California to Monitor FDA Warning Letters to Doctors

Dec. 31, 2018

Following an investigation by the Milwaukee Journal Sentinel and MedPage Today that uncovered doctors receiving warning letters from the US Food and Drug Administration (FDA) but not receiving any action from states, California has said it is monitoring the FDA’s warning letters to doctors. The letters reportedly included serious allegations in a five-year period, but of 73 doctors across the US who received a warning letter, only one doctor ever faced discipline. Some of the doctors’ alleged actions could constitute medical malpractice if patients suffered harm as a result.  

At Cutter Law, we’re proud to represent patients who have been the victim of serious medical malpractice. We are committed to ensuring that all medical professionals uphold their duty to their patients, and holding those professionals accountable when they do not meet the required standard of care. We know that patients like you put their faith in the medical system and that the results of medical negligence or malpractice can be devastating.

FDA Warning Letters Included Allegations of Serious Negligence

Among the serious violations raised in the reported FDA warning letters are fertility clinics not testing egg and sperm donors for communicable diseases, doctors who encourage patients to use suspect treatments or supplements, and researchers not protecting patients who are enrolled in drug and device trials.

The FDA sends out these warning letters after its officials inspect offices, clinics and other medical sites to see if anyone at those locations is violating federal rules. The FDA does not have the authority to punish medical personnel; all it can do is send warning letters. Unfortunately, in too many cases the state regulatory boards have also done nothing, possibly due to a lack of communication between the FDA and state regulatory boards.

Highlighted in the article is Benedict Liao, who has faced warning letters from the FDA, a lawsuit filed by a patient, and a raid by federal agents, all linked to a $1,800 a month treatment he offered patients. That cure was called “Allesgen” and was marketed by Liao as a cure for cancer. Additionally, a patient who saw Liao for her breast cancer later filed a lawsuit alleging that Liao not only failed to entirely remove the cancerous tumor, he then told her Allesgen was a safe alternative to radiation or chemotherapy.

The FDA also sent Liao multiple warning letters regarding clinical trials he operated despite the FDA requesting the trial be postponed.

According to the report, the California medical board did reprimand Liao for his actions involving an abortion in 2005 but did not issue any disciplinary actions against him linked to Allesgen.

Another California Doctor Received Three Warning Letters (H2)

Meanwhile, another doctor in California, Michael Arata, also received warning letters from the FDA, these linked to vein-opening procedures done on multiple sclerosis patients. The FDA considers the treatment unproven and sent letters to Arata warning him to stop. It also noted that Arata does not have training to treat MS but says Arata claimed he could treat “automatic” symptoms. In June 2018, California’s medical board initiated proceedings against Arata. Those proceedings could result in his license being suspended or revoked.

The Milwaukee Journal Sentinel notes that one patient died after receiving treatment from Arata. The California medical board accused Arata of gross negligence, repeated negligence and unprofessional conduct.

Thomas Gionis is a doctor who operates stem cell clinics in California, New York and Florida. The FDA sent him a warning letter regarding potential product contamination and not having the proper license to use those products in people.

California Begins Monitoring Warning Letters

Carlos Villatoro, a spokesperson for the California medical board, said the board began receiving the FDA’s warning letters in June and would look into any physicians that the board licensed. For its part, the FDA said it was considering notifying state boards of any safety issues regarding patients that it uncovered in its investigations.

Medical Malpractice Attorneys

At Cutter Law, we know how devastating the consequences of medical malpractice and medical negligence can be. Whether the malpractice is committed by a doctor attempting to scam patients or a medical professional who fails to respond to an emergency situation adequately, for some patients the results can be fatal or permanently debilitating. That is why we’re committed to holding medical professionals accountable for the care they provide.  

If you have been harmed by medical malpractice or medical negligence, you need a skilled attorney with a history of successfully represent patients harmed by healthcare professionals. Our attorneys have obtained numerous medical malpractice verdicts, including one of the largest ever in Sacramento County. Contact an attorney at Cutter Law today to find out how we can help you.

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