A well-trained physician can be selectively targeted, deliberately ensnared, inappropriately tried, and wrongfully convicted

A well-trained physician can be selectively targeted, deliberately ensnared, inappropriately tried, and wrongfully convicted

https://www.daily-remedy.com/letter-to-the-alabama-board-of-medical-examiners/

Letter to the Alabama Board of Medical Examiners

Xiulu Ruan, MD 66857019 E1

F.C.I. Oakdale 1

P.O. Box 5000 Oakdale, LA 71463

 

July 16, 2019

 

Mark H. Lequire, MD, Chairman

Michael T. Flanagan, MD, Vice Chairman Alabama Board of Medical Examiners

P.O. Box 946 Montgomery, AL 36101

 

Dear Drs. Lequire and Flanagan:

 

It must be quite a shock for you to receive a letter from a physician felon. I was convicted as a mobster after a seven-week jury trial in the Southern District of Alabama on February 23, 2017, and am serving a twenty-one year sentence in a federal prison In Oakdale, Louisiana. As a result of my indictment and subsequent conviction, I have lost my Alabama medical license, along with those of Michigan, Florida, and Mississippi. However, the truth of the matter is that I have not committed any crime; I have been only criminalized and vilified.

 

The purpose of my letter to you is manifold. Though this may seem to serve as a means of venting my indignation about the grave Injustice of my case, this is not my main goal. Despite the fact that I feel quite urged to share with you the horrendous ordeal and misery that my family members and those close to me have gone through, I want to focus on a broader issue, namely the movement to prosecute physicians in this nation. It is mainly for this reason that I have decided to share with you what I have recently written. Using my own trial as a foundation, I aim to show how, in this country, a well-trained physician can be selectively targeted, deliberately ensnared, inappropriately tried, and wrongfully convicted.

 

It is well recognized that 97% of federal convictions and 94% of state convictions are the result of guilty pleas. In his book entitled “Prosecution Complex,” Daniel S. Medwed (a Professor of Law at the University of Utah and a legal scholar in the field of wrongful conviction) opines: “There is a stark sentencing differential in the American criminal justice system depending on whether a defendant pleads guilty or is convicted after a trial. Defendants who reject a plea offer customarily receive a steeper sentence upon conviction on those charges after trial than the one contained in the plea offer” (p. 61). Professor Medwed also holds that it is impossible to quantify the social cost of the current mode of plea bargaining in the United States that places pressure on innocent defendants to plead guilty (p. 60).

 

The overwhelming majority of prosecuted physicians choose to sign plea agreements with the government, and by doing so they have given up their rights to challenge or openly present their cases to the public. On the other hand, the prosecutors representing the federal government have total control in deciding what the public should be told in each case. Deliberate misrepresentation in order to unfairly prejudice against the defendant physicians is a general rule rather than an exception. Here I want to substantiate the aforementioned point with the use of my medical credentials as an example.

 

As a fellowship-trained, board certified interventional pain management specialist, I took a great deal of pride and had devoted my level best effort in building up my professional credentials. At the time of my arrest in May 2015, I had an active and unrestricted licenses in four states, namely Alabama, Michigan, Florida, and Mississippi. I also had eight active medical board/subspecialty certificates, including Physical Medicine & Rehabilitation, Pain Medicine, Addiction Medicine, Electrodiagnostlc Medicine, lnterventional Pain Management, Subspeclalty Board Certification in Neuromuscular Medicine and Pain Management, as well as a board certificate by the American Board of Independent Medical Examiners.

 

Further, I was an active member in a host of national specialty/subspecialty societies such as the American Society of lnterventional Pain Physicians (ASIPP), the American Academy of Pain Medicine (AAPM), the American Society of Addiction Medicine (ASAM), the American Pain Society (APS), the American Academy of Physical Medicine & Rehabilitation (AAPMR), and so forth. I had served a number of leadership roles in some of them and their state chapters, for example, at the time of my indictment, I served as the President of the Alabama Society of lnterventional Pain Physicians (under ASIPP), as well as being the Immediate Past President of the Alabama Society of Addiction Medicine (under ASAM). I had previously also served as a National Director-at-Large in the ASIPP.

 

Academically, I held the title of an Adjunct Clinical Associate professor at the Department of Anesthesiology, Louisiana State University Health Science Center in New Orleans, LA, and I served as an editorial board member for a handful of professional journals. By the time of my jury trial in January 2017, and as a lead and/or corresponding author, I had published over ten dozen papers in peer-reviewed and PubMed Indexed journals such as JAMA Internal Medicine, JAMA Psychiatry, JAMA Oncology, JAMA Surgery, Neurosurgery, Lancet Psychiatry, American Journal of Psychiatry, Psychiatric Research, Pain, Pain Medicine, Pain Physician, Journal of Pain, Clinical Journal of Pain, Regional Anesthesia & Pain Medicine, Anesthesia & Analgesia, European Journal of Pain, European Journal of Cancer, European Journal of Anesthesiology, Journal of Opioid Management, American Journal of Physical Medicine & Rehabilitation, Muscle & Nerve, Journal of Clinical Pharmacology, Clinical Therapeutics, Expert Opinion on Pharmacotherapy, Journal of Pharmacological Sciences, Annals of Pharmacotherapy, Pharmacological Research, Therapeutic Advances in Drug Safety, American Journal of Hospice & Palliative Care, American Journal of Surgery, American Journal of Medical Quality, American Journal of Hematology, American Heart Journal, Journal of Rheumatology, Journal of Forensic Sciences, Forensic Science, Medicine, and Pathology, Journal of Forensic & Legal Medicine, American Journal of Forensic Medicine and Pathology, International Journal of Legal Medicine, Medico-Legal Journal, American Journal of Medicine, Academic Medicine, Addiction, Journal of Addictive Disease, American Journal of Drug & Alcohol Abuse, Journal of Analytical Toxicology, Clinical Toxicology, Journal of Medical Toxicology, Journal of Critical Care, Annals of Emergency Medicine, Annals of Epidemiology, and others.

 

The professional information related to my clinical training and education, academic title and publications, and board/subspecialty board certifications was easily accessible on my personal website as well as on my company website (Physicians’ Pain Specialists of Alabama). However, in the Grand Jury Indictment release on April 30, 2015, there was only one sentence given pertaining to my clinical background: “Defendant Xiulu Ruan, MD was a Mobile, Alabama physician licensed to practice medicine in the State of Alabama.”

 

Clearly, the prosecutors decided that none of my other qualifying information, particularly as a fellowship-trained and board certified pain specialist was relevant. They had no intention of letting the public know the full level of my professionalism.

 

Instead, they showed no misgivings in painting me to be an unscrupulous, fraudulent, greedy doctor who was only concerned about money. I believe this dirty tactic of character assassination is the modus operandi utilized by prosecutors when prosecuting physicians. Thus it is no longer an issue as to how a certain specialty or subspecialty of medicine is practiced; the issue has become a sociopolitical one. As a result, what physicians have learned through their clinical training and education becomes essentially irrelevant. There is no objective standard at trial; what the prosecutors ever need is an inflammatory and incriminating rhetoric that they can use to instigate confusion and prejudice among the jury against the physician defendant, who has already been found “guilty” before the trial even starts. Specifically, my trial was replete with deliberate misinterpretations, misrepresentations, and distortions. To forewarn my fellow colleagues of such vulnerability and peril (in case when being targeted and facing prosecution), is the other important reason that prompts me to share some of my writings with various physician organizations, medico-legal professionals, as well as some journalists.

 

Finally, please keep in mind that I have been convicted as a head “gangster” of an illusory “criminal enterprise,” following a seven-week jury trial. I believe that my case clearly represents a political persecution that is both shameful and disgraceful.

 

Thank you very much for your time and attention.

 

Sincerely,

Xiulu Ruan, MD

 

If you ever have blood pressure that’s 180/120 or above, it’s an EMERGENCY

If you ever have blood pressure that’s 180/120 or above, it’s an EMERGENCY

According to this article How Do I Know if I Need High Blood Pressure Drugs?  If you ever have blood pressure that’s 180/120 or above, it’s an EMERGENCY You need medical help right away to get it under control.

did everyone know that Medicare checks pts taking meds for diabetes,high blood pressure, and high cholesterol checks to see if they are taking their meds as prescribed… medically being compliant. Supposedly, they are suppose to “financially ding” prescribers and pharmacists/pharmacies if their pts are NOT routinely compliant.  Apparently there is no verification that the medication that the pt is being prescribed and routinely taking is not getting their blood pressure to an acceptable levels – typically <135/85.

How many chronic pain pts has their blood pressure increase as the prescriber has been reducing their pain meds.  You are put on up to 5 different blood pressure meds and your pressure remains at/near same HIGH LEVELS. They refuse to see any relationship with your reduced pain meds and your elevated BP and all the BP meds being prescribed … are DOING NOTHING !

They claim that there are no tests to evaluate that a pt is dealing with chronic pain and the intensity of their pain.  It is becoming quite obvious that many chronic pain pts who have their med therapies reduced and their blood pressure has increased and the prescriber adds 4-5 different categories of pharma anti-hypertensive meds and the pt’s elevated BP does go down.

Shouldn’t prescribers give pts a 30 day trial of a opiate to see if opiate therapy would lower their blood pressure ? I would suggest giving a pt Norco-10 and let the pt to be able to determine what dose they need to lower their overall pain. Norco-10 every 3 hrs around the clock as needed.  This dose is both under the 2016 CDC guideline of max of 90 MME/day and under the max recommended dose of Acetaminophen/Tylenol/day.  I would suggest that the pt take their blood pressure when they get up in the AM, after lunch, after supper and at bedtime and the pt – ideally – the pt should create a chart using a spread sheet over the 30 days, and the pt should wean themselves down over the last week of available meds.

What if the pt’s BP goes down some, but no where near the ideal BP of  < 135/85 ?  That would strongly suggest that the pt may still be dealing with under treated pain, but that their body – because of still high BP… is still dealing with elevated BP that higher dosing or using a different opiate may help lower the pt’s BP even lower.   This is may also be a good time for the pt to do DNA pharmacogenomic testing that would point out if the pt is a fast/ultra fast metabolizer for Hydrocodone and/or would better metabolizer of a different opiate.

The long term adverse health affects to pts with under/untreated pain can be quite dramatic.  High blood pressure has always been labeled as the SILENT KILLER. Attached graphic illustrates most all of those “bad outcomes” of under/untreated high blood pressure.

Medical Board Takes Action Against Misinformation Doc

— Pathologist Ryan Cole, MD, is facing discipline for negligence, spreading false statements

https://www.medpagetoday.com/special-reports/features/10270

An Idaho pathologist who previously came under fireopens in a new tab or window for prescribing ivermectin to COVID-19 patients and spreading falsities about vaccines, is facing disciplinary actionopens in a new tab or window by the Medical Commission in Washington state, where he is also licensed to practice.

Ryan Cole, MD, is said to have made “numerous false and misleading statements” during public presentations on the pandemic, COVID vaccines, the use of ivermectin to treat COVID, and the effectiveness of masks, according to a statement of chargesopens in a new tab or window issued by the Washington Medical Commission earlier this month. He also allegedly provided negligent care to a number of patients in the prevention or treatment of COVID.

“Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust,” the commission wrote in the statement. “That public trust is essential to effective delivery of medical care. Knowingly false statements or those made in reckless disregard for the truth, such as the medical disinformation statements by respondent … erode the public’s trust in physicians and their medical treatment and advice, and thereby injure public health.”

Specifically, at all times relevant to the case, Cole, an anatomical and clinical pathologist, ran an independent medical laboratory that he owns, provided direct care to patients via telemedicine through the website MyFreeDoctor.com, and spoke at public and private forums, as well as on news shows and podcasts, the statement noted.

According to the commission, since March 2021, Cole is said to have made false and misleading comments during his presentations, including, “Children survive [COVID-19] at a hundred percent,” and “A hundred percent of world [ivermectin] trials have shown benefit.”

Other public statements Cole is said to have made include that the COVID vaccine is “an experimental biological gene therapy immune-modulatory injection,” in addition to “a fake vaccine … the clot shot, needle rape.”

In a written statement to the Washington Medical Commission dated Feb. 7, 2022, Cole wrote that he had not advised patients or the general public to not get the COVID vaccine, contrary to other remarks included in the statement of charges.

As for the allegations of negligent patient care, the statement included descriptions of telemedicine provided in June and July 2021 to four unnamed patients.

“For all of these patients, respondent prescribed medications that are not indicated for a COVID-19 infection, failed to properly document adequate justification for the treatment in the medical record, failed to take a history or perform a physical examination, and failed to obtain appropriate informed consent,” the commission wrote. “Respondent also provided inadequate opportunity for follow-up care, treated patients beyond his competency level, and did not advise patients about standard treatment guidelines and preventative measures.”

The Idaho Capital Sun reported that Cole has until the end of the monthopens in a new tab or window to respond to the statement of charges, and that the physician has previously maintained that he did not violate standardsopens in a new tab or window while treating patients for COVID via telemedicine.

The news outlet further noted that Cole serves as the CEO of his laboratory, Cole Diagnostics, located in Garden City, Idaho, and is currently licensed by the Idaho Board of Medicine, as well as medical boards in several other states.

A search of the Idaho Board of Medicine’s online portal showed no action against his license there.

Cole did not immediately return a request for comment.

Utah man arrested for murder after telling police he killed his wife at her own request

Utah man arrested for murder after telling police he killed his wife at her own request

 

https://www.fox13now.com/news/local-news/utah-man-arrested-after-telling-police-he-killed-his-wife-at-her-own-request

ROY, Utah — A man was arrested Saturday for allegedly shooting and killing his wife in Roy, claiming she asked him to do so because she was in extreme pain.

He also told police that he killed her earlier in the week but waited about four days to report it.

Dave Meyer, age 69, was booked on suspicion of murder for his wife’s death, as well as other charges in connection to the incident.

Police responded to Meyer’s home on Saturday after emergency dispatch indicated that he killed his wife. Officers took him into custody without incident, then while sweeping the home, they found a woman who was dead. The victim was confirmed as his wife, 62-year-old Suzanne Meyer.

Meyer agreed to speak with police after being informed of his Miranda rights, according to the arrest report. He said his wife had been in pain for 11 years because of a car accident, and he had watched her suffer from back pain and nerve damage for many years. He claimed that she had been “asking him to kill her for a while now due to the amount of pain she has been in.”

Meyer explained to investigators that he was rubbing his wife’s back one day when he saw his 9mm handgun on the dresser, and he shot her in the head. Police said he couldn’t recall exactly what day this occurred, but they believe it was Tuesday.

Meyer said he then left her body in the room for several days before reporting the incident.

He was booked and ordered to be held without bail, facing charges of 1st-degree felony murder and 2nd-degree felony obstruction of justice for waiting several days to report his wife’s death.

He also told police that he and his wife used marijuana every night for the past 10 years. Neither of them had medical marijuana cards. Police said this meant he was restricted from possessing firearms, so he also faces two charges of illegal firearm possession. He told police he owned another handgun in addition to the one he allegedly used to kill his wife.

__________

Resources for domestic violence victims/prevention (free, 24/7, confidential):

  • Utah Domestic Violence Coalition:
    • Hotline: 1-800-897-LINK (5465)
    • Online help: udvc.org
  • National Domestic Violence Hotline
  • If you or someone else is in immediate danger, or in an emergency, call 9-1-1 immediately.

__________

For those struggling with thoughts of suicide, the National Suicide and Crisis Lifeline can now be reached by simply dialing 988 any time for free support. Resources are also available online at utahsuicideprevention.org.

The federal agencies are not likely to make any changes to these policies or guidelines

I wonder if this letter represents the mindset of many of those in the Senate.  These new rules/guidelines do not prevent any physician from prescribing pain medications outside the normal prescribed dose as long as the physician can support the decision to do so, through documentation.

Just who defines “normal prescribed dose”– the FDA— the CDC — the DEA ? What I have mostly read from articles on prescriber being taken  to federal court that the prescriber exceeded standard of care and best practices… Are they referencing the FDA dosing guidelines in the professional dosing information or are the following the CDC MME system recommendations – which has no science nor double blind clinical studies supporting their conclusion ?

The typical chronic painer is not waiting for a federal/state agency to compel the prescriber to prescribe them opiates.  At least Senator Johnson understands that the DEA has intimated may prescribers to stop prescribing or dramatically lower the pt’s dose.

Senator Johnson wrote this in Jan, 2023The federal agencies are not likely to make any changes to these policies or guidelines – that is SIX MONTHS after the SCOTUS ruled (9-0 vote ) in the Ruan/Kahn that the DEA could not use OBJECTIVE CRITERIA in judging prescriber treating pts dealing with SUBJECTIVE DISEASES.  Does Senator Johnson and other members of Congress knows something about the DEA future plans in dealing with prescribers that is not being shared with others ?

From: Office of Senator Johnson <no-reply@ronjohnson.senate.gov>
Date: Fri, Jan 20, 2023 at 10:26 AM
Subject: Responding to your message

 

Thank you for contacting the office of Senator Ron Johnson with your request for a meeting to discuss the FDA, CDC and DEA medication prescribing recommendations as it relates to pain management medications. 

Several years ago, these federal agencies put out new guidelines for prescribing pain medications as a result of over-prescribing which led to a severe addiction problem among U.S. citizens. I have attached the CDC’s guidelines here for your review. 

These new rules/guidelines do not prevent any physician from prescribing pain medications outside the normal prescribed dose as long as the physician can support the decision to do so, through documentation. These changes did result in many prescribers making the decision to no longer prescribe any pain management medications and instead referring their pain management patients to a pain management specialist or clinic. 

Many prescribers have chosen not to prescribe these medications outside the “normal” recommended dosages for fear of extra scrutiny by the DEA. Admittedly, these changes in policy have resulted in some challenges for patients who truly need and require high doses of opioids and other pain medications to manage their pain. However, the prescribers are within their right to decide these matters and no federal or state agency can compel them to prescribe these medications.

The federal agencies are not likely to make any changes to these policies or guidelines as they continue their fight to deal with the epidemic of opioid abuse, addiction and overdoses. 

Please do not hesitate to contact Senator Johnson or his staff in the future to request assistance concerning federal issues or to share your ideas and opinions. We truly appreciate the opportunity to hear your concerns. Senator Johnson believes one of the most important duties he has as your Senator is to listen to the views of the citizens of Wisconsin, and in turn, communicate his views.

Doc found INNOCENT of violating CSA – getting license back may be another battle

when DEA facts and statistics don’t “add up”… what is really the TRUTH ?

There is a term in pharmacology – LD50 – it is the dose that 50% of the animal/human taking such a dose – 50% would die !
https://go.drugbank.com/drugs/DB00813

Fentanyl has an intravenous LD50 of 2.91mg/kg in rats1, an oral LD50 of 18mg/kg in rats and 368mg/kg in mice.MSDS The LD50 in humans is not known.

This is all I could find regarding LD50 for Fentanyl, but according to Wikipedia there is some 400 known different analogs of fentanyl… and the FDA approved analog – citrate – is claimed to be about twice the potency of the analog (acetate) that is typically used in illegal fentanyl tabs from the Mexican cartels.

 


Connect The Dots Coloring Book Flower Puzzle Clip Art, PNG, 504x600px ...
“back in the day” we kids had “connect the dots” graphic that would display some sort of image when all the dots were connected. Over the last few weeks, I have seen where numerous federal entities or members of Congress are publicly sharing “dots” of information about the war on drugs. Such things as the attached video where the “expert” testifying on a trial, showing the cartels and the routes of distributions used by the various cartels and that the DEA has been fully aware of all of this for maybe TWO DECADES.

Recently on a national new program it was stated that 379 MILLION illegal fentanyl tabs were confiscated in the USA in the last calendar year and/or last federal fiscal year and just this week a member of Congress from Arizona on national TV program and the millions of illegal fentanyl tablets that are being released to the media only represents 8% to 15% of what actually comes across the border.

So this would mean that anywhere from  2.52 BILLION to   4.7 BILLION is coming across our boarders every year.  This means that 2.15 BILLION to 4.32 BILLION illegal fentanyl tablets actually gets to our streets.

This is a basic ROAD MAP of the major players in our healthcare system and who “owns” who and who “controls ” who


This is a basic ROAD MAP of the major players in our healthcare system and who “owns” who and who “controls ” who
https://i0.wp.com/ncpa.org/sites/default/files/2023-01/verical-bus-chart.jpg?w=468&ssl=1

This DEA GUIDANCE DOCUMENT seems to only address the pts being treated with ADDICTION


I am not sure what this means, it is around the change of practitioners treating pts who are addicted or diagnosed with Opiate Use Disorder. What interpretations that the DEA generates in the future – one can only guess –

 

 


FDA WARNING LETTER: Optum Infusion Services 308 LLC

WARNING LETTER

Optum Infusion Services 308 LLC

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/optum-infusion-services-308-llc-647842-12132022

Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs

Recipient:
William J. Kottmer, PharmD
General Manager
Optum Infusion Services 308 LLC

2555 West Fairview Street Suite 104 Building D Chandler, AZ 85224-4708 United States

bkottmer@optum.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States


WARNING LETTER

December 13, 2022

Dear Dr. Kottmer:

From March 8, 2022, to March 18, 2022, a U.S. Food and Drug Administration investigator inspected your facility, Optum Infusion Services 308 LLC, located at
2555 West Fairview Street Suite 104 Building D, Chandler, Arizona 85224. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

FDA issued a Form FDA 483 to your firm on March 18, 2022. FDA acknowledges receipt of your facility’s response, dated April 8, 2022. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

A. Compounded Drug Products Under the FDCA

Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].

B. Violations of the FDCA

Adulterated Drug Products

The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:

1. You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area. Vermin are a source of microbial contamination. Therefore, your products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination.

2. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

3. An operator placed their gloved hands outside the ISO 5 area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.

It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

C. Corrective Actions

We have reviewed your firm’s responses to the Form FDA 483. Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:

1. In response to Observation 5 of the Form FDA 483, you stated that you changed pest control providers, installed insect light traps, and that you will be installing air curtains on exterior doors and plastic flap curtains inside of the warehouse door. It is unclear where the insect light traps, air curtains, or vortex curtains will be installed in relation to the classified areas. Additionally, it is unclear when these corrective actions will be fully implemented.

2. Regarding your response to Observation 1 of the FDA 483, we acknowledge your response indicating that you will update the way you assess and document the risk associated with every “patient compound” potentially affected by an excursion and train staff on the new policy. Also, you stated that you have conducted a retrospective review of “compounds” referenced in the observation and found there to be no product or patient impact. However, your response lacked supporting evidence, for example, you did not provide the retrospective review referenced. Furthermore, we acknowledge your response states, in SOP Compounded Sterile Product Impact Assessment Process, that a low risk level would be determined by the pharmacist in charge (PIC) based on the actionable microbial growth. Please note, any microbial contamination in the ISO 5 area is considered an insanitary condition.

Additionally, your response states, in SOP Compounded Sterile Product Impact Assessment Process, that “(b)(4).” Please note, any microbial contamination within the ISO 5 area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.

3. In response to Observation 2 of the Form FDA 483, you stated that you provided on-site training to staff. However, you did not provide the attachment Aseptic Technique Evaluation Update 04072022 referenced in your response.

Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation.

D. Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time in which you will do so.

Send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506

Please identify your response with unique identifier 647842.

If you have any further questions, please contact Nayan Patel, compliance officer, by email at Nayan.Patel1@fda.hhs.gov or by phone at (303) 236-3010.

Sincerely,
/S/
Steven E. Porter, Jr.
Program Division Director
Division of Pharmaceutical Quality Operations IV

CC: Keith McFalls, Regional Vice President (via e-mail k.mcfalls@optum.com)
3428 Wild Oaks Court
Burleson, TX 76028
(817) 676-8760

“BAD ESI”: Pt paralyzed, confined to a wheelchair and renders her incontinent

Singer Is Paralyzed After Delay in Care; Hospital Must Pay

https://www.medscape.com/viewarticle/986937

Delay in Treatment Will Cost Hospital Millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Texas, prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Jessie remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department (ED), staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself it wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Adams continued to experience excruciating pain. “I kept screaming, ‘Help me,’ ” she recalls today. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Adams and her husband $10.1 million, including $500,000 for Richard Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Richard spends most of his time taking care of Jessie.