BioSphere Medical Inc. (NSDQ:BSMD) agreed to settle a product liability lawsuit filed by a California man who went blind in one eye after at treatment aimed at stopping his severe nosebleeds.
The Rockland, Mass.-based microsphere maker, which didn’t admit any liability in the case, said it settled the case March 24 "for the payment by BioSphere of an amount that the parties have agreed will be confidential," according to a regulatory filing.
In June 2008, Hamid Rashidi sued BioSphere, Franklin Moser, M.D., and 100 nurses, doctors and associates at Cedars-Sinai Medical Center in Los Angeles, after a procedure to treat his severe nosebleeds left him permanently blind in one eye. Rashidi went to the hospital in early April 2007 with a severe nosebleed. He was given a cold pack to hold to his nose and sent home, but was back about a month later with another nosebleed, according to court documents. On May 3, 2007, Moser advised Rashidi to have an operation to treat the "arteriovenous malformation" Moser believed was causing the nosebleeds, using BioSphere’s Embosphere microspheres to embolize blood vessels. The procedure involved threading a catheter through the femoral artery in the groin to the blood vessels in the head that were causing the nosebleeds. When Rashidi woke up he was permanently blind in one eye, according to the documents.
The lawsuit accused BioSphere of failing to notify the Food & Drug Administration, doctors and patients of the possibility that the Embospheres could migrate to and occlude blood vessels other than those intended for embolization.
"Plaintiff suffered permanent blindness in one eye as a result of the failure of a medical device … because it contained a manufacturing defect and was, therefore, not in compliance with applicable federal law, including federal medical device manufacturing requirements," according to court documents. "The BioSphere Medical Inc. Embosphere microspheres injected into plaintiff’s blood vessels were designed, manufactured, and sold in violation of federal law and in violation of BioSphere Medical’s federally approved device specifications. They contained a latent defect not disclosed to the [FDA], were adulterated, breached BioSphere Medical’s express and implied warranties, and were unsafe and unreasonably dangerous for their intended use."
Rashidi also accused Moser of malpractice and charged the doctor with failing to inform Rashidi that the procedure could lead to blindness and that it would involve the catheterization procedure.
"Had he known of the risk of possible loss of sight the plaintiff would not have consented to the operation," according to the documents. "Plaintiff did not consent to the passage of an object through the blood vessels of his leg, his abdomen and his chest."
BioSphere said the settlement resolves all the claims against it and that its product liability insurance will likely cover the full amount of the settlement.
It’s not the first lawsuit stemming from a patient losing sight after an embolization using a BioSphere product. In September 2009, the company reached a tentative settlement in a Missouri case involving a youth who was blinded in both eyes after a procedure to treat a benign throat tumor using Biosphere’s EmboGold microspheres.
BioSphere cut its losses in half during 2009, ending the year with a 7 percent sales increase. The company reported a net loss of $293,000 on $8.4 million in sales during the three months ended Dec. 31, 2009, compared to a $1.7 million loss on $7.2 million in sales for the same period in 2008. For the full year, BioSphere halved its losses, reporting a $3.2 million loss on $31 million in sales, compared to a $6 million loss on $29 million in revenues during 2008.