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Will Injured Plaintiffs Who Took Generic Testosterone Be Able to Recover Damages?

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On June 6, 2014, all federal testosterone replacement therapy [TRT] lawsuits were consolidated into one court in the Northern District of Illinois. Claims include those made against both the name-brand and generic manufacturers of testosterone replacement drugs.

Generic drug defendants have recently indicated that they intend to pursue the dismissal of their cases, arguing that according to current federal law, generic drugs cannot be held liable for failure-to-warn claims. They are bound by the law to ensure that their labels match exactly the labels of the brand-name products, and thus cannot be expected to make changes that would result in key differences between the two.

On April 21, 2015, at a recent MDL TRT status conference the issue was discussed, with the Court requiring that any such motions involving generics be filed no later than May 15, 2015.

Key Court Decision Leaves Generic Drug Makers Blameless

A few years ago, plaintiffs who took the generic equivalent of the heartburn drug Reglan and then suffered from side effects like tardive dyskinesia (a serious movement disorder) tried to recover damages in court. In 2011, the issue went all the way to the U.S. Supreme Court.

In Pliva v. Mensing, the justices ruled that generic companies, because they were required to maintain the same warnings and labels as those on the brand-name drugs, could not be expected to add new side effect warnings to drugs that differed from the brand-name drug warnings. The ruling left many patients who had taken generic drugs and then suffered from side effects with no way to pursue compensation for their injuries.

Generic Testosterone Drugs Fall Under Different Rules

Now, we’re facing the same issue with generic testosterone drugs as we did with generic heartburn drugs. Patients who took generics—either by choice or because their insurance policies simply made the switch—may again end up with no recourse for injuries if the courts follow the same path.

At the April 21, 2015 MDL status conference, the parties discussed the issue, seeking the court’s guidance by generic TRT manufacturers. The court directed that the motions requesting dismissal be filed no later than May 15, 2015, and that plaintiffs must submit their responses by June 15th, with replies due by June 30th.

Plaintiffs do have reason to be hopeful. After the 2011 Supreme Court decision, the FDA began considering new regulations that would allow generic drug makers to change their warning labels whenever they felt it was necessary. Reports of adverse events connected with a drug, for instance, or study results showing potential risks might encourage additional warnings that generic manufacturers would be allowed to add to their products.

Such changes to the current regulation are being hotly debated, however. Though potentially beneficial to injured patients, they could also increase costs of generic drugs, as the companies would be required to increase staffing and other departments to keep up with safety data and potential label changes.

Generic drug makers, in general, oppose such changes. If the FDA moves forward with them, however, plaintiffs would again have a way to recover damages for injuries suffered because of inadequate warnings on drugs, generic or otherwise.

MDL Moves Forward with Over 1,000 Cases

Other topics such as state/federal coordination, plaintiff fact sheets, and master complaints were also discussed at the recent MDL status conference. Currently, about 1,400 testosterone lawsuits are pending in the MDL, with some of these concerning brand-name testosterone replacement products like AndroGel and Testim, and others concerning the generic equivalents of these and similar drugs.

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  1. Gary says:
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    The Mensing decision made it clear that as long as the generics didn’t deviate from the “approved” labeling of the name-brand drugs, they would be absolved of any liability for that labeling being inadequate, it would only be if they tried to deviate and add their own additional warnings that they risk liability