In product liability litigation, one common assertion is the product in question was defectively designed. This means there is an inherent flaw or error in the design of the product that renders it unreasonably dangerous. When it comes to medical devices – hip and knee replacement joints, surgical mesh, or other implants – questions are often raised regarding how much study or research went into vetting the product in question and making sure it was as safe as possible.
A number of recent lawsuits against Mentor Worldwide, a subsidiary of manufacturing behemoth Johnson & Johnson, allege the company failed in its duty to conduct proper studies of the silicone-based breast implants it sold to women across the country. Such studies are required by regulators to ensure products are safe, but the plaintiffs allege the defendant manufacturers failed to abide by basic industry standards.
You may recall there was a great deal of litigation back in the 1980s and 1990s over defective breast implants, particularly those made of silicone. These newer lawsuits could be the next wave.
Two or three decades ago, the devices were associated with leaking of silicone that resulted in serious injuries, as well as instances of cancer and rheumatoid arthritis. Regulators banned silicone breast implants back in 1992, due to the ongoing problems with the device because hundreds of thousands of women were suing manufacturers. A number of those companies eventually filed for bankruptcy. One of those, Dow Corning Corp., ultimately paid $3.2 billion to compensate implant victims, and it was only after making good on those payments it was allowed to emerge from Chapter 11 bankruptcy.
Following a 14-year ban on the devices, the U.S. Food and Drug Administration authorized just three companies to sell silicone-based implants in 2006. The market ballooned to $635 million in 2016, and 80 percent of women who undergo the surgery today choose the silicone-based implants that are available.
Johnson & Johnson acquired Mentor for $1 billion back in 2008.
The latest lawsuit alleges Mentor did not warn the plaintiff of the serious defects and potentially life-altering complications that can result from leaking implants. The plaintiff alleges she is suffering from a host of health problems connected to the allegedly defective products, including nausea, muscle pain, extreme fatigue, and skin rashes.
Additional similar claims are expected in the future. Generally, claims of product liability assert one or more of the following:
- Strict liability – The manufacturer sold the product in a dangerous condition, the manufacturer intended the product to reach the consumer unaltered, and the consumer was injured by the product’s dangerous condition;
- Failure to warn – The manufacturer knew or should have known about a particular inherent risk but failed to provide an adequate warning;
- Breach of express and implied warranties – The manufacturer failed to ensure the product met the purposes for which it was purchased or the product failed to perform in a certain way that conformed to certain standards;
- Negligence – The manufacturer owed a duty of reasonable care, the manufacturer breached that duty, the manufacturer’s breach was the cause of the plaintiff’s injuries, and the plaintiff’s injuries are compensable; or
- Fraud – The manufacturer misrepresented the product in some way to consumers.
If you have suffered injuries or illness due to a defective breast implant, we can help you seek damages.
Contact the Carolina injury lawyers at the Lee Law Offices by calling 800-887-1965.
Johnson & Johnson Unit Sued Over Leaking Breast Implants, Feb. 3, 2017, By Jef feeley and Edvard Pettersson, Bloomberg
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