WASHINGTON – Following two U.S. Supreme Court decisions that shut the door on state-law failure-to-warn and design-defect claims over generic drugs, the Food and Drug Administration is taking steps that could ultimately open a window for plaintiffs.
WASHINGTON — The Food and Drug Administration has taken action against more than 9,600 websites, claiming they illegally sold potentially dangerous prescription drugs that put unwitting consumers at risk.
The Department of Justice has decided not to appeal a court decision striking down the Food and Drug Administration’s new graphic warnings on cigarette packages on First Amendment grounds.
In light of recent studies, the Food and Drug Administration cautioned that azithromycin, a drug used to treat bacterial infections, can cause abnormal and even fatal heart rhythms.
Published: March 1, 2013
Tags: Children’s Motrin, consumer protection, drug litigation, failure to warn, FDA, Food and Drug Administration, Johnson & Johnson, Motrin, preemption, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
A Massachusetts jury awarded $63 million to a teenaged girl and her parents after the girl suffered an adverse reaction to Children’s Motrin that left her scarred and blind, with permanent brain and lung damage.
And the award may increase.
Published: February 7, 2013
Tags: ADHD, Daytrana, drug litigation, FDA, Food and Drug Administration, Institute for Safe Medication Practices, multidistrict litigation, Noven Therapeutics, product liability, Propecia, Proscar, QuarterWatch
Sexual side effects experienced by men taking the hair-loss drug Propecia may be permanent, according to a new report by a drug industry watchdog.
Published: February 4, 2013
Tags: Affordable Care Act, contraception, contraceptive mandate, Department of Health and Human Services, FDA, Food and Drug Administration, health care reform, HHS, Obamacare, Patient Protection and Affordable Care Act, Religious Freedom Restoration Act
The new federal requirement that all group health plans must include coverage for FDA-approved contraceptive methods probably violates the religious rights of an employer who is a devout Catholic, the 8th Circuit has ruled in granting a preliminary injunction.
There have been more than 80 deaths and thousands of injuries involving patients who underwent procedures with the da Vinci surgical robot, according to a new analysis of Food and Drug Administration adverse event reports.
Federal law does not preempt a state failure-to-warn lawsuit brought by a man who claimed he suffered paralysis as the result of the surgical implantation of a Medtronic pain pump, the en banc 9th Circuit has ruled.
The decision overturns a contrary panel ruling. (See “» Continue Reading.