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Bayer Healthcare Pharmaceuticals 19 articles

Bayer recalls 1.5M tubes of diaper rash cream

Bayer Healthcare Pharmaceuticals is recalling more than a million tubes of A+D Diaper Rash Cream due to a labeling claim issue regarding a possible undeclared excipient formulated along with the active ingredients. The recall affects A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, specifically 468,576 1.5-oz tubes with the UPC 041100811288; 203,868 3-oz. tubes with the UPC 041100811301, and 802,620 4-oz. tubes with the UPC 041100811325. The diaper creams were distributed by Bayer Healthcare LLC of Whippany, New Jersey. The products were distributed nationwide, in Puerto Rico, and in Iceland. The following lot numbers are included in ... Read More

FDA adds warnings to permanent female sterilization implants

Just months after the Food and Drug Administration (FDA) recommended a boxed warning be placed on the permanent birth control device Essure over injuries and unintended pregnancies, the agency recommended boxed warnings be added to all female sterilization implants to address concerns that women are not receiving or understanding information about the risks and benefits of these implants. The devices are called hysteroscopically placed tubal implants and they are designed to be a less invasive alternative to tubal ligation, which involves surgically cutting or closing the fallopian tubes to permanently prevent pregnancy. Essure, made by Bayer Healthcare Pharmaceuticals, was approved ... Read More

Bayer sues over loss of revenue with Mirena IUD

Bayer HealthCare Pharmaceuticals has slapped RJ Health Systems International with a lawsuit alleging the a drug-information company conflated prices of its Mirena IUD and Actavis PLC’s Liletta IUD, which put the company at risk of losing millions of dollars in monthly revenue. Bayer clams RJ Health Systems, which a vast majority of health insurers rely on, set reimbursement prices for the Mirena IUD at Liletta IUD system’s lower wholesale cost. This created potential reimbursement gaps and forced Bayer to temporarily discount its Mirena IUD. Bayer’s complaint argued that if it took no mitigating action, “RJ Health’s conduct would cause serious ... Read More

Judge refuses to dismiss second Mirena IUD side effects lawsuit

A New York federal judge refused to dismiss a woman’s lawsuit alleging injuries caused by Bayer Healthcare Pharmaceuticals Inc.’s contraceptive, the Mirena IUD, based on the grounds that a second and similar lawsuit filed by the woman in a different state had already been dismissed. U.S. District Judge Cathy Seibel, who is overseeing a multidistrict litigation, found that while plaintiff Ashley Brown’s claims in a California lawsuit had been time-barred and dismissed, a similar lawsuit that she filed in Missouri could not be thrown out based on the same grounds. Brown’s lawsuits claim she had been implanted with the Mirena ... Read More

Woman claims Mirena IUD caused partial blindness

A woman who filed a lawsuit against Bayer Healthcare Pharmaceuticals Inc., alleging the company’s Mirena IUD (intrauterine device) caused her to go partially blind will move forward after a Kentucky federal judge kept alive two contested claims with strict liability and negligent misrepresentation. The judge did trim an implied warranty claim, supporting Bayer’s argument that the plaintiff did not buy the device directly from the company. Kara Stanley’s lawsuit claims she had the Mirena IUD inserted by a doctor at a women’s health care facility in southern Indiana in May 2012. Seven months later, she began having severe headaches and ... Read More

Federal judge sets trial date for Yaz personal injury lawsuit

An Illinois federal judge has set a June trial date for a lawsuit in a multidistrict litigation involving stroke risks with Bayer Healthcare Pharmaceuticals’ birth control pill Yaz, saying Bayer’s feet-dragging strategy in the litigation over the past six years appeared to be an attempt to shrink the number of lawsuits in the MDL through attrition. U.S. District Judge David R. Herndon said the drug company’s strategy in the Yaz personal injury lawsuit amounted to “wearing everyone down over time,” and to expedite the process, selected plaintiff Pamel Schuchert’s case to be tried. Schuchert, who joined the litigation in 2010, ... Read More

Lawsuits against Bayer alleging neurological side effects from Mirena IUD will not be centralized

Nine lawsuits against Bayer Healthcare Pharmaceuticals alleging the company’s Mirena IUD caused neurological conditions will not be consolidated into a multidistrict litigation because there are just too few to justify the motion. Plaintiffs had asked that the lawsuits be centralized in Tennessee; Bayer opposed centralization or to have them consolidated in New York. Bayer already faces multidistrict litigation with its Mirena intrauterine device over uterine perforation, a different injury. These nine lawsuits claim that the Mirena IUD contraceptive device releases a synthetic hormone that can cause neurological problems, including a type of brain damage known as pseudo tumor cerebra (PTC) ... Read More

FDA approves Bayer Inserter for Skyla, Mirena IUDs

The Food and Drug Administration (FDA) has approved a new inserter device by Bayer HealthCare Pharmaceuticals designed to aid in the insertion of the company’s own intrauterine devices, the Mirena IUD and Skyla IUD. Both the Mirena and Skyla IUDs are flexible, T-shaped devices that are inserted into the cervix where they release the hormone levonorgestrel. Skyla prevents pregnancy for up to thee years, while Mirena is considered effective for up to five years. Mirena is also indicated to treat heavy bleeding in women who choose to use an IUD as their method of contraception. Mirena is designed for women ... Read More

Bayer files motion to dismiss some of its Mirena IUD lawsuits

Bayer Healthcare Pharmaceuticals is hoping to ditch some of the 450 lawsuits it faces over inadequate warnings for possible complications with its Mirena intrauterine device on the grounds that the cases have exceeded the statute of limitations. The Mirena IUD is a flexible, T-shaped device that is inserted into the cervix to prevent pregnancy for up to five years. U.S. District Judge Cathy Seibel asked attorneys on both sides of the issue to select a dozen cases to serve as an initial disposition pool with a goal of going to trial. The lawsuits allege that the Mirena IUD can migrate from ... Read More

Woman files Mirena IUD injury lawsuit against Bayer

A Pennsylvania woman is suing Bayer Healthcare Pharmaceuticals because she became pregnant while using the company’s Mirena IUD birth control. She claims the implantable contraceptive device migrated from the cervix where it was implanted, and thus, failed to prevent contraception. Rebecca Syx filed the lawsuit in U.S. District Court in Philadelphia, claiming Bayer was negligent by manufacturing and marketing a defective device. According to the complaint, Rebecca was implanted with the Mirena intrauterine device, or IUD, in the spring of 2011. She went for a follow-up visit in mid-June, during which the doctor confirmed the IUD was in its proper ... Read More