Complaint | Consent Judgment

TRENTON – Attorney General Gurbir S. Grewal announced today that C.R. Bard, Inc. (“Bard”), a medical technology company, will pay the State over $1.28 million in a settlement resolving a multi-state investigation of the company for allegedly misrepresenting the safety and effectiveness of surgical mesh products.

The total settlement payment of $60 million is being divided among 48 States and the District of Columbia. Bard and its parent company, Becton Dickinson, also agreed to restrictions on their future marketing practices.

Both Bard and Becton Dickinson have their principal place of business in Franklin Lakes, New Jersey.

“Healthcare companies have a duty to avoid making unfounded or misleading claims about their products, and a duty to make required disclosures about their risks,” said Attorney General Grewal. “Our ability to trust that medical products are safe depends on companies living up to those responsibilities. When companies fail to meet their fundamental obligations, we will take action to protect New Jersey consumers and hold them accountable.”

The investigation that led to the settlement centered on allegations Bard violated state consumer protection laws by making misleading claims about, and failing to disclose the risks associated with, a surgical mesh product used to treat women who suffer from conditions known as stress urinary incontinence and pelvic organ prolapse.

These conditions may occur when the pelvic musculature becomes weakened — often in the aftermath of childbirth or surgery — causing the pelvic organs to become displaced and causing discomfort, as well as other problems.

In cases where treatment involves use of surgical mesh, the mesh product is implanted transvaginally to support weakened pelvic organs.

Potentially serious and life-altering complications from implantation of surgical mesh have included erosion of the mesh device through organs, distortion of the sexual organs, chronic pain, painful sexual relations and recurring infections.

The participating States alleged that Bard knew women who underwent such implants could potentially experience such complications, but did not fully provide that information to consumers or to surgeons who implanted the mesh.

Now a subsidiary of Becton Dickinson, Bard has indicated that it ceased the sale and promotion of all surgical mesh products in the U.S. by December 31, 2016.

However, the settlement announced today includes certain injunctive terms that will apply should Bard reenter the domestic surgical mesh market. The terms will be effective for 10 years from the date of Bard’s first sale of surgical mesh after its reentry to the market, or until 20 years from the effective date of the agreement, whichever is earlier.

Among other injunctive terms, Bard will be required to:

• Include descriptions of complications — in terms reasonably understandable to a patient — in marketing materials that are intended to reach patients or consumers;
• Include a list of certain complications in all marketing materials that purport to address the subject of complications;
• In any training in which Bard provides risk information, disclose significant complications and inherent mesh complications;
• When submitting a clinical study, clinical data, or preclinical data for publication, disclose the company’s role as a sponsor and any author’s potential conflict of interest;
• Include a sponsorship disclosure provision in contracts that requires the consultant to agree to disclose in any public presentation or submission for publication Bard’s sponsorship of the contracted-for activity;
• Register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov; and
• Adequately inform and train employees and others who sell, market or promote surgical mesh to report all patient complaints and adverse events to the company.

Bard is the second company to enter into a settlement with New Jersey and other States concerning misleading claims and failure to disclose risks and complications associated with surgical mesh.

In October 2019, New-Jersey-based Johnson & Johnson entered into a multi-state settlement to resolve similar allegations about misrepresentations of the safety and effectiveness of surgical mesh marketed by its subsidiary Ethicon, Inc. Under that settlement, Johnson & Johnson agreed to pay the State of New Jersey more than $3 million and to comply with similar injunctive terms. Overall, the participating jurisdictions divided a total settlement payment by Johnson & Johnson of $116.9 million.

Deputy Attorney General and Section Chief Patricia Schiripo, of the Division of Law’s Consumer Fraud Prosecution Section, handled both the Bard and Johnson & Johnson matters on behalf of the State.

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The mission of the Division of Consumer Affairs, within the Department of Law and Public Safety, is to protect the public from fraud, deceit, misrepresentation and professional misconduct in the sale of goods and services in New Jersey through education, advocacy, regulation and enforcement. The Division pursues its mission through its 51 professional and occupational boards that oversee 720,000 licensees in the state, its Regulated Business section that oversees 60,000 NJ registered businesses, as well as its Office of Consumer Protection, Bureau of Securities, Charities Registration section, Office of Weights and Measures, and Legalized Games of Chance section.

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