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lawsuit 3552 articles

Rapid growth in Taxotere MDL as more chemo patients learn reason for their permanent hair loss

bald woman, Taxotere - Pixabay image

The Daily Hornet reports on the recent significant increase in the number of lawsuits alleging the chemotherapy drug Taxotere causes permanent hair loss. When lawsuits that had been filed across the nation against drug-maker Sanofi-Aventis were consolidated into multidistrict litigation (MDL) in the Eastern District of Louisiana under U.S. District Judge Kurt D. Engelhardt last October, there were 33 cases. According to updates from the Judicial Panel on Multidistrict Litigation (JPML) in mid-December there were 267 lawsuits. A month later the number of suits had risen to 705, nearly tripling the size of the litigation. “The number of lawsuits has ... Read More

Widow recalls husband’s painful death following tainted steroid injection

Syringe

When Colette Rybinski spoke in the courtroom, her voice was barely audible. She talked about her husband Tom, who at 55, died after receiving a steroid injection to relieve lower back pain at a medical clinic near his home in Tennessee. Shortly afterward, at a time when the pain should have been easing from his back, his head began to ache so badly that Colette had no choice but to seek medical attention. His meningitis diagnosis was confounding. How could he have contracted the deadly brain inflammation? For weeks, Colette watched as Tom’s health went from better to worse in ... Read More

New Xarelto lawsuit claims blood thinner caused bleeding death

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The children of a Louisiana woman who allegedly bled to death after taking the blood thinner Xarelto joined a massive multidistrict litigation (MDL) accusing Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer of failing to warn of risks associated with the drug. Terrie Toups, Duane Rochelle and Patty Buras, children of Florence Bourgeois, filed their lawsuit in Louisiana federal court, where U.S. District Judge Eldon Fallon is overseeing the near-14,000 lawsuits in the multidistrict litigation against the drug companies involving bleeding risks. Xarelto, known chemically as rivaroxaban, was approved by the Food and Drug Administration (FDA) in 2011 and ... Read More

J&J agrees to pay $5 million over false claims with its bedtime bath products

baby in crib - CPSC photo

It took six long years, but Johnson & Johnson is finally ready to settle a class action lawsuit by a group of consumers who took issue with the company’s advertisement claims that its bedtime bath products were “clinically proven” to help babies sleep better. The consumer health care giant asked an Illinois federal judge to approve its payout of $5 million to settle the claims. The national class was certified in August and a preliminary agreement was approved by U.S. District Judge Eline Bucklo. The agreement will be final as soon as she gives the last nod. Johnson & Johnson says ... Read More

Baxter Healthcare To Pay $18M For Potentially Botching IV Solutions

Baxter IV bag

Baxter Healthcare Corporation has agreed to pay the U.S. more than $18 million to resolve criminal and civil liabilities stemming from its failure to follow Good Manufacturing Practices when manufacturing sterile drug products at one of its U.S. manufacturing facilities. The settlement, announced by the U.S. Department of Justice Jan.12, includes a deferred prosecution agreement, penalties, and forfeiture totaling $16 million and a civil settlement resolving a whistleblower’s False Claims Act lawsuit totaling approximately $2.158 million. According to the court documents, the U.S. alleged that Baxter’s Marion, N.C., manufacturing facility introduced adulterated drugs into the U.S. market because it failed to ... Read More

Mass. Ambulance Company Pays $12.7 Million To Resolve Whistleblower’s Allegations of Medicare Fraud

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Massachusetts-based MedStar Ambulance, four subsidiary companies, and two owners have agreed to pay $12.7 million to resolve a whistleblower lawsuit accusing the company of inflating charges billed to Medicare and falsely billing it for unnecessary medical transport services. Worcester-based MedStar, which has operations throughout Worcester County and the MetroWest area, routinely billed Medicare for transportation services that did not qualify for reimbursement because they were “not medically reasonable and necessary,” the U.S. Department of Justice claimed in the lawsuit. The company also billed Medicare for higher levels of services than were required by patients’ conditions, and for services that were ... Read More

First Xarelto bleeding risks trial scheduled for March 2017

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The first trial in a massive multidistrict litigation of nearly 14,000 cases involving bleeding risks allegedly caused by the blood thinner Xarelto is scheduled for March, with other trials, each serving as bellwethers, slated for April and May. The first case to be tried involves that of Joseph Boudreaux, who claims he began taking Xarelto in January 2014 as a treatment for his heart condition called atrial fibrillation. About a month later, he was hospitalized for internal bleeding, resulting in multiple blood transfusions. Like the thousands of other lawsuits, Boudreaux claims that Xarelto’s makers, Johnson & Johnson’s Janssen Pharmaceuticals and ... Read More

European Medical Device Regulations Tightened Due to Metal-on-Metal Hip Implant Safety Concerns

artificial hip

New medical device regulations (MDR) have been put in place by European Parliament after four years of negotiation. The decision to tighten regulation was spurred by safety concerns over breast implants and metal-on-metal hips. The regulation amendments are expected to begin in early 2017, and medtechs will be allowed three years to comply. If the medical products fail to meet the new regulation standards, the manufacturer will lose their CE rating, which allows legal marketing of the product. The new regulations include stricter rules regarding clinical trials, quality management, and marketing necessities such as product labeling and design. Regulators will now inspect Class ... Read More

Shire Pharmaceuticals Pays $350 Million To Settle ‘Landmark’ False Claims Act Suit

Pills - Stethoscope on Money

Shire Pharmaceuticals LLC and subsidiaries of the Ireland-based drug maker have entered into a “landmark” settlement with the U.S. government, agreeing to pay $350 million to resolve a series of whistleblower lawsuits alleging the company used kickbacks and unlawful tactics to boost sales of its Dermagraft treatment for diabetic foot ulcers. According to Benjamin Mizer, principal deputy assistant attorney general and head of the Justice Department’s civil division, the settlement is the largest False Claims Act recovery in the U.S. in a kickback case involving a medical device. Allegations resolved by the settlement were brought in six lawsuits filed under the qui tam, ... Read More

Patients suing maker of defective blood test kits

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Two people have filed a proposed class action lawsuit in Massachusetts federal court alleging health diagnostics company Alere Inc. used deceptive marketing practices to lure customers into buying its inaccurate home blood test kits that yielded inaccurate results and put patients’ lives at risk. J.E. from Virginia and J.D. from Arizona filed an amended complaint in October over Alere’s INRatio system, which is used to measure blood clotting factors in patients’ blood and lets patients know whether dosages of their blood thinning medication warfarin need to be adjusted to prevent spontaneous bleeding or the formation of a blood clot. According ... Read More