Accompanying those bowel movements are fatigue, dehydration, anemia, cramping, abdominal pain, and bloating. The symptoms often wax and wane, but the condition is regarded as permanent. [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.
Edward Berk, Bockus Gastroenterology 1338 (5th ed.1995). Sleisenger & Fordtran's Gastrointestinal and Liver Disease, supra, at 2039. 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.
Kendall only recalled being warned not to become pregnant. Thomson discussed with Kendall and her mother, he provided Kendall with a copy of the Accutane patient brochure.
As noted, the 1994 brochure, in effect in 1997, warned that patients should be alert for stomach pain, diarrhea, and rectal bleeding, and advised that patients “discontinue” Accutane and consult with a doctor if experiencing any of those symptoms.
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. 65, 67–68 (1981),plaintiff injured her ankle and was operated on by defendant. Included were plaintiff's faith in defendant, his reassurances that the pain and swelling were part of the healing process, and the fact that a physician whom plaintiff later consulted did not suggest defendant's medical negligence until after the statute had run. As those cases reveal, the discovery rule balances the need to protect injured persons unaware that they have a cause of action against the injustice of compelling a defendant to defend against a stale claim.
IBD Diagnosis Seven months later, in April 1999, Kendall experienced a severe case of bloody diarrhea, abdominal pain, and cramping, for which she was hospitalized. Book did not identify a cause for Kendall's colitis, hospital records indicated that Kendall's grandmother also suffered from the disease. Book discussed the use of Accutane with Kendall and her mother. Book did not know of a connection between Accutane and ulcerative colitis, she did not raise that issue with the Kendalls. Kendall was given a copy of the patient brochure, which was the same as that provided in 1997.
On April 14, 1999, Kendall's pediatric gastroenterologist, Dr. To treat her ulcerative colitis, Kendall testified to taking various medications. Again she experienced several side effects, but no diarrhea or other gastrointestinal side effects.
She indicated that the symptoms of IBD disappeared and reappeared frequently, as is often the course of the disease.3. Thus, by 2000, Kendall had taken five courses of Accutane, never experiencing any gastrointestinal symptoms while on the drug.
Additional Accutane Treatments In October 2000, Kendall returned to Dr. Three years later, in August 2003, Kendall returned to Dr. Before that final course of treatment, Kendall received the 2003 warnings, including the “Be Smart, Be Safe, Be Sure” binder.