It is a bracing preview of the kind of evidence that plaintiffs will be prepared to present at trial if and when Bell v. Boehringer Ingelheim Pharmaceuticals, Inc. et al is consolidated with other cases in the multidistrict litigation (MDL) now pending in the Southern District of Florida.
Who killed Carl Glasper?
Carl Glasper is dead. This much we know for sure.
What killed Carl is a threshold issue. As the Complaint describes it, “Mr. Glasper purchased and ingested Zantac that was manufactured, marketed, and sold by Defendants. As a direct and proximate result of ingesting Zantac, Mr. Glasper contracted cancer and died.” Defendants, Boehringer Ingelheim Pharmaceuticals, Glaxosmithkline, Sanofi US Services and John Does 1-5, will certainly plead intervening causes. In other words, the killer was someone (something) else.
The question of “what” is a factual issue that must, ultimately, be resolved at trial. That’s where the scientific evidence will play its starring role.
Who killed Carl is the legal issue. It gets to who knew what and when. Was there willful ignorance or deliberate deception? And how long did it go on?
Powerful evidence of toxicity - 178 pounds of bacon in 24 hours
The Complaint is worth a deep dive for those with the background in chemistry and medicine to fully appreciate the evidence that Zantac causes cancer. For the rest of us, here are the high points:
- N-Nitrosodimethylamine (NDMA) is a powerful carcinogen;
- In small doses, which the FDA finds harmless, it exists in the environment and food like bacon;
- In higher doses, NMDA has been linked to several forms of cancer, including bladder cancer, breast cancer, stomach cancer and various forms of reproductive cancer;
- every single dose of Zantac, produces levels of NDMA in an amount that exceeds the FDA’s permissible daily limits for the carcinogen by thousands of times.
Who knew what? When? And did they keep it a secret to maximize profits?
At the outset, it is important to note that Zantac was a wildly successful drug, reaching $1 billion in total sales between its approval in 1983 and December 1986. Even though its market dominance declined in later years, it is reasonable to assume that there were still powerful economic incentives to hide the bad news.
During those and later years, there was a significant amount of scientific literature that linked Zantac to certain types of cancers in humans. In 2004, an epidemiology study linked Zantac use to bladder cancer. For example, the study noted that among those participants who took either cimetidine (a related drug) or Zantac, “[w]e observed an increase in bladder cancer risk among men who reported taking either of these medications.”
The legal arguments
READ MORE ZANTAC HEARTBURN MEDICATION LEGAL NEWS
- By design, Zantac was and is unreasonably dangerous and unsafe;
- Defendants failed to provide any warnings of the dangers surrounding the fact that NDMA and other harmful metabolites form in the body following ingestion of Zantac;
- Carl Glasper was injured because he took Zantac;
- If he had known of the defects in Zantac, he would not have taken it. Instead, he would have taken a safer alternative to Zantac that would not have exposed him to harmful levels of NDMA;
- Defendants had a duty to monitor the adverse effects associated with Zantac, which they failed to do;
- In fact, defendants knew that the drug was dangerous and that Carl and his family had no way of knowing that. They intentionally omitted from its prescriber and/or patient labeling any type of warning alerting patients and their physicians that Zantac forms high levels of NDMA and other harmful chemicals in the body.
- Carl’s pain is ended, but Hiheshia continues to suffer the loss of her husband.
Next steps
The FDA asked manufacturers to withdraw Zantac and similar prescription and over-the-counter heartburn medications from the market. It has also advised those who use similar OTC heartburn medications to stop taking them immediately and patients with prescriptions to speak with their health care providers.
The U.S. Judicial Panel on Multidistrict Litigation recently ordered that all Zantac cancer lawsuits be centralized and consolidated in the District Court for the Southern District of Florida for coordinated discovery and pretrial proceedings. That is likely the next stop for the Bell lawsuit.