Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation

Jan 12th, 2012 | By | Category: Legal News

JANUARY 12, 2012 ~ A growing number of women from around the country who are plaintiffs in transvaginal mesh litigation have a court date of Wednesday, January 26 in Miami. The Judicial Panel on Multidistrict Litigation (MDL)  is set to hear requests by plaintiff attorneys to have thousands of defective mesh lawsuits consolidated in the same federal court.

Here is the Notice of Hearing.

The proceeding will consider whether the injured women should have their cases centralized before the U.S. District Court for the Southern District of West Virginia before Chief Judge Joseph R. Goodwin.

The Honorable Joseph R. Goodwin

The women all claim injuries following surgery with synthetic transvaginal mesh which range from intense pain, disability, mesh erosion and shrinkage, nerve damage, and infection, among other injuries.

The companies named in lawsuits include Boston Scientific Corp., American Medical Systems (acquired by Endo Pharmaceuticals Holdings), and Ethicon (Johnson & Johnson). The Food & Drug Administration (FDA) has received more than 4,000 reports of injuries to women who received the permanent implants to treat pelvic organ prolapse and incontinence which have led to hundreds of lawsuits, background story here.

The plaintiffs argue that claims by the injured women are substantially similar and Judge Goodwin is familiar with the Bard Avaulta mesh injuries and will understand how to handle claims where multiple mesh devices from different manufacturers were used on the same female patient.

Multidistrict Litigation (MDL)

An MDL is a special procedure in which noncriminal cases are consolidated into one court. An MDL is different from a class action lawsuit in that the MDL allows those injured to file individual product liability lawsuits while at the same time sharing discovery and experts and to benefit from a uniform set of rules and rulings.

An MDL cuts down on the cost of bringing a case forward.  One judge oversees discovery, rules and procedures while the cost of duplicating documents for thousands of plaintiffs is reduced making litigation more cost and time effective.

There must be common questions of facts pending in federal courts around the country to have the cases consolidated.

The Judicial Panel on Multidistrict Litigation meets in various cities to decide which request should be consolidated.

Benefit of MDL

For a large corporation an MDL is cheaper and allows fewer expert depositions, decreasing the change the person with knowledge will be inconsistent.

In an MDL, the damage amount awarded will be tailored to the individual’s damages they suffered as opposed to a class action where everyone is awarded the same amount regardless of their injury.

Plaintiff attorneys say that the costs of bringing the case forward is reduced for each plaintiff because the various law firms representing the women will be allowed to share the information they uncover during the discovery process in documents and depositions with the defendants, in this case the mesh makers. And a MDL does not preclude a woman suffering from damages from transvaginal surgical mesh to end up having her own trial.

The product liability litigation charges the companies knew or should have known their products were defective in their manufacture, their design and in their marketing materials in a failure to warn the public about the potential dangers.

The public became aware about the dangers of defective surgical mesh on July 13, 2011 when the FDA issued a safety notification warning that complications from the plastic petroleum-based mesh are “not rare” and questioning whether mesh provides any benefit over non-mesh surgery for pelvic organ prolapse and incontinence.

As recently as January 4, 2012, the FDA said in a notification

“Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.”

A Class III designation would required mesh manufacturers to conduct premarket approval, scientific studies for safety and efficacy on the permanent transvaginal mesh implant before they reach consumers. Presently mesh is a Class II device and those safety assurances are not required. #

 

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2 Comments to “Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation”

  1. Jane Akre says:

    UPDATE ON MDL HEARINGS*

    As of Friday, January 27, the Judicial Panel had not issued a ruling on the consolidation request. The U.S. Judicial Panel on Multidistrict Litigation (MDL) is based in Washington D.C. but travels around the country to consider consolidation requests. In this case, thousands of product liability lawsuits filed against Boston Scientific, American Medical Systems, and Ethicon could be consolidated before Judge Joseph R. Goodwin in the Southern District of West Virginia.

    Judge Goodwin is already overseeing all defective product cases filed against C.R. Bard.

    A final ruling could be issued within a few days.

Leave a Comment

We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.