The recent decision of a New Jersey appeals court to overturn a $10.5 million Accutane lawsuit verdict has drawn attention to the ongoing debate over the effectiveness of drug warning labels.
The reversal is the latest development in a lawsuit filed by Kamie Kendall, who first began taking Accutane in 1997 when she was 13 years old. By the time she was 15, she began experiencing bloody diarrhea and other abnormal gastrointestinal symptoms, which continued for years and eventually led to the surgical removal of her colon.
The crux of Kendall's argument against Roche Pharmaceuticals, the manufacturer of Accutane, was that the company did not do enough to warn her of the risks of severe gastrointestinal problems associated with the medication. Even though Accutane's information label contained a warning that the medication may increase the risk of severe conditions such as inflammatory bowel disease, Kendall claimed the warning was buried in a label that gave more attention to other potential side effects such as birth defects and suicide.
Even though at 19 Kendall signed two informed consent forms stating she had read the patient warning information about Accutane, which included a warning to stop taking the medication if gastrointestinal problems occurred, she testified at trial that she did not finally link her symptoms to Accutane until 2004, when her grandmother saw an ad about the medication's side effects on TV.
At the end of the trial in April 2008, the court ultimately sided with Kendall's argument, awarding her the large sum of $10.5 million in damages. Now that an appeals court has overturned the ruling because of an error regarding barred evidence, the case has been sent back for retrial.
The fight over drug warnings is not expected to die down anytime soon, however. Kendall's lawsuit is just one of many that draw into question the efficacy of warning and disclosure labels. As stricter drug laws require pharmaceutical companies to disclose more and more side effect information, some are questioning whether this information is providing a benefit for patients, or merely overwhelming them with information that is difficult to prioritize and sort out.
In Kendall's case, the jury agreed that she had been so overloaded with warning information that it was understandable that it took her years to recognize Accutane as the cause of her symptoms.
In a Forbes article entitled "Disclosed to Death," author Kai Falkenberg notes the pervasiveness of excessive disclosure in today's world when she states, "consumers are so inundated with verbiage that they become numb."
A 2009 study conducted by researchers at Michigan State University also drew into question the effectiveness of disclosure and warning labels. After recording the amount of time consumers spent looking at different sections on a medication box and asking them to recall specific purchasing information, the researchers found that patients paid much more attention to brand names than warning labels and were often unable to recall a number of key warning statements.
As the debate over drug safety warnings continues to play out in American courtrooms, a number of experts are calling for a deeper evaluation of the role both companies and consumers play in the struggle to determine the benefits and risks of a medication for each individual patient.
Article from DrugWatch.com.