In the Southern District of Florida, generic manufacturers and repackagers of ranitidine recently filed a motion to dismiss the complaint pending against them in the case, In Re: Zantac (Ranitidine) Products Liability Litigation. This MDL consolidated over 500 lawsuits following the recall of ranitidine, sold both generically and under the brand name, Zantac. The generic drugmakers allege that the plaintiff consumers suffered no injury.
The Zantac Recall
Earlier this year, the United States Food and Drug Administration issued a recall of Zantac, a medication used to treat heartburn. This was prompted by the discovery that the medicine contained high levels of a cancerous chemical, N-nitrosodimethylamine (NDMA). The recall also applied to all generic manufacturers of ranitidine, Zantac’s generic name.
The dangerousness of ranitidine was first discovered in September 2019, when an online pharmacy advised the FDA that its products tested positive for unsafe amounts of NDMA. The FDA issued a statement advising manufacturers to test its products, and by November 2019, the FDA released its own testing results indicating ranitidine medications could exceed safe amounts of NDMA when stored at high temperatures over time. By December 2019, over a dozen ranitidine manufacturers issued recalls of its products and retail pharmacies suspended sales of the drug.
Class action lawsuits against Zantac and its generic manufacturers were quickly filed by plaintiffs who had developed cancer after years of taking Zantac. As a result, over 500 lawsuits were consolidated by the Judicial Panel for Multidistrict Litigation and transferred to the Southern District of Florida (In Re: Zantac (Ranitdine) Products Liability Litigation, MDL No. 2924). In response, the generic manufacturers and repackagers of ranitidine filed a motion to dismiss the complaint, alleging that the plaintiffs suffered no injury. The motion is currently pending before the Southern District of Florida.
Ranitidine Manufacturers’ Claims
Most of the class actions are comprised of plaintiffs who had taken Zantac or the generic drug for years and later developed cancer. But some plaintiffs filed on the basis that they will develop cancer in the future and will require medical monitoring. Ranitidine manufacturers have moved to dismiss these lawsuits because they do not allege an “actual physical injury” nor claim that the medications were ineffective. The defendants allege that the complaints actually affirm the medication’s efficacy and that because the ranitidine did exactly what it was supposed to do without causing an injury-in-fact, According to the defendants, absent any physical injury or ineffectiveness, plaintiffs’ claims that the medications were “worthless” is not a recognizable injury. But rather, “a purchaser who consumed the medication, received symptom relief, and suffered no apparent adverse effects attributable to the alleged defect” is not entitled to damages.
In their complaint, the plaintiffs alleged physical damages in the form of “cellular, sub-cellular, and/or genetic injuries that significantly increased their risk of developing various types of potentially deadly cancers.” The defendants argue that such a risk does not rise to the level of a physical injury, but rather, is based on speculation.
The defendants further argue that plaintiffs’ request for an injunctive remedy in the form of a trust fund to pay for their medical monitoring should be denied because such funds are considered monetary damages and not injunctive or equitable relief. The defendants also note that injunctive relief seeking to prevent defendants from marketing and selling ranitidine is a moot point because the defendants have already recalled the medication from the market and ceased sales.
Plaintiffs’ Opposition to the Motion to Dismiss
In opposition to the ranitidine manufacturers’ motion to dismiss, the plaintiffs argue that their injuries are cognizable under Eleventh Circuit case law which holds that “products that are so unsafe that they are illegal to buy or sell are also economically worthless” give rise to a constitutional injury-in-fact under Article III. The ranitidine medication, plaintiffs argue, was misbranded and adulterated to an extent that deemed it worthless, regardless of its efficacy in performing as advertised to treat heartburn and other ailments. The premise of the argument, supported by prior case law, is that consumers would not have bought the product, regardless of efficacy, if it was deemed unsafe. Further, the plaintiffs argue that the medication was not lawfully sold “at least as soon as Defendants knew or should have known that the molecule breaks down into NDMA.”
As to the possibility of developing cancer, plaintiffs point out that all ranitidine breaks down into NDMA and can cause cancer, so the medication taken by plaintiffs who now have cancer was no different than the medication ingested by those who have not (or not yet) been diagnosed. There is no evidence that the medication differed in defectiveness or likelihood of breaking down into NDMA. But plaintiffs who have not been diagnosed with cancer still “face an increased risk of developing cancer and will be forced to pay for and endure lifelong medical monitoring, treatments, and/or medications, and to live with the fear and risk of developing additional health consequences.”
Lastly, because the defendant manufacturers may seek to market ranitidine in the future, the plaintiffs argue that their request for injunctive relief demanding defendants to cease all sales of the medication is not moot. The plaintiffs further note that the “billions of dollars” the defendants made by “deceiving millions of consumers” for decades suggests that they will not permanently stop the sale and marketing of ranitidine unless ordered to do so by the court.
It is estimated that prior to its recall, more than 15 million Americans were taking prescription ranitidine and millions more were taking the over-the-counter version. With such a potentially large pool of potentially affected individuals, and with additional class actions constantly accruing, the defendants’ motion to dismiss plaintiffs’ complaint will undoubtedly set the tone for future litigation moving forward.
