Additional Information for Temp R. Patterson, MD P.A.

The following describes a pending government action that has been formally brought by a government agency but has not yet been resolved. We are providing a summary of the governments allegations, which have not yet been proven.

On August 7, 2019, in the United States District Court for the District of Idaho, Temp Ray Patterson, MD hereinafter (“Defendant”)  entered into a Plea Agreement with the United States of America. Temp Patterson voluntarily plead guilty to Count One of the Information, which charges the defendant with Receipt and Delivery of Misbranded Devices, a felony violation of 21 U.S.C. §§ 331(c) and 333(a)(2).

The elements of the crime of Receipt and Delivery of Misbranded Devices, a felony violation of 21 U.S.C. §§ 331(c) and 333(a)(2), as charged in count One, are as follows:

1. The defendant received devices, as defined in 21 U.S.C. § 321(h) (breast implants), in interstate commerce;
2. Those devices were misbranded in one or more ways;
3. The defendant delivered or proffered the delivery of those misbranded devices for pay or otherwise; and
4. The defendant did and caused these acts with the intent to mislead.

From on or about March 2014 through April 2015, in the District of Idaho, the defendant knowingly received and implanted in patients nine pairs of misbranded breast implants that were not approved by the Food and Drug Administration ("FDA"). The breast implants were shipped to the Defendant in interstate commerce from China to Idaho. Breast implants were Class III medical devices under the Food, Drug and Cosmetic Act ("FDCA"). As such, they require an approved premarket approval application ("PMA") before they can be marketed, or they must meet one of the listed exceptions. See 21 C.F.R. § 814.1. The breast implants the Defendant received did not have a PMA and did not meet a listed exception. The nine pairs of breast implants were misbranded devices.

The Defendant delivered and proffered for delivery the misbranded devices with the intent to mislead. The Defendant provided his breast augmentation patients with labeling for FDA approved breast implants including brochures, handouts, pre-operative worksheets, and sample sizers. The provided labeling misled his patients into believing that they would receive FDA approved implants, when they did not.

The Defendant charged the nine patients a total of $34,875 for the breast augmentation surgeries he performed.

In addition to any forfeiture, fine, or costs imposed, the Defendant agrees to pay restitution equal to the loss caused to any uncompensated victim. The parties agree the restitution obligation in this case is equal to $8,200, which represents the amount owed to one of the victims, which the Defendant agrees to pay at or prior to his plea hearing.

On August 28, 2019, in a hearing, Temp Patterson was ordered not to obtain a passport or be involved in any cosmetic surgery as a condition of his release from jail ahead of the sentencing.

A Sentencing hearing is scheduled for November 13, 2019.

For more information, please contact the United States Attorney’s Office, District of Idaho, https://www.justice.gov/usao-id or (208) 334-1211.