Rio Salado Community College Food and Drug Law Discussion

  • 1. Wilson

Lytle and his co-conspirators presented to the consumers the Q laser device claiming that it could be used to treat more than 200 medical conditions such as diabetes, HIV, and heart diseases. The information on the label was misleading giving a false perception to the consumers who were mostly elderly that they adequate clinical data supporting their claims. The Q laser device was not yet approved by the FDA for the several medical conditions they claimed it could treat.

I think bringing them to justice was fair because their actions did not only hurt the elderly population, but it also defrauded them to the tone of at least $16,669,015. These consumers were already suffering with serve medical conditions and selling misbranded devices to them obviously led to the death of some making them accomplices. Even after being ordered by the federal court to stop distribution and sales they continued. The meting out of fines and prison sentences and the involvement of the US postal service to stop distribution of the Q laser device to end this bad practice.

Labeling requirement for medical devices is found within the regulation FDA 21 CFR Part 820 (Kahan & Heyl, 2020) which is one of the regulations violated by the manufacturers. Misbranding or misleading labeling of the Q Laser as a veterinary device is against the regulation. It is the quality system approved by the FDA and these requirements are to ensure that medical devices are both safe and effective. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR 820 compliance. The information convincing the consumer that the device is safe and can be used in the treatment of 200 medical conditions was falsified.

Most of FDA’s medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299 which entails aspects of design, clinical evaluation, manufacturing, packaging, labeling and post market surveillance of medical devices.

2. Kim

In the case of United States of America (plaintiff) vs Robert Larry Lytle (defendant), the defendant is accused of conspiracy to introduce misbranded medical devices into interstate commerce with intent to defraud. The defendant designed a device named the QLaser for veterinary use but intended to distribute it for human use. The veterinary label was used with intent to evade review by the Food and Drug Administration (FDA).The QLaser devices were marketed to consumers as safe to use in the treatment of over 200 medical conditions. This device was marketed as scientifically proven to be safe., when in fact no trials were conducted on this device. The defendant continued to distribute the device for sale after receiving his preliminary injunction. Robert Larry Lytle who had his license to practice revoked continued to present himself to potential customers as a retired practitioner. Lytle and his accomplices defrauded the elderly and those that were ill, the action by the court was fair and just, a maximum statutory sentence of 5 years meets the sentencing criteria and guidelines of the crimes, as several regulations were violated. (justice.gov)

Key Points

Establishment Regulation – 21 CFR Part 807 requires manufacturers of devices to register their devices, the defendant and his accomplices evaded the FDA but manufacturing a device with a veterinary label. Under 21 CFR Part 807 Sub Part E, a Pre-Market notification 510 (k) must be submitted, this was not done. No FDA inspection was performed as required by Quality System Regulation (QS Regulation) under 21 CFR Part 820. The device was labeled as a veterinary device; this breaks 21 CFR Part 801 which outlines labeling requirements. As a result of evading the FDA, the device subsequently defies 21 CFR Part 803; no medical device reporting was conducted. (fda.gov)

Summary The action taken by the court was fair and just. The sentencing met the suggested sentencing guidelines. Robert Larry Lytle and his co-conspirators broke several laws in their attempt to distribute the QLaser device using illegal methods to market and distribute it. The device was marketed and sold to unsuspecting elderly and ill victims. Robert Larry Lytle misrepresented his identity in order to deceive the unsuspecting victims into thinking that he was a credible medical practitioner. The defendants continued to defraud unsuspecting victims even after receiving their preliminary injunction.

Instructions

Provide a response to both discussion posts following the outlined criteria:

  • Each post must be 2 paragraphs
  • Each paragraph must be at least 7 sentences
  • Each response must include 1 reference
  • #1 must have a 2-paragraph response
  • #2 must have a 2-paragraph response

**THE FOLLOWING REFERENCES CAN’T BE USED AND YOU MUST FIND ANOTHER REFERENCE FOR EACH:

Department of Justice. (2018, January 26). Leader of Fraudulent Medical Device Scheme Pleads Guilty. Office of Public Affairs.

Quality Assurance & Food Safety. (2021, January 29). Top 5 violations cited by FDA during FY 2020 inspections. Quality Assurance & Food Safety. https://www.qualityassurancemag.com/article/top-five-fda-citations-2020/

Assignment Background Informatino has been attached


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