J&J And Ethicon, Inc. To Pay $5.5M Over TVM Devices

J&J And Ethicon, Inc. To Pay $5.5M Over TVM Devices

Introduction

On Friday, Oregon Attorney General Ellen Rosenblum made an announcement stating that Johnson & Johnson (J&J) and its subsidiary Ethicon, Inc. agreed to pay $5.5 million over the allegations of deceptive marketing of transvaginal surgical mesh devices.

Allegations included though the defendant companies knew about the possible serious medical complications associated with the devices, yet they failed to warn the patients and physicians about the risks. An investigation also revealed that the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use, which resulted in the settlement deal.

Rosenblum, while announcing the deal, also affirmed that companies must completely disclose the risks associated with their products, and the settlement has made these companies address some of the harm caused by the devices to women. She further stated that the companies are required to provide all the necessary information to patients and medical professionals to make sound decisions.

According to the settlement deal, the state will receive $2 million, and J&J will be distributing the remaining funds to five non-profit medical clinics that provide health care to women in Oregon, which include:

Outside In - $951,086

Virginia Garcia Memorial Health Center - $608,640

North by Northeast Community Health Center - $190,274

Planned Parenthood Southwestern Oregon - $825,000

Planned Parenthood Columbia Willamette - $925,000

Additionally, the state’s agreement prohibits J&J from making unfair or deceptive statements regarding surgical mesh, including the ones about risks associated with the devices. It further states that J&J's promotional material must be truthful, accurate, and presented in a balanced way, and if the company sponsors a related study or research and cites, then it should disclose its sponsorship. The company should also reveal if it learns about new, significant risks associated with the devices.

Last year, the state had opted out of a $117 million settlement deal that J&J had agreed to pay over the lawsuit brought by 41 states and the District of Columbia. Oregon instead filed suit in Multnomah County Circuit Court and negotiated this recent settlement, which has been filed and requires court approval to become final.

This is the third multi-million settlement deal that J&J is making in October. The first one was the more than $100 million agreement to resolve about 1,000 lawsuits that allege the presence of asbestos in its Baby Powder and other talcum powder products over the risk of cancer. The second one came last week, where J&J issued a press release indicating that it would contribute $1 billion more to the originally proposed $4 billion opioid settlement fund in October 2019.