The FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis.
Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years. None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.
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.
In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.
Patients using Raptiva should:
Be aware that Raptiva increases the risk of developing PML. PML is a disease that is fatal or causes severe disability.
Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
Contact their healthcare provider immediately if they experience these symptoms.
Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML
The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.
Fast food giant McDonald’s has denied workers compensation benefits to a minimum wage employee who was shot when he ejected a customer who had been beating a woman inside the restaurant.
Nigel Haskett, then aged 21, was working at a McDonald’s in Little Rock, Arkansas last summer when he saw a patron, later identified as Perry Kennon, smacking a woman in the face. Haskett tackled Kennon, threw him out, and then stood by the door to prevent him from reentering. Kennon returned with a gun and shot Haskett in the stonmach.
(Haskett has since undergone three abdominal surgeries and has incurred over $300,000 in medical bills.
A representative of the administrator for McDonald’s workers compensation plan explained that “we have denied this claim in its entirety as it is our opinion that Mr. Haskett’s injuries did not arise out of or within the course and scope of his employment.”
“McDonald’s position now is that during thirty-minute orientation Mr. Haskett and the other individuals going through the orientation were supposedly told that in the event of a robbery or anything like a robbery . . . not to be a hero and simply call 911. Mr. Haskett denies that anything like that was even mentioned during orientation or at any time during his employment with McDonald’s.”
McDonald’s may be on shaky legal ground in their attempt to deny benefits. As courts have repeatedly ruled that injuries incurred in the course of “good samaritan” acts while on the job are entitled to compensation, especially if they result in good will towards the employer.
