Since the US Supreme Court decision in Pliva v. Mensing barred most lawsuits against generic drug manufacturers, it seemed that people injured by generic drugs that lacked adequate labeling may have no right to compensation. On Friday January 11, though, the Alabama Supreme Court proposed a logical solution to the problem: people injured by generic … [Read more...]
FDA Warns LASIK Providers about Lack of Risk Information
On December 18, the FDA sent warning letters to five LASIK providers that they are failing to provide adequate information about risks to potential patients. This targeted follow-up comes after more than three years of communication with eye care professionals about failing to give consumers adequate information to make informed decisions about … [Read more...]
FDA Investigates Bed Rails to Stop the Sleep of Death
Bed rails are supposed to protect elderly and frail patients from the risk of serious injury or even death from falling out of bed. However, bed rails actually cause injury and death. Regulators know it. Bed rail manufacturers know it. And health care providers know it, but until now little has been done. With regulators and others slow to act, … [Read more...]
FDA Inspection of Plant in Meningitis Outbreak Reveals NECC May Have Known of Contamination
An FDA inspection of the New England Compounding Center (NECC) linked to the meningitis outbreak revealed the company may have known about contamination for months before the outbreak but did not take action. The inspection’s results revealed numerous conditions that justify the recall of all NECC products issued earlier this month. Inspectors … [Read more...]
New Johnson & Johnson Group Chairman to Oversee Consent Decree Due to Recalls
Beginning on Dec. 1, Sandra E. Peterson, a Bayer executive, will become the group worldwide chairman of Johnson & Johnson (J&J), and will oversee a consent decree at the company's troubled over-the-counter drug manufacturing plants after dozens of product recalls. As Reuters reports: J&J's McNeil Consumer Healthcare has been operating under a … [Read more...]
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