Earlier this year a federal court jury in Boston found the owner of a now-defunct compounding pharmacy guilty of racketeering and fraud for his role in a meningitis outbreak that sickened hundreds and led to the deaths of 76 people. On June 27, Barry Cadden, the owner and head pharmacist at the New England Compounding Center (NECC), was sentenced to 9 years in prison.

Cadden and NECC were big news in the latter months of 2012 and early 2013, as a massive and nationwide outbreak of fungal meningitis that sickened hundreds was traced to tainted steroid medications shipped out from NECC’s Boston facility. In all, over 700 fell ill and, to date, 76 people have died.  The subsequent investigation demonstrated that NECC not only operated in a filthy, unsanitary environment, but that it compounded, sold, and shipped drugs to persons without valid prescriptions, and that those drugs contained expired or contaminated ingredients. More than 17,000 vials of the steroid were shipped from the pharmacy to dozens of hospitals and other medical facilities nationwide. While Cadden was convicted of 52 counts of mail fraud and racketeering, the 25 counts of second-degree murder, however, appeared to be a bridge too far for the jury, which failed to convict Cadden on those charges.

Prosecutors had asked U.S. District Judge Richard Stearns to impose a 35-year sentence, while Cadden’s defense team recommended a sentence of 3 years. Stearns, however, remarked that neither side had correctly interpreted the federal sentencing guidelines, which he believed called for a 7 to 9-year sentence.  The judge, who said that he had spent the weekend reviewing statements from victims and their family members, opted for a sentence at the high end of the scale.

It was the 2012 fungal meningitis outbreak and the revelations of how NECC and other compounding pharmacies conducted operations that led to the passage of the Drug Quality and Security Act in 2013. The Act modified the Federal Food, Drug, and Cosmetic Act to give more authority to the Food and Drug Administration to regulate and monitor entities that manufacture compounded drugs.

Should you have questions regarding this alert, please do not hesitate to contact any of the FisherBroyles Health and Pharmacy Law attorneys listed below.

 

Brian Dickerson, FisherBroyles Partner
Brian E. Dickerson
brian.dickerson@fisherbroyles.legal
202.570.0248

Anthony Calamunci, FisherBroyles Partner
Anthony Calamunci
Anthony.calaunci@fisherbroyles.legal
419.376.1776

Nicole Waid, FisherBroyles Partner
Nicole Hughes Waid
nicole.waid@fisherbroyles.legal
202.906.9572

Amy Butler, FisherBroyles Partner
Amy Butler
amy.butler@fisherbroyles.legal
419.340.8466

Katy Wane, FisherBroyles Partner
Katy Wane
Katy.wane@fisherbroyles.legal
502-890-5920