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Bayer 396 articles

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 makers don’t want patients to amend complaint

A month before a new round of bellwether trials is scheduled to begin in a mass tort program involving the blood thinner Xarelto, drug makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer have asked a Pennsylvania judge not to allow a substantially amended master complaint because they say it would significantly prejudice them in presenting a logical defense. There are 1,700 Xarelto-related cases in the mass tort program in the Philadelphia County Court of Common Pleas. The new master complaint lays out general allegations regarding bleeding risks on each case. Created in January 2015, the mass tort alleges that Janssen ... Read More

Woman fights to keep $28M Xarelto jury award

A woman’s near-$28 million jury verdict for injuries suffered while taking the blood thinner Xarelto was reversed last month, but she is fighting to get the compensation she believes she’s entitled to. Lynn Hartman has outlined issues she intends to raise with the Pennsylvania Superior Court in a brief challenging the Philadelphia Court of Common Pleas ruling to eliminate her $27.8 million award, the first win for plaintiffs in a multidistrict litigation accusing Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer of not adequately warning about Xarelto side effects. Hartman’s appeal includes a challenge of Judge Michael Erdos’ statement ... Read More

Common aspirin as effective as Xarelto at preventing blood clots

The pricey blood thinner Xarelto is no better than common aspirin at preventing blood clots in patients who have recently undergone hip or knee replacement surgery, and bleeding risks between the two medications were similar, according to a study published in the New England Journal of Medicine. People who undergo hip or knee replacement surgeries are prone to developing blood clots, or venous thromboemboli (VTE), and are typically given blood thinners prophylactically. The study involved nearly 35,000 patients, all of whom were treated with Xarelto for five days after hip or knee replacement surgery. After five days, about half remained ... Read More

Woman fights to keep $28 million Xarelto jury award

A woman who was awarded $28 million in a bellwether case alleging the blood thinner Xarelto caused her life-threatening injuries argued that the Pennsylvania judge who axed her award ignored the fact that she would not have taken the drug if additional warnings had been added to its label. Instead, Judge Micahel Erdos threw out the first-of-its-kind verdict in January, siding with Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer AG that the plaintiff’s doctor testified that additional warning on Xarelto would not have changed his decision to prescribe the drug. Lynn Hartman was awarded $28 million in December ... Read More

Xarelto possibly linked to cases of liver injury

Cases of liver injury in patients treated with the blood thinner Xarelto have been reported to the FDA’s Adverse Event Reporting System (FAERS) and flagged in the July to September 2017 quarterly review, but the agency has determined that no action is necessary at this time based on the available information. The appearance of a drug on the FAERS list does not mean that the FDA has concluded that the drug has the listed risk. It means that the agency has identified a potential safety issue. If after further review the FDA determines the drug is associated with the risk, ... 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

Judge pushes for resolution in massive Xarelto MDL

U.S. District Court Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, appears to be pushing both sides toward a resolution, stating in the Jan. 30, 2018, monthly status conference hearing that “I need to devise an end game.” The nationwide MDL involves more than 21,000 lawsuits alleging Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer did not adequately warn about the bleeding risks with its top selling blood thinner. The MDL was created in 2014 in New Orleans, and since then, hundreds of new cases have been filed each month. Cases in state courts in Philadelphia and Los Angeles ... Read More

Xarelto, Eliquis antidote review postponed

The Food and Drug Administration (FDA) has postponed its decision whether to approve an antidote to the blood thinners Xarelto and Eliquis, pushing the action date from early February to early May in order to consider additional information it had requested from the manufacturer. The news came as a blow not only to Portola Pharmaceuticals, maker of the antidote called AndexXa, but also to Eliquis’ Pfizer and Bristol-Myers Squibb, and Xarelto’s Johnson & Johnson and Bayer. “The agency has instituted an extension to allow more time for a thorough review of the information provided and to work with the company ... Read More

Bayer tries to skirt $28M Xarelto verdict

Bayer AG is trying to wiggle out of a $28 million verdict involving Xarelto side effects by saying the plaintiff’s legal team made xenophobic and offensive statements and tried associate the German company with Nazis in the minds of jurors. Bayer Healthcare Pharmaceuticals Inc., and Johnson & Johnson unit Janssen Pharmaceuticals cited an Instagram post by plaintiff Lynn Hartman’s legal team that used the hashtag “killinnazis,” and referenced “multiple inflammatory and xenophobic references” made during closing arguments. Hartman’s case is the latest to go to trial in the Xarelto mass tort program in Philadelphia County Court of Common Pleas where ... Read More