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Xarelto MDL Judge Orders Redacted Personnel Files of Two Bayer Doctors

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New Orleans, LAThe expected wave of litigation stemming from Xarelto Bleeding complications has come to pass, with a parade of cases continuing to find harbor in Multi-District Litigation (In Re Xarelto MDL 2592, US District Court, Eastern District of Louisiana). More than 7,000 cases are pending, with the expectation of further cases given the deadline extension issued last month by US District Court Judge Eldon Fallon.

Plaintiffs and their Xarelto bleeding issue attorneys still have more than two months to file.

In a related development, Judge Fallon has ordered Bayer, the manufacturer of Xarelto and one of the defendants in litigation, to release to the Court the redacted personnel records of two doctors reported to be on Bayer’s payroll, who would be in a position to testify to plaintiff claims that Xarelto was rushed to market in haste.

“As this is a nationwide MDL, the rights of thousands of American citizens hinge on the timely production of materials that fall within the scope of the Federal Rules of Civil Procedure.”
Those allegations are not without merit, considering the long-simmering frustration with regard to managing a patient on Coumadin (warfarin), the de-facto anti-coagulant standard for patients in need of treatment with blood thinners that has been widely used for some fifty years. Coumadin has long been effective as a hedge against blood clots and stroke. However, an involved series of monitoring functions are required to ensure the optimum level and effectiveness of Coumadin. Diet, for example, can play a big part in whether warfarin thins the blood too much, or too little. A constant watch over diet and frequent blood testing has long frustrated both patients and their doctors, all of whom have been calling for an easier way.

That ‘Mecca’ came first in the form of Pradaxa, followed closely by Xarelto. Not only would Rivaroxaban (Xarelto) achieve optimum blood thinning, the new drug also would not require the kind of strict, ongoing monitoring usually associated with warfarin.

The issue, however – and a common refrain in many a Xarelto lawsuit – is that Rivaroxaban was brought to market without the kind of effective antidote currently available with warfarin. To that end, a sudden bleeding episode exacerbated by blood that is too thin, can be quickly reversed with the intervention of Vitamin K.

However, that strategy doesn’t work with Xarelto. While Bayer has been working on a reversing agent in order to give doctors additional tools to stop a hemorrhage, Xarelto was brought to market without a reversing agent in place.

This has led to a serious Xarelto Bleeding Issue for scores of patients and in some cases, Xarelto Death. Plaintiffs assert that not only were they unaware that Xarelto could not be quickly reversed in the same fashion that Coumadin can, the manufacturers and marketers of Xarelto were negligent in claiming that strict monitoring was no longer necessary when – given the unavailability of an antidote – monitoring was more important than ever, or so it is alleged.

While Bayer developed Xarelto and markets the product in Europe, Janssen Pharmaceuticals (a unit of Johnson & Johnson) is licensed to market Xarelto in the US.

Plaintiffs in Xarelto bleedout lawsuits seek the personnel records of the two Bayer doctors in view of the potential for evidence of aggressive compensation packages, in addition to the rush-to-market claims.

The doctors involved have been identified as Dr. Dagmar Kubitza, Head of Clinical Pharmacodynamics at Bayer, and Frank Misselwitz, Corporate Vice President, Bayer, both working in Germany. Performance reviews, evaluations for promotion and self-assessment would be redacted.

“The Court is concerned by the evasiveness exhibited by Bayer in certain depositions and is troubled by the possibility of further evasive responses by deponents,” Judge Fallon wrote. “As this is a nationwide MDL, the rights of thousands of American citizens hinge on the timely production of materials that fall within the scope of the Federal Rules of Civil Procedure.”

Xarelto Side Effects, which encompass a majority of the lawsuits currently housed in the Xarelto MDL include various forms of Xarelto Bleeding complications, and Xarelto Death. The MDL is restricted to cases involving hemorrhagic strokes caused by internal bleeding. Thousands of additional Xarelto lawsuits involving ischemic strokes have been filed before Judge Arnold L. New in the Philadelphia Court of Common Pleas.

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