A Supreme Court decision handed down last month and previously addressed on this blog may have huge implications not only for the pharmaceutical and medical device industry, but for product liability laws across most manufacturers’ product lines as well.
If you recall, the Supreme Court overwhelmingly ruled in favor of Bristol-Myers Squibb by 8-1 in June. At question was whether plaintiffs from states other than California could join ...
continue reading...The U.S. Consumer Product Safety Commission (CPSC) is recalling residential elevator units after three reports of incidents, one of which left a 10-year-old boy with a catastrophic brain injury. The elevators in question are Elmira Hydraulic residential elevators, manufactured by Cambridge Elevating and distributed by Coastal Carolina Elevators.
Elmira Hydraulic units were installed in homes with multiple floors. According to the CPSC’s description, “they have a manual accordion-style car gate door with vinyl laminate inserts and a control panel ...
continue reading...A recent story in the Washington Post describes a report by the Endocrine Society that many men are receiving testosterone therapy when they do not need it. The research demonstrates that a large portion of patients do not meet the accepted clinical criteria for receiving testosterone treatment.
The male sex hormone, testosterone, naturally declines with age. Hypogonadism is a condition that results from low testosterone and one that is generally treated with therapy. However, many men are ...
continue reading...A Food and Drug Administration panel of experts ruled that the labeling of the popular birth-control pills Yaz and Beyaz should be updated to reflect recent data showing the drug poses a higher risk of causing blood clots than older contraceptives.
Already, 10,458 lawsuits have been filed in federal court against pharmaceutical giant Bayer AG, maker of the contraceptives Yaz, Beyaz, and Yasmin. Plaintiffs claim they weren’t warned of the drug’s harmful side effects, according to the Southern District of ...
continue reading...The federal Food and Drug Administration has announced that a batch of birth control pills has been recalled because of a packaging error that may leave women at risk of unintended pregnancy.
On Feb. 24, Glenmark Generics Inc. USA – the domestic distributor for Glenmark Generics Ltd. India – issued the recall of seven lots of norgestimate and ethinyl estradiol tablets.
According to a release by Glenmark, select blisters on the packaging were rotated 180 degrees within the card, reversing the weekly ...
continue reading...The New York Times has reported that Johnson & Johnson marketed an artificial hip overseas after the federal Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.
In addition, the company continued to sell a related model of artificial hip in the U.S. after the FDA rejection, which went on the market because the company used a regulatory loophole that enabled it to avoid a similar safety review
According to the Feb. ...
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