And people wonder why infant mortality is so high in geographic regions with highly sought after land and resources.
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| Paul J. Elmer, former CEO Pharmakon |
The verdict came after an eight-day trial before U.S. District Judge James R. Sweeney II in Indianapolis, Indiana.
Elmer, 67, formerly a licensed pharmacist and a resident of Fishers, Indiana, was charged by grand jury in a superseding indictment on Feb. 7, 2019. The superseding indictment charged that, from 2013 to 2016, Elmer and Caprice R. Bearden, Pharmakon’s former director of compliance, caused Pharmakon ─ which compounded sterile, intravenous drugs ─ to distribute approximately 70 lots of over- and under-potent drugs to military and civilian hospitals throughout the country.
“As these convictions show, the Department of Justice takes very seriously conduct that unlawfully undermines the safety of compounded drugs,” said Assistant Attorney General Jody Hunt of the Civil Division. “We will not tolerate actions that impede the FDA’s efforts to ensure the safety of products. With its law enforcement partners, the Department of Justice will thoroughly investigate and prosecute those who knowingly prevent the FDA from protecting patients and ensuring compounded drugs are safe.”
“The jury’s findings in this case resonate with citizens of every age,” said Josh J. Minkler, United States Attorney. “Specifically, hospitals and patients from every walk of life rely on the integrity of pharmaceutical manufacturers like Pharmakon to make safe drugs. This defendant prioritized profit over safety and the jury’s verdict demonstrates the government’s resolve to protect our citizens. Good pharmaceutical manufacturers who work with the FDA achieve that goal.”
“Producing unsafe drugs puts patients at risk and is particularly concerning when they reach already vulnerable populations such as premature infants. This conviction demonstrates that those, including drug compounders, who distribute harmful drugs will be held accountable under the law,” said Director Catherine A. Hermsen, FDA Office of Criminal Investigations. “The FDA continues to play an important role in protecting patients—including young children—and we will continue to work with our law enforcement partners to pursue and bring to justice those who place profits before the health of U.S. patients.”
“When drug compounders disregard safety standards and violate the law, patient health can be put at significant risk. In this case, we saw unacceptable behavior from the defendant whose company distributed dangerous products that led to serious adverse events in infants,” said Stacy Amin, FDA Chief Counsel. “The FDA is fully committed to working with the Department of Justice to stop these bad actors and protect patients from potential public health risks.”
Bearden pleaded guilty to all the charges in the original indictment on Nov. 21, 2017. Her sentencing date has not been scheduled.
Evidence at Elmer’s trial showed that, from 2013 to 2016, Pharmakon routinely shipped compounded drugs at Elmer’s direction to customers without having received laboratory test results that verified the drugs were the strength they were supposed to be. Furthermore, evidence showed that, despite receiving test results showing potency failures, Elmer did not recall the drugs, notify the customer, notify the FDA of the potency failures, or conduct any root cause investigation to determine the cause of the failure.
FDA consumer safety officers testified about two inspections of Pharmakon they conducted in 2014. One inspection was prompted by Pharmakon’s distribution of 200 percent potent midazolam, a sedative that was used to treat premature infants, to an Indianapolis hospital. They observed numerous violations of FDA regulations during each inspection, and informed Elmer. But former Pharmakon employees testified that Elmer and Bearden misled and interfered with these first two FDA inspections, in order to prevent the FDA from knowing about the potency failures as well as other aspects of the business. Former employees also testified that certain changes in process that Elmer and Bearden told the FDA Pharmakon would enact, never happened.
According to evidence at trial, in February 2016, the multiple potency failures culminated in Pharmakon’s distribution of 2,460 percent super potent morphine sulfate, an opioid pain medication, to hospitals in Indianapolis and Chicago. Nurses at the Indianapolis hospital administered the morphine, not knowing that it was 2,460 percent super potent, to infants in the pediatric unit. Three infants suffered adverse effects from the narcotic overdose. One infant needed to be revived through the administration of Naloxone (commonly known as Narcan) and sent by helicopter to a nearby hospital with a neo-natal intensive care unit. These adverse events led to a final FDA inspection in which FDA consumer safety officers testified that they discovered evidence of multiple previous potency failures that had been concealed by Bearden during the first two inspections. Former employees testified that Elmer and Bearden misled and interfered with this final FDA inspection as well.
Elmer was convicted of one felony count of conspiracy to defraud the FDA and to obstruct FDA inspections, carrying a maximum punishment of five years in prison and a fine of up to $250,000. He was also convicted of three misdemeanor counts of introducing adulterated drugs into interstate commerce and six misdemeanor counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce. Each of the adulteration counts is punishable by up to one year in prison and a fine of $100,000.
Elmer’s sentencing date has not been scheduled.
Assistant Attorney General Jody Hunt and U.S. Attorney Minkler commended the FDA’s Office of Criminal Investigations, which conducted the investigation. The case was prosecuted by Assistant U.S. Attorney Cindy J. Cho of the U.S. Attorney’s Office for the Southern District of Indiana and Trial Attorney David A. Frank of the Department’s Consumer Protection Branch and, with assistance from Paul Joseph of the FDA’s Office of Chief Counsel.
For more information about the Consumer Protection Branch, visit its website at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Indiana visit its website at https://www.justice.gov/usao-sdin.
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