Category: Medical Device Fraud

Medical Device Manufacturer Triggered False Claims Act Liability by Allegedly Submitting False NIH Grant Application

Each year, the federal government doles out billions of dollars in grant money, some of which is acquired or used based upon fraudulent misrepresentations made...

FCA Liability Awaits Medical Device Companies That Submit False 510(k) Notices to Avoid Class III Premarket Approval Process

Increasingly, the United State Department of Justice is cracking down on medical device makers who fraudulently obtain FDA clearance for their products. DOJ is particularly...

Start-Up Medical Device Fraud is Rampant in Silicon Valley

Silicon Valley has become a hotbed for start-up medical device companies…and also some medical device fraud. In particular, several medical device companies are marketing their...

Medtronic Companies Pay Millions as Devices were Manufactured Outside of the United States

Recently, the United States alleged medical device fraud when Medtronic companies (Medtronic plc, Medtronic Inc., Medtronic USA Inc., and Medtronic sofamor Danek USA Inc.) were caught...

DOJ Recovers Funds from Physician Who Allegedly Received Kickbacks

Last year, medical device maker CareFusion agreed to pay the government $40.1 million to settle False Claims Act (FCA) allegations that it paid kickbacks to...

Are Some Medical Device Companies Trying to Induce Hospitals to Perform Unnecessary Inpatient Procedures?

As medical technology has advanced, more and more surgical procedures have become outpatient procedures. Medicare has encouraged this migration out of the hospital by only...

Medical Device Manufacturers Marketing Pre-1976 Devices for Unapproved Uses

In 1976, Congress amended the FDCA to require any post-1976 devices to be approved via the rigorous Pre-Market Approval (PMA) process, unless the manufacturer could...

Medical Device Manufacturer and Its Former CEO Plead Guilty to Distributing FDA-Rejected Devices to Heath Care Providers

False Claims Act violations can arise when medical device manufacturers sidestep the FDA pre-marketing approval process. Evidence of such misdirection is especially compelling when manufacturers...

When Physician Speaking Engagements Break the Law

Every day across the country, some physicians receive large speakers’ honoraria checks from pharmaceutical and medical device companies. These funds compensate the physicians for speaking...

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