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Train Conductor’s Arm Amputation Triggers Lawsuit

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An accidental arm amputation is the basis of a former railroad conductor’s lawsuit against Pan Am Railways. The lawsuit, filed by former Pan Am Railways conductor Matthew Larson in New York Supreme Court in Schenectady, alleges that the regional railway failed to provide a safe working environment by making sure the tracks were clear of debris, the Albany Times Union reports. Mr. Larson, 22, of Rensselaer County, New York, was on a train approaching a switch to the main line Dec. 15. He was giving a countdown to the engineer when an object, believed to be a tree limb, pulled ... Read More

Is Physiomesh ‘Substantially Equivalent’ to Prior Devices?


Physiomesh, a now-recalled hernia repair mesh, is not substantially equivalent to prior devices despite FDA 510(k) approval, according to lawsuits filed that claim the device is linked to injuries and high revision rates. Physiomesh is a polypropylene mesh that is designed to assist in the repairing of a hernia. The mesh was approved by the U.S. Food and Drug Administration (FDA) using a 510(k) approval, which is a fast-track approval method that allows a product to be marketed as long as it is “substantially equivalent” to a device already approved. Ethicon, a subsidiary of Johnson & Johnson and the maker ... Read More

California Man Joins Bard IVC Filter MDL

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A man from California has joined the multidistrict litigation (MDL) involving claims related to IVC filters. The man’s lawsuit claims his IVC filter made by Bard failed, resulting in injury. Clarence M. was given a G2 retrievable inferior vena cava (IVC) filter made by C.R. Bard to help prevent any potential blood clots from traveling to his lungs, which would result in a deadly pulmonary embolism (PE). According to The Daily Hornet, the G2 IVC Filter was surgically placed in Clarence’s vena cava vein May 8, 2010, at a California hospital. Clarence’s lawsuit claims the device maker downplayed the risks of the G2 IVC ... Read More

Idaho Man Files Lawsuit Over Cook IVC Filter

IVC filter

An Idaho man has filed a lawsuit against Cook Medical over an IVC filter that he claims is defective and led to his injuries. Jacob B. was implanted with a retrievable Celect inferior vena cava (IVC) filter on April 27, 2010, at Kootenai Medical Center in Coeur D’ Alene, Idaho. Dr. Nicole Burbank inserted the filter to catch blood clots in his bloodstream, preventing a potential pulmonary embolism (PE). According to The Daily Hornet, the Celect filter has an extremely high rate of vein perforation, more so than other IVC filters available. The Celect has been accused of defective design as far back ... Read More

AbbVie hit with $150M punitive damages in testosterone trial


AbbVie Inc.’s AndroGel may not have caused Jesse Mitchell’s heart attack, but the company was sorely fraudulent in marketing its testosterone replacement therapy to Mitchell and other men for a made-up ailment, an Illinois federal jury found while laying out a $150 million verdict against the drug company, Law360 reported. Mitchell’s case was one of thousands in a multidistrict litigation (MDL) accusing manufacturers of testosterone treatments of not adequately warning that the hormone replacement therapy could cause heart attacks, strokes and blood clots, some of which can be fatal. The lawsuits also blame testosterone makers for creating a condition, called Low T, to ... Read More

Bleeding most reported drug-related adverse event


There are unacceptably high risks associated with oral blood thinners, most of which involve life threatening bleeding events, according to the Food and Drug Administration (FDA) Adverse Events database and a new systematic study by the Centers for Disease Control and Prevention (CDC). The issue was identified by the Institute for Safe Medication Practices (ISMP) in its fourth quarter QuarterWatch report. ISMP’s annual report focused on drugs and specific adverse reactions that affect large patient populations and involve substantial numbers of serious injuries. There were nearly 22,000 serious adverse events reports linked to use of anticoagulants, and in particular Xarelto, ... Read More

Doctor Faces False Claims Act charges of Medicaid Fraud

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Connecticut initiated a False Claims Act lawsuit against a Norwalk doctor and his practice, alleging they defrauded the state’s Medicaid program out of thousands of dollars by billing it for services that were never performed. “The audacity of the alleged fraudulent conduct in this case is astounding,” said Attorney General George Jepsen. “In one case, this provider billed Medicaid for at least 500 visits to a particular patient that never happened, receiving $80,000 in taxpayer dollars for services never rendered, and at the same time, sought to receive Medicaid benefits himself. “ The state’s False Claims Act lawsuit alleges that ... Read More

Lawsuit over Merck’s shingles vaccine

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A group of consumers across the country claim they have suffered a persistent strain of shingles after receiving Merck & Co.’s shingles vaccine Zostavax, and have launched a product liability action against the drug maker in New Jersey state court for not adequately warning about the risks associated with the vaccine, Law360 reported. Some consumers claim to have developed a condition called postherpetic neuralgia, resulting in nerve damage and pain. One victim says her symptoms were accompanied by scarring. The lawsuit was filed July 11 in Middlesex County Superior Court by 18 plaintiffs from Louisiana, South Carolina, Tennessee, Kentucky, Mississippi, ... Read More

Virginia Chipotle reopens after food poisoning outbreak


Chipotle Mexican Grill Inc. reopened one of its Sterling, Virginia restaurants this week after having closed the burrito fast food chain for two days after receiving several reports of customers who became ill after dining at the restaurant, Reuters reported. The incident brings back sore memories for Chipotle. In 2015, the company faced multiple foodborne illness outbreaks at several restaurants across the country that sickened more than 500 people with E.coli, salmonella and norovirus. Symptoms of those illnesses include nausea, vomiting, and diarrhea that can be bloody. The outbreaks led to Chipotle falling under a federal investigation and getting hit with around ... Read More

Axiron safety label updated


The Patient Counseling Information/Patient Information/Medication Guide for the topical testosterone gel Axiron has been updated to include clarifications such as ensuring patients know how to administer the correct dosage as well as understanding that they should not drink the product. Axiron is a testosterone supplement intended for men with low levels of the male hormone due to injury or disease. It is a topical gel that is applied to the armpits. Patients are advised to wash their hands right away with soap and water after applying the gel and, once the solution has dried, to cover the area with clothing to ... Read More