Last week, Barry Cadden, the owner of a Massachusetts compounding pharmacy, was acquitted of 25 counts of second-degree murder stemming from a 2012 meningitis outbreak caused by contaminated drugs that his company had sold. The outbreak swept panic throughout the country, as the Centers for Disease Control and Prevention estimated that 13,000 people might have been injected with the drug. The trial is considered one of the biggest criminal cases to have been tried in connection to contaminated pharmaceuticals.
In 2012, the compounding pharmacy, New England Compounding Center, had distributed 17,600 vials of methylprednisolone, a steroid that was contaminated with mold. The outbreak resulted in 64 deaths and sickened over 700 people in 20 states across the country. In December 2014, more than a dozen employees were charged in Massachusetts federal court in connection with the outbreak, including NECC’s former co-owner, president, and lead pharmacist, Barry Cadden. Cadden and his supervising pharmacist, Glenn A. Chin, were charged with 25 counts of second-degree murder under federal racketeering laws, as well as mail fraud, conspiracy, contempt, structuring, and violations of the Food, Drug, and Cosmetic Act. The indictment alleges that NECC did not comply with safety regulations and that many employees – from its owners to its pharmacists – lied about the conditions at NECC. The unsafe and unsanitary conditions alleged in the indictment include the pharmacists’ failure to properly sterilize drugs, failure to properly test drugs for sterility, failure to wait for test results before sending the drugs to customers, lack of proper cleaning and failure to take any action when its own environmental monitoring repeatedly detected mold and bacteria within NECC throughout 2012.
At trial, the prosecutors alleged that Cadden knew about the contaminated steroids, but that he recklessly disregarded safety regulations for the sake of his own profits. In proving the top charge of second-degree murder, prosecutors claimed that Cadden knew, or recklessly disregarded, that the drugs he was distributing were going to sicken or kill people.
The prosecution put forth a slew of expert witnesses to help aid the jury in understanding the medical and pharmaceutical complexities of the case. Eric S. Kastango, a pharmaceutical expert, testified at length about the industry standards for sterilization and safety. Kastango asserted that NECC failed to meet the industry standards for drug compounding. According to Kastango, NECC did not use validated procedures to sterilize the drugs. He also testified that NECC failed to maintain sanitary conditions and properly control temperature and humidity. Kastango also testified that the company failed to adhere to the industry standard of providing written notice to physicians and patients about a drug’s adverse test results. Kastango underwent a lengthy cross examination, during which defense counsel challenged the industry standards that he had cited in his direct testimony.
An investigator for the Massachusetts Pharmacy Board testified that he immediately saw that something was wrong with the vials of steroids when he visually inspected them. Samuel Penta testified that while inspecting NECC, he saw filaments and black spots in the drug’s container. Penta explained that he first heard of a possible outbreak on September 24, 2012, and on October 3, 2012, the Food and Drug Administration tested a vial and found fungus.
A physician from the U.S. Centers for Disease Control and Prevention testified as to the damage suffered by the victims of the meningitis outbreak. Dr. Sherif Zaki showed slides to describe how the fungus in the drug, which was administered through injection, traveled through the spinal columns and then attacked the brain cells in some victims. Dr. Zaki explained how the fungus attacked each patient differently. An expert medical assistant confirmed the cause of death of each victim and through her testimony, presented autopsy records and death certificates.
On March 22, 2017, the jury acquitted Cadden of 25 counts of second-degree murder, but found him guilty of more than 50 counts of racketeering and mail fraud. Cadden’s attorneys have stated that they plan to appeal the convictions. Sentencing is scheduled for June 21, 2017. Although Cadden will evade life imprisonment due to the second-degree murder acquittal, each of the fraud counts carries a 20-year maximum sentence. Cadden’s sentence is likely to set an example for future drug contamination and outbreak cases to come, including the impending trial of NECC’s co-owner and Cadden’s co-defendant, Glenn A. Chin. Chin does not yet have a scheduled trial date. While Cadden’s trial has concluded, the criminal and civil litigation surrounding NECC is far from over.
Since the 2012 meningitis outbreak, compounding pharmacies have been under a closer scrutiny. Congress has taken steps to improve regulations, and in 2013, President Obama signed a law to increase federal oversight of such facilities. Although there were no cited cases of meningitis in Massachusetts, in 2014, former Gov. Deval Patrick signed a law increasing state oversight of the state’s compounding pharmacies. In light of the ongoing litigation in the NECC case, it is safe to say that the consequences and implications of the meningitis outbreak will be far-reaching.