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Bayer 368 articles

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

Xarelto clinical trial halted early for lack of efficacy

A clinical trial pitting the blood thinner Xarelto against low-dose aspirin in patients who had recently suffered a stroke was stopped prematurely for lack of efficacy, Bayer announced. Patients taking Xarelto also had more major bleeding events, the study revealed. Xarelto makers Bayer and Johnson & Johnson’s Janssen Pharmaceuticals had high hopes that the study would show Xarelto superior in efficacy, even boasting that they expected the product’s sales to jump from $3.4 billion annually to more than $5.3 billion a year. Bleeding risks are a known side effect with Xarelto. The drug companies currently face more than 18,000 lawsuits in state and ... Read More

Xarelto victim wants new trial over injuries

Attorneys for a woman who sued Janssen Pharmaceuticals and Bayer over bleeding injuries allegedly caused by the blood thinner Xarelto have filed a motion seeking a retrial based on new evidence that contradicts courtroom testimony that could have swayed jurors. A jury from the U.S. District Court for the Southern District of Mississippi found in favor of the drug companies during the third bellwether trial over Xarelto side effect. Dora Mingo, 69, claimed that she was prescribed Xarelto after suffering a blood clot following hip replacement surgery. But shortly after starting treatment with the blood thinner, she suffered a life threatening ... Read More

New evidence could lead to Xarelto re-trial

Attorneys for a woman who suffered a major bleeding event after taking the blood thinner Xarelto are seeking a new trial after discovering new evidence that questions the accuracy of statements made by the drug’s makers. Jurors found in favor of Johnson & Johnson’s Janssen Pharmaceuticals and Bayer. During the trial, jurors were told by the drug companies that there was no effective test to determine whether patients were at an increased risk for internal bleeds while taking Xarelto, and dismissed plaintiff Dora Mingo’s expert witness’ testimony that a lab test called prothrombin time – or PT – would not ... Read More

Korea adds severe skin reaction warning to Xarelto

Korea’s Ministry of Food and Drug Safety (MFDS) is requiring an update to the safety label of the blood thinner Xarelto to include new warnings regarding the risk of the serious and sometimes fatal skin reactions known as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). The warning comes after the European Commission issued a public safety alert regarding serious skin conditions with Xarelto. Most side effects were reported within the first week of treatment. The ministry collected opinions and reviewed them last month and determined that the warnings should also come with a recommendation for doctors to discontinue ... Read More

Xarelto users should avoid grapefruit

People who take the blood thinner Xarelto should limit their intake of grapefruit while taking the drug, cautions Joe Graedon and Teresa Graedon with the People’s Pharmacy published in myAJC. Xarelto hit the market in 2011 and was promoted as a novel oral anticoagulant that was just as effective but far more convenient than the long-used warfarin. For decades, warfarin had been the go-to treatment for the prevention of strokes in patients with the common heart rhythm abnormality called atrial fibrillation. But taking warfarin came at a price. The blood thinner can interact adversely with numerous medications or foods. For ... 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 data: benefits don’t outweigh the harms

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer have been fast to tout the news that their blood thinner Xarelto in combination with aspirin cut the risk of cardiovascular death, heart attacks or strokes in patients with coronary artery disease and/or peripheral artery disease (PAD/CAD) – a population that’s at higher risk for cardiovascular events. But, while it’s a win for the drug companies, it’s not so much for patients, according to Dr. John Mandrola’s commentary in Medscape. If approved for the prevention of strokes and heart attacks in PAD/CAD patients based on COMPASS data, the drug would become a candidate ... Read More