Bridges v. Chattem Chemicals, Inc.

District Court, E.D. Tennessee·Decided June 13, 2022·No. 1:20-cv-00065·Unknown

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TENNESSEE AT CHATTANOOGA

MICHAEL W. BRIDGES, JR., ) ) Plaintiff, ) ) No. 1:20-cv-00065 v. ) ) Judge Christopher H. Steger CHATTEM CHEMICALS, INC. ) ) Defendant. )

MEMORANDUM OPINION

I. Introduction This matter is before the Court following a five-day bench trial commencing February 15, 2022. Plaintiff Michael Bridges, Jr., alleged his former employer, Chattem Chemicals, Inc. ("Chattem"), terminated his employment in violation of the Tennessee Public Protection Act, Tenn. Code Ann. § 50-1-304 ("TPPA"),1 for refusing to remain silent about violations of Federal Drug Administration ("FDA") regulations pertaining to record-keeping with respect to the manufacture of a pharmaceutical drug or its ingredients. For reasons that follow, the Court finds that Chattem terminated Plaintiff's employment for reasons other than a refusal to remain silent about alleged violations of FDA regulations. Consequently, Plaintiff will not prevail in this action, and judgment will be entered in favor of Chattem. II. Findings of Fact Having observed firsthand the testimony and evidence presented at trial, the Court makes the following findings of fact: Chattem manufactures pharmaceuticals and pharmaceutical

1 This action was removed from the Hamilton County Circuit Court in Tennessee pursuant to 28 U.S.C. § 1441(a) and 28 U.S.C. § 1331. In his complaint which Chattem removed to this Court, Plaintiff brought a claim under the Family Medical Leave Act. This claim was dismissed at the summary judgment stage. This Court now exercises supplemental jurisdiction over the TPPA claim pursuant to 28 U.S.C. § 1367. components at its plant in Chattanooga, Tennessee, including methamphetamine, fentanyl, and methenamine mandelate. Because of the nature of its products, Chattem is subject to FDA and DEA oversight and must follow all applicable regulations in the manufacture of pharmaceuticals and their components. Chattem is also required to possess a license from the FDA and the federal

Drug Enforcement Agency. The employees who are hands-on in the manufacturing process— mixing ingredients and running the manufacturing machines—are called chemical operators ("operators"). The operators generally work in pairs. Because the manufacturing process can last for hours, it is not unusual for a shift change to occur during the course of the manufacture of a single batch of product. Plaintiff was a chemical operator at Chattem from September 2013 until his termination on March 19, 2019. Prior to his termination, Plaintiff had not been disciplined at Chattem. The FDA promulgates regulations concerning the manufacture of pharmaceuticals and their ingredients. The FDA requires manufacturers to create, follow, and enforce internal regulations for manufacturing pharmaceuticals and their components, including keeping accurate

records for each batch of product made. To this end, Chattem has developed and maintains a set of Standard Operating Procedures ("SOP"). Among other things, Chattem's SOP requires the operator actually engaged in the manufacturing process to make a notation of each step in the manufacturing process. This notation should include the time each step occurred as well as the operator's initials. As a general matter, these records—referred to as batch records—are checked by the second of the two operators to assure accuracy of content and adherence to the proper notation format. Minor notation errors and subsequent correction of those errors are not uncommon. An operator has a duty to bring concerns about incorrect batch records to management's attention. The FDA is authorized to investigate batch record inaccuracies. The pharmaceutical products manufactured at Chattem required precision and attention to detail. The duties undertaken by the operators carried with them some risk and could be stressful at times. Disagreements and coarse language were not uncommon. The operators' supervisors worked in a building that was separate from the manufacturing building; however, they met with

the operators each morning. During these morning meetings, supervisors provided instructions to the operators and the operators could bring their concerns to the supervisors. On occasion the supervisors used profanity when expressing frustration or discussing deficiencies with respect to the operators' work. On Thursday, March 7, 2019, Operator Billy Brewton brought a set of batch records to Plaintiff. The records were for a batch of methenamine mandelate which Plaintiff had helped manufacture. Brewton told Plaintiff that the records were "f ***** up." Plaintiff examined the records and saw what he believed to be a number or errors in the form of the notations.2 He also saw that Operator Gene Giles—who had assumed control over the manufacturing process for that batch after Plaintiff's shift ended—had made changes to Plaintiff's notations. Plaintiff believed that

Giles' changes to the notations were incorrect, and that Giles had compounded the problem by not consulting Plaintiff before making those changes. Plaintiff believed that Giles' conduct constituted a violation of Chattem's SOP. One disputed notation involved a time entry for a step in the manufacturing process. This dispute centered on whether the time in the notation should be recorded to memorialize the commencement of the step or the completion of the step (which, in this case, would be a difference of several hours). Beyond the substantive change in the notation, Plaintiff believed that Giles' change to the notation violated Chattem's SOP because Giles had not

2 There have been no allegations that there was anything wrong with the actual manner in which the methenamine mandelate was manufactured. been personally involved in that particular step of the manufacturing process and, therefore, was not authorized to correct the notation. As a result of the dispute between Plaintiff and Giles concerning the correction to a batch record notation, Plaintiff initiated a conversation that same day with his direct supervisor, Engineer

Dan Weeks. Weeks testified at length during the trial about the operators' responsibilities and conduct generally. He also testified about his interactions with Plaintiff, and the discussions he had with his supervisors and other employees which ultimately led to Plaintiff's termination. Weeks testified that, two to three times a week, operators came to him with questions about a potentially incorrect notation in a batch record. Weeks was happy to address those questions with the operators. What distinguished those routine supervisor-operator conversations from Weeks' March 7 conversation with Plaintiff was the level of anger expressed by Plaintiff during their meeting. When Plaintiff entered Weeks' office, he slammed down onto Weeks' desk a three-ring- binder containing the batch records. He called Gene Giles a "son-of a bitch," accused Giles of trying to get him fired, and stated that the changes Giles made were incorrect. Plaintiff's anger was

directed at Gene Giles—not Weeks—but it was so intense that Weeks' attention was necessarily focused on managing Plaintiff's anger instead of focusing on the specific notations in the records. Eventually, Plaintiff "ran out of steam," and Weeks told him that he would talk with Giles and get back to him. After Plaintiff left his office, Weeks went directly to the office of his supervisor, Engineering Manager Brad Parr.

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Bridges v. Chattem Chemicals, Inc., (E.D. Tenn. 2022).

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