Genentech, Biogen And A ‘Flaccid’ Quadriplegic
1 CommentBy Ed Silverman // August 13th, 2010 // 7:23 am
Earlier this week, a 23-year-old Omaha man filed a lawsuit claiming that Genentech and Biogen failed to warn of the risks involving the use of their Rituxan immunosupressant -and the subsequent damage has transformed him into a “flaccid” quadriplegic who is dependent on a ventilator and requires round-the-clock care. Beyond dramatic images, what makes this case potentially significant is it may be the first product-liability lawsuit to level such charges.
The story begins in 1995, when Jesse Peetz was 11 and diagnosed with thrombotic thrombocytopenia purpura, or TTP. His doctor prescribed Rituxan, which was approved to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis, but not TTP, which is an autoimmune disorder. His lawsuit claims that neither he nor his doctor were aware the drug would make him more susceptible to severe and untreatable infections. And two years later, he developed a near-fatal viral infection.
By 2007, warnings were issued that Rituxan users were “uniquely vulnerable” to community viral infections that could cause “catastrophic injury and death,” according to the lawsuit. Peetz’s lawyer claims the drugmakers knew there would be off-label use and his doctor would not have prescribed Rituxan had he known of the dangers.
“This case explores what happens when pharmaceutical companies dedicate more focus to marketing and sales than to safety,” Maren Chaloupka, Peetz’s lawyer, tells us. “Patients and doctors are forced to trust that pharmaceutical manufacturers will be honest about the risks involved with the drugs being marketed. If the pharmaceutical manufacturers conceal and deceive, the results to the patient can be absolutely devastating.”
This is not the first time, however, that Genentech and Biogen were accused of off-label marketing of Rituxan. In 2005, a former Genetech employee named Paul McDermott filed a whistleblower lawsuit accusing the drugmakers of actively promoting Rituxan for treating rheumatoid arthritis years before it was approved for the affliction. His allegations included what are, by now, familiar charges about offering ‘kickbacks’ to docs to promote and prescribe the med at dinners and, in the process, defrauding Medicare and Medicaid. The lawsuit, which involved a separate, but related employment claim, was eventually settled and we are told the terms remain confidential.
Salient point
What the patient is going through is awful, but two very large assumptions are being made here: 1) that the company was aware in 1995 of a serious AE that required them to change the label 12 years later; 2) that it promoted off-label use to this physician.