Feds Demand Answers in Zantac Safety Scandal

| Sep 2, 2020 | Products Liability

The Department of Justice instructed GlaxoSmithKline and Sanofi, Zantac’s manufacturers, to provide information about its knowledge of the popular heartburn drug’s NDMA contamination.

DOJ lawyers believe that these manufacturers might have violated the False Claims Act. Many of the thousands of Zantac lawsuits currently pending claim that the drug makers knew about the risk of NDMA contamination as far back as the early 1980s, yet they did nothing to warn consumers. In 2019, almost forty years after this evidence appeared, the Food and Drug Administration finally issued a partial recall order.

NDMA, or N-nitrosodimethylamine, is one of the most dangerous cancer-causing agents known to science.

Theoretical Liability

Manufacturers are strictly liable for the injuries their dangerous drugs or other dangerous products cause. Malice, recklessness (intentionally disregarding a known risk), or even negligence is essentially irrelevant. 

Dangerous products have the potential to harm so many people that a strict liability standard is necessary to protect people. Otherwise, most companies would not hesitate to put profits before people. 

The Takata airbag saga is a good example. For many years, Takata used a stable chemical propellant in its airbags. As a result, the airbags inflated rapidly without exploding. But in the 1990s, the company switched to ammonium nitrate. That’s basically the same chemical which was involved in the recent ship explosion in Beirut. As a result, Takata airbags often exploded as well, especially if certain conditions were present.

Unforeseeable misuse is about the only legal defense in strict liability claims. For example, hand sanitizer labels clearly state that people should not drink the product. But since they contain so much alcohol, it is foreseeable that people will drink them. As a result, hand sanitizer manufacturers must ensure that their products are not unreasonably dangerous when drank.

Practical Liability

Victims must establish a link between product use and their injuries. The good news is that the burden of proof is only a preponderance of the evidence (more likely than not). That’s the lowest standard of proof in Kentucky law. So, a little evidence goes a long way.

The bad news is that the low burden of proof is a two-edged sword. Manufacturers must only refute these claims by a preponderance of the evidence. And, large companies have almost unlimited resources with which to hire expert witnesses. These individuals inevitably testify that the product was safe.

So, a Lexington personal injury attorney must partner with expert witnesses as well. And, Kentucky judges apply a very rigorous standard when they evaluate expert witnesses and determine their competency to testify. 

Moreover, the victim/plaintiff also has the burden of persuasion. So, expert witnesses must be able to convince jurors that their testimony is more reliable than the other side’s experts.

Things like negligence and recklessness are not relevant in terms of liability. But they are relevant in terms of damages, specifically punitive damages. This additional compensation is available if there is clear and convincing evidence that the defendant intentionally disregarded a known risk. 

Your Claim for Damages

As mentioned, dangerous drugs like Zantac often injure thousands or millions of people. It’s very inefficient to try these cases individually. However, the individual facts are so unique that a class-action claim is not appropriate either.

So, specialized Multidistrict Litigation panels often handle dangerous drug claims. For pretrial purposes, including discovery, one judge handles all these claims. These judges usually appoint special masters who have expertise in a given matter. If the case does not settle, it usually returns to its home jurisdiction for trial. This referral satisfies Seventh Amendment requirements and also respects the unique aspects of the laws in different states.

However, MDL claims usually settle out of court. Victim/plaintiffs may pool their resources so they can take on large, multinational corporations. Additionally, once one case settles, that action usually triggers a domino effect. 

There are exceptions to the general rule of out-of-court settlements. Frequently, the drug company feels that its brand name is at stake, so it fights dangerous product claims tooth and nail.

Dangerous drugs often cause serious injuries. For a free consultation with an experienced personal injury lawyer in Lexington, contact the Goode Law Office, PLLC. You have a limited amount of time to act.