Parents beware. A new recall has been issued for an estimated 1,500 DEMDACO infant bib and bootie sets after it was discovered that the “rattles sewn into the booties can detach, posing a choking hazard.” The recall itself was issued by the United States Consumer Product Safety Commission (CPSC), and it specifically involves the “Story Time bib and bootie sets for infants ages 3-6 months.”
Earlier this month, Dutch pharmaceutical company Novo Nordisk settled eight suits, brought by the Department of Justice, claiming that the company violated the Federal Food, Drug, and Cosmetic Act (FDCA) and the False Claims Act (FCA). The DOJ asserted that the company had misbranded its popular Type II diabetes drug, Victoza, by failing to comply with an “FDA-mandated Risk Evaluation and Mitigation Strategy (REMS).” The company agreed to the settlement of $58.65M. That amount includes disgorgement (repayment of illegally-earned profits) of $12.15M for the FDCA violations, which the DOJ claimed took place from 2010 to 2012, and a $46.5M payment for the FCA violations. The latter, according to the DOJ, took place from 2010 to 2014.
For one woman, a trip to Graceland with all the girls of her family ended up costing her her life after she fell ill with Legionnaires' Disease. Now her family has filed a wrongful death lawsuit against the Guest House at Graceland, where the woman stayed, claiming she died from a “Legionnaires' Disease outbreak at the hotel.” It also claimed the “hotel's water systems were not properly maintained.”
Bayer, the manufacturer of the controversial “permanent” birth control device Essure, announced on September 18 that it is discontinuing all sales and marketing efforts of the device in all European markets. Citing “commercial reasons,” the company continued to stand by the safety and efficacy of the device despite tens of thousands of reported injuries. The Essure device will remain on the market in the U.S. For now.
Ella Ebaugh, a resident of Pennsylvania, knows about pain. She was diagnosed with stress urinary incontinence (SUI) in 2005. In 2007, Mrs. Ebaugh did as many women: she trusted that pelvic mesh implants would fix the problem. Also like many women, Mrs. Ebaugh discovered that the mesh devices – these made by Johnson & Johnson’s Ethicon division – caused more problems than they solved. Problems that ultimately lead Mrs. Ebaugh to sue J&J. Earlier this month, a jury in Philadelphia awarded Mrs. Ebaugh $57.1M.
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