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Abbott Nutrition Executives Should Face Criminal Penalties Over Contamination of Infant Formula

05/24/2022

Following a preliminary investigation following the inspection of the Abbott nutrition plant in Sturgis, MI., the U.S. Department of Justice has filed a complaint on behalf of the Food and Drug Administration alleging that products were adulterated. The legal definition of "adulterated" includes the presence of any poisonous or deleterious substance which may render injurious to health or a product prepared, packed or held under insanitary conditions whereby it may have become contaminated or rendered injurious to health".

 

Based on a review by William Marler, a prominent plaintiff's attorney specializing in foodborne infection, Abbott in agreeing to a Consent Decree has effectively admitted liability. On his law- firm website, Marler posted the 2021 inspection report, the document prepared by the Whistleblower as submitted to the FDA in October 2021, the Department of Justice Complaint and the Consent Decree.

 

To support a felony violation, the Department of Justice would have to demonstrate that the adulteration occurred with intent to defraud or mislead by placing a food product in interstate commerce.  A misdemeanor violation would involve negligence through failure to prevent adulteration but does not require proof of fraudulent intent or willful conduct.

 

Marler makes the case that any producer of food should face penalties for marketing adulterated food whether willfully or not, a position endorsed by EGG-NEWS.  Penalties for both misdemeanors and felonies include substantial fines and the possibility of incarceration.

 

The responsibility of owners or executive management involved in foodborne outbreaks is exemplified by long prison terms handed down to the Parnell Brothers following the extensive outbreak of salmonellosis in 2009. Their company, The Peanut Corporation of America was responsible for 714 cases, 172 hospitalizations and nine fatalities. Paul Kruse then the CEO and majority shareholder of Blue Bell Creameries is under indictment for his actions in an outbreak of listeriosis in 2017. In both instances there were allegations of concealment of results of assays and falsification of records. Despite a self-exculpatory article in the Washington Post, Abbott Laboratories Chairman and CEO, Robert Ford will be subject to DOJ investigation with the inevitable questions of “what did he know and when did he know it”

 

The bar for CEOs and senior management of food companies is much higher since passage of the FDA Food Safety Modernization Act. In addition to civil penalties imposed by the DOJ and civil lawsuits executive officers now face criminal action with even misdemeanor violations carrying the threat of incarceration.