The parents of a deceased patient failed to state a “failure to warn” claim against drugmakers that adequately warned a physician of potential drug side effects
Many defective pharmaceuticals cases are filed in San Francisco and throughout California every year. Many involve “failure to warn” claims in which patients allege that drugmakers failed to warn them of all the potential risks associated with a drug.
An important element in any failure to warn case is causation. A patient has to show a link between their injury and a pharmaceutical company’s failure to disclose the risks and side effects of a particular drug. One recent pharmaceutical product liability case was dismissed because the parents of a deceased patient failed to show that several drugmakers’ alleged failure to warn was linked to their son’s death.
The patient suffered from inflammatory bowel disease and received combination therapy treatments involving the drugs Remicade, Humira and mercaptopurine (also known as 6-mercaptopurine, 6-MP and Purinethol).
The parents alleged that there was evidence that the combination therapy increased the risk that a patient would develop hepatosplenic T-cell lymphoma. Their son did eventually develop hepatosplenic T-cell lymphoma and died, which prompted the pharmaceutical liability lawsuit.
The parents allege that they would have opted for safer alternative forms of treatment had they known about the risk associated with this particular combination of drugs and that the pharmaceutical companies were negligent in failing to warn them of the potential side effects of these drugs.
A court recently dismissed the parents’ case against some of the drugmakers named in the suit because the patient’s doctor testified that he knew of the “nonzero increased risk of malignancies” in connection with Remicade use and that he knew of the risk of malignancies associated with 6-MP and Humira, but still prescribed the medications.
The court concluded that the drugmakers could therefore not be held liable for a failure to warn claim in this case because “no harm could have been caused by failure to warn of a risk already known.” It appears that it was the doctor, and not the drug companies, who failed to warn the parents. It is unclear whether the doctor will in turn face a medical malpractice lawsuit arising out of this case.
Source: Wendell v. Johnson & Johnson, 2011 WL 6291792, U.S. District Court, N.D. California, Dec. 15, 2011