Month: October 2016

Sexual Harassment and Arbitration Clauses In the Office

Gretchen Carlson is both extraordinary—in her cultural visibility, in her multimillion-dollar career, in her personal accomplishments—and utterly ordinary. When she filed a lawsuit in July alleging sexual harassment during her tenure at Fox News, she became part of a disturbing statistic: at least 25% of American women say they have experienced sexual harassment in the workplace, according to a 2016 report from the Equal Employment Opportunity Commission. She also faced an obstacle that blocks an untold lot of them: an arbitration clause in her employment contract.

There is no reliable data on how many Americans have ceded their rights to a court hearing through arbitration clauses; one academic study estimates, using projections based on narrow data sets, that as many as a quarter of nonunionized American workers may be subject to the restrictions. Arbitration clauses are found not only in multimillion-dollar contracts like Carlson’s but also in the most mundane hiring materials—form contracts, even employee handbooks—that have been given to employees at Anheuser-Busch or Applebee’s or some editors at TIME.

FDA Backs Xarelto Benefits Despite Recalled Clinical Trial Device

After critics accused Johnson & Johnson and Bayer of hiding data in clinical trials for their blockbuster blood thinner Xarelto (rivaroxaban), the U.S. Food and Drug Administration said the drug is safe and effective.

Since its approval in 2011, Xarelto has made billions for J&J and Bayer. On Oct. 11, 2016, the FDA released its reanalysis of the ROCKET AF clinical trial data — the original trial used to approve Xarelto. According to the agency, the drug is still a safe and effective alternative to warfarin despite a faulty device used in the clinical trials.

The FDA conducted the reanalysis after The BMJ and other critics questioned trial results following the discovery that the INRatio — a device used to administer warfarin to patients in the trial — was faulty. In 2014, the FDA recalled the INRatio device because it could deliver significantly lower results than a lab method, resulting in warfarin patients receiving too high of a dose and an increased risk of bleeding. Alere, the device’s manufacturer, said it received 18,924 reports of malfunctions, 14 of which led to serious injuries.

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