(May 20, 2012) – A federal judge in Texas has dismissed failure-to-warn claims brought against makers of generic Reglan, ruling that they are preempted because the U.S. Food and Drug Administration approved the drug makers’ warnings.
On April 30, 2012, the judge for the U.S. District for the Southern District of Texas ruled that the claims are preempted under Pliva v. Mensing and Texas state law.
A victim sued Qualitest Pharmaceuticals Inc. and Vintage Pharmaceuticals LLC, alleging that he developed tardive dyskinesia (TD) as a result of ingesting metoclopramide, the generic version of Reglan. The drug makers moved to dismiss the complaint pursuant to Pliva Inc. v Mensing, in which the U.S. Supreme Court ruled that federal law governing the labeling of pharmaceuticals preempts state law failure to warn claims.
The judge explained that despite the multiple claims asserted by the victim, this is essentially a products liability case, with the claims arising from the drug makers’ alleged failure to warn.
In Texas, there is a statutorily created presumption in certain products liability failure to warn actions that the drug maker is not liable if the FDA had approved the warnings, which accompanied the drug, as noted by the judge. It has been 11 months since the U.S. Supreme Court limited consumer’s ability to sue generic drug companies for personal injuries in Pliva v. Mensing. Reglan, and its generic version, metoclopramide, were the topic in the high courts. The ruling held that since generic drugs are required to carry the same warning labels as the name-brand version of the drugs, generic manufacturers could not be held liable for failing to warn consumers of the side effects.
There are thousands of suits being filed by metoclopramide users who claim they were not warned about the long-term risks and dangers of developing tardive dyskinesia (TD), a neurological disorder. State courts in Pennsylvania, California, and New Jersey are still trying to decide how to handle these suits. (The cases were mostly filed in state courts after the Judicial Panel on MultiDistrict Litigation, MDL, denied a bid to consolidate the metoclopramide litigation on a federal level). Judges in those states have taken very different approaches to their metoclopramide dockets. For example, in San Francisco and Philadelphia, judges have allowed thousands of personal injury suits against the generics to move forward, despite Mensing. But last week, a Superior Court judge in Atlantic City, N.J., ruled that generics are off the hook in her court. She said that until the FDA modifies its regulations, or Congress amends the status, there is no authority to allow claims for “failure to warn” to proceed against generic drug manufacturers that have mimicked the brand name labeling.
On the other hand, the results in San Francisco and Philadelphia were based on plaintiffs’ claims against generic drug makers that even if the generics could not change the FDA-mandated labels, they could have taken other steps to warn consumers, such as sending letters to physicians regarding the drugs’ risks, or pulling metoclopramide products from the shelves.
Reglan is an acid reflux drug used to treat various conditions, including gastroesophageal reflux disease (GERD) and heartburn. The drug has been linked to serious neurological side effects, most commonly known as tardive dyskinesia (TD). TD is a condition that causes Parkinson’s-like symptoms, including involuntary movement of the extremities, lip smacking, and grimacing. The condition is often permanent and can be very debilitating. The involuntary shaking associated with TD can also be socially embarrassing, especially for a young person. TD is a horrible, devastating syndrome, which can last a lifetime.
Even though there is a black box warning for this dangerous drug – the most severe warning label the FDA can assign to a drug – it comes too late for so many people who took Reglan and its generic, metoclopramide.
In June 2011, the Supreme Court ruled with a 5-4 decision that generic drug companies do not share the same level of responsibility as the makers of brand-name drugs to update their product labeling. This decision is forcing many plaintiffs who have filed lawsuits over their side effects to alter their lawsuits. Hopefully, with all the available research to back up plaintiff’s lawsuits, things will improve for them.
Do you think this is fair that generic companies have no liability to the consumers, even though they were aware of the potential risks their drugs would cause? These injuries are permanent and life changing, and if the generic companies continue to get away with this, nothing will ever change. Can you imagine taking a generic drug, the makers of which know causes debilitating side effects which are not on the brand-name’s warning label, yet because of this Supreme Court ruling, they have no liability or responsibility to alter the brand-names’ warnings?