Sunday, May 27, 2012

Transvaginal Mesh Litigation Issues: Part One: Multidistrict Litigation

What is an MDL?

Earlier this year, all lawsuits regarding complications arising from the use of vaginal mesh were centralized into what is known as multidistrict litigation by the U.S. Judicial Panel on Multidistrict Litigation. Multidistrict litigation is significantly different from a class action lawsuit. A class action lawsuit involves a few plaintiffs suing on behalf of themselves and others who suffered similar harm, but who are not individually named in the lawsuit. Should the named plaintiffs win at trial, the unnamed plaintiffs win as well. Most multidistrict litigation takes place in federal courts and occurs when the safety of a drug or medical device comes under fire when it is believed to have caused harm to recipients or created a very real danger. Attorneys begin filing lawsuits on behalf of their clients against the manufacturer of the drug or device, and once enough suits are filed a federal court, the manufacturer or the plaintiff’s attorneys can ask that an MDL proceeding be initiated.

While some MDLs will be settled individually, others will be settled as a group. Another approach allows manufacturers to agree to a set sum of money requiring all plaintiffs to apply for compensation based on the individual merits of their case. While the claimants are free to accept or reject the award, should they choose to accept it they are in effect releasing the manufacturer from further liability. Should there be no settlement in an MDL, all the individual cases which were not resolved will be transferred back to the court they were originally filed in and will be tried before a jury.

Who Are the Defendants?

In the case of vaginal mesh products, all plaintiffs allege they have suffered harm as a result of a specific defect in the mesh products which are surgically implanted to treat stress urinary incontinence and pelvic organ prolapse. Vaginal mesh is manufactured and sold by four primary defendants, each of which has been assigned its own multidistrict litigation, meaning there are presently four federal vaginal mesh lawsuit consolidations. The defendants in the vaginal mesh cases are American Medical Systems, C.R. Bard, Ethicon and Boston Scientific and will be heard before Chief District Judge Joseph R. Goodwin. The allegations by the plaintiffs in each case are similar and state that the manufacturers failed to adequately research the mesh products and further failed to warn physicians and patients of possible complications including chronic infection, erosion and chronic, debilitating pain.

Judge Goodwin appointed a Steering Committee for the Plaintiff’s composed of more than 60 attorneys who will divide pre-trial duties and coordinate discovery which is common to all cases. Goodwin has directed that there be some “outside the box” discovery taking place to determine whether mesh devices affect all women in the same manner. The defendants in this litigation are attempting to separate from one another, claiming their devices are different. This assertion is contradicted by the fact that these manufacturers pushed their devices through the FDA 510K application by stating their device was substantially similar to those already approved.

First Bellwether Trial is Set

The first MDL trial is set for February 5, 2012 and involves complications resulting from the Bard Avaulta mesh implant. A bellwether case is generally chosen for trial because it involves facts, claims or defenses which are comparable in nature to the facts, claims and defenses which are being submitted in a broad range of related cases. Even though the Bard Avaulta MDL was actually assigned in 2010, the FDA did not come through with a mesh warning until the following year although they acknowledged potential problems as early as 2008, calling reported complications “rare.” In 2011 the FDA noted a higher than usual number of serious complications stemming from implantation of the Bard implant, adding they found no benefit of using the mesh device over other approved treatments for SUI and POP.

Congressional Report

On March 22, 2012, a Congressional report indicated a serious issue with medical devices receiving FDA approval based on similar devices which could themselves have problematic safety issues. Clinical trials are not required in an FDA fast-track 510(k) clearance process therefore safety is not fully established before the product is approved. When a new device is approved based on an older device with safety concerns, the harm to consumers can happen again and again. Literally thousands of patients have been harmed due to medical devices which were modeled after recalled devices, including mesh implants. Although the original vaginal mesh implant suffered a recall in 1999, subsequent meshes were approved by the FDA based on those defective products.

The FDA stated in 2011 that erosion, chronic and severe pain, serious infections, bleeding, and protrusion of the device were all complications associated with mesh implants and that surgeries to correct these complications might not be entirely successful. A Massachusetts Congressman recently introduced the Safety of Untested and New Devices Act which gives the FDA the ability to reject 510(k) applications should the device simply repeat the flaws of its predecessor. The Act will also mandate that the FDA review any high-risk medical devices to determine whether a predecessor has been recalled.

MDL Mesh Lawsuits

There are currently over a hundred mesh cases pending before Judge Goodwin, all sharing similarities of fact and injury sustained. The MDL process is expected to reduce lawsuit costs, increase convenience for plaintiffs, limit redundancy in the discovery process and basically streamline the process for all involved. Once the pre-trial process is done, each case will maintain its individual status, with many returning to their original filing court for trial. The state-level mesh lawsuits have been consolidated in New Jersey Superior Court and are moving forward, however cases against Bard are advancing in coordinated yet separate proceedings. Judges in these proceedings have indicated they will not tolerate the over-designation of documents as being private or inadmissible and that protective orders will be frowned upon.

Part Two of this four part series of articles will further explore the claims made by the manufacturers that their products are different from one another as well as their claims that the specific surgical procedure is at fault.

Author: Sullo & Sullo Attorneys

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