Horrible Ending to Clinical Drug Trial
HARTFORD (CN) - An experimental cancer drug gave a patient in a clinical trial an incurable, debilitating brain infection, the woman claims in court.
Mary Ellen Gatti, who suffered from chronic lymphocytic leukemia, participated in a clinical trial of the drug Rituximab.
The drug is made by San Francisco-based Genentech, a member of the Roche group. It has been on the market since 1997.
Rituximab can cause serious side effects that sometimes lead to death, Gatti and her husband claim in their July 2 Petition for Leave to Take Pre-Complaint Deposition of Mary Ellen Gatti, in Superior Court.
Progressive multifocal leukoencephalopathy (PML), a serious brain infection caused by a virus, is one such side effect listed in Genetech's prospectus for the drug, according to the petition. The infection damages nerves in the brain and spinal cord, leading to severe cognitive impairment, loss of voluntary movement, and eventually death.
Gatti says she developed the infection while participating in the trial.
She and her husband claim the Hartford-based hospital that enrolled Gatti in the trial, defendant St. Francis Hospital and Medical Center, did not warn her that participants could develop PML, an untreatable condition.
Gatti's memory and comprehension are deteriorating rapidly, and her death is imminent, according to the petition.
The Gattis plan to sue the hospital and two oncologists for medical and research malpractice, assault and battery, lack of informed consent, fiduciary duty, and fraud/intentional misrepresentation. They will also bring product liability and negligence claims against Genentech and the review board that approved the clinical trial, according to the petition.
The couple asked the court to expedite Gatti's deposition, claiming her condition, including her ability to understand and answer questions, is rapidly deteriorating.
They say Gatti may be the only source of information about her knowledge of the risks and her injuries.
The Gattis are represented by Suzanne Gatti with Gatti-Foz of Huntington Beach, Calif., and Bruce Luckman with Sherman, Silverstein, Kohl, Rose & Podolsky, of Moorestown, N.J.