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Years after a tampered IV bag became deadly, no new rules are in place. Survivors want to change that.
Years after a tampered IV bag became deadly, no new rules are in place. Survivors want to change that.

CBS News

time21-05-2025

  • Health
  • CBS News

Years after a tampered IV bag became deadly, no new rules are in place. Survivors want to change that.

More than a year after a former Dallas anesthesiologist was convicted of tampering with IV bags, survivors and their families say they are still waiting for the medical industry to take action. "We almost lost him," Dovi Alderstein told the CBS Texas I-Team, referring to his son, Jack, who he says suffered a near-fatal cardiac event following a routine procedure at a surgical center in North Dallas. "It was the scariest experience of our lives." In late 2024, Dr. Raynaldo Ortiz was sentenced to 190 years in federal prison for secretly injecting dangerous drugs into IV bags at Baylor Scott & White Surgicare North Dallas. His actions harmed ten patients and led to the death of Dr. Melanie Kaspar, a fellow anesthesiologist who used one of the compromised bags to treat her own dehydration at home. Now, victims are seeking accountability from the manufacturer of the IV bags themselves. A lawsuit and a familiar warning Attorney Bruce Steckler filed a lawsuit on behalf of Kaspar and her husband, John, against Baxter International, the manufacturer of the IV bags. The suit argues that the design of the bags allowed Ortiz to tamper with them without being detected, and that it didn't have to be that way. "This could have been avoided with a tamper-resistant design," Steckler said in an interview with the I-Team. "You can inject any kind of medication into that port without any sign of entry. That's exactly what happened here." Baxter is the largest producer of IV bags in the U.S., according to the lawsuit. The suit claims the company manufactures fixes — after-market foil seals and tamper-evident caps — that could deter or at least reveal tampering. In a statement to the I-Team from 2022, the FDA confirmed that standard IV bags "do not normally contain tamper-proof or tamper-evident features." Nearly three years later, despite the high-profile nature of the Ortiz case, the agency told the I-Team it has "no new information" regarding any regulatory changes. The Texas State Board of Pharmacy and the National Association of Boards of Pharmacy also confirmed they have "no new information" regarding guidelines. Echoes of the Tylenol murders The allegations have drawn comparisons to the 1982 Tylenol poisonings in Chicago, where seven people died after ingesting cyanide-laced capsules that had been placed on store shelves. In the wake of those murders, the pharmaceutical industry adopted strict packaging requirements, including triple-sealed bottles and tamper-evident warnings. "Why didn't Baxter get the message?" Steckler said. More than 40 years later, most over-the-counter medications still bear those protections; however, in medical settings, IV bags, which are often administered when patients are unconscious or sedated, appear to remain more vulnerable. Dr. Marvin Shepherd, the former director of the University of Texas College of Pharmacy, predicted in a 2022 I-Team interview that the FDA would impose new mandates after the Ortiz case. "It's highly probable," he said at the time. "Very probable." But so far, nothing has changed. IV bags vs "a jar of pickles" At the center of the lawsuit and the public call for reform is Melanie Kaspar. "She's the one that's not here. And we are," said Melody Naylor, a dentist who also suffered cardiac arrest after undergoing a minor procedure at the same surgical center. "So we have to speak for her." Naylor said her family now insists on inspecting IV bags before they're administered. They look for punctures, leaks or any signs of tampering. She said patients should remember they have a right to ask questions and to see the bags. But not all signs are visible. Ortiz tampered with the IV bags in a way that was subtle and left no clear puncture mark. Even Kaspar, a trained anesthesiologist, could not detect it. "There is no reason that you should have greater confidence in the fact that the jar of pickles that you buy at the supermarket hasn't been tampered with than you are that your IV bag hasn't been tampered with," Alderstein said. The father said he believes a basic safety seal, the kind used on common foods and household items, might have saved lives. "It would have prevented it entirely," Alderstein said. "Jack wouldn't have gone through that. None of the victims would have. And most importantly, Dr. Kaspar would still be with us." Baxter responds Baxter International sent the I-Team the following statement: "As a matter of course, Baxter does not comment on pending litigation." In court documents responding to the lawsuit, Baxter issued a general denial stating, among its defenses, the incident was "caused solely by … criminal acts… ." It also states the IV bags were "designed, manufactured, and sold in compliance with all applicable codes, standards, regulations, and … laws." North Texas hospitals The I-Team reached out to seven major hospital systems in North Texas to ask whether the Ortiz case prompted changes to how IV bags are stored, monitored or sourced. Four of the facilities, including Methodist Health System, UT Southwestern, Texas Health Resources and Parkland Health did not respond despite repeated inquiries. Medical City Healthcare and JPS Health Network replied but did not answer the questions. Baylor Scott & White, where the tampering occurred, issued the only statement: "Immediately upon determining an IV bag had potentially been compromised, Surgicare North Dallas ceased all operations, notified local and federal authorities and engaged several experts to review its protocols and procedures. The facility decided to resume operations more than four weeks later, only after extensive investigation and the issuance of the Department of Justice's criminal complaint against Dr. Raynaldo Ortiz, which noted investigators' belief that the problem was limited to one individual. Our priorities in the matter were always the safety and wellbeing of our patients and seeing justice served. It is important to note that anesthesiologists, like Dr. Ortiz, are authorized users of IV fluids and medications in a surgical care setting, and IV fluids and medications must be made readily available to authorized users for safe patient care. The handling and storage of IV bags and medications at the facility was reviewed and deemed appropriate by experts and in line with industry standards. And we continuously review processes and safeguards to assure the highest levels of patient safety. Surgicare North Dallas is accredited by The Joint Commission, licensed by the Texas Department of Health and Human Services, and it is certified and approved by the Centers for Medicare and Medicaid Services." What can patients do? IV bags vary in design. Some include protective caps on both ports, while others do not. Most of them arrive in a plastic overwrap with a printed warning to inspect for damage. Patients should remember they are also customers and have the right to ask to see the bag. Ask who is preparing and administering the IV: Hospitals should be transparent about who is handling medication. Patients can ask that an IV be prepared in their presence or by a licensed professional under supervision. Hospitals should be transparent about who is handling medication. Patients can ask that an IV be prepared in their presence or by a licensed professional under supervision. Look for clean, sealed packaging: IV bags should come in sealed plastic wraps. If a bag appears opened, cloudy or is leaking, ask for a new one. IV bags should come in sealed plastic wraps. If a bag appears opened, cloudy or is leaking, ask for a new one. Do not hesitate to speak up: If anything seems off, from the appearance of the IV to the person administering it, or how you're feeling after receiving it, let someone know immediately. Ask for a supervisor or patient advocate if needed. If anything seems off, from the appearance of the IV to the person administering it, or how you're feeling after receiving it, let someone know immediately. Ask for a supervisor or patient advocate if needed. Have a family member or advocate present: For patients who are sedated or cannot monitor their own care, having someone at bedside who can observe, ask questions and raise concerns can be critical. For patients who are sedated or cannot monitor their own care, having someone at bedside who can observe, ask questions and raise concerns can be critical. Request documentation: Patients can ask for a record of what medications were administered and when. This can help in follow-up care or in the event of complications. Patients can ask for a record of what medications were administered and when. This can help in follow-up care or in the event of complications. Report concerns: If a patient suspects something went wrong, they can report it to the hospital's patient safety office. These reports can trigger investigations that protect others. Even for someone who follows all of this advice, there is no guarantee. That is why the victims of the Ortiz case are hoping the lawsuit inspires a change with Baxter as well as the entire industry. "You'd like to think after all of this that they would've done the right thing," Steckler said. The case is scheduled to go to trial in May of 2026.

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