News Room

FDA Under the Microscope for Approving Dangerous Devices

Written on behalf of Brian S. Kabateck
August 24, 2018

This summer’s scariest horror flick is the true-life stories of dozens of people who have experienced enormous pain and suffering because of dangerous medical devices. The Netflix documentary “The Bleeding Edge” presents harrowing accounts of victims who have suffered severe complications from FDA-approved products that are marketed as safe for consumers. The filmmakers reveal how an outdated approval process provides loopholes for medical device makers, which allows many devices to go to market without sufficient clinical testing.

Some of the most heartbreaking stories involved women who used the surgically implanted, permanent contraceptive device called Essure. The metal coil, used as an alternative to tubal ligation, is manufactured by Bayer which faces more than 16-thousand lawsuits filed by plaintiffs alleging medical problems ranging from migraines, organ perforations and dangerous pregnancies according to

The film described how women across the country are speaking out and using social media to organize and commiserate about a myriad of medical issues. It appears Bayer got the message. The pharmaceutical giant decided to pull Essure from the United States market by the end of the year.

The other dangerous devices profiled in the film include a cobalt-based hip replacement that allegedly causes neurological problems from metal poisoning. And if that doesn’t sound scary enough, a group of women described the gory aftermath involving their botched hysterectomies, performed with a robotic surgical device.

One of the most shocking cases profiled in this film is the story of a nurse who had a transvaginal mesh (TVM or “pelvic mesh”) implanted to relieve pelvic organ prolapse. It wasn’t long before she started suffering from excruciating pain because the mesh eroded and migrated, causing sharp shards of plastic to move throughout her body which can cut or slice organs and tissue. When surgeons tried to remove the mesh, it was so deeply embedded in her body that it was impossible to get all of the plastic shards. It turns out that the manufacturer, Johnson & Johnson never tested the TVM before the FDA’s 510(K) process fast tracked the device’s approval, allowing doctors to put the pelvic mesh into millions of women’s bodies.

Our firm obtained a $16 million ongoing settlement for clients who had the defective Trans-Vaginal Mesh product implanted in their bodies that resulted in various complications often resulting in the need to have the mesh surgically removed. This was part of a mass tort action.

A mass tort is a civil action that involves a large group of plaintiffs who’ve suffered injuries and consolidate their cases to sue one or a few corporations in state or federal court.
In U.S. federal courts, mass tort claims are frequently consolidated as multi-district litigation. While the plaintiffs may live in different geographical locations, they share a common injury or damage.

Mass disaster torts, mass toxic torts and consumer product liability torts are the main categories associated with this cause of action. A mass tort action is different from a class action. In a mass tort action, each plaintiff has an individual claim resulting from unique damages. Each plaintiff receives his or her own separate trial, unlike in a class action where the many plaintiffs typically are not considered individually and there is only one trial.

KBK has many years of experience handling mass tort cases and multi-district litigation.
If you or a loved one has experienced injuries due to a disaster, a dangerous drug or a defective product, contact one of our experienced attorneys at Kabateck Brown, LLP to learn more about recovering damages and to explore your options.