Attorney Tommy Odom Helps Achieve Justice in Whistleblower Case - $18 Million Settlement
February 28th, 2018
Contributor: Tommy Odom
Attorney Tommy Odom of The Odom Firm was instrumental in helping to achieve justice for an employee who reported unsafe conditions at the national pharmaceutical company for which he worked. The employee risked his own career to ensure his employer was following safe practices.
Chris Wall, who works in HVAC maintenance for Baxter Healthcare Corporation, has been employed by the company since 1979. Baxter is headquartered in Deerfield, Illinois, but has multiple manufacturing plants in the United States and abroad. Wall works at the facility in Marion, North Carolina, which employs about 2,000 people.
The Marion facility manufactures hundreds of types of intravenous (IV) solutions and related products, including solutions for peritoneal dialysis. Products from this plant alone are used in medical facilities throughout the United States and in over 50 other countries. The products are packaged in a so-called "clean room," which is supposed to be a sterile environment. From there, they are prepared for distribution nationally and internationally.
A Disturbing Discovery
Wall was working along with another HVAC technician, performing regularly scheduled maintenance of the Marion facility's HVAC system in July 2011 when he spotted mold on an air filter in the ceiling. Air was pushed into the room through these high-efficiency particulate absorption, or HEPA, filters, meaning that mold on the filters could contaminate the room and the medical products in it.
Wall did the right thing: he reported the presence of mold to the management of the facility, and together with his coworker began removing and replacing the moldy filters. Approximately halfway through this process, Wall's supervisor instructed the workers to stop changing the filters. The federal government later charged that the company failed to follow the Food and Drug Administration's Good Manufacturing Practices rules between July 2011 and November 2012—more than a year during which products prepared in the room could have been contaminated by mold.
Following a plant-wide meeting in October of 2011, Wall communicated to the plant manager that he feared retaliation from a supervisor for reporting the mold on the filters. This concern was referred to human resources and treated as a personnel issue, but the moldy filters were not addressed. Between July 2011 and November 2012, millions of IV bags were produced in non-sterile conditions, with the knowledge of the manufacturer.
Taking Legal Action
When reporting his concerns to managers at Baxter yielded no changes, and when he was instructed to stop changing the moldy HEPA filters, Chris Wall grew increasingly concerned about the safety of those exposed to the Baxter products manufactured in the Marion plant. A July 2012 maintenance inspection, one year after Wall's initial discovery, revealed 29 moldy filters in the same room in which Wall had originally found mold.
A frustrated Wall, concerned for the health of the patients exposed to Baxter's products, reported the problem the the FDA. When the agency made a surprise inspection of Baxter's Marion, NC facility in November of 2012, it identified a mold problem as well.
Wall worked with attorneys Tommy Odom and Tony Scheer to file a legal action in federal court against Baxter, providing the attorneys with documentation of the discolored air filters he observed. The complaint filed on Wall's behalf alleged that Baxter filled IV bags knowing of mold contamination in the "clean room;"that the bags in the affected area contained adulterated drugs; that the company made false records concealing the fact that the drugs were adulterated; and that the company sold these adulterated drugs in violation of express warranties.
Attorney Tommy Odom stated that Baxter's violations "had potential serious and far-reaching consequences" to patients in the United States who were exposed to the adulterated IV fluids.
Justice is Served
The case involved not only whistleblower Chris Wall and Baxter, but the United States Department of Justice and the departments of justice for several states, including North Carolina. As part of the settlement with Wall, the complaint filed in 2015 was unsealed in 2017.
The settlement includes Baxter's admission that the company distributed adulterated products in interstate commerce in violation of federal law. The terms of the deferred prosecution agreement require Baxter to pay $16 million in monetary penalties and forfeiture. Baxter must also pay approximately $2.158 million to the federal government as part of a civil settlement under the False Claims Act. Chris Wall, the concerned employee who called the hazardous conditions first to his employer's attention, and then to the attention of the government when his employers did not take action, will receive $431,535.99 as part of the civil settlement.
In addition, Baxter Healthcare Corporation agreed to put in place enhanced compliance protocols and to certify to the government as needed that those measures are being followed. Chris Wall continues to work for Baxter.