Attorney’s Widow Seeks To Toss GSK's Paxil Case Win

Attorney’s Widow Seeks To Toss GSK's Paxil Case Win
Mon, 12/20/2021 - 09:11

On December 19, attorneys for a plaintiff 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 $3 million jury award given to the widow of a lawyer who worked as a partner at a law firm and consumed 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.

Getinge AB, the Swiss parent company of Atrium Medical Corporation, has set aside an amount totaling to $200 million (SEK 1.8 billion) to cover the ongoing costs of litigation and future hernia mesh settlements involving around 900 lawsuits filed against Atrium Medical in the U.S and Canada.

Earlier, in a conference call, the Chief Executive Officer Mattias Perjos and Chief Financial Officer Lars Sandstrom of Getinge confirmed that the plan had been outlined to cover all present and future costs linked to the litigation over Atrium hernia mesh defects. Apart from the $200 million compensation, the company also revealed it has liability insurance to cover the expenses involved in some or all of the Atrium hernia mesh cases. The Food and Drug Administration had announced a recall for certain C-Qur surgical mesh devices in October 2013. Atrium hernia mesh multidistrict litigation (MDL No. 2753; In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation) was established by the JPML in December 2016 assigned to the Honorable Landya B. McCafferty in New Hampshire District Court. The first trials for Atrium hernia mesh defects would commence in the late 2019 or early 2020.

As of September 2018, more than 2,300 hernia mesh lawsuits are pending in the federal MDLs targeting Ethicon’s Physiomesh Flexible Composite mesh, Atrium C-Qur products, and C.R. Bard's polypropylene products.


J&J Agrees To Pay More Than $1.5 Million To Settle Talc Case

J&J Agrees To Pay More Than $1.5 Million To Settle Talc Case
Mon, 12/20/2021 - 09:09

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 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.

Earlier, Chancellor Dewayne Thomas of the Chancery Court of Mississippi’s First Judicial District in Hinds County on Tuesday denied Johnson & Johnson's motion to escape a talcum powder lawsuit filed by the state attorney general alleging the company failed to adequately warn residents of the risks of its talc-based products and thus increased their risks of developing ovarian cancer due to exposure to asbestos contained talc. The court denied the overturn request considering it would be a “remiss” if the lawsuit was tossed before allowing the “full development of all potentially relevant facts.”

J&J failed in yet another overturn attempt on December 19, 2018, as Judge Rex Burlison in St. Louis rejected the company’s bid to set aside a $4.7 billion July verdict which was awarded to 22 women who blamed asbestos exposure from the company's Baby Powder and other talc products for their ovarian cancer.

Regulators in India are testing J&J's Baby Powder after a stunning report suggested that the company was aware for years that some of its talc products had the presence of asbestos in them. The talcum giant confirmed that officials from India’s Central Drugs Standard Control Organization (CDSCO) and some state-based Food and Drug Administrations (FDA) visited its manufacturing plants in India. As per Reuters, J&J has tested asbestos presence since the 1970s, and several tests conducted revealed traces of asbestos in the Baby Powder and Shower-to-Shower powder. Reuters suggested Internal memos and documents indicated the test reports made officials at Johnson & Johnson worried, but still, they failed to warn consumers or regulators about asbestos traces in their talc-products.


FDA Warns Fluoroquinolone Can Lead To Aortic Dissection

FDA Warns Fluoroquinolone Can Lead To Aortic Dissection
Mon, 12/20/2021 - 09:08

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.


Federal Court Asks To Store Hernia Mesh Samples For Testing

Federal Court Asks To Store Hernia Mesh Samples For Testing
Mon, 12/20/2021 - 09:05

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.

As per an order submitted on September 7, hernia mesh lawsuits involving C.R. Bard Inc 's polypropylene implants can be filed directly in the multidistrict litigation which is underway in the U.S. District Court, Southern District of Ohio. The direct filing would eliminate delays in transferring the cases from other jurisdiction. Also, it would promote judicial efficiency and facilitate coordinated discovery and other pretrial proceedings. Any case remaining unresolved would be remanded back to appropriate jurisdiction and venue for trial by the Court.

There are more than 170 hernia mesh lawsuits pending in the federal MDL filed by individuals who suffered serious injuries allegedly due to the defective polypropylene hernia mesh implants. Ventralex, Perfix, and Composix devices sold by C.R. Bard and its Davol, Inc. subsidiary have been reported to be defectively designed in the lawsuits.