Professor Lens Interviewed in the Blog 'Abnormal Use'

September 11, 2013


"Abnormal News," a blog dedicated to the discussion of federal and state product liability litigation, interviewed Baylor Assistant Law Professor Jill Wieber Lens about the most significant new developments in torts or products liability in the last year.

The blog post appeared on Sept. 10. Here's an excerpt:

  • What do you think is the most significant new development in torts or products liability of the last year?

  • "One significant new development in products liability in the last year has to be the Supreme Court's decision Mutual Pharmaceutical Co. v. Bartlett, in which the Court found that design defect claims based on generic drugs are preempted.

    The result was not surprising based on the Court's prior finding in Pliva, Inc. v. Mensing that failure to warn claims based on generic drug manufacturers were preempted. Both of the results are based on FDA regulations that require generic drugs to mirror the prior FDA-approved name brand version; thus, generic drug manufacturers lack any ability to alter the design of the drug or the warning.

    Because of the practical inability to both comply with FDA regulations and to use a design/warning that would comply with tort law obligations, the Supreme Court has found that defective design and warning claims against generic drug manufacturers are preempted. The Bartlett and Mensing decisions have huge consequences. After these cases, people injured by design or warning defects in generic drugs have no legal redress against the drug manufacturers.

    Ironically, had those injured people taken the name brand version, their claims against the name brand manufacturer are not preempted. But if the injured people take the generic version -- which most people do because it is cheaper and state law allows pharmacists to automatically fill the prescription with a generic version -- they have no legal redress against the generic drug manufacturer.

    This is something to be concerned about when considering President Obama's health care law. Health insurance companies are likely to push generic drugs even more to further lower costs. But patients injured by design or warning defects in the generic drugs will be unable to pursue relief against the drug manufacturer.

    Admittedly, this issue becomes moot if the FDA alters its rules regarding a generic drug manufacturer's ability to change the design of the drug and the warning. That, however, would also likely increase generic drug manufacturers' costs--and the prices of generic drugs."

Read the entire interview at

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