Modified Medical Devices

Manufacturers that fundamentally change designs of medical devices, after having received an approved application for premarket approval (PMA), or 510(k) clearance, must obtain an approved application. If they do not, the modified devices are adulterated and misbranded.

A common fact pattern is where the device has undergone design changes, in furtherance of an extension to the product line, since the device was initially cleared. Typically, the promotional material on a manufacturer’s website and product brochures tout the major changes or modifications to the intended use(s) of the device. These changes can include but are not limited to: design changes in how the product functions, design changes in how the product achieves its results, material changes, material size changes, and additional intended uses, to name a few.

Depending on how the expanded product line is reimbursed, damages can be substantial. Certain new technologies, which obtained approval through the PMA process, receive separate reimbursement. The new technology generally must represent a substantial clinical improvement relative to existing technologies and meet specific cost thresholds.

Medical devices cleared through the 510(k) process, however, are typically not new technologies, as they, at most, represent incremental improvements to medical devices and other technologies already on the market.  Therefore, these devices are not separately reimbursed but rather bundled into the DRG or other composite payment.

Manufacturers of medical devices that have undergone fundamental changes without FDA approval or clearance run not only the risk of violating the federal Food Drug and Cosmetic Act, but also the federal False Claims Act.

REAL PEOPLE making real change Meet Some of our Heroes

Kathleen Hawkins

Dignity Health
$37 million

Kathleen Hawkins, RN MSN, had been employed by Defendant, Catholic Healthcare West (CHW) for approximately 6 years when she decided she had had enough of trying to change the hospital system from within.

CHW, a California not-for-profit corporation that operated hospitals in California, Arizona, and Nevada, was at the time the eighth largest hospital system in the nation and the largest not-for-profit hospital provider in California.

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Joe Strom

Johnson & Johnson
$184 Million

Joe Strom contacted us in 2005. We were very grateful that he did. We immediately formed an all-star legal team and a process to stop a very harmful pharmaceutical marketing strategy. It was this process we set into motion that ultimately returned hundreds of millions of dollars to the U.S. Treasury, and a portion of that, very well-deserved, into Joe’s bank account.

Joe told us a very troubling story about the off-label promotion of a pharmaceutical drug for patients who already suffered from chronic heart failure.

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Bruce A. Moilan Sr.

$27 Million

Bruce Moilan was a seasoned hospital systems expert by the time he contacted our Firm. At the time he decided to file his qui tam lawsuit, he was employed by South Texas Health System as a System Director for Materials Management. In this position, he oversaw $24 million in annual purchases of supplies and equipment and helped determine budget, reduction and cost analysis throughout the contract bidding and negotiations process. His job was to insure proper implementation for purchasing, receiving and management of inventory, for McAllen Hospitals, L.P.

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“I collaborated with Nolan, Auerbach and White on a broad variety of cases where whistleblowers stepped forward to disclose tactics employed by large companies to influence physicians' medical decision-making in patient care. They provide ample resources to not only optimize their client cases, but in doing so consistently leverage best medical evidence to further patient safety and resource utilization.”

— Fred Polsky M.D., Former Medical Director, CMS Zone 7 Integrity Contractor

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