Mirena IUD Plaintiffs Successfully Get 2d MDL for Intracranial Hypertension Claims

Plaintiffs who have filed suit against Bayer over its Mirena hormone-coated birth control device have succeeded in having a second multidistrict litigation docket (MDL) focusing on injuries caused by increased intracranial pressure.

Judge Paul A. Engelmayer in the Southern District of New York will preside over 113 actions pending in 17 districts in MDL No. 2767, In Re: Mirena Ius Levonorgestrel-related Products Liability Litigation (No. II).

First answer is “no”

In July 2014, the Judicial Panel on Multidistrict Litigation (MDL) denied a motion for centralization filed by a different group of plaintiffs alleging that Mirena’s hormonal component causes or substantially contributes to the development of intracranial hypertension. See In re: Mirena Levonorgestrel-Related Prods. Liab. Litig., 38 F. Supp. 3d 1380 (J.P.M.L. 2014). The motion sought centralization of nine actions pending in six districts, all brought by the same counsel against a single defendant, BHCP. At that time, there were six potential tag-along actions.

In denying centralization, the JPMDL observed that the actions involved common factual issues, but determined that informal coordination was preferable to centralization in light of the limited number of actions, the few involved plaintiffs’ counsel, and defendant BHCP’s commitment to coordinating common discovery.

In November, the JPMDL reopened MDL 2434 in the Southern District of New York for product liability claims involving migration of the IUD in the uterus. It does not include any claims that the synthetic levonorgestrel hormone coating causes intracranial pressure or hypertension.

In the second motion for centralization, plaintiffs argue that the litigation has expanded dramatically over the past two years in terms of the number of actions, districts, and distinct plaintiffs’ firms independently litigating the actions, and informal coordination of discovery and pretrial motions has become impracticable. Bayer opposed centralization.

Second answer is “yes”

The JPMDL said, “First, the number of actions, districts, and counsel have grown substantially. The motion for centralization encompasses 113 pending actions in 17 districts, and there are at least 37 potential tagalong actions bringing the total number of involved districts to 20. The number of distinct plaintiffs’ counsel involved in this litigation also has expanded. There now are at least 12 unaffiliated plaintiffs’ firms in widely dispersed geographic locations. And although Bayer continues to have national coordinating counsel, at least 20 firms are litigating the underlying actions on the motion on its behalf. In our judgment, the number of actions, districts, and plaintiffs’ and defense counsel make effective coordination on an informal basis impracticable.”

Second, the plaintiff-specific causation issues identified byBayer presently do not appear to be an obstacle to centralization, considering the development of the litigation over the past two years. While we previously expressed concern that individualized causation issues might predominate in this litigation, the records in the manyactions filed since then demonstrate that discoveryand pretrial motions concerning the issue of general causation have been, or will be, at the center of all actions – that is, whetherthe hormonal component in Mirena is capable of causing intracranial hypertension.”

Third, the record demonstrates that centralization is necessary to facilitate the efficient conduct of common discovery. Although fact and expert discovery has closed in the ten longest pending actions, discovery remains open in nearly all other actions, with most actions at a relatively early stage of discovery or still at the pleading stage. While Bayer asserts that the longer pending 4 proceedings have resulted in the completion of all common discovery, plaintiffs vigorously disagree.”

Fourth, although a handful of actions are in an advanced procedural posture, the transferee judge possesses broad discretion to formulate a pretrial program that accounts for any significant differences among the actions and ensures that duplicative activity is minimized or eliminated.”

The lawsuits share factual questions arising out of allegations that the synthetic hormone released by Mirena causes abnormal elevation of cerebrospinal fluid in the skull, resulting in a neurological condition referred to as intracranial hypertension or pseudotumor cerebri, and that defendants did not adequately warn prescribing physicians or consumers of the alleged risk. Issues concerning general causation, the background science, and Mirena’s labeling and regulatory history with respect to the alleged injury will be common to all actions.



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New MDLs Requested for Farxiga, Mirena, Hip Implants and Sorin 3T Heater

farxiga320x320The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear argument on March 30 on whether to create new multi-district litigation docket (MDL) No. 2776 for Farxiga and Xigudo diabetes medicines.

Oral argument is scheduled starting in the morning at the US Courthouse in Phoenix, Arizona. In addition, oral arguments will be held to create the following MDLs:

Ketoacidosis and kidney failure

Plaintiff’s attorney Holly Dolejsi of Robins Kaplan L.L.P. in Minneapolis moved to transfer currently filed Faxiga and Xigduo cases to either the Southern District of New York before Judge Lorna G. Schofield, the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel, who all have Farxiga cases assigned to them.

The motion involves 18 pending cases in 6 district courts, with 13 of the 18 filed in New York. The Defendants The Defendants in these cases are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, and AstraZeneca PLC.

As a result of ingesting Farxiga, the plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories. On January 8, 2014, the FDA approved Farxiga for use in

On January 8, 2014, the FDA approved Farxiga for use in treatment of type 2 diabetics.2 Farxiga is a part of the gliflozin drug class. The gliflozin class is referred to generally as SGLT2 (short for “Sodium Glucose Cotransporter 2”) inhibitors. Xigduo XR was (dapagliflozin combined with metformin) designed and made by the same defendants as Farxiga, and is an extension of the Farxiga product line. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.

FDA safety warning

On December 4, 2015 the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”

The same safety communication also warned of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis). In light of the data disclosed in the December 4, 2015 safety communication, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis. On June 14, 2016, the FDA issued a safety announcement which advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.

While a cross-motion to include Farxiga cases with Invokana MDL No. 2750 was raised, considered and ultimately denied by the Panel following the hearing in Charlotte, North Carolina, that request was opposed by both the Invokana Plaintiffs’ counsel and Defendants who claimed that the litigations were sufficiently different such that a joint SGLT2 MDL was improvident.

A total of 100 lawsuits have been filed in the MDL since the courts created it in December.


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Federal Court Reopens Mirena IUD Product Liability MDL

mirena-side-effectsIn an unusual move, the Judicial Panel on Multidistrict Litigation (JPMDL) reopened MDL 2434 for product liability claims against Bayer Healthcare Pharmaceuticals Inc. concerning its Mirena intrauterine device (IUD).

The MDL, In re Mirena IUD Products Liability Litigation, No. 13-MD-(CS), had been closed on Aug. 9 after US Judge Cathy Seibel of the Southern District of New York granted summary judgment on July 28 for defendant Bayer Healthcare Pharmaceuticals Inc. and dismissed all 1,377 cases for lack of causation expert testimony. The decision is on appeal to the Second US Circuit Court of Appeals.

The Nov. 3 decision to reopen the MDL came at the behest of Bayer and over the objections of the plaintiffs. Bayer requested the decision because it expected new cases to be filed against it.

It said that other MDLs have remained open while similar appeals are pending, such as the Incretin MDL in the Southern District of California, the Zoloft MDL in the Eastern District of Pennsylvania and the Fosamax MDL in the District of New Jersey.

New evidence

Citing new evidence, the plaintiffs assert that Bayer appears to acknowledge in a patent application for another IUD, when explaining why it chose a different progestin, that levonorgestrel – the progestin used in Mirena – actually does affect uterine tissues.

“As this Court knows, this position is directly contrary to Bayer’s many assertions in this litigation that levonorgestrel does not affect the uterus. Plaintiffs with newly-filed cases are entitled to take discovery on this evidence and related issues, and to obtain additional expert testimony in support of their claims. This issue is already being briefed in New Jersey, and it would be appropriate here as well if the MDL were re-opened,” wrote plaintiff’s counsel Michael K. Johnson of Johnson Becker in St. Paul.

Mirena is a T-shaped plastic device coated with the hormone levonorgestrel.  It is inserted into the uterus to provide birth control for up to five years. Plaintiffs charge that Mirena can migrate once inserted into the uterus, perforating the uterus or cervix upon insertion, and filed lawsuits alleging that Bayer failed to adequately warn doctors and women about the risk of uterine perforation.

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