Boston Scientific, a Massachusetts-based global medical device company, agreed to pay $188.6 million spread across 47 states, including $4.9 million for Tennessee, to resolve allegations that the company deceptively marketed transvaginal surgical mesh devices to patients.
Let’s take a look at the problems with Boston Scientific’s surgical mesh, the litigation to date, and what the latest settlement might mean for your claim.
Personal injury lawsuits based on defective surgical mesh products
Boston Scientific began manufacturing pelvic mesh devices, also called transvaginal mesh devices, in the early 2000s. The devices, which are implanted in the pelvic floor, were intended to treat stress urinary incontinence (SUI) and pelvic organ prolapse.
However, the surgical mesh devices caused immediate problems. Women who received the implants complained of everything from intense pain and excessive bleeding to loss of sexual functioning.
Throughout the early 2000s, Boston Scientific was sued by hundreds of women and lost multiple jury verdicts. In 2015, the company settled 3,000 surgical mesh lawsuits for $119 million. The company settled an additional 350 lawsuits in 2017.
In 2018, Boston Scientific set aside $800 million to resolve tens of thousands of additional lawsuits involving their surgical mesh products.
In 2019, the U.S. Food and Drug Administration (FDA) ordered a stop to the sale of all surgical mesh products intended for transvaginal repair and pelvic organ prolapse. At the time of the order, the regulatory agency determined that Boston Scientific failed to demonstrate a reasonable assurance of safety and effectiveness for their devices.
“[Boston Scientific] failed to provide an adequate assessment of the long-term safety of these devices and failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh (native tissue repair).”
On April 16, 2019, Boston Scientific announced that it would stop selling its surgical mesh products.
Boston Scientific’s $4.9 million settlement with the State of Tennessee
On March 23, 2021, the State of Tennessee filed a lawsuit against Boston Scientific Corporation under the Tennessee Consumer Protection Act.
What is the Tennessee Consumer Protection Act?
The Tennessee Consumer Protection Act was passed in 1977 to protect consumers from unfair and deceptive acts.
The Act lists 52 specific actions that are considered unfair or deceptive. These actions include, but are not limited to:
- Falsely passing off goods or services as something they are not,
- Causing confusion about the source, sponsorship, approval, or certification of goods or services,
- Causing confusion about the affiliation, connection, or association with, or certification by, another,
- Using deceptive representations or designations of geographic origin in connection with goods or services,
- Representing that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits or quantities that they do not have,
- Representing that goods are original or new if they are deteriorated, altered to the point of decreasing the value, reconditioned, reclaimed, used or secondhand,
- Representing that goods or services are of a particular standard, quality or grade, or that goods are of a particular style or model, if they are of another,
- Disparaging the goods, services, or business of another by false or misleading statements,
- Advertising goods or services with intent not to sell them as advertised (i.e. false advertising),
- Advertising goods or services with intent not to supply reasonably expectable public demand, unless the advertisement discloses a limitation of quantity
The lawsuit filed by the State of Tennessee against Boston Scientific alleges that “Boston Scientific misrepresented and failed to disclose the full range of risks and complications associated with their [surgical mesh] devices,” and that “such false statements and misrepresentations constitute unfair or deceptive trade practices prohibited by the [Tennessee Consumer Protection Act].”
According to the lawsuit, some of the risks and complications Boston Scientific failed to disclose include:
- Heightened risk of infection
- Rigid scar plate formation
- Mesh shrinkage
- Voiding dysfunction
- De novo incontinence
- Urinary tract infection
- Risk of delayed occurrence of complications
- Defecatory dysfunction
On March 23, 2021, Boston Scientific agreed to pay $188.7 million as part of a multi-state settlement. The company also agreed to describe more accurately to consumers the safety and risks of using surgical mesh devices and to make significant reforms to ensure its practices conform with the law going forward.
Can I file a lawsuit against Boston Scientific?
Even though Boston Scientific settled its claims with the State of Tennessee, individuals are still free to sue the company assuming they suffered a surgical-mesh-related injury and the statute of limitations hasn’t expired.
If you experienced any problems as a result of a surgical mesh product, it’s a good idea to sit down with an experienced product liability attorney near you to discuss your potential claim.