Raptiva and Progressive Multifocal Leukoencephalopathy (PML)

UPDATE: 04/09/2009: Audet & Partners, LLP, a San Francisco, California-based trial law firm, filed the first complaint against Genentech arising out of the recently announced withdrawal of Raptiva medication.  Filed in Alameda Superior Court, the complaint seeks general and punitive damages.

Raptiva is a medication used to treat severe to moderate psoriasis and works by suppressing the immune system.  According to allegations in the complaint filed by Audet & Partners, LLP, Raptiva allegedly causes a number of serious life-threatening infections, including encephalitis, viral meningitis and a rare brain infection known as progressive multifocal leukoencephalopathy (PML).  At least three and possibly four cases of PML brain infections have been confirmed by the FDA.

Click on the image to the right to read the complaint (PDF format).

UPDATE: 04/08/2009: Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva will no longer be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.

The Food and Drug Administration has reported that U.S. regulators have received three confirmed reports of a serious brain infection in patients treated with Genentech's psoriasis drug Raptiva. 

The FDA said it also was aware of a fourth possible case of progressive multifocal leukoencephalopathy (PML) in a Raptiva patient. Two of the patients with confirmed PML died, as did the patient with a possible case, the agency said.

The FDA said it was reviewing the information and their investigation is on-going. On October 16, 2008 the FDA mandated a "black box" warning for Raptiva, the FDA's sternest warning, about the risk of life-threatening infections.

PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.  When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML. 

Raptiva is a weekly injection used to treat plaque psoriasis. Psoriasis is a disorder affecting joints and skin. It is a chronic condition and its cause is unknown. Psoriasis causes skin inflammation and scaly skin patches. Plaque psoriasis is the most common type of psoriasis, accounting for 80-90% of cases. Psoriasis can be mild to severe.

Raptiva is designed to treat severe psoriasis. It is used in adults who are in need of either phototherapy (light therapy) or other systemic (oral or injected therapy) treatments. Raptiva works by supressing the immune system to reduce psorasis flare ups but, as with many other immunosuppressive medications, the tendancy for serious infection is much greater. Raptiva “suppress [es] the body’s natural defense system.” Without the body’s defense system, there is a serious risk patients using Raptiva will contract life-threatening infections. Published reports have also noted an increased tendancy for thrombocytopenia (low platelet counts) in Raptiva patients.

Dozens of Raptiva users have contacted Audet and Partners, LLP recently regarding Raptiva. If you or a loved on has taken Raptiva, and have suffered from progressive multifocal leukoencephalopathy (PML), please contact our law firm immediately to protect your legal rights.
 

Audet & Partners represents individuals, governmental entities, small businesses and institutional shareholders in product liability, tort, negligence, consumer, construction defect, investment fraud, securities, insider trading, antitrust, environmental, whistle blower, aviation and employment cases. In recognition of their outstanding abilities and commitment to the legal profession over the years, the firm and its members have served as Court-appointed Plaintiffs’ Counsel in dozens of federal and state cases throughout the United States.