In an order submitted on December 18, defendants must furnish eight exemplary samples for ten different variations of Ethicon Physiomesh at the earliest by next month. The Court expects some of the samples to be kept for other purposes though plaintiffs may conduct destructive testing on some of them. The remaining samples would be returned to Ethicon when the multidistrict litigation concludes.
Ethicon took off their Physiomesh in May 2016 from the global market following reports from two European hernia registries that the mesh was prone to cause complications requiring correction surgeries compared to other products available in the market. Though official recalls were conducted in Canada and other countries, in the U.S Ethicon informed healthcare providers to return any implants which were unused. Over 1,600 lawsuits have been filed against Ethicon in the Georgia federal court, all with similar complaints of inadequate pre-market testing and negligent conduct to forewarn doctors and patients about the risks of Physiomesh. Plaintiffs claimed the mesh is defectively designed and leads to infections, adhesions, and chronic pain. Hundreds of hernia mesh lawsuits linked to Ethicon Inc 's Physiomesh Composite Flexible Mesh are moving forward in the U.S. District Court, Northern District of Georgia overlooked by Judge Richard W. Story. The bellwether trials for the federal Physiomesh cases would begin in December 2019.
In a drug safety alert sent out on December 20, the Food and Drug Administration (FDA) warned that systemic use of fluoroquinolone antibiotics like Levaquin, Avelox, and Cipro could increase the chances of aortic dissections. The federal agency also indicated this information would be added to the drug's prescription as well as the patient medication guides which are handed over to the patients.
The safety alert was the result of a recent publication based on studies over the last few years which has linked fluoroquinolones to fatal and life-threatening consequences like aortic aneurysms and aortic dissections (AA/AD). The FDA notified health care professionals should refrain from prescribing this class of antibiotics to patients who are suffering from an aortic aneurysm or who are at risk for an aortic aneurysm and doctors must immediately stop the treatment if a patient is diagnosed with a serious aortic condition. The FDA suggested patients should take emergency services if they are experiencing pain in stomach, back or chest while taking any of the fluoroquinolones. In a May 2016 warning notice, the FDA indicated permanent nerve damage, known as peripheral neuropathy and tendon ruptures as a possible health risk associated with fluoroquinolone intake. In July 2018, the antibiotics label was updated to highlight the risk of significant blood sugar levels and some critical mental health side effects. Janssen Pharmaceuticals took off the oral and IV versions of Levaquin in December 2017; however, it may be available in pharmacies until 2020.
In a stipulation of discontinuance without prejudice filed on December 21 in the New York Supreme Court for New York County, the parties involved in an asbestos cancer case have reached a settlement agreement in a case slated to begin trial next month. In a first-of-its-kind settlement, Johnson & Johnson and its talc supplier Imerys America Inc. has agreed to pay more than 1.5 million to a 78-year-old Manhattan woman, Ann Zoas, who blamed exposure to asbestos fibers from J&J's talcum powder for her mesothelioma.
J&J has been sued by individuals across the nation over ovarian cancer and mesothelioma risks related to the company's asbestos contaminated talcum powder use.
On December 19, attorneys for Wendy Dolin filed a petition with the U.S. Supreme Court requesting to determine whether her claims were preempted because federal law prevents GlaxoSmithKline from adding a suicide warning label in Paxil taken by her deceased husband as an antidepressant.
The Seventh Circuit sanctioned an appeal filed by the company in August to reverse a $3million jury award given to the widow of Stewart Dolin, who worked as a partner at Reed Smith LLP and consumed Dolin, the generic version of Paxil before jumping in front of a commuter train to commit suicide in 2010. According to a 2011 ruling by the U.S. Supreme Court, generic drug companies are not responsible for failing to provide inadequate label warnings since federal law requires them to use only brand versions' labels.
Paxil lawsuits are consolidated for pre-trial proceedings in the Central District of California (withdrawal) and in the Philadelphia County Court of Common Pleas (birth defects). U.S. District Court Judge Mariana Pfaelzer overlooks the MDL No. 1574 (Ninth Circuit: In re Paxil Products Liability Litigation) in the Central District of California for cases filed over withdrawal symptoms.