NEW MDL LITIGATION ON THE HORIZON

By Brandon Salter

Michael Brady Lynch Firm

August 1, 2022

(Mass Tort News) – 2022 has been a momentous year for Multi-district Litigation, particularly in pharmaceutical MDLs such as Zantac, Valsartan, Elmiron, Taxotere, Nexium & Prilosec. It is expected that some of these cases will go to trial in the year 2023; however, the best is yet to come with new pharmaceutical multi-district litigation being consolidated by the JPML Panel. The first multi-district litigation on the horizon will probably be the vaccine Gardasil under MDL No. 3036. Now, Gardasil is a vaccine used to prevent HPV and was approved by the FDA in 2006,  developed by the pharmaceutical company Merck.  

Merck obtained FDA approval for Gardasil based on lackluster research and clinical trials that may have allegedly materially misrepresented the vaccine’s efficacy while covering up its safety risks and side effects. Once Gardasil became available to the public, thousands of adolescents and adults reported side effects after receiving the vaccine. The most prominent of the side effects is postural orthostatic tachycardia syndrome (POTS). POTS is the likely signature injury for the potential MDL, and it affects blood flow to the body resulting in a variety of symptoms such as fainting and rapid heartbeat.

POTS is a blood circulation condition that is caused by a unique set of symptoms when standing upright and a heart rate that rises at least 30 bpm from the horizontal to the standing position. Some of the injuries that are acquainted with this would be lightheadedness, fainting, trouble syncing, brain fog, weariness, headache, confusion, fuzzy vision, palpitations, and several other types of symptoms. POTS causes the patients who took Gardasil to have a much lower amount of blood circulation when they stand. Typically, the more standing the patient does, the more the blood collects in, the lower half of the body, which results in insufficient blood returning to the brain. So the re-uptake system is essentially flawed by the taking of the drug. In some cases, POTS can lead to very severe amounts of hypotension, which is a drop in blood pressure when standing, and it can be fatal.

In May 2022, there was a request made by plaintiffs’ lawyers of the injured Gardasil clients that asked the JPML Clerk to start a new MDL for the Gardasil HPV vaccine. Currently, there are 34 pending Gardasil lawsuits in 25 different federal districts. The Gardasil litigation is expected to grow very rapidly over the next year, and the main claim currently is an injury criteria of an autoimmune and neurological disorder.

Additionally, the preemption argument has been addressed with Gardasil. Preemption is the ability of injured patients and victims to hold manufacturers of medical drugs and devices accountable for the side effects that some of the drugs may have. Under the supremacy clause, the United States Constitution asserts that federal law is superior to state law. This means the FDA’s powers are seen as supreme in the case of medical injuries and damages. One example of preemption is the MDL Eliquis, where the federal law impliedly preempted the plaintiff’s failure to warn and design defects.

Also, regarding preemption: a federal court in Nevada struck down a Gardasil case, stating, “It was partially preempted by the Vaccine Act,” Which bars designed flaws and other certain failures to warn “against vaccine producers while permitting negligence claims.” Therefore, although preemption is always a concern when dealing with NMDL, yet it is not something that is impossible to work around in the potential Gardasil MDL.

The next MDL that is on the horizon is the Benzene sunscreen litigation. Benzene is one of the 20 most commonly used chemicals in the United States. It is also a known carcinogen. One of the common injury criteria right now for the benzene sunscreen litigation is leukemia because long-term exposure to it has shown linkage to leukemia. One key source of information regarding the benzene sunscreen litigation has been Valisure. Valisure is an independent laboratory that conducts research on products. Shortly after their research was published in July 2021, which revealed the cancer linkage of benzene products in sunscreen, there was a massive recall of sunscreen by multiple brands like Johnson & Johnson and Coppertone. There are currently 16 cases in the sunscreen MDL.  They are being presided over by the Honorable Raag Singhal in Ft. Lauderdale.

Another notable MDL on the horizon is Injectafer. It is a ferric carboxymaltose iron supplement used to treat iron-deficiency anemia. A single course comprises two doses administered seven days apart. Injectafer is primarily for anemic patients who neither tolerate oral iron supplements nor find them effective. In 2013, the FDA approved the iron supplement Injectafer, and over 800,000 U.S. patients have taken it. Shortly after FDA approval, studies revealed that the use of Injectafer could cause severe hypophosphatemia (HPP) in some patients, which is the signature injury. Hypophosphatemia is a very low blood phosphate level in the body. When it falls below 0.3 millimoles per liter, it becomes a condition known as severe hypophosphatemia which can be fatal. This is backed by research at Johns Hopkins, where some studies found that about half of the people who took the drug developed hypophosphatemia.  Also, according to a study done by the National Library of Medicine, the chances of developing hypophosphatemia after a dose of ferric carboxymaltose (FCM) were an astounding 70 percent. Yet another study done by researchers at JCI included about 2000 participants that had comparable incidences of severe hyperphosphatemia in those who received two different types of drugs: Injectafer and Feraheme. The study indicates that about 50% of the patients that used Injectafer had experienced some levels of hypophosphatemia, not necessarily severe hypophosphatemia. This was in contrast to Feraheme, which showed only about 0.9% of patients experiencing hypophosphatemia. And even after the studies, there was no warningincluded in Injectafer as a side effect.

Currently, as of July 2022, a total of 13 Injectafer product liability lawsuits have been filed in federal courts. Most of the Injectafer cases have been filed in the Eastern District of Pennsylvania, but at least one claim has been filed in the Middle District of Florida. Although the number of cases is small at this time, it is widely considered that there could certainly be a consolidated MDL dependent upon how many patients have experienced side effects of HPP from this drug. Additionally, it is essential to address the issue of preemption in any potential multi-district litigation. And in this case, it is no different. In 2020, an Eastern District of Pennsylvania judge rejected a preemption failure to warn claim, stating that the company lawyers failed to show that “the federal drugpreempts state law claims alleging inadequate warning and design defect.” That court stated that “a drug maker must show that it fully informed the FDA of the justifications for the warning required by state law” to prevail on preemption. That is not to say that another district judge will have the same opinion. However, it simply is to address the fact that preemption has been raised in addressed and at least one district. It will be essential to keep an eye on the preemption argument moving forward in this potentially upcoming MDL. 

Last but not least, the final MDL to watch is Elmiron. Elmiron is a medication that treats symptoms of interstitial cystitis, which is a type of bladder pain syndrome and is when someone has chronic pain that affects the bladder and pelvic floor. Currently, there are 1,725 cases in the MDL presided over by Judge Brian R. Martinotti, with trials expected in the coming year. There are still potential cases to be filed before the bellwether trials begin. One of the key injury criteria in the Elmiron litigation is maculopathy, which can result in the blindness of the patients who took this drug. Maculopathy is a term used for any disease or pathologic condition affecting the macula, which is the central region of the retina in the eye. The victims are mainly filing against Janssen Pharmaceuticals after they suffered vision problems that could lead to blindness. 

According to the annual meeting of the American Academy of Ophthalmology in 2019, a detailed study into the safety of Elmiron and its potential toxicity to the eyes was conducted by a team of ophthalmologists in Northern California based on thousands of patient records, which indicated the linkage to maculopathy and other damaging injuries to the eye for the unsuspecting patient. This study also conclusively showed that Elmiron was toxic to retinal tissue in the back of the eyes and that about 25% of the patients who used Elmiron displayed symptoms and signs of maculopathy or eye damage. The allegation is that Janssen failed to warn doctors and patients about the side effects, which included vision loss and potential maculopathy. In addition to those claims are the additional claims that Elmiron is a defective drug and that the adverse reporting of the injuries to the general public who have been prescribed Elmiron has been withheld. 

Michael Brady Lynch Firm

Here at the Michael Brady Lynch Firm, we are currently accepting each of the dockets listed above,  We have been litigating in the multi-district litigation field for over 10 years in Florida and will continue to do so and advocate on behalf of clients injured by the pharmaceutical industry. Each of these individual dockets is expected to be a major player on the horizon in the upcoming 2022 in 2023, and we will be at the forefront of each of them. 

Brandon Salter, brandon@mblynchfirm.com