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Bayer 221 articles

Proposed bill will clear the way for women who claim they were harmed by Essure birth control to sue Bayer

Essure

Kristina Burrell had three children and three stepchildren. She felt her family was more than complete. When discussing birth control options with her gynecologist, she was thrilled to hear about Essure, the only non-surgical permanent birth control method available in the U.S. The procedure didn’t require any incisions or operating rooms, and recovery would be much shorter than if she had opted for tubal ligation, a surgical sterilization method. Essure, made by Bayer, consists of two nickel alloy coils that are inserted into the fallopian tubes. Over the course of about three months, the coils build up scar tissue and ... Read More

Health care professionals encouraged to report problems with defective blood monitors

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The Food and Drug Administration (FDA) is encouraging health care providers to report any errors or resulting adverse effects with blood monitors Alere INRatio and INRatio2 prothrombin time/international normalized ratio (PT/INR) because the monitors give inaccurate results. The monitoring system is used to measure the effectiveness of some blood thinning medications. The company recently announced it was recalling the devices due to the errors, which had been plaguing the company for years. In December 2014, Alere alerted its users of an “urgent correction” with the INRatio and INRatio monitors that detailed certain medical conditions that should not be tested using the ... Read More

Ariel Grace’s law aims to give people harmed by medical devices their day in court

Essure

On June 8, exactly one year after the death of Ariel Grace, a bipartisan bill was introduced in the U.S. House of Representatives that would allow citizens claiming they were harmed by certain medical devices the opportunity to sue the manufacturer. Ariel Grace’s law (H.R. 5403) stems from a U.S. Supreme Court ruling (Riegel vs. Medtronic) that protected manufacturers of certain medical devices from litigation. It is named to honor the in utero loss of Ariel Grace, who died at 27-28 weeks gestation due to the failure of a permanent device, Essure. Essure, made by Bayer, was approved in 2002 ... Read More

Bayer meds, devices subject of personal injury lawsuits

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Bayer’s tagline is “Science for a better life,” but not everyone exposed to their products reaps benefits. Here’s a look at a few Bayer medications and medical devices that have become the focus of numerous personal injury lawsuits. Testosterone replacement therapy – Bayer’s testosterone treatment injection Nebido is one of the top five in the market. The hormones are intended for men with low levels of testosterone who are suffering symptoms such as muscle loss and low sex drive. However, aggressive marketing campaigns from testosterone manufacturers have resulted in skyrocketing sales. Recent studies have linked testosterone replacement therapy to cardiovascular risks ... Read More

Testosterone side effects likely to hamper sales

Low T

The risk of cardiovascular events has hampered sales of testosterone replacement therapies, and numerous studies providing evidence of adverse events associated with the synthetic hormones are causing many people to look at the products in a negative light. These are just some barriers manufacturers of testosterone treatments face in the near future, an analyst with Transparency Market Research (TMR) predicts. Sales of testosterone replacement therapies have boomed in recent years with new formulations and brands entering the market, each pushing products through heavy direct-to-consumer marketing campaigns. The companies have even coined the phrase “Low T,” and suggested to men that ... Read More

FDA recalls blood monitor device held in question during Xarelto clinical trials

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A device used to monitor patients while taking the blood thinner warfarin is being withdrawn from the market after the Food and Drug Administration (FDA) concluded that improvements made on the device were not enough to ensure its safety and efficacy. In 2014, Alere Inc., makers of the INRatio and INRatio2 PT/INR Monitor Systems, warned that patients with certain medical conditions including anemia, inflammatory conditions, and infections should not use the devices because they could give an inaccurate reading, putting patients at risk for blood clots or major bleeding events. At the time of the recall, Alere warned that it ... Read More

Hearings for first Xarelto bleeding risks lawsuits expected for early 2017

xarelto

Bellwether cases in the multidistrict litigation (MDL) over alleged injuries with the blood thinner Xarelto are currently being selected and are expected to be heard sometime in early 2017, according to Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana. The federal Xarelto MDL consolidates individual actions filed against Xarelto’s manufacturers Johnson & Johnson, its subsidiary Janssen Pharmaceuticals, and Bayer. The lawsuits claim that the drug companies failed to warn that Xarelto could cause an increased risk for gastrointestinal bleeds and brain hemorrhages if taken once daily. Plaintiffs contend Xarelto bleeding risks would be ... Read More

FDA approves updated warning label on diabetes drug Farxiga

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The Food and Drug Administration (FDA) has approved changes to the safety label of the type 2 diabetes drug Farxiga to include stronger warnings for the risk of acute kidney injury. The update replaces the previous warning for impaired renal function. The warning states that Farxiga causes intravascular volume contradiction, which can lead to renal impairment. The FDA and the drug companies have received post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients taking Farxiga. Some of the reports involved patients younger than 65. “Before initiating Farxiga, consider factors that may predispose patients to acute kidney ... Read More

Xarelto expected to be top selling drug in Europe

xarelto

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer’s anticoagulant Xarelto is poised to be the No. 1 product in Europe by 2022, though it is only ranked 20th in the world, according to new forecast models from EvaluatePharma, a life science market intelligence and analysis firm. Xarelto was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2011. It is currently indicated for the prevention of strokes in patients with the heart rhythm abnormality atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently ... Read More

Women fight to sue Bayer over Essure side effects

Essure

Bayer thought it was protected from personal injury lawsuits involving its permanent contraceptive device Essure, but women who allege they were injured by the birth control method are demanding their day in court. Essure was approved by the Food and Drug Administration (FDA) in 2002 and remains the only non-surgical permanent birth control device on the market. It consists of two nickel alloy coils that are inserted into the fallopian tubes. Over a few weeks, the body builds up scar tissue around the coils, which form a natural barrier preventing the sperm from fertilizing the egg. Essure is intended to ... Read More