Device Maker Has Been Target of Legal and Regulatory Actions

C.R. Bard, one of 11 companies that make blood-clot filters, is a global giant that manufactures and sells thousands of medical products. Based in New Jersey but operating in more than 90 countries, it has 12,000 employees and annual sales of $3.3 billion.

The company has been named in several legal and regulatory actions:

  • In 1994, the company pleaded guilty to 391 criminal charges and agreed to pay $61 million after prosecutors said it made false statements to regulators and illegally altered and marketed catheters. Three executives went to prison, and the CEO said in court that "what the company did was wrong." In a statement at the time, Bard said it had taken action three years earlier to prevent a repeat of the problem.
  • Two years ago, the company agreed to pay $48 million to settle a whistleblower lawsuit joined by the Justice Department that accused it of giving kickbacks to doctors and health-care facilities who bought a prostate radiation treatment. The company did not admit to wrongdoing in a statement after the settlement.
  • The FDA sent Bard a warning letter in July about violations found at two of its facilities, including the marketing of a device without FDA approval or clearance. In response to the FDA warning, Bard told NBC News: "We are committed to strict compliance with FDA regulations and are working diligently with the agency to address its concerns in regards to the warning letter. Bard's IVC filters have protected the lives of thousands of patients at risk of pulmonary embolism who otherwise would have had limited treatment options. Access to these life-saving devices is in the best interests of patients and healthcare providers around the world."