In an order issued on October 24, 2022, in the Elmiron MDL 2973 products liability cases, Judge Martinotti of the United States District Court in New Jersey rescheduled the Windham bellwether trial to begin on March 27, 2023.
The Judicial Panel on Multidistrict Litigation (JPML) is the judicial entity that creates MDL cases from the pool of product liability cases filed in various federal and state courts. JPML creates these MDL cases for several organizational reasons. The first reason is to consolidate those product liability cases with similar claims, plaintiffs, and defendants to streamline pre-trial matters, such as discovery orders and the appointment of Special Masters.
Another significant part of the MDL process presents MDL plaintiffs and defendants with the opportunity to select bellwether cases and suggest them to the court. Bellwether cases are test trial cases selected from the larger group of the MDL’s cases. The bellwether cases test the plaintiffs’ arguments and defendants’ defenses to determine whether they will succeed in court.
The results of bellwether trials may also have a significant impact on settlement negotiations.
The following discussion presents a timeline of the significant events regarding the bellwether trials in the MDL 2973 litigation. The article concludes with a summary of the plaintiffs’ disputes against the Elmiron manufacturers.
MDL 2973 Significant Events Timeline (Most Current first)
Note: The following are the significant court orders regarding establishing the MDL 2973 and selecting MDL 2973’s bellwether cases. The court’s website lists many other case management orders setting pre-trial discovery and conference matters.
- November 1, 2022: Judge Martinotti of the U.S. District Court for New Jersey noted that MDL 2973 has 1,926 cases (1,680 federal and 169 state cases). Judge Martinotti amended his pre-trial order No. 17 to show that the Windham Bellwether trial was initially slated to begin on January 30, 2023.
- October 24, 2022: Judge Martinotti delayed the Windham bellwether trial to begin on March 23, 2023. The order does not indicate why the court delayed the start of the Windham trial.
- August 1, 2022: Judge Martinotti determined the order of the bellwether trials: The Windham case is the first bellwether case, followed by whatever case the defendants select, and the Manning case is the third bellwether case.
- June 1, 2022: Judge Martinotti ordered the Windham case as the court’s presumptive bellwether case. The plaintiffs selected Julia Manning v. Janssen Pharmaceuticals, Inc. as their bellwether case. The defendants will select their bellwether case, and that will be the third bellwether case.
- May 25, 2022: Judge Martinotti declared that 20 bellwether cases were selected out of the discovery pool, and of those bellwether choices, three cases were selected as test trial cases.
- March 7, 2022: The order set the fact discovery deadline for bellwether cases as March 31, 2022, and the bellwether case selection deadline as April 8, 2022.
- January 27, 2022: The parties identified 20 bellwether cases and continued to meet and confer on discovery issues for those cases.
- December 22, 2021: The bellwether cases were set as an agenda item, and disputes regarding the bellwether cases were set for resolution by the special master.
- May 13, 2021: The District Court for New Jersey issued a new case management order stating as of May 12, 2021, MDL 2973 consolidated cases numbered 225, 192 federal and 33 state cases. The court ordered that the first Elmiron bellwether trial commences in January 2023, with other bellwether trials to follow.
- April 30, 2021: Judge Martinotti appointed a Special Master to resolve any disputes defined as litigation proceeds.
- April 26, 2021: Judge Martinotti ordered the direct filing of cases under the MDL 2973 to avoid the delays inherent in transfers from other district courts.
- April 14, 2021: The U.S. District Court for New Jersey noted that MDL 2973 cases now numbered 209, made up of 180 federal and 29 state cases. The court ordered that the parties submit proposed orders to the court regarding plaintiff and defendant fact sheets and various discovery matters.
- March 10, 2021: The District of New Jersey said plaintiffs filed 196 product liability claims under MDL 2973, including 171 federal cases and 25 New Jersey and state cases. The order set April 14, 2021, for the next case management conference.
- January 15, 2021: The second case management order dismissed defendants Teva and Bayer from the case.
- December 18, 2020: Judge Martinotti issued the first case management order for MDL 2973, setting out the cases transferred to the court and setting the first case management conference.
- December 15, 2020: By this point, plaintiffs had filed more than 100 Elmiron lawsuits in various state and federal courts. On December 15, 2020, the Judicial Panel on Multidistrict Litigation (JPML) created the Multidistrict Litigation (MDL) No. 2973. For issues arising in discovery and pre-trial matters, the Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order to consolidate the lawsuits to the U.S. District Court for the District of New Jersey under Judge Martinotti.
The MDL 2973 case name is In Re: Elmiron Products Liability Litigation (Pentosan Polysulfate Sodium). The MDL plaintiffs seek monetary compensation for injuries they suffered due to taking Elmiron. The MDL 2973 defendants: Janssen, TEVA, Bayer, Alza, Centocor, Ortho-McNeil, and IVAX.
Recapping the Formation of Elmiron Litigation
The plaintiffs in the Elmiron MDL 2973 cases are various American consumers who suffered vision problems after taking Elmiron for I.C. Plaintiffs filed their cases in at least 11 federal judicial districts and various state courts before the JPML created MDL 2973.
The primary defendant in the product liability case is Janssen Pharmaceuticals, Inc. Since 1963, Janssen has been a wholly owned subsidiary of Johnson & Johnson, the massive health products company. Other defendants initially included other distributors, such as TEVA, Bayer, Alza, Centocor, Ortho-McNeil, and IVAX. Janssen is the only defendant in all the cases because it owns the New Drug Application with FDA on Elmiron.
Several parties conferred on the dismissal of Bayer, TEVA, and various TEVA entities as defendants regarding the claims in which they were named. Janssen also agreed to hold Bayer “harmless for any claims related to promotion, marketing, or sale of Elmiron during the time the agreement” between Janssen and Bayer was in effect.
Who Is Janssen Pharmaceuticals, Inc?
Janssen is a manufacturer and distributor of many popular and best-selling drugs on the U.S. market. For one example, Janssen is the manufacturer of Johnson & Johnson’s COVID-19 vaccine. Janssen says that it “partners directly with patients and caregivers” to develop medicines.
The drugs developed by Janssen include products to treat:
- Heart disease,
- Alzheimer’s disease,
- Vaccines for infectious diseases,
- Treatments in the field of neurology, and
- Treatments for various forms of cancer.
Janssen developed 80 drugs in those areas over the years. Two drugs developed by Janssen that have harmed patients include the diabetes drug Invokana, and the antipsychotic drug, Risperdal.
Janssen is headquartered in Titusville, New Jersey, which made the U.S. District Court for New Jersey the choice for consolidation of the plaintiffs’ claims.
Plaintiffs filed various lawsuits against Janssen. Some claimed the products were defective in design. Others, like Elmiron, claim that Janssen did not warn the consumers, physician, or FDA about known risks associated with taking the drugs.
What Is Elmiron?
Elmiron is a drug known as pentosan polysulfate sodium (also referred to as PPS). Janssen first introduced PPS into the U.S. market in 1996 under the drug’s brand name, Elmiron. The Food and Drug Administration (FDA) approved the drug to treat the painful bladder condition known as interstitial cystitis (I.C.).
The drug will not cure I.C., but it relieves symptoms. Elmiron was, and still is, the only drug FDA-approved for treatment of I.C. That singular approval means Janssen enjoyed market domination from 1996 until now.
Elmiron relieves common symptoms of I.C.:
- Painful and urgent urination,
- Neuropathic pain (perceived as burning), and
- Lower abdomen, pelvic areas are tender to the touch.
Like most drugs, Elmiron has side effects:
- Hair loss (also known as alopecia),
- Weight gain,
- Abdominal pain,
- Abnormal liver function,
- Rectal bleeding,
- Bleeding gums, and
The drug causes bruising and bleeding because it is a mild blood thinner.
Elmiron and Vision Problems
Starting in 2018, patients reported these symptoms after taking Elmiron:
- Blurred central vision,
- Pigmentary maculopathy, a particular form of macular degeneration, a disease that causes loss of central vision,
- Pigmentary retinopathy, a particular form of the disease of the retina that causes loss of vision, and
- Impaired vision.
Damage to the macula is the most horrific reaction because the macula is the part of the eye that is the most sensitive to light. It is the place where vision is the sharpest.
A study reported on the long-term use of Elmiron in adult patients. The drug causes injury to the retina. Other studies strongly suggest that pigmentary macular damage may singularly affect Elmiron patients due to the drug’s toxicity. Then, in 2019, experts noted that maculopathy worsened even when patients stopped taking the drug. There are more general forms of maculopathy, but pigmentary macular damage only affects Elmiron patients.
In addition to the vision loss described above, the Elmiron lawsuits indicate serious vision loss from:
- Halo vision that causes bright circles or rings around lights,
- Nyctalopia (or night blindness) that causes patients decreased night vision or reduced vision in poor light,
- Metamorphosis, or shape distortion, and
- Unilateral (or bilateral) blindness from a lack of light perception due to optic nerve or retina injury.
In June 2020, the FDA announced that going forward, Elmiron’s labels must exhibit a warning about the potential for vision damage. The labels contained no such warning before June 16, 2020, apart from its common side effects. The new label also warned that the vision problems may not subside after patients stop taking Elmiron. In other words, the damage may become irreversible.
To date, FDA has not recalled Elmiron, and the drug remains highly accessible in the marketplace. Elmiron’s position as the only FDA-approved treatment for sufferers of I.C. continues to assure the drug’s availability to the public despite its disturbing history.
The Elmiron Claims
The difficulty for Elmiron patients is that they often take the drug on a long-term basis. Over the long term, patients frequently find their doctor must increase the dosage before they feel the benefit. The increase in dosage further increases the negative aftereffects. The long-term use and negative aftereffects provide ample opportunity for numerous plaintiffs to file product liability lawsuits. The latest case numbers from the U.S. District Court for New Jersey indicate plaintiffs filed 1,680 cases, both federal and state.
Furthermore, the lawsuits filed against Elmiron manufacturers indicate that clinical trials in the 1990s demonstrated that Elmiron caused vision issues. Yet, Janssen Pharmaceuticals did not warn patients, physicians, or the FDA about the growing evidence. The drug’s label before 2020 did not show any warnings about product use. Janssen continued to market the drug as safe until, in 2020, the FDA required a warning on the label.
Who Qualifies as an Elmiron Plaintiff?
People may qualify as a plaintiff in an Elmiron products liability lawsuit if they have taken the drug for at least two years and they:
- Suffer from vision issues; OR
- If they started having vision problems that persisted or worsened within one year of stopping treatment.
Medical records help confirm the diagnosis and show the doctor’s expectations for the condition. Patients will want to describe the emotional toll and how the condition affects daily activities.
MDL 2973 is still open for new cases even though the bellwether trials could start within months.