If 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.

Many 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.

The Master Complaint in the Zantac MDL makes over one hundred pages of allegations against companies involved in the manufacture, sale, distribution, and repackaging of ranitidine, both with brand-name Zantac and its generic equivalents.

Let’s dive in. Before the Master Complaint can even get to the allegations connecting ranitidine to cancer-causing compounds, it must first set out the parties involved.

The Plaintiffs:

The Plaintiffs in the Zantac MDL are people who took prescription or over-the-counter (OTC) Zantac or generic ranitidine over a period of time, later developed certain cancers, and then brought a claim for damages. For MDL No. 2924, these plaintiffs must be residents of the United States, and they can include not only the individuals who were diagnosed with cancer, but also the spouses, children, heirs, and estates of other cancer-stricken plaintiffs. The cancers involved include “bladder, brain, breast, colorectal, esophageal or throat, intestinal, kidney, liver, lung, ovarian, pancreatic, prostate, stomach, testicular, thyroid, and uterine.” Master Complaint, p. 5. Other cancers may well be involved in this litigation, and this list should not be taken as exhaustive. The bottom-line is this: if you took Zantac and later developed any cancer, you should have a competent attorney investigate your possible case.

The Defendants: Brand-Name Manufacturers. These are the multi-national pharmaceutical companies that manufactured and sold brand-name Zantac for decades:

• Boehringer Ingelheim Pharmaceuticals, Inc.
• GlaxoSmithKline (GSK)
• Pfizer
• Sanofi-Aventis

Generic Manufacturers. These are the companies that manufactured, marketed and sold generic ranitidine. There are dozens of these companies, from Acic Pharmaceuticals to Zydus Pharmaceuticals (literally A to Z). I won’t list them all here, but you can access all of them in the Master Complaint if interested.

Distributor Defendants. These are the companies that purchase ranitidine products from manufacturers and then sell to Retailers. The following distributor defendants control 92% of the total volume of ranitidine distribution:

• AmerisourceBergen
• Cardinal Health, Inc.
• McKesson Corporation

Retailer Defendants. Retail Defendants are those companies with drugstores you can walk into, or online pharmacies from which you can purchase medications like Zantac. These companies may also repackage ranitidine and place their own individual labels. As you can imagine there are dozens of these companies. I won’t list them all here, but Retailer Defendants include Amazon, Costco, CVS, RiteAid, Walgreens, Walmart, and many smaller companies.

Repackager Defendants. These defendants include several defendants referenced above, but this class of defendants is simple enough: repackagers take a generic ranitidine product and place different labels on the medication and sell as their own product. For example, when you buy Costco or CVS brand ranitidine, you are buying from a repackager. Other Repackager Defendants include Denton Pharma, Golden State Medical Supply, and Precision Dose.

So these are the players in the Zantac litigation as identified in the Master Complaint. In Part 2, I will work to simplify the factual allegations involving Zantac and ranitidine, focusing on the key allegations connecting the medication to N-Nitrosodimethylamine (“NDMA”), which is a cancer-causing compound, and which, according to the Complaint, has caused hundreds of thousands of people to be afflicted with many types of cancer.

As always, if you took Zantac or a generic and have further questions, you can always call me to discuss further: (919) 830-5602. Good luck.

“Apples to Oranges”

In a stunning marketing document directed at surgeons titled “Apples to Oranges,” Smith & Nephew announced boldly that the Birmingham Hip Resurfacing system “is not your average ‘metal on metal.’ It’s BHR.” Depicted in the advertisement is an apple with the names of other artificial hip products: ASR, Durom, Cormet, Conserve. It is rather astonishing, suggesting that the BHR was better and safer than these other MoM hips. I guess the BHR is the orange.

[I must interject that most surgeons and hip device makers acknowledge by now that all metal-on-metal hip devices are not safe to implant in human beings.]

S&N did not stop there. In letter to physicians in 2010, S&N represented that:

• there is no evidence connecting hip replacement surgery to “any” malignant disease;
• there is no evidence that increased cobalt and chromium levels are associated with toxicity found in some MoM patients;
• there is no evidence that increased chromium and cobalt levels in the body cause adverse health effects.

Essentially, it appears that S&N represented that cobalt and chromium ions in the blood and tissue were not a health risk, or at least, that no evidence supported such a conclusion. Let me stop here and state that metallosis–caused by higher chromium and cobalt levels in the blood from MoM hips–is not safe. You can read more about these health risks here and here. In any event, the Master Complaint points out that S&N knew about the medical evidence showing that metal levels have harmful effects on the human body, but did not update its product materials or its communications to surgeons with this vital information.

“A Bald-Faced Lie”

In fact, S&N doubled-down on its representations of BHR’s superiority and safety. In an advertisement in the Journal of Bone and Joint Surgery, S&N announced:

• “The bottom line is that the poor results of a few [MoM hips] have painted a negative picture of all metal on metal devices. But the BHR hip is not your average metal on metal device; it’s BHR!” [I suppose the exclamation point settles the debate.]
• the BHR device had a 95% survivorship rate after ten years.
• A recent study . . . showed “no revisions of BHR hips due to metal wear.”

The Master Complaint calls the assertion that no BHR hips had required revision due to metal wear a “bald-faced lie.” MC Paragraph No. 79. Studies showed, instead, that patients with the S&N BHR were getting revision surgeries due to metal wear.

Surgeons Needed 1,000 Surgeries to Master the Hip Resurfacing Technique

Dr. Derek McMinn, the inventor of the S&N BHR device, stated that orthopedic surgeons needed to perform 1,000 resurfacing surgeries in order to get proficient with the surgical procedure. S&N did not disclose this information to surgeons. Further, as part of the premarket approval for the BHR, S&N was required to provide surgical training and to study the surgeons’ resurfacing techniques, but failed to complete this vital part of the PMA requirements.

Not surprisingly, a 2012 BHR study found that the revision rate was three times higher for BHR patients than it was for the specific English surgeons (including BHR inventor, McMinn) trained in the resurfacing technique. The study concluded that orthopedic surgeons who were not a part of the BHR design team were not able to reproduce the results of the BHR design team. Which is to say, if you were lucky enough to have the BHR implanted by one of the BHR designers in England, you may get a positive result with the BHR, but if your orthopedic surgeon down the street in your hometown performed the resurfacing procedure, there was a much greater likelihood the BHR would fail.

A second study in 2012 found even worse results for orthopedic surgeons not carefully (even exhaustively) trained in the BHR resurfacing technique. A third study in 2012 found similarly bad results for recipients of the BHR.

The Master Complaint then states the worst part of all this: Smith & Nephew did not provide these studies to the medical community or to the FDA. Instead, according to the Complaint, for years S&N cherry-picked the data to put the best spin on the results of the BHR.

Finally, after several years, several studies, and thousands of BHR failures, S&N finally recalled the BHR on September 10, 2015.

There is much more to process in the Master Complaint. I will continue to summarize my review in later posts. In the meantime, if you had the BHR implanted and it failed, requiring revision surgery, give me a call to discuss your possible legal case against Smith & Nephew.

Note: The information in this post was obtained from the Master Amended Consolidated Complaint in the S&N BHR MDL. The statements in the Master Complaint are allegations, which means they are not yet proven or established. Smith & Nephew has answered the Complaint and has denied many of the allegations.

But First, How Do We Get to a “Master Complaint”?

This is how product liability multidistrict litigation begins: a product (like an artificial hip) hits the market. The artificial hip is implanted in thousands of patients. A year passes, then a few more. Patients complain of aches, pains, inflammation, noises, maybe even neurological symptoms. Doctors notify the manufacturer and their patients of these bad outcomes. Post-market studies are done. Problems are discovered with the product (in the case of metal-on-metal artificial hips, those problems included metallosis, loosening, pseudotumors, and many other “bad outcomes”). Injured people file lawsuits in courts around the country. The Judicial Panel on Multidistrict Litigation (JPML) eventually realizes it needs to designate one court to handle pretrial issues with the hundreds of cases being filed, so a multidistrict litigation (MDL) site is chosen, and the lawsuits are transferred to that MDL court. From there, the plaintiffs consolidate their efforts, and eventually a Master Complaint is carefully drafted and filed.

Smith & Nephew Birmingham Hip MDL

So it was with the Smith & Nephew Birmingham Hip Resurfacing (“BHR”) Artificial Hip MDL. In April 2017, the JPML designated the federal court in Maryland as the site for the S&N BHR cases (MDL 2775). Once designated, plaintiffs organized themselves, began discovery, filed motions with the court, and eventually produced the Master Amended Consolidated Complaint. Filed with the court on August 11, 2017, it is a staggering document. The Master Complaint is 160 pages, and sets out allegations involving misrepresentations, misleading studies, cherry-picked data, aggressive marketing, corporate negligence, and hundreds of injured recipients of the S&N BHR device. In this post (and in later posts) I will set out the key allegations and claims in the S&N Master Complaint.

Misrepresentations Alleged in the Master Complaint

The S&N BHR was first sold in the United States in 2006. Although the BHR was approved by the FDA for sale following a “pre-market approval” (PMA) process, the plaintiffs allege that S&N failed to comply with many of the PMA conditions (more on that later). The Master Complaint alleges that S&N was also negligent in its manufacturing processes. And despite the fact that metal-on-metal artificial hips from other companies were failing and were recalled, and despite mounting evidence that the S&N BHR was also failing at an unacceptable rate, S&N did not recall the BHR until September 2015. This was more than five years after the DePuy ASR was recalled. In that five year period, many people received the BHR and were later harmed by the failure of the BHR.

In a hip resurfacing procedure, the femoral head is not replaced. Instead a smooth metal covering is fixed over the existing femoral head, and a metal acetabular cup secured in the patient’s acetabulum. From there, the cup and the metal femoral covering in a cup and ball system. When the patient walks, the acetabular cup and the femoral head metal cover “articulates” or moves together. In this motion, metal debris can be spun off and released into the person’s body. S&N represented early in the life-cycle of the BHR that its metal-on-metal construction was different from other metal-on-metal hips like the ASR and the Zimmer Durom. According to the Master Complaint, Smith & Nephew openly represented that the BHR components released less metal debris than other metal-on-metal hips, and also had higher success rates than other MoM hips. In one promotional marketing document, S&N stated that the amounts of chromium and cobalt released in the body from the BHR “are so small that they’re measured in a unit called a micron. For perspective, a human hair is about 100 microns in diameter.”

Further, in a 2012 press release, a senior VP from S&N stated that the BHR was “unlike any other [metal-on-metal] hip implant” and that the BHR had a “distinctive metallurgy heritage” (whatever that means). See Complaint, ¶ 41. S&N also allegedly stated that pseudotumors were “benign.” S&N pronounced the BHR safer than hips containing ceramic components (such as a femoral head).

Injured Plaintiffs: The Birmingham Hip Was Not Safe

The Master Complaint states that these representations by Smith & Nephew were false. Instead, plaintiffs allege that the BHR was not safe, that MoM hips as a class are unsafe, and that ceramic hips are safer than MoM hips. Beyond that, plaintiffs allege:

• the BHR failed at a much higher rate in women and in patients with smaller femoral head sizes;
• studies showing greater BHR safety were done by surgeons who designed and sold the BHR for S&N;
• one designer believed that surgeons needed 1,000 surgeries before they would be considered effective in the hip resurfacing technique, but did not widely convey this critical information to the medical community;
• metal ions in the blood are harmful, period;
• the BHR produced more metal ion levels than were normally found in the body;
• the S&N BHR studies lost track of many BHR patients;
• the real world failure rate was higher than early studies upon which S&N relied;
• the revision surgery for a resurfacing patient is more complex and difficult than a revision surgery for a patient with a total hip replacement.

In my next Smith & Nephew Birmingham Hip Resurfacing blog post, I will look further into the allegations made in the Master Complaint.

Note: The information in this post was obtained from the Master Amended Consolidated Complaint in the S&N BHR MDL. The statements in the Master Complaint are allegations, which means they are not yet proven or established. Smith & Nephew has answered the Complaint and has denied many of the allegations.