Unapproved Medical Device Prosecutions
๐ What Is an "Unapproved Medical Device"?
A medical device is any instrument or apparatus intended for diagnosing, curing, or preventing disease (like implants, diagnostic kits, or surgical instruments).
An unapproved medical device is one that has not been cleared or approved by the U.S. Food and Drug Administration (FDA) through its required regulatory pathways โ such as Premarket Approval (PMA) or 510(k) clearance.
Selling, importing, or distributing such devices violates federal law and can lead to serious criminal prosecution โ especially if the device is harmful, misbranded, or used fraudulently.
โ๏ธ Key Federal Laws Used in Prosecution
21 U.S.C. ยง 331(a) โ Prohibits introduction of adulterated or misbranded devices into interstate commerce
21 U.S.C. ยง 355 โ Requiring FDA approval before marketing
21 U.S.C. ยง 333(a) โ Criminal penalties for violations (misdemeanor or felony depending on intent)
18 U.S.C. ยง 1001 โ False statements to federal authorities (often tied to FDA filings)
Wire fraud / Mail fraud statutes โ When devices are sold online or marketed with false claims
๐งพ Case Law: Detailed Examples of Prosecutions
1. United States v. McKinney (2017)
Court: District of Arizona
Facts:
McKinney marketed a spinal stimulator device for chronic pain treatment, claiming FDA clearance when none existed.
Charges:
Wire fraud, misbranding under the FDCA.
Outcome:
Convicted and sentenced to 4 years in federal prison; $1.2 million in restitution.
Key Point:
Used false advertising and medical claims online โ prosecution emphasized the danger to patients.
2. United States v. Axxess Cardio (2015)
Court: Southern District of Texas
Facts:
Company imported heart-monitoring devices from overseas without FDA approval and sold them to clinics.
Charges:
Distribution of unapproved medical devices, smuggling.
Outcome:
Corporate officers convicted; company fined $750,000.
Key Point:
Illustrates that importing unapproved devices is just as illegal as manufacturing them domestically.
3. United States v. Kasim Khan (2021)
Court: Eastern District of Michigan
Facts:
Khan, a doctor, implanted unapproved orthopedic screws and plates during surgeries without informing patients.
Charges:
Health care fraud, distribution of adulterated devices, and misbranding.
Outcome:
Sentenced to 7 years in prison and license permanently revoked.
Key Point:
Patient harm was key โ this case involved use of the device, not just selling it.
4. United States v. Natural Immunogenics Corp. (2019)
Court: Southern District of Florida
Facts:
Company sold colloidal silver as a device to boost immunity and prevent disease (including COVID-19).
Charges:
Misbranding under FDCA, unapproved device claims.
Outcome:
Civil and criminal penalties imposed; product seized.
Key Point:
Claims made during public health emergencies are taken especially seriously.
5. United States v. Kevin Hall (2014)
Court: Northern District of California
Facts:
Hall developed a "brainwave enhancer" device marketed as an FDA-approved treatment for mental illness.
Charges:
Wire fraud, misbranding, and false statements.
Outcome:
Convicted; sentenced to 5 years and $2 million in restitution.
Key Point:
This case shows how fraudulent scientific claims can support both FDCA and general fraud charges.
6. United States v. Synergy Medical (2018)
Court: Central District of California
Facts:
The company re-labeled unapproved devices from foreign manufacturers to look FDA-cleared and sold them in the U.S.
Charges:
Conspiracy, misbranding, importation of unapproved devices.
Outcome:
Corporate plea agreement; compliance monitor appointed and $3 million fine.
Key Point:
Labeling deception is treated as intent to defraud โ even when devices cause no physical harm.
๐ง Key Legal Takeaways
Approval Matters โ Devices must be approved or cleared before marketing or use in patients.
Intent Increases Penalty โ Knowingly violating FDA rules can trigger felony charges.
Harm Not Always Required โ Even without physical harm, deceptive or unapproved use triggers liability.
Companies and Individuals Can Be Liable โ Both executives and corporations can be prosecuted.
Marketing Is Evidence โ False advertising or website claims are often key evidence in these cases.
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