A routine inspection of test site (Advanced Interventional Pain Center, Indiana) was conducted in September of 2013, where the LILA medical device was used for a clinical trial. The inspection identified 9 patients who were not part of the trial, but were misconstrued as being part of the trial. The inspectors requested the required additional documentation to be sent to FDA’s Detroit Office. In response and under mutual agreement, the IRB was disbanded, since the clinical trial was already completed and new patients were not being enrolled while the additional documents were sent to FDA’s Detroit office in 3 different sets. While the first set of documents were accepted by the FDA’s Detroit office, the additional sets (2 and 3) when sent to the same office, same address were returned as undeliverable several times. See pictures of undelivered mail below (post office tried delivery several times during working business hours unsuccessfully). The non receipt of the additional documentation triggered the FDA warning letter from its DC office. These warning letters contain 100% misinformation that is not substantiated by any facts and on the pretext that the requested information was not received by the FDA. On clarification that FDA’s warning letter was unsubstantiated, FDA issued a final letter in May of 2014 indicating that the actions taken were satisfactory and eventually resolving the matter (See attached). This final letter is not available on FDA’s website for public view resulting in incomplete and incorrect information regarding these warnings by the public who happen to see only the warnings but not test site’s response or the resolutions. In summary, the FDA warning letter had no legitimate basis for its issuance in the first place and must therefore be considered invalid. Additionally, by promoting warning letters on its website and elsewhere without retraction and hiding the parent company’s response to them, FDA is misinforming the Public through serious omissions. The latter indicates dishonesty and lack of transparency at the FDA. Patients and the general public are therefore cautioned when reading negative information about physicians (e.g. Dr. Pattanam Srinivasan) from FDA promoting websites. FDA has no place in the treatment decisions made by the physicians caring for their patients. It should be emphasized that “FDA is NOT a physician.” FDA has NO authority to advise, endorse or object clinical care of patients by their physicians (See United States Court of Appeals for the Fifth Circuit, Case # 22-40802)

For the above reasons, Prime Interventional Consultants is posting the following information for public view and clarification.

In 2020, FDA had clarified that “FDA does not intend to interfere with the physician-patient relationship and the associated treatment decisions that you (Dr. Srinivasan) have determined are in the best interest of your patients” Physician treatments with a device cannot be used for collecting prospective data for FDA submissions i.e. investigative determinations on safety and effectiveness (this activity was already concluded in 2013 and all data had already been submitted to the FDA, while FDA has not identified a single adverse effect or a side effect associated with the LILA device since then). FDA will NOT interfere with any treatments performed by a physician in the best interest of the patient. See below: