AO 91 (Rev. 11/11) Criminal Complaint

UNITED STATES DISTRICT COURT

for the

__________ District of __________

United States of America )

)

)

)

)

)

)

v.

Case No. 3:22-MJ-884-BK

Defendant(s)

CRIMINAL COMPLAINT

in the county of in the

District of , the defendant(s) violated:

Code Section Offense Description

This criminal complaint is based on these facts: 

u Continued on the attached sheet.

Complainant’s signature

Printed name and title

$JHQWVZRUQDQGVLJQDWXUHFRQILUPHGYLDUHOLDEOHHOHFWURQLFPHDQVSXUVXDQWWR)HG5&ULP3

Date:

Judge’s signature

City and state:

Printed name and title

 Northern District of Texas

RAYNALDO RIVERA ORTIZ JR.

I, the complainant in this case, state that the following is true to the best of my knowledge and belief.

On or about the date(s) ofPLGDallas

Northern Texas

18 U.S.C. § 1365(a);

21 U.S.C. § 331(k);

21 U.S.C. § 333(b)(7); and

21 U.S.C. § 351(d).

Tampering with a Consumer Product and Tampering with a Consumer Product Causing

Death and/or Serious Bodily Injury;

Doing of an Act that Results in a Drug being Adulterated while Held for Sale after Shipment

of the Drug in Interstate Commerce;

Intentional Adulteration of a Drug having a Reasonable Probability of Causing Serious

Adverse Health Consequences; and

Adulteration of a Drug by Mixing or Substituting Another Substance.

Please see attached affidavit in support of criminal complaint.

✔

Chad Medaris, FDA, SA

Dallas, Texas RENÉE HARRIS TOLIVER, U.S. Magistrate Judge

September 13, 2022

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AFFIDAVIT 

I, CHAD MEDARIS, a Special Agent with the United States Food and Drug 

Administration Office of Criminal Investigations, being duly sworn, depose and state: 

1. I am a “federal law enforcement officer” within the meaning of Federal 

Rule of Criminal Procedure 41(a)(2)(C), that is, a government agent engaged in enforcing 

the criminal laws; and I am duly authorized by the Attorney General to make criminal 

complaints. I have been a Special Agent with FDA-OCI for approximately nine years. 

Prior to working for FDA-OCI, I was employed for approximately eight years as a 

Special Agent with the United States Office of Personnel Management-Office of the 

Inspector General. I have had formal training in healthcare fraud, medical device fraud, 

and criminal activity related to foods and drugs under federal law. 

2. I am familiar with the facts and circumstances of the investigation set forth 

below through my personal participation; from discussions with witnesses, other federal 

agents, and law enforcement officers; and from my review of records and reports relating 

to the investigation. Because this affidavit is submitted for the limited purpose of filing a 

criminal complaint, I have not included details of every aspect of the investigation; rather 

only those facts necessary to establish probable cause. 

3. This affidavit is made in support of a criminal complaint against 

RAYNALDO RIVERA ORTIZ JR. (“ORTIZ”) for violations of 18 U.S.C. § 1365(a) 

(tampering with a consumer product and tampering with a consumer product causing 

death and/or serious bodily injury); 21 U.S.C. §§ 331(k) (doing an act that results in a 

drug being adulterated while held for sale after shipment of the drug in interstate 

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commerce), 333(b)(7) (intentional adulteration of a drug having a reasonable probability 

of causing serious adverse health consequences); and 351(d) (adulteration of a drug by 

mixing or substituting another substance) in the Northern District of Texas. 

FACTS 

4. ORTIZ is an anesthesiologist who frequently provides medical services to 

surgical patients at a surgical center located in Dallas (“Facility-1”), as well as other 

surgical facilities in the area. As of mid-2022, a substantial portion of ORTIZ’s work 

was performed at Facility-1 and a substantial portion of his income was derived from his 

work at Facility-1. ORTIZ has been a licensed physician in Texas since 1991. 

5. ORTIZ has a disciplinary history both with the Texas Medical Board and 

with medical facilities at which he has been employed. In November 2020, ORTIZ was 

the anesthesiologist for a procedure at a surgical facility in Garland, Texas (“Facility-2”), 

during which the patient suffered serious complications during anesthesia. In April 2021, 

in lieu of having his privileges revoked by Facility-2, ORTIZ relinquished his medical 

staff membership and all clinical privileges at Facility-2. 

6. On August 19, 2022, ORTIZ entered into an agreed order with the Texas 

Medical Board related to the November 2020 incident at Facility-2. The Texas Medical 

Board found that ORTIZ “did not respond to the patient’s issues in an appropriate 

manner,” “failed to document the critical events,” and “did not recognize the patient’s 

inadequate oxygenation and ventilation.” ORTIZ agreed to a number of conditions, 

including submitting to extensive ongoing monitoring by a Board-selected physician at 

ORTIZ’s expense, re-taking a Medical Jurisprudence Examination given by the Texas 

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Medical Board, completing 16 hours of continuing medical education credits, and paying 

a penalty of $3,000. 

7. In addition to the above, there is another, nonpublic disciplinary inquiry 

currently pending against ORTIZ at Facility-1. Specifically, Facility-1 is investigating 

an incident on or around May 19, 2022 during which a patient, G.A., stopped breathing 

under ORTIZ’s care during a routine procedure. According to a review commissioned 

by Facility-1, ORTIZ deviated from the standard of care by failing to maintain the 

patient’s airway and failing to document critical aspects of the incident—conduct of a 

type that also noted during the November 2020 incident at Facility-2. 

8. According to Facility-1 personnel, ORTIZ was aware of the investigation 

into the May 2022 incident and expressed his unhappiness with it. He expressed to a 

fellow doctor that Facility-1 was trying to “crucify” him. A doctor who is a principal at 

Facility-1, who was personally familiar with ORTIZ, stated that ORTIZ losing his work 

at Facility-1 would be financially “devastating” to ORTIZ. 

9. M.K. was a 55-year-old female who worked as an anesthesiologist at 

Facility-1. On June 21, 2022, M.K. was at home treating herself for dehydration using an 

IV bag that investigators believe she had obtained from Facility-1. Minutes after the IV 

bag was attached to M.K. intravenously, she experienced a major medical event and died 

before emergency medical personnel arrived on the scene. An autopsy report that was 

completed on or around August 24, 2022 concluded that M.K. died of an accident 

involving bupivacaine toxicity, and bupivacaine was found in her bloodstream. 

Bupivacaine is not a drug of abuse, but is rather a common “nerve block” agent used in 

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regional anesthesia procedures. Bupivacaine solution is stocked at Facility-1. Medical 

professionals with whom I consulted as part of the investigation told me that it is highly 

unlikely that a medical professional knowingly injected herself with bupivacaine 

intravenously. Furthermore, the investigation has shown that the circumstances of 

M.K.’s death do not indicate that she desired to commit suicide. 

10. On August 24, 2022, J.A., an 18-year-old male, went to Facility-1 for a 

scheduled ENT surgery. During the surgery, unexpected complications arose when 

J.A.’s heart started beating out of control and his blood pressure spiked to around 

200/150. CPR was employed to save J.A.’s life. J.A. was transferred to an emergency 

medical facility. J.A. was intubated for a time and spent about four days in the hospital. 

11. Agents obtained, as relevant here, four IV bags from Facility-1: two bags 

that were used during J.A.’s surgery and two bags that Facility-1 believed had been 

compromised, which Facility-1 personnel obtained from Facility-1’s “warmer” device. 

Physical inspection of the two suspected compromised IV bags obtained from Facility1’s warmer showed small puncture holes in the clear plastic packaging bags that encase 

the IV bags. The bags with puncture holes appeared to have been physically tampered 

with, as there is no explanation for why a supposedly sealed IV bag would have a 

puncture hole in the packaging surrounding it. 

12. Chemical testing of IV fluid from the IV bag that was attached to J.A.’s 

arm when the adverse event began occurring was performed by scientists at the 

University of North Texas in Denton. That testing confirmed the presence in the IV bag 

of epinephrine, which is a potent pharmaceutical stimulant that—according to health 

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professionals I consulted—could easily cause the cardiac symptoms J.A. experienced if it 

had been administered unintentionally and intravenously. The fluid in the IV bag also 

tested positive for bupivacaine and lidocaine. The IV bag was a “lactated ringer’s” saline 

solution not labeled to contain epinephrine, bupivacaine, or lidocaine. The two other 

suspected compromised bags obtained from Facility-1’s warmer also tested positive for 

bupivacaine and lidocaine. 

13. In reviewing the medical supplies at Facility-1, I noted that there are 

numerous vials of epinephrine solution, as well as bupivacaine, bupivacaine / epinephrine 

solution, and lidocaine, at Facility-1. 

14. I contacted Company-1, which is headquartered in Illinois and provides the 

IV bags for use at Facility-1, including the IV bags used during the surgery on J.A. and 

the other bags obtained from Facility-1. Company-1 confirmed that the bags in use at 

Facility-1 had traveled in interstate commerce. Company-1 also confirmed that IV bags 

provided to Facility-1 would not, to the best of Company-1’s knowledge, have puncture 

holes in the plastic bag surrounding the IV bag nor be compromised in the manner 

described herein. 

15. After the incident involving J.A. and the autopsy report on M.K.’s death, 

Facility-1 personnel identified that the incidents involving J.A. and M.K. were likely not 

isolated and were likely part of a pattern of intentional adulteration of IV bags used for 

procedures at Facility-1. Facility-1 personnel determined that there were approximately 

ten other suspected incidents since late May 2022 where patients experienced unexpected 

cardiovascular complications during otherwise unremarkable surgeries. 

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16. Facility-1 personnel related that the incidents generally seemed to follow 

the same pattern—a patient’s blood pressure would spike to dangerous levels at some 

point during the surgery, usually after the placement of additional IV bags. Facility-1 

personnel told me that medical staff were typically able to save the lives of these patients 

only by using the “crash cart”—a set of emergency tools used when complications arise 

during surgeries—and by transferring the patients to emergency medical facilities. 

17. Facility-1 personnel, as well as other medical professionals with whom I 

consulted, told me that approximately ten cardiac events during otherwise unremarkable 

surgeries at Facility-1 is a high and unnatural number of anesthesia complications in such 

a short time period. For example, Facility personnel stated that in the year 2021, Facility1 had five “transfers” for emergency treatment for the entire year; this year, there were 

five transfers for the month of August 2022 alone. 

18. Facility-1 personnel also determined that the cardiac incidents seemed to 

occur mostly during longer surgeries, when the patients required a second or subsequent 

IV bag from what Facility-1 personnel call the “warmer,” or a device that increases the 

temperature of the IV bag to prepare it for use during the surgery. The warmer is a 

device that looks like a stainless-steel refrigerator and holds multiple IV bags. Facility-1 

personnel explained to me that the second or subsequent IV bags used during a longer 

surgery would as a matter of practice come from the warmer, whereas the first, roomtemperature IV bag used for a procedure at Facility-1 would as a matter of practice come 

from a different location. 

19. Facility-1 personnel determined that, while ORTIZ was the 

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anesthesiologist during numerous surgeries at Facility-1 since May 2022, none of the 

suspected cardiovascular complications from IV bags had occurred during any surgery in 

which ORTIZ was the anesthesiologist. 

20. Facility-1 personnel told me that ORTIZ was informed of the disciplinary 

inquiry against him related to the May 19 incident on or around Tuesday, May 24, 2022, 

and that the first cardiac incidents in the pattern under investigation occurred on or 

around Thursday and Friday, May 26 and 27, 2022, later the same week. ORTIZ

appeared at another meeting related to the May 19 incident on or around Wednesday, 

June 22, 2022, and there was a suspected cardiovascular incident the following week on 

or around Monday, June 27, 2022. 

21. Other cardiovascular incidents involving suspected compromised IV bags 

occurred on or around July 7, 15, and 18; and August 1, 4, 9, and 19. ORTIZ performed 

services at Facility-1 on or around—or on or around days leading up to—those days. 

ORTIZ was on vacation from on or around July 23 until on or around July 28, 2022. No 

cardiovascular events occurred during the time he was on vacation, but the incidents 

started occurring again after he returned to Facility-1 from vacation on or around July 29, 

2022; the first suspected incident thereafter occurred on or around August 1, 2022. 

22. Facility-1 personnel told me that ORTIZ had access to the IV bags at 

Facility-1 during the time periods in question as well as epinephrine, lidocaine, and 

bupivacaine, none of which are controlled substances. 

23. Members of law enforcement as well as personnel from Facility-1—who 

are familiar with ORTIZ and are able to identify ORTIZ—have reviewed portions of the 

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surveillance footage that was obtained from Facility-1 during the time periods under 

investigation. Surveillance footage exists dating from on or around August 2, 2022—

earlier footage is unavailable due to the automated deletion features of the digital video 

recorder attached to the surveillance system. The video in question was collected and 

reviewed by agents directly from Facility-1’s surveillance system. The review of the 

video that that has been completed so far implicates ORTIZ in the August incidents 

under investigation. 

24. A surveillance camera is mounted at, among other locations, an elevated 

position on one end of the hallway where the main operating rooms are located at 

Facility-1 (the “OR Hall”). The warmer is also located in the OR Hall, as well as other 

medical and surgical supplies. The room-temperature IV bags are located in a different 

area of Facility-1. 

25. Surveillance video shows that, on August 4, 2022 at or around 11:35 a.m., 

ORTIZ exited Operating Room 5 and walked toward the warmer with an IV bag in his 

hand. No one else is visible in the video from the OR Hall at this time. In the footage, 

ORTIZ walked slightly past the warmer, then turned and quickly placed the IV bag into 

the warmer. After he placed the IV bag in the warmer, he looked both directions in the 

OR Hall and then quickly walked away. A short time later, ORTIZ opened the warmer 

and looked inside, then quickly closed the warmer. 

26. T.Y., a 56-year-old female, was in Operating Room 1 for a scheduled 

cosmetic surgery at or around the same time that ORTIZ placed the IV bag in the 

warmer on August 4. At or around 12:11 p.m., video shows a nurse obtaining an IV bag 

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from the warmer for T.Y.’s surgery in Operating Room 1. Surveillance video shows that 

no other staff member accessed the warmer between the time ORTIZ accessed the 

warmer and the time that the staff member obtained the bag at 12:11 p.m. After that IV 

bag was placed, T.Y. developed severe hypertension and cardiac arrhythmias at or around 

12:50 p.m. She was given emergency treatment and transferred to an emergency facility. 

27. On August 9, 2022, at or around 10:19 a.m., surveillance video shows 

ORTIZ exiting Operating Room 5 with an IV bag in his hand. The OR Hall was empty 

at the time. ORTIZ walked to the warmer and quickly placed the IV bag in the warmer. 

28. J.E., a 78-year-old male, was in Operating Room 4 for a scheduled wrist 

surgery at or around the time that ORTIZ placed the IV bag in the warmer on August 9. 

At or around 10:54 a.m., a staff member exited Operating Room 4 and retrieved an IV 

bag from the warmer. Surveillance video shows that no other staff member accessed the 

warmer between the time ORTIZ placed the IV bag in the warmer and the time that the 

staff member obtained the bag at 10:54 a.m. Medical records reflect that J.E.’s blood 

pressure spiked at or around 11:02 a.m. Emergency measures were employed, and J.E. 

was transferred to an emergency facility. 

29. On August 19, 2022, at or around 10:34 a.m., surveillance video shows 

ORTIZ exiting Operating Room 5 with an IV bag hidden under what appears to be a 

paper folder. ORTIZ walked to the warmer and appeared to swap the IV bag under the 

paper folder for a different IV bag in the warmer. 

30. K.P., a 54-year-old female, was in Operating Room 2 for a scheduled 

abdominal cosmetic procedure at or around the same time that ORTIZ placed the IV bag 

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in the warmer on August 19. At or around 10:42 a.m., a staff member exited Operating 

Room 2 and retrieved an IV bag from the warmer. Medical records reflect that the IV 

bag was administered to K.P. at or around 10:45 a.m., and that K.P.’s blood pressure 

spiked at or around 11 a.m. Emergency measures were employed, and K.P. was 

transferred to an emergency facility. 

31. On August 23, 2022, at or around 8:30 a.m., surveillance video shows 

ORTIZ exiting Operating Room 5 with an IV bag. ORTIZ walked to the warmer and 

placed the IV bag in the warmer. 

32. On August 23, 2022, at or around 11:49 a.m., a staff member at Facility-1 

rolled a cart containing a large cardboard box to the warmer and restocked the warmer 

with what appears to be a number of new IV bags. J.A.’s incident, described above, 

occurred on August 24. According to Facility-1’s records, ORTIZ was not at Facility-1 

on August 24. 

33. ORTIZ’s behavior as described in the preceding paragraphs—according to 

information received during the investigation—is alarming and unusual. Facility-1 

personnel stated, and other portions of the surveillance footage show, that the warmer is 

stocked by staff members on an as-needed basis from cardboard boxes of IV bags. 

Facility personnel stated that doctors at Facility-1 did not typically place single IV bags 

in the warmer. Furthermore, Facility-1 personnel stated that IV bags that have been taken 

into an operating room for use or potential use in a medical procedure would not be 

brought back out into the hallway and placed into the warmer. 

34. A nurse at Facility-1 told investigators that she was working during a 

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surgery that she recalls occurring in August 2022. She stated that ORTIZ was the 

anesthesiologist for the surgery. The nurse stated that she retrieved an IV bag from the 

warmer to use during the surgery, but that ORTIZ strongly refused to use the bag and 

physically waived the bag off. The nurse stated that she recalled the event as unusual. 

The nurse also stated that, around the same time, ORTIZ retrieved his own IV bags for 

use during his procedures. The nurse said that it was unusual for ORTIZ to engage in 

this practice, as doctors at Facility-1 did not typically obtain their own IV bags. 

35. Based on the facts recited above, there is a direct and likely correlation 

between ORTIZ placing IV bags in the warmer and the incidents under investigation in 

which patients other than ORTIZ’s patients experienced severe adverse medical events. 

There also appears to be a likely correlation between ORTIZ coming under scrutiny for 

medical errors and the adverse events affecting other anesthesiologists’ patients at 

Facility-1. 

36. Other potential explanations have been investigated but do not fit the facts 

that the investigation has revealed. For example, in the surveillance video, investigators 

have not yet located other instances of people regularly placing single IV bags in the 

warmer, and certainly not anyone placing IV bags in the warmer that are so closely 

associated with the timing of the adverse events under investigation. 

37. Furthermore, as described above, the warmer is typically stocked by 

Facility-1 staff from large cardboard boxes filled with IV bags from Company-1. If those 

IV bags had been compromised, there would have been many more adverse medical 

events and/or the phenomenon would likely be more widespread—but Company-1 has 

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not received similar reports of compromised IV bags or similar reports of adverse events 

from other facilities in this timeframe. Similarly, if IV bags at Facility-1 coming from a 

location other than the warmer were responsible for these events, patients would have 

experienced their adverse events at the beginning of their surgeries and not the middle or 

end. If someone else at Facility-1 other than ORTIZ were responsible for these events, 

there would likely be some video evidence of that person handling IV bags; instead, the 

video evidence shows ORTIZ inexplicably placing single IV bags in the warmer 

precisely near the times of the adverse events under investigation. 

CONCLUSION

38. Based on the above information, Affiant believes there is probable cause to

believe that RAYNALDO RIVERA ORTIZ JR. committed violations of 18 U.S.C. § 

1365(a) (tampering with a consumer product and tampering with a consumer product 

causing death and/or serious bodily injury); 21 U.S.C. §§ 331(k) (doing an act that results 

in a drug being adulterated while held for sale after shipment of the drug in interstate 

commerce), 333(b)(7) (intentional adulteration of a drug having a reasonable probability 

of causing serious adverse health consequences); and 351(d) (adulteration of a drug by 

mixing or substituting another substance) in the Northern District of Texas. 

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____________________________

Chad Medaris, Special Agent 

FDA Office of Criminal Investigations 

Agent sworn and signature confirmed via reliable electronic means, pursuant to Fed. R. 

Crim. P. 4.1. on this _____ day of September 2022. 

___________________________________ 

RENÉE HARRIS TOLIVER 

UNITED STATES MAGISTRATE JUDGE 

13th

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