VENTURA, Calif. (CN) - A man was blinded in one eye by Genentech's drug Avastin, which was contaminated with streptococcus and injected into his eye, the man claims in court.
Scott Wieser and his wife sued Genentech, Avella of Phoenix II dba Apothecary Shop of Phoenix II, Miramar Eye Surgical Associates Medical Clinic dba Miramar Eye Specialists, and Drs. Adam Martidis and William McHugh, in Superior Court.
Wieser claims the Avastin "was not sterile, but was contaminated with Streptococcus and/or other contaminants and that the Streptococcus was injected into plaintiff's eye."
Avastin is primarily used to treat cancer, but it can be used to treat eye conditions, according to the lawsuit.
"The off-label use of Avastin for treatment of ocular conditions such as macular degeneration requires compounding and re-formulation of the product by a pharmacist under sterile conditions in order to prepare lower doses for injection from single-dose vials/syringes rather than the manufacturer provided packaging utilized for intravenous cancer use," the complaint states.
The Wiesers claim Genentech sells Avastin in bulk to the Apothecary Shop and other compounding pharmacies to increase its profits, despite the "increased the risk of infection, contamination, and injury."
"Avastin is packaged in vials measuring 100mg to 400 mg," the complaint states. "Consequently, if Avastin is going to be used to treat wet age-related macular degeneration, it has to be re-packaged. Repackaging is known to result in bacterial contamination. The ease-to-use single dose vials marketed under the name of Lucentis cost $1,575.00 or more. This provides a profit motive and cost incentive for Genentech to distribute Lucentis in single dose vials as opposed to distributing Avastin in bulk at a cost of $7.00 after repackaging. The repackaged cheaper bulk product is attractive to HMOs, Medicare, and other entities looking for a less expensive way to provide Avastin which is exactly like Lucentis. Genentech, therefore, has manipulated and controlled the supply of Avastin to favor the much more costly but easy-to-use Lucentis. Wieser received the cheaper and more inherently dangerous product, the repackaged bulk Avastin, and was injured in California by the Genentech product."
Genentech knew years before Wieser was blinded that repackaging Avastin into single-use shots could compromise the medicine's sterility, the Wiesers say: "In October 2006, a medical advisory panel for the Department of Veterans Affairs issued a bulletin raising concern about sterility issues while compounding Avastin into single shot vials," the complaint states.
"In October 2007, Genentech cited safety concerns and safety issues as the reason for temporarily halting sales of Avastin to compounding pharmacies that had been dividing the drug into smaller quantities needed for ocular injection."
Genentech refused to make Avastin in single doses instead of in bulk, despite the inherent risks, the Wiesers claim. They say Genentech failed to warn the public and the medical community that reformulating bulk Avastin could contaminate it and lead to bacterial infections.
As a result of Genentech's deception and negligence, the Wiesers say, Scott is now blind in his right eye.
Wieser says he received an injection of Avastin from defendant Dr. Martidis at Miramar Eye Specialists on May 18, 2012.
The next day, he says, he woke up "with a swollen right eye, severe headache and blurred vision." He scheduled an appointment with defendant Dr. McHugh, who prescribed medicine and sent him home with instructions to return on Monday.
When Wieser went back for his appointment, Dr. Frambach "diagnosed Scott with endophthalmitis in the right eye. It was at that time that the doctors warned Scott and Kim that it was more than likely that Scott's vision would not return," the complaint states.
Dr. Frambach, whose first name is not stated, is not a party to the complaint.
Wieser had surgery later that day to take a fluid sample for diagnosis. The test "confirmed that Wieser's eye had been injured by a bacterial infection, Streptococcus Viridians (Strep)," the complaint states.
Both Genentech and the FDA received an Adverse Event notice, according to the complaint. The FDA investigated and learned that "Miramar purchased Avastin from an out of state compounding pharmacy, Apothecary, which repackaged bulk Avastin into injectable per physician prescriptions. It further confirmed that Wieser was 100% blind in the right eye," the complaint states.
The FDA then spoke with the quality control officer at Apothecary and Genentech's safety physician, who "confirmed that both defendants knew of prior similar incidents in Florida involving bacteria resulting from compounding," according to the lawsuit.
The Wiesers claim the FDA also learned that Martidis had injected the Avastin into Scott's eye though it was roughly two weeks past its use-by date.
They claim the Apothecary Store negligently compounded the Avastin by, among other things, failing to ensure the product was sterile, failing to prevent contamination during repackaging, and failing to test the medicine for contamination before distribution.
They claim the doctors should have known better than to use medication beyond its use-by date, and could have saved Wieser's sight had they acted sooner to treat the infection caused by the contaminated Avastin.
Wieser says his semi-blindness caused "disability, disfigurement, mental anguish, [and] loss of capacity for the enjoyment of life."
The Wiesers seek punitive damages for product liability, breach of warranty, medical malpractice and loss of consortium.
They are represented by Jeffrey C. Bogert with the Sizemore Law Firm of El Segundo.
Genentech, based in San Francisco, describes itself on its website as one of the founders of the biotechnology industry. Genentech joined the Roche Group in 2009.
Genentech senior manager Allison Neves told Courthouse News that the company does not comment on pending litigation.
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