Manufacturers of Generic Drugs Off the Hook in Zantac MDL
Plaintiffs in the Zantac multi-district litigation (MDL) received a blow when a judge for the United States District Court for the Southern District of Florida ruled in favor of the generic defendants in the case. The judge granted a Motion to Dismiss filed by the generic defendants. The result is that the generic defendants are released from the Zantac lawsuits.
Why Did the Judge Allow Generic Defendants to Escape Liability?
The Zantac lawsuits accuse the makers of Zantac of selling a defectively designed medication, failing to provide adequate warnings to consumers and physicians of potential cancer risks, and other product liability claims. The lawsuits also name 32 companies that made, repackaged, sold, or distributed generic forms of Zantac.
The judge in the case ruled that claims against the generic drug manufacturers were preempted. The judge said the defendants could not provide additional warnings and remain within federal law, and they could not remedy a design defect. Therefore, the claims against these generic defendants were dismissed.
Attorneys for the plaintiffs argued that the generic defendants could have changed one crucial piece of information on the packaging and still been in compliance with federal law. They could have changed the expiration dates for the medication.
The issue of the expiration dates is important in this case. Plaintiffs argue that the medication did not remain stable through the expiration date. The instability of the medication increased the levels of N-nitrosodimethylamine (NDMA), a known carcinogenic.
Therefore, plaintiffs claim that the generic defendants could have shortened the expiration dates because that would not violate federal law. The judge agreed that under a separate legal precedent that the generic defendants could be liable. The “failure to warn” claim would survive if the plaintiffs could prove that the generic defendants could have legally changed the drug’s labeling to shorten the expiration date.
Unfortunately, the plaintiffs did not include these allegations in their complaints. The judge also noted that the plaintiffs’ allegation about the drug becoming more dangerous over time could contradict their allegations that the medication was defective and dangerous upon its manufacture.
The judge gave the plaintiffs 30 days to file additional allegations against the makers of generic Zantac. Therefore, the generic makers may remain in the lawsuit pending the judge’s decision on any new pleadings filed by the plaintiffs.
What Are the Zantac Lawsuits About?
Zantac was a very popular heartburn medication. GlaxoSmithKline (GSK) first created Zantac in 1977. GSK gained approval by the Food and Drug Administration in 1986, and the medication went generic in 1984. There were more than ten manufacturers who made the prescription form of the drug.
The main ingredient in Zantac is ranitidine. Pfizer created an over-the-counter ranitidine medication in 2004. Before the products were removed from store shelves, more than 20 manufacturers made the over-the-counter ranitidine.
Plaintiffs are suing the drug manufacturers claiming that the medication had a design defect, and the companies failed to warn consumers of the risk of cancer.
On April 1, 2020, the FDA requested the removal of all ranitidine products from the market. It is alleged that ranitidine has NDMA. Therefore, taking Zantac or one of the generic forms of ranitidine increases a person’s risk of developing cancer.
Individuals who developed cancer after taking Zantac or ranitidine filed lawsuits against the drug manufacturers, including those companies who produced the generic versions of ranitidine.
What is the Status of the Zantac Lawsuits?
The lawsuits were combined into an MDL or multi-district litigation. The U.S. District Court for the Southern District of Florida is handling the Zantac MDL. Even though the cases are being heard in Florida, victims throughout the United States can file to join the lawsuit.
The MDL is not a class-action lawsuit. It merely combines numerous cases related to the same event into one large collection of cases. Combining the cases allows for efficient and expedited handling of the claims, but the cases remain separate.
There have not been any settlements in the case. Zantac litigation began toward the end of 2020. The judge will allow a few cases to proceed to trial. The other plaintiffs and the defendants analyze the results of those cases and use that information for negotiations to settle their own cases.
There Are Deadlines for Filing Zantac and Ranitidine Lawsuits
The deadlines for filing ranitidine lawsuits vary by state. Your deadline to file a lawsuit could be as short as one to two years after your diagnosis.
Therefore, it is best to seek legal counsel as soon as possible if you suspect that your cancer was caused by taking Zantac or ranitidine. Lawyers familiar with defective drug claims who handle mass tort cases are generally better equipped to advise you about these claims than attorneys who do not handle mass tort claims.