Tyler Evans

Tyler Evans

Tyler Evans is an associate in the firm’s Washington, DC office and a member of the Government Contracts and Litigation Practice Groups. He has experience advising clients in the life sciences and defense industries on schedule contracting, cost disputes, mergers and acquisitions, and small business issues.

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FDA Finalizes Guidance for Management of Cybersecurity in Medical Devices

The U.S. Food and Drug Administration (“FDA”) has increasingly focused on promoting cybersecurity because compromised medical devices can pose a risk to patient health as well as the confidentiality of personal medical information.  On October 2, 2014, FDA issued final guidance on the content of premarket submissions for the management of cybersecurity in medical devices.  … Continue Reading

Recent Settlement Highlights Importance of Tracing Country of Origin When Selling Medical Devices to the U.S. Government

Earlier this month, a medical device company settled allegations that it had violated the False Claims Act (FCA) by improperly certifying that it had complied with the Trade Agreements Act (TAA) when providing the U.S. Government with end products manufactured in Malaysia.  The TAA requires certain end products sold to the U.S. Government to be … Continue Reading

New Reporting Requirements May Affect Employment Practices of Medical Device Manufacturers and Suppliers with U.S. Government Contracts

On July 31, 2014, President Barack Obama issued a new executive order requiring federal government contractors to disclose labor violations when competing for contracts valued at more than $500,000.  The new executive order also requires contractors to periodically report labor violations throughout contract performance, provide employees with accurate information explaining the basis for their pay, … Continue Reading

Device Manufacturers Selling Their Products to the U.S. Government May Soon Be Required to Detect and Report Counterfeit or Nonconforming Items

Medical device manufacturers that sell their products to the U.S. government may soon be required to implement programs for the detection and reporting of counterfeit or nonconforming end items and parts.  On June 10, 2014, the Federal Acquisition Regulatory (FAR) Council issued a proposed rule that would require government contractors to report to the Government-Industry Data … Continue Reading

Amid High Recoveries for Health Care Fraud, Government Contractors May Be Able to Expect Fair Treatment

The Department of Justice (DOJ) recently announced that it had recovered $3.8 billion under the False Claims Act (FCA) in Fiscal Year 2013.  According to DOJ, $2.6 billion of this recovery was associated with health care fraud, and some of the largest recoveries resulted from judgments or settlements involving companies in the pharmaceutical and medical device … Continue Reading