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Bayer 187 articles

Women want Essure cases in state court

Nearly five dozen women suing Bayer over claims that its permanent birth control device Essure perforated their uteruses and is linked to other injuries asked a California federal judge to send their case back to state court, arguing that only state law applies, according to Law360. The case was originally filed in Contra Costa County Superior Court in February, but was removed to federal court a month later. The complaint alleges Bayer violated California negligence, strict products liability, warranty and fraud statues. Bayer argued the case belonged in federal court because it implicates the Federal Food, Drug and Cosmetic Act ... Read More

Former FDA chief to testify on Xarelto makers’ conduct

In January 2015, former Food and Drug Administration (FDA) Commissioner David Kessler testified in a Philadelphia court that five years before Johnson & Johnson subsidiary Janssen Pharmaceuticals added warnings to its antipsychotic Risperdal regarding a side effect involving disfiguring breast growth in adolescent boys, the company was aware of its danger to minors. It was the first bellwether trial among thousands involving claims that Janssen tried to cover up Risperdal side effects. Kessler testified that Risperdal “probably or very likely” triggered breast growth in boys – a condition called gynecomastia. He backed up that claim by referencing a 2001 study ... Read More

Xarelto makers want to know if plaintiffs cases are funded by third parties

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, facing more than 1,200 cases in a mass tort over bleeding risks with their jointly produced blood thinner Xarelto, filed a motion requesting that the Philadelphia Court of Common Pleas force plaintiffs to reveal whether their lawsuits are being funded by a third party. The motion specifically targets cases that may be picked for the first wave of bellwether trials. If they are being financed, then the defendants want to know by whom. The defendants also requested access to any “third-party control, consultation, or funding” agreements. Currently, both parties are working to determine which ... Read More

Farxiga lawsuits consolidated by Judicial Panel on Multidistrict Litigation

The U.S. Judiciary Panel on Multidistrict Litigation (JPML) created a new product liability MDL involving over kidney-related injuries with the type 2 diabetes drug Farxiga. The 18 actions consolidated in New York are currently pending in six federal district courts and share common questions of fact that would benefit from a centralized pre-trial MDL docket, the JPML concluded. The lawsuits, waged at the makers of Farxiga, as well as its so-called sister drug Xigduo XR, Bristol-Myers Squibb Co. and AstraZeneca, allege that use of the diabetes medications can cause acute kidney injury and diabetic ketoacidosis, a serious condition in which ... Read More

MiraLAX laxitive associated with serious side effects in pediatric patients

Children’s Hospital of Philadelphia (CHOP) is leading a study into reports of devastating side effects in children who were treated for constipation with the over-the-counter laxative MiraLAX. The Food and Drug Administration (FDA) awarded CHOP with a grant to conduct the research in early 2014, during which the agency disclosed that MiraLAX powder contains a small amount of Polyethylene glycol 3350 (PEG 3350). Under certain conditions, PEG 3350 can degrade into ethylene glycol or diethylene glycol – toxic ingredients that can be found in antifreeze. The FDA disclosed in the grant that it had received a number of reports of ... Read More

J&J faces more potential million-dollar product liability judgments in 2017

The world’s largest health care company, Johnson & Johnson, was slapped with six of the seven largest product liability verdicts in 2016, and 2017 is shaping up to be just as woeful with the company facing potential verdicts totaling into the hundreds of millions of dollars. J&J faces at least 17 state and federal trials this year involving serious injuries and deaths allegedly caused by the company’s pharmaceuticals, medical devices, and consumer products. Last year the company was hit with a $1 billion judgment over faulty hip implants, a $72 million verdict involving ovarian cancer claims with Johnson’s baby powder, and ... Read More

Large group of parents claim MiraLAX causes neurological, psychological side effects in children

The over-the-counter constipation-relieving powder MiraLAX, made by Bayer, can “flip a switch” in the brains of otherwise happy children making them act out bouts of anger, aggression, rage and paranoia, a group of families claim. Their concerns, along with mounting adverse event reports reported to the Food and Drug Administration (FDA), have prompted Children’s Hospital of Philadelphia to launch a study to determine if these parents’ claims have merit. After examining preliminary reserach, it appears the parents’ suspicions may have basis. The FDA stated that MiraLAX powder contains polyethylene glycol 3350 (PEG 3350), an ingredient that may degrade into two ... Read More

Risperdal, Xarelto mass tort programs dominate in Pennsylvania court system

Only two mass tort programs in Philadelphia’s Complex Litigation Center involving pharmaceuticals grew in 2016: the litigation involving the antipsychotic drug Risperdal and the blood thinner Xarelto. All other pharmaceutical mass torts lost between 6 and 100 percent of their inventory in 2016. As of Jan. 1, 5,601 pharmaceutical cases were pending in Philadelphia – nearly 200 more than were pending at the start of 2012, the year the court started implementing changes designed to clear its mass tort inventory. The Xarelto mass tort grew by 664 cases in 2016, bringing the total of cases pending to 1,214. The program ... Read More

Bayer recalls administration sets used with infusion system

Bayer is recalling more than 86,000 Source Administration Sets used with the Medrad Intego PET Infusion System because they may produce a particulate matter in the medicine vials created when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter into the patient and cause serious adverse health consequences including infection, tissue damage, and death. Medrad Intego PET Infusion Systems control and deliver medications from a chamber to patients through a needle inserted into a vein during nuclear medicine procedures. These procedures are used to diagnose and treat diseases ... Read More

Boxed warning, patient checklist to come with Essure permanent birth control

The controversial permanent birth control device Essure will now come with an updated safety label that includes a boxed warning about potential injuries and a patient decision checklist to ensure that women who are considering being implanted with the device are aware of the potential risks associated with it. Essure, manufactured by Bayer, was approved by the Food and Drug Administration (FDA) in 2002. It consists of two nickel alloy coils that are inserted into each of the fallopian tubes. Scar tissue builds up around the coils forming a permanent barrier preventing sperm from reaching the egg. In recent years, ... Read More