If you stop seeing Zantac and other generic heartburn medications on the shelves of your local CVS or Walgreens, it’s for a very good reason: CVS Health Corp decided to pull the drug until further notice. The FDA is currently looking into whether the trace amounts of the carcinogen “N-nitrosodimethylamine” (NDMA) found in the medication poses a risk to those taking it. The FDA did not recommend pulling the drug, and does not recommend that those who need it stop taking it, stating “although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
While the risk of the medication being declared dangerous is relatively low, let’s still take this opportunity to look into what might happen legally if consumers start reporting adverse drug events.
Classifying the Defect
For a case to be brought to trial, the defect of the drug must be determined. This generally comes down to where there is fault along the line from designer to consumer. If the drug is dangerous because the designer chose to replace safe ingredients with cheaper, dangerous ingredients. This is called Defective Design. If the drug was designed to be safe, but the manufacturer uses incorrect materials or fails quality control tests in their facilities, this is Defective Manufacturing. If the drug was designed and manufactured correctly, and there are known, unavoidable risks of the drug but the marketing campaigns for the drug fail to mention the risks, this is Failure to Warn or Defective Marketing.
Due to the recent nature of the pull and the investigation of batches of ranitidine (the drug NDMA was found in) instead of every heartburn medication on the market, it is unlikely that the defective would lie in design or marketing. This means it would probably be a claim of Defective Manufacturing.
Type of Lawsuit
If large numbers of people begin coming forward with reports of adverse drug events, a lawsuit is bound to occur, one way or another. When it comes to defective drugs, it would be most likely to be a mass tort, multidistrict litigation (MDL), or a class-action lawsuit.
A mass tort occurs when multiple people file a suit against the party responsible for their suffering. They are most common with defective drug and medical device cases. The plaintiffs all have similar complaints about the same drug and work as a group to gain momentum and power during a lawsuit against a major company.
Multidistrict Litigation (MDL)
MDL occurs when multiple mass torts merge to use combined resources to speed up the trial. The transformation into MDL happens for federal trials, after which individual cases may be heard in state courts.
Class-action lawsuits are less common for defective drugs and medical devices, and describe a case in which multiple plaintiffs are consolidated into a single “class.” The class may have representatives from the group, and often includes people with a common complaint.
Should Zantac and other heartburn medications be found to be dangerous, it is likely that a mass tort and eventually MDL would be filed against the manufacturers of ranitidine. NDMA has been shown to increase the risk of uterine and colorectal cancers, in high enough doses. If people do start getting hurt from their use of this medication, they’ll want a good lawyer.