Teva Pharmaceuticals Requests Reglan Rehearing

September 5, 2013

Thumbnail image for Thumbnail image for Thumbnail image for 1409595_gavel_5.jpgReglan lawyers at Pintas & Mullins report that Teva Pharmaceuticals, the generic Reglan manufacturer, recently requested a rehearing after a Pennsylvania court ruled that thousands of generic Reglan claims were not preempted by federal law. Specifically, the court ruled that the product liability claims were not influenced by the Supreme Court decision in PLIVA vs. Mensing.

In the 2011 Mensing decision, SOCTUS ruled that generic Reglan manufacturers could not be held liable for the injuries caused by the drug, most notably the development of tardive dyskinesia, a severe neurological disorder. The justices ruled that generic manufacturers could not be sued for failure-to-warn claims because generics are required by federal law to use the exact same warning labels as their brand names.

In this most recent Reglan (metoclopramide) case, thousands of plaintiffs are suing Teva under claims of product liability rather than under failure-to-warn. The generic manufacturer, however, is arguing that the plaintiffs improperly grounded their case on the drug's failure to live up to its labels, instead of the inadequacy of the label itself. Teva claims plaintiffs erred in basing their fraud claims on the company's advertising and promotional materials.

There are currently about 2,300 mass tort cases regarding generic Reglan in Pennsylvania's Superior Court. Recently, a Philadelphia judge refused to issue full dismissal of these claims under Mensing-preemption grounds, which a nine-judge panel later backed. The judge agreed with the plaintiffs' assertion that Mensing only applied to generic failure-to-warn claims brought before the FDA Amendment Acts of 2007.

The majority of judges ruled that some of the plaintiffs' claims, such as those alleging design defects and false advertising, were not rooted in failure-to-warn, and therefore not preempted and allowed to continue. This mass tort case has been ongoing for several years now, during entirety of which Teva has been attempting, over and over again, to have the cases dismissed based on PLIVA vs. Mensing.

Over and over, however, Pennsylvania judges have denied its motions to dismiss. Judges rule that plaintiffs have provided the courts with an array of feasible reasons why Mensing does not preempt their specific claims. Some hold that, after realizing the severe side effects associated with metoclopramide, generic manufacturers of Relgan should have engaged in risk management strategies, suspended drug sales, or at least communicated the risks to the medical community. None of these issues were addressed or even brought up in the Mensing decision, hence the new litigation.

Since Mensing, which was decided five-to-four, several state courts have ruled in conflicting decisions on the matter. Some have dismissed all claims, while others (South Carolina, Alabama, Nevada) have authored several exceptions based on Mensings applicability only to product labels themselves.

Those in the legal and medical community, as well as the public at large, were concerned after Mensing that it would grant immunity to all generic manufacturers. Fortunately, this has not been the case, at least in a handful of state courts. Instead, judges are holding that the decision applied only to a small part of the cause of action: failing to change the content of the label to reflect the increased health risks. Additional plaintiffs, however, have largely been able to proceed based on their claims of misrepresentation, negligence, breach of warranty, etc.

Reglan was developed in the 1960s and has been available as a generic since 1985. It is prescribed to treat digestive disorders, however, it has also been linked to an incurable neurological disorder, which causes involuntary muscle movements and spasms. Several studies have found that up to 29% of patients who use the drug long-term develop the condition.

Reglan attorneys at Pintas & Mullins are currently investigating and accepting cases of tardive dyskinesia caused by brand-name or generic Reglan. Patients suffering from tarfive dyskinesia may be entitled to compensation through a lawsuit against the manufacturer, and should contact a skilled attorney as soon as possible for a free legal evaluation.