Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Articles Tagged with Bayer

J&J successfully blocks first Xarelto Bleeding Injury trial. A Louisiana jury found for Johnson & Johnson and Bayer AG in the first Xarelto internal bleeding product liability lawsuit to go to trial.

Xarelto Bleeding Injury

Xarelto bleeding injury lawsuits. Xarelto linked to uncontrollable bleeding and death according to 18,000 lawsuits.

Xarelto Bleeding Injury Trial

As a Dallas Xarelto Bleeding Death attorney and Texas medical doctor, I would like to update my readers about the ongoing status of the Xarelto bleeding side effects and wrongful death litigation. Most recently, a wrongful death lawsuit was filed against the makers of Xarelto; Bayer Healthcare and Johnson and Johnson’s subsidiary, Janssen.

According to recent revelations in the New York Times did two major pharmaceutical companies, to protect their blockbuster drug, Xarelto, intentionally mislead editors at one of the world’s most prestigious medical journals?

Xarelto Wrongful Death Lawsuits
Several thousand injured plaintiffs have filed personal injury and product liability claims against Johnson & Johnson and Bayer over the safety of its anti-clotting drug Xarelto and its increased risk of potentially deadly bleeding side effects.

Now plaintiffs claim that a letter published in The New England Journal of Medicine and written by researchers at Duke University deliberately left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies provided the very same data to regulators in the United States and Europe.

The New York Times article suggests that Bayer, Johnson & Johnson and those who ran clinical trials at Duke University that led to the FDA approval of the blood thinner, may have lied to editors at the New England Journal of Medicine.

Defective Medical Device Results In Flawed Xarelto data

The heart of the controversy alleges that a key medical device that measures the levels of blood thinner in patients involved in the study was defective and that those running the clinical trial knew it, but failed to reveal that information.

The New York Times reports that documents produced by the drug makers during Xarelto lawsuits suggest that those running the clinical trial were asked if there were lab tests that confirmed the accuracy of the device. The editors were told there was not, when in actuality there were such tests.

It is now confirmed that the measuring device was defective and may have compromised the approval process for Xarelto, which has since been promoted as a superior alternative to warfarin. Warfarin is the gold standard anticoagulant drug that has been in use for the past 60 years.

Flawed Xarelto Bleeding Medical Studies?

The Xarelto blood testing problems in the clinical trial were first reported in the medical journal The BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to warfarin.

The ROCKET-AF clinical trials compared the rate of bleeding events between Xarelto and warfarin. The potentially defective blood testing device, known as the INRatio by Alere, was used to measure the levels of warfarin in patients’ blood and was used to adjust their dosage. An INRatio recall has since been issued after it was discovered that the device may show results that were falsely low.

The recall could affect the ROCKET-AF results, because falsely low readings may have resulted in warfarin patients being given too high a dose, increasing their risk of bleeding. If the device caused excessive bleeding among warfarin patients, it could have given the false impression that Xarelto had a lower rate of bleeding problems.

The clinical trials, led by Dr. Robert Califf, who is now the FDA commissioner, have come under intense criticism since Xarelto was approved, as the drug has been linked to a shocking number of adverse event reports involving severe and uncontrollable bleeding problems. Due to a lack of a reversal agent for Xarelto, doctors have been unable to stop serious bleeding problems that occur, increasing the risk of severe injury or death.

Xarelto Lawsuits Over Bleeding Problems

Xarelto is a new class of blood thinners released in recent years as a replacement for warfarin. Xarelto was approved in 2011, this new-generation treatment has been prescribed instead of warfarin to reduce the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.

Xarelto lawsuits allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. But, independent studies published after Xarelto was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.

Undue Big Pharma Influence for Xarelto

Big Pharma is the nickname given to the vast and influential pharmaceutical industry and its trade group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars every year by selling drugs and medical devices.

Pharmaceuticals are HUGE business and these Big Pharma” companies stand to reap billions of dollars over the life span of a block buster drug. Big Pharma industry influence has led to the concealment of critical unfavorable data or ghost written medical articles (written by industry insiders) — when crucial clinical data went missing from journal articles, leading to embarrassing corrections and ethics policies to limit the influence of drug companies on medical literature.

Xarelto Billion Dollar Block Buster

Xarelto, is sold in the United States by Johnson & Johnson and overseas by Bayer, had nearly $2 billion in United States sales last year. Xarelto is the best seller in a new category of drugs seeking to replace warfarin.

Recently, lawyers in the case against Johnson & Johnson and Bayer filed in federal court in New Orleans, have asked the judge to unseal documents in the case, which involves more than 5,000 lawsuits filed by patients and their families who claim they were harmed by Xarelto. Of those, 500 involve patient deaths.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, served on the Food and Drug Administration advisory panel that voted to approve Xarelto in 2011. He was one of two members who voted against the drug. He expressed doubt that any after-the-fact analysis would give doctors and patients answers. “Given the fact that the device was inaccurate, there is no way anybody can tell you what would have happened in the trial,” he said.

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Oren Fells from Georgia recently filed a Xarelto uncontrollable intracranial or brain bleeding lawsuit in the U.S. District Court for the Eastern District of Louisiana. The lawsuit was filed against Bayer Healthcare, Johnson & Johnson, and its Janssen subsidiary, the manufacturers of Xarelto.

Xarelto Injury LawsuitsCatastrophic Xarelto Brain Bleeding Allegations

Fells began taking the newer anticoagulant or blood thinner Xarelto in 2013, for the treatment of atrial fibrillation, a common heart rthym problem. Fells suffered a brain bleed in January, 2014, causing him to develop life long permanent injuries.

As a Dallas Xarelto Bleeding Death attorney and Texas medical doctor, I would like to update my readers about the ongoing status of the Xarelto litigation. Most recently, a wrongful death lawsuit was filed against the makers of Xarelto; Bayer Healthcare and Johnson and Johnson’s subsidiary, Janssen.

The U.S. Judicial Panel on Multidistrict Litigation announced consolidation and centralization of all nationwide Xarelto lawsuits filed in federal courts before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana.

1-Xarelto Bleeding Hemorrhage AttorneyOver 50 Federal Xarelto Lawsuits

Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary are exposed to at least 50 product liability lawsuits over their new-generation anticoagulant. These personal injury and wrongful death claims are pending in 24 different federal courts.

Today, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments to consolidate all federal Xarelto lawsuits before one judge, in one centralized U.S. District Court.

xarelto side effects attorneyIt is widely anticipated that the U.S. JPML will establish centralized proceedings for coordinated discovery and a series of bellwether trials.

Patients who took Xarelto accuse the drug manufacturers of downplaying Xarelto’s bleeding risks and asked that the cases be sent to U.S District Judge David Herndon in East St. Louis, Illinois. An order maybe granted before the upcoming holiday season.

xarelto side effects attorneyThe medications reduce the incidence of blood clots and reduce the rate of strokes as in the case of atrial fibrillation and to prevent catastrophic injuries from pulmonary embolism including death.

Untreated deep vein thrombosis (blood clot in the leg) can result in a pulmonary embolism when the blood clot in the leg breaks off and travels in the venous system to the lung.

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