD.

In the initial lawsuit, the plaintiff was awarded $10.5 million plus approximately $80,000 in medical expenses. Hoffman-La Roche (maker of Accutane) appealed the lawsuit, arguing that the statute of limitations had run out prior to the plaintiff's lawsuit being filed, which barred her from filing the lawsuit.

At issue is whether the statute of limitations was running from the time the warning label for Accutane included the risk of gastrointestinal problems or whether it started running when the patient became aware that her IBD could have been caused by Accutane.

According to the court's decision, the statute of limitations does not run if the injured person is reasonably unaware that they have been injured or, if they are aware of the injury, do not know that the injury is the fault of someone else. In other words, the statute of limitations begins to run when the patient knows she is injured and either knows or should have known that her injury was caused by the drug maker.

The question then becomes whether the warning given on the medication guide for patients was strong enough that the patient should have been aware of the risk of IBD. The judge found that the documents given to the plaintiff focused mainly on the risk of birth defects and not abdominal problems. Furthermore, of the 3,000 words typed in the first section of a brochure about Accutane, only 80 related to gastrointestinal side effects. Finally, the consent forms signed by the patients focused only on birth defects and suicide, not IBD or bowel problems.

What this means for patients who took Accutane is that they may not yet be barred from filing a lawsuit because the statute of limitations began to run when they became aware of their injury and when they should reasonably have been aware that Accutane could have caused that injury. For some people, this is not necessarily when the warning label was updated, but when they started learning of Accutane lawsuits and allegations of serious side effects.