Lubin & Meyer Lawsuit Leads to FDA Recommendation of Ban on Electronic Shock Devices for Use on Autistic Children

When the U.S. Food and Drug Administration (FDA) announced last week a proposal to ban electrical stimulation devices (ESDs), it was a long awaited final chapter in a lawsuit brought by Lubin & Meyer on behalf of Cheryl McCollins whose son Andre had been severely injured due to repeated electrical shock treatments while a student at the Judge Rotenberg Center.

"Many children and families have long awaited this historic news," said Lubin & Meyer attorney Benjamin Novotny, who represented McCollins at trial. "It is encouraging that the FDA is following the United Nations' footsteps and labeling this practice for what it is, torture."

The disturbing video evidence presented at trial, helped to reach a settlement, mount public outrage and move an FDA panel to hold a hearing to consider banning the practice of aversive electronic shock treatments. That hearing led to a recommendation to ban the practice, and now — two years later — the FDA has issued a proposal to ban the devices.

"The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health. ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behavior. Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction.

In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent. As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health."

The proposed rule is available online at www.regulations.gov for public comment for 30 days.

See our previous posts on this subject:

• FDA Advisory Panel Recommends Banning Shock Therapy at Judge Rotenberg Center
• Lubin & Meyer Lawsuit Prompts CBS News Investigation

View our main website at LubinandMeyer.com - Lubin & Meyer PC - New England's Leader in Medical Malpractice and Personal Injury Law

FDA Gives Power Morcellators Its Strongest Warning

A series of investigative articles in the Wall Street Journal examines the controversial marketing, training and use of power morcellators used in laproscopic hysterectomies and myomectomies for their role in spreading undetected cancers, and the FDA's recently updated safety warning on the devices. According the WSJ:

"The Food and Drug Administration used its authority to call for an immediate “black box” warning for laparoscopic power morcellators, the strongest caution the agency issues. Typically, such warnings on product labels undergo a lengthy comment period before being completed, lawyers for device makers said."

5 Things to Know About FDA Warning on #Morcellators, Uterine Fibroids http://t.co/biTVXT7VxG via @WSJ
— Lubin and Meyer, PC (@LubinandMeyer) December 8, 2014

The updated FDA Safety Communication on Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy states:

"Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy. Many of these laparoscopic procedures are performed using a power morcellator. 

Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma. 

If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood. 

Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids." 

Follow this link to the Wall Street Journal article, Surgical Tool Gets Strongest Warning, with links to more information and reporting on the topic.

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Lubin & Meyer PC - New England's Leader in Medical Malpractice and Personal Injury Law. Attorneys licensed and practicing in MA, NH and RI.