Brief Supporting New Mirena MDL Strikes Back At Bayer’s Opposition

Plaintiffs’ attorneys are firing back at Bayer, in their push to create a new federal multidistrict litigation (MDL) for Mirena IUD lawsuits filed on behalf of women diagnosed with idiopathic intracranial hypertension (IIH), describing the drug maker’s response to their original motion as “unusually vitriolic.”

In May, a group of nine plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to centralize all Mirena IIH lawsuits filed in the federal court system as part of a new MDL, separate from the existing litigation involving women who have experienced problems where Mirena IUD migrated and caused perforation injuries.

Mirena is a small T-shaped birth control device, which is implanted into the uterus to provide protection against pregnancy for up to five years. Known as an intrauterine device (IUD) or intrauterine system (IUS), the polyethylene frame for Mirena contains a steroid reservoir that release levonorgestrel, which is a second generation progestin used in many forms of birth control.

Plaintiffs in these new cases allege that Bayer knew about the link between levonorgestrel and IIH, also known as pseudotumor cerebri (PTC), yet failed to provide any warnings about the risk of problems caused by pressure on the brain from the build-up of cerebrospinal fluid while on Mirena birth control.

Earlier last month, Bayer filed a response in opposition to the creation of a new Mirena MDL, suggesting that plaintiffs were attempting to manufacture the litigation and arguing that the claims have no scientific basis.

In a reply brief (PDF) filed by plaintiffs on June 25, Bayer was called out for focusing more on “ad hominem” attacks than facts, suggesting that Bayer would have the MDL panel “believe that Plaintiffs’ counsel is the legal amalgamation of such diabolical villains as Professor Moriarty or Dr. Evil.”

“According to Bayer, [Plaintiffs’] counsel has masterminded a nefarious scheme in which he has a) ginned up meritless cases across the country, b) ‘manufacture[d] an MDL’, and c) ‘transparently’ manipulated federal court dockets… –all in hopes of having this Panel centralize the cases with a transferee judge before whom Plaintiffs’ counsel has never previously had a case,” wrote attorney Lawrence L. Jones, II.

Mirena IIH Side Effects

Bayer argued against centralization for the IIH lawsuits based on the merits of the underlying cases. The drug maker maintained that since most plaintiffs’ doctors described the condition as “idiopathic intracranial hypertension”, this suggests that problems are not a side effect of Mirena birth control, but rather a disease of unknown etiology, as indicated by the term “idiopathic.”

While plaintiffs maintain in the reply brief that the merits of the underlying case are not at issue before the MDL panel, which typically determines whether consolidation and centralization of the lawsuits is appropriate based on the number of claims and common elements in the cases, they point out that doctors only described the injury as idiopathic intracranial hypertension because Bayer failed to warn that the levonorgestrel in Mirena IUD could cause the injury.

“In terms of providing immediate care for the patient, the doctor cares less about the cause of the patient’s condition and more about the symptoms to be treated,” the reply states. “Had Bayer warned the physicians about the connection between levonorgestrel and intracranial hypertension, as it was legally required to do, not only would the physicians have diagnosed the IH as ‘secondary’ to Mirena usage, the physicians could have mitigated the permanent harm these women suffered by actually removing the device.”

IIH, also known as pseudotumor cerebri (PTC), develops when cerebrospinal fluid levels become elevated. This causes increased pressure in the skull, acting like a tumor. Victims develop severe migraines, double vision, temporary blindness, and other vision loss symptoms. They often develop swelling of the optic disk, and ringing in the ears known as tinnitus.

The plaintiffs’ reply brief also points out that IIH often presents as a swelling of the optic nerves, known as papilledema. In several other places around the world, including South Africa and Hong Kong, Mirena labels include warnings that papilledema is a possible side effect. However, the company has not given American women or the U.S. medical community the same warning.

In response to Bayer’s claims that there are too few cases, with only nine Mirena IIH complaints filed to date, the plaintiffs’ reply points out that about half of all MDLs currently established by the U.S. JPML involve fewer than 10 cases. In addition, lawyers indicate that they are prepared to file complaints on behalf of at least 65 other women who have experienced similar brain problems after being implanted with the Mirena IUD.

Centralization as part of an MDL is designed to reduce duplicative discovery, avoid conflicting orders from different judges and to serve the convenience of the parties, witnesses and the courts. Plaintiffs maintain that coordinated pretrial proceedings are necessary because Bayer has refused to informally cooperate and coordinate discovery schedules in the various cases.

The U.S. JPML is currently scheduled to hear oral arguments on the motion during an upcoming session on July 31, in Kansas City, Kansas.

Mirena Lawsuits Over Migration, Perforation

In addition to the IIH lawsuits over Mirena, Bayer currently faces about 2,000 product liability cases involving allegations that plaintiffs suffered internal injuries when the IUD perforated their uterus and migrated to other areas of the body.

In the federal court system, an MDL has already been established before U.S. District Judge Cathy Seibel in the Southern District of New York, but the proceedings are limited to claims involving spontaneous migration of the Mirena IUD.

Bayer has previously maintained that it intends to defend the migration injury cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs in that litigation maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.

As part of the coordinated proceedings in the Mirena migration MDL, a small group of cases are being prepared for early trial dates, known as known as “bellwether” cases, which are expected to begin in the second half of 2015.

While the outcomes of these bellwether trials will not be binding in other cases, they are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. If Bayer continues to refuse to make any Mirena settlement offers following a series of bellwether trials in the MDL, the drug maker could face hundreds of individual trials throughout the United States.