Articles Posted in Zantac

iStock-518657244-300x286After news broke that Zantac (the brand name for ranitidine) was linked to cancer, a large wave of lawsuits started making their way into state and federal courts. Many of these cases have been consolidated into the Zantac multi-district litigation, or MDL 2924.

The Zantac MDL is still in the early stages of litigation, but the court just handed down two major decisions that could dramatically undermine a majority of the cases and claims.

We’ll go over these two decisions, but before we do, we need to provide a little context. We’ll start with outlining the defendants and claims in the Zantac MDL, then discuss a legal concept called “preemption.”

Zantac and generic ranitidine
Generic drugs are a big deal in the United States. According to the U.S. Food and Drug Administration (FDA), 90% of prescription medications are filled with a generic drug. One of the reasons so many people take generic medications is the cost savings. From 2007 to 2016, generic medications saved $1.67 trillion. A generic version of Zantac has been sold since 1997.

But how is a generic drug different from a brand-name drug? Does this difference matter in the Zantac litigation? If so, where does innovator liability come in? I’ll address these questions in the following blog post. But first, a brief update into the Zantac litigation.

Current Status of Zantac Litigation

iStock-518657244-300x286In Part 2 of this series we looked at the development of ranitidine (brand name Zantac), its rise as a hugely profitable heartburn drug, and the discovery that the carcinogen NDMA was found in rantidine, eventually leading to its recall and removal from the market. In this Part 3 I discuss how ranitidine can evolve into the cancer-causing chemical NDMA.

Nanitidine Can Form NDMA in the Stomach

When ranitidine enters the stomach, it can interact with “nitrites.” Nitrites are chemicals often found in spicy or salty foods. Food producers add nitrites to certain foods to prolong shelf life. All the way back in 1981, Dr. Silvio de Flora published a study showing that when ranitidine is introduced to nitrites it can lead to “toxic effects.” Dr. de Flora cautioned that if people take ranitidine, they should eat foods low in nitrites and avoid ranitidine near meal times.

Zantac Master Complaint
In Part 1 I discussed the concept of the Master Complaint in product liability multi-district litigation, and we also set the table with the plaintiffs and the many defendant-companies involved in the Zantac litigation. Now let’s keep grinding through the Zantac Master Complaint. The story of Zantac, the presence of the carcinogen NDMA, and the links to cancer can be found in the Factual Allegations, beginning on page 39 of the Master Complaint. (Note that I use the brand-name Zantac and its actual name ranitidine mostly interchangeably in this post.)

These are the key elements of the story:

Inventing and Selling Ranitidine

Zantac Master ComplaintIf you truly want to learn about a particular litigation involving a defective product (such as Zantac), the best place to start is the Master Complaint. This is the lengthy comprehensive document filed by the plaintiffs in a multi-district litigation involving a defective product. This does not mean the case is a class action. Most product liability cases are not class action lawsuits but are rather individual lawsuits gathered together in a “multi-district litigation or MDL.” These cases are transferred from across the country in one court, where one federal court judge will oversee the litigation until either (1) a global settlement is reached or (2) the cases are ready to be returned to the their home courts for trial.

The multi-district litigation involving the drug Zantac is located in the Southern District of Florida (MDL No. 2924). On June 22, 2020 the plaintiffs filed their Master Personal Injury Complaint. It is a long and detailed document, and it is worth your time to read if you have taken Zantac over an extended period, and certainly if you have taken Zantac and later developed cancer.

ZantacMany people, understandably, are not thrilled to read a 158-page legal document. So today and in the days to follow I am going to write up key bullet points from the Zantac Master Complaint. First, a few general guidelines: a complaint is the document a plaintiff files in a court to start a civil case. It can be a single page, alleging that the neighbor’s dog bit the plaintiff and caused injuries, or it can be hundreds of pages long, involving many defendants and many claims. The key thing to remember is that the complaint involves allegations, not proven facts. It may well be that every word of a complaint is true and that the plaintiffs provide compelling evidence for every allegation at trial. But at the start of a civil case the complaint should be understood as a series of allegations, which the defendants are allowed to deny and which they often deny. And that’s where the courts and juries come in: to figure out which side has proven its case.

Zantac and cancer
Earlier this year I wrote a blog post that discussed the recent revelation that Zantac might cause cancer. Scientists found a link between N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance, and ranitidine, the key ingredient in Zantac.

A few things have changed since that blog post, such as the U.S. Food and Drug Administration (FDA) asking all manufacturers to immediately recall drugs containing ranitidine from the market.

Why Did the FDA Ask for a Recall?

Zantac and cancer-causing NDMA
Many of us suffer from heartburn, and one of the most popular ways to treat it is by taking Zantac. Until recently, Zantac was considered a very safe medication and was available without a prescription.

Given how well it worked, along with its affordable price and the perception of safety, hundreds of thousands of people, if not millions, took Zantac. In the fall of last year, the US Food and Drug Administration (FDA) reported that this popular drug might contain N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance.

The past few months have resulted in mass voluntary recalls and a rush of FDA updates and reports about the possible dangers of taking Zantac and what it means for consumers. This blog post will attempt to summarize what’s going on and briefly discuss what happens next.

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