Pharmaceutical Lawsuit and Recall Information
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The National Journal (2/28, Fox, Subscription Publication) reports the FDA will meet March 22-23 to “solicit feedback on whether making some medicines more easily available will get more people to use them.” “A new paradigm” to make prescriptions easier to fill. “Under this paradigm, the agency would approve certain drugs that would otherwise require a prescription [...]
MedPage Today (2/27, Fiore) reported, “Patients of pain medicine specialists may be at greater risk of opioid overdose death than those who get their medications from primary care physicians,” according to an abstract presented at the American Academy of Pain Medicine meeting. Specifically, “the proportion of patients in Utah who had scripts from pain doctors when [...]
CNBC (2/25) reported that in a television interview, “FDA’s Margaret Hamburg” addressed the “backlog of generic drug applications at the Food & Drug Administration.” She said, “We frankly are taking too long to review important applications, and we want to help get those products out.” Hamburg aims “to bring the median review time of generic [...]
Isradipine Recalled Dow Jones Newswires (2/25, Loftus, Subscription Publication) reported that on Friday, GlaxoSmithKline PLC voluntarily recalled more than 394,200 bottles of isradipine because of a potential tablet mix up at Novartis AG. U.K.-based Glaxo said Friday “it issued the voluntary recall of all bottles of [DynaCirc] remaining in the U.S. market from wholesalers, pharmacies [...]
Recalled Birth Control Pills Glenmark Generics Inc. USA today issued a “voluntary, nationwide, consumer-level recall of seven lots of Norgestimate and Ethinyl Estradiol Tablets.” The recall is being implemented because of a packaging error that was discovered when Glenmark received a complaint from a consumer, stating that she – “received one blister pack in which [...]
The Wall Street Journal (2/23, B4, Dooren, Subscription Publication) reports that yesterday, the Food and Drug Administration announced that “22 Chinese companies supplied contaminated raw materials that were used in the making of the blood thinner heparin.” ”The contamination was linked to 80 deaths”, with many more being sickened by allergic reactions that happened after taking the [...]
In an article on the front of its business section, the New York Times (2/22, B1, Meier, Subscription Publication) reports that, in contrast to Johnson & Johnson’s statements prior to its recall of an all-metal artificial hip that “it was safe and maintained that its internal studies refuted complaints by surgeons and regulators abroad that the [...]
Regulatory System for Medical Devices Is Weak CQ (2/18, Bristol, Subscription Publication) reported, “While the Food and Drug Administration takes heat from members of Congress over slow approval for medical devices, Public Citizen argues the regulatory system is too weak and that new proposals could endanger patients. ” Public Citizen “objects in particular to bills introduced [...]
Draft Guidance on Biological Products Issued By FDA Modern Healthcare (2/12, Lee, Subscription Publication) reported, “The Food and Drug Administration issued draft guidance addressing the amounts and types of safety data that companies developing drug and biological products should collect in late-stage, pre-market and post-market clinical investigations.” The FDA “said in the draft guidance that ‘more selective safety [...]
Defective Medical Devices Recalled Too Slowly Bloomberg News (2/15, Cortez) reports, “St. Jude Medical Inc. (STJ)’s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn’t spotted quickly enough because US surveillance systems are lacking,” according to an article published in the New England Journal of Medicine. “St. [...]
