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Bayer 187 articles

FDA restricts sales of permanent birth control device Essure

Sales of the permanent birth control device Essure have been restricted by the Food and Drug Administration (FDA) for only doctors and health care facilities that agree to go over a checklist with women before the device is implanted explaining possible risks. The action comes more than a year after the FDA ordered manufacturer Bayer to update the safety label of Essure to include a black box warning about potential injuries associated with use. Essure was approved by the FDA in 2002. It consists of two nickel alloy coils that are inserted into the each of the fallopian tubes. Over ... Read More

Bayer recalls mislabeled packages of Alka-Seltzer Plus

Bayer is recalling some of its Alka-Seltzer Plus medicines because the ingredients on the front sticker of the boxes may not match the actual product in the carton, which poses an allergy or anaphylactic reaction risk, a medication contraindication risk, and the potential for serious health consequences. To date, however, no injuries related to this issue have been reported. Affected Alka-Seltzer Plus products were sold in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores), Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and drug after Feb. 9, 2018. They can be identified by ... Read More

FDA chief updates public about Essure side effects review

Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., last month met with a group of women who claim to have been injured by the permanent birth control device Essure, and issued a statement updating the public on steps the agency has taken and plans to take in the future to better ensure patient safety. Essure is a device that consists of two small, metal coils that are implanted in the fallopian tubes. The device is designed to prevent sperm from reaching the egg. It is a permanent form of birth control that has been used on more than 750,000 ... Read More

Xarelto mass tort program in PA continues to grow

The Xarelto mass tort program in Philadelphia experienced the second-highest level of growth during 2017, jumping from 1,214 cases at the start of the year to 1,619 by year’s end, representing a 33 percent growth, according to court statistics. The only other mass tort program that grew more was that involving the antipsychotic Risperdal. Three Xarelto bellwether trials have already occurred in the federal multidistrict litigation (MDL) where another 20,000 lawsuits are currently pending. One case tried in Philadelphia resulted in a $27.8 million verdict for the plaintiff. The award was overturned and is currently on appeal to the Supreme ... Read More

Risperdal, Xarelto mass tort programs largest in PA court

Two of the biggest mass tort programs on the Philadelphia Complex Litigation Center docket involve medications that are all or partially made by Johnson & Johnson and its subsidiary Janssen Pharmaceuticals – the antipsychotic Risperdal and the blood thinner Xarelto. Risperdal is used to treat schizophrenia, bipolar disorder and irritability with autism in adults and children. It is often used off-label to treat behavioral problems including attention deficit hyperactivity disorder (ADHD) and Tourette’s. The drug has been found to raise levels of prolactin, the hormone produced by pregnant women to induce lactation. When this occurs in adolescent boys taking Risperdal, ... Read More

Motions considered before Xarelto side effects trial

Philadelphia Court of Common Pleas Judge Arnold New is considering a several motions in next month’s Xarelto side effects bellwether trial, in particular whether the court should allow punitive damages. Plaintiff Lynn Hartman is suing Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Germany-based Bayer for not adequately warning that use of the drug could cause major bleeding, including gastrointestinal bleeds and brain hemorrhages. The drug companies claim that either New Jersey or German law should apply to the case, which would mean Hartman would not be able to seek punitive damages. Hartman’s attorneys argue that Indiana law applies in ... Read More

Whistleblower Lawsuit Against Bayer Revived by U.S. Appeals Court

A whistleblower suing Bayer A.G. in connection to a statin drug that was pulled from the market in 2001 over health risks has had her case revived by a federal appeals court for the second time. According to Business Insurance, Laurie Simpson filed a whistleblower lawsuit against the Germany-based drug giant and its units under the False Claims Act, which authorizes private parties to sue on behalf of the U.S. government in cases of suspected fraud targeting taxpayer-funded programs and government agencies. Ms. Simpson’s whistleblower suit accuses Bayer of misrepresenting the efficacy of its cholesterol-lowering statin Baycol compared with competing ... Read More

Xarelto cases in state court start soon

Drug maker Bayer asked the Philadelphia Court of Common Pleas to dismiss punitive damages from two of the first bellwether trials scheduled pending in state court involving Xarelto side effects. Meanwhile, attorneys representing people suing Xarelto’s makers filed two motions seeking to bar defense experts from testifying that attorney advertising affects the incidence of bleeding events, or that bleeding events can be beneficial if they lead to early diagnosis of other conditions. Bayer asked the court to apply either New Jersey law or German law to the cases, which would free the drug company from paying punitive damages. The motion ... Read More

Xarelto mass tort grows in first half of 2017

Lawsuits alleging bleeding risks with the blood thinner Xarelto pending in the Philadelphia Court of Common Pleas increased by 210 cases – or 17 percent – from Jan. 1 to June 14, 2017, according to Law.com. The number of cases jumped from 1,214 to 1,424. The Xarelto mass tort is one of nine pending in the Philadelphia. There are also about 1,600 Xarelto lawsuits that have been consolidated in a multidistrict litigation (MDL) in the Eastern District of Louisiana under Judge Eldon E. Fallon. Two Xarelto cases in the MDL have been heard, with the third scheduled for August. A total ... Read More

Mirena poses risk of adverse pregnancy outcomes

The Food and Drug Administration (FDA) has approved updates to the safety label for the intrauterine device Mirena to include new risks regarding pregnancy or suspected pregnancy. Mirena is a contraceptive device made by Bayer to prevent pregnancy for up to five years. It is also used to treat heavy menstrual cycles. Mirena is a T-shaped device that is inserted into the cervix where it releases a small amount of the hormone levonorgestrel. The birth control has been linked to risks such as migration of the device, perforation of organs and tissue damage, a well as a ectopic pregnancy. The update states ... Read More