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Pharmaceutical litigation is governed by product liability laws

Lawsuits for personal injury or death arising from the use of prescribed pharmaceuticals are included in that area of tort law known as product liability. The three generally used theories of recovery in a product liability case filed in Ohio and elsewhere are negligence, strict liability and breach of warranty. Each of those claims is proved by a different set of facts, but in tort law, including in pharmaceutical litigation, alternative and even conflicting theories may be alleged and proved.

A relatively new drug called Xarelto is one of the more recent pharmaceuticals to face the fire of consumer litigation. In one class action lawsuit, the plaintiff users of the drug claim that the defendant manufacturer, Janssen Research and Development, put the drug on the market with insufficient testing and inadequate warnings. In the past few years, Xarelto has been a highly visible and advertised medication touted as a blood thinner to prevent strokes.

The drug has apparently not performed as well as expected and has allegedly brought on a host of dangerous side effects for its unwitting users. The case was filed in a federal district court in Louisiana, based on the three alternative claims of negligence, strict liability, and breach of warranty. The complaint makes allegations of consumer fraud against the manufacturer, including that the defendant knew about the excessive dangers and concealed the facts from the public.

Some of the drug's alleged severe and permanent side effects relate to excessive bleeding, reduced life span and other dangerous defects. In pharmaceutical litigation filed throughout the nation, including in Ohio, strict liability often provides the strongest theory of recovery because proof of the defect can establish liability without having to prove any specific negligence by the defendant. However, there are various requirements that must be proved in a strict liability case, such as that the product must have been used as it was intended. Additionally, even if a defect is proved, the defendant may raise the affirmative defense that it gave adequate and conspicuous warnings to prospective users that there were defects in the product that could affect the user.

Source:, "Xarelto suit accuses Janssen R&D of negligence, wrongful death", Robert Hadley, Dec. 10, 2015

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