Whistleblower or Disgruntled Employee? Lawsuit Alleges cGMP Violations

Quality corners were cut in a rush to market, a former emloyee claims

 

In a case that could set a precedent for drug manufacturers if it reaches the courtroom, Mark Livingston, former associate director of training and continuous improvement at Wyeth Pharmaceuticals’ Sanford, N.C. plant, has invoked the employee protection provisions of the Sarbanes-Oxley Act of 2002 to sue his former employer as well as the plant’s managing director and human resources director. Livingston, a training specialist with 20 years of manufacturing experience, charges that he was terminated for "protected disclosures" involving lack of compliance with cGMP at the site.

At issue are training and quality procedures involved at Sanford in manufacturing Prevnar, a conjugated vaccine used to protect infants against pneumococcal diseases such as pneumonia and meningitis. The vaccine, which is produced in a complex, multi-step production process, had been approved on a "fast track" basis by FDA in 2000, and, by December 2002, generated $1.9 billion in sales. Livingstone believes that some of the vaccine produced was not manufactured according to cGMP standards. "The marketing machine was outracing the development scientists charged with trying to figure out how to manufacture it in bulk," Livingston says. "You can get fast track approval, but you can’t fast track the manufacturing process."

Wyeth refused to comment on any specific allegations in the lawsuit, launched in North Carolina Middle District Court last October. The company says the suit is without merit and that it fired Livingstone for "unruly, unprofessional behavior" toward quality and manufacturing managers at the site. In fact, spokesman Doug Petkus says, the Department of Labor  investigated Livingston’s dismissal and found that the company had acted reasonably in letting him go. For his part, Livingston alleges he was at the receiving end of the profanity and abusive language.  "There was a 'hockey rink' culture at the facility," Livingston contends.

Prevnar has been shown to be extremely effective in preventing pneumoccocal bacterial infections, and has quickly become part of package of immunizations recommended for very young children in the U.S. However, its manufacturing facilities have faced a number of challenges in bringing the vaccine to market. Shortly after Prevnar was approved, on a "fast track" basis, by FDA, .the Agency cited Wyeth for GMP violations at its manufacturing site in Pennsylvania and its filling and packaging plant in Pearl River, N.Y. The company paid $30 million in fines and launched corporate quality improvement programs, specifically, SCI, Sustainable Compliance Initiative, Livingston says. At the same time, the company launched an Office of Compliance to respond to and investigate any complaints of cGMP noncompliance, from employees or others, via a 24-h hotline.

A third-party auditor had previously reported that training at Sanford didn’t meet standards, so Livingston says he was brought on as SCI Project Team leader to direct its GMP training program. When he joined the company, he says, the site’s trainer had been on personal leave for six months, and an administrative assistant had just begun to compile training records centrally. The audit trail of training records at the site level lacked integration with departmental training records and procedures for GMP documentation, he says. Training largely consisted of new associates’ "reading and signing" SOPs, each over 50 pages long, extremely complex and written by Ph.D.s from scaleup or pilot plants. Everyone signed, and supervisors verified that they had read and understood the procedures, in direct violation of Wyeth's internal document, GMP-4024 Revision F, he says.

.To get the training program to meet basic compliance, Livingston says, he implemented a six-week GMP boot camp for bioprocessing technicians, and renovated an offsite leased training facility where people could "make mistakes" without washing costly batches down the drain. He also revised training procedures twice to eliminate "read and sign" for SOPs, and oversaw validation and implementation of a training records management system. He also hired and led a team of 12 site-training people to provide help for each of the 45 work teams at the site.

Like many drug manufacturing operations, the facility had problems retaining and recruiting skilled staff, Livingston says. Before the Consent Decree, the site had lost half its skilled manufacturing and quality assurance staff, as operators left for more lucrative jobs with Research Triangle Park manufacturers.

Livingston alleges that there was no attempt to provide incentives for employees to become more involved in quality, since supervisors were rotated every two months and team members, every three. "People were bailing out of manufacturing," Livingston says. When he arrived at the site, he says, some new hires were thrown into the breach, handling million-dollar batches after one day of orientation and signing off on SOPs that were probably over their heads. Most people eventually moved on to pilot and scaleup, he says. The attendance policy, and record, was poor, and batch failures were written into the manufacturing budget, he says.

Typically, two or three key skilled and experienced people handled critical process operations, but they were often overworked, Livingston alleges, and when they took time off, less experienced substitutes took over. Between 2000 and 2002, the number of people employed at the company tripled to 900, he says, and now stands at over 1,200---most entry-level operators were H.S. grads with no GMP experience, while most new supervisors had four-year degrees but no experience in the industry.

Training inadequacies might not have been so severe had the plant not been producing a new biologic, Livingston says. Operators at a traditional pharmaceutical plant, such as Wyeth’s sister antibiotics plant, in Sanford, can be trained in eight weeks, he says, since they have about 40 to 50 procedures to master, he says. However, production of Prevnar involved 248 procedures plus another few hundreds of batch documentation. "For biologicals, the basics take a year," he says, and, when he arrived at the plant, most line operators only received one day of cGMPtraining, in addition to the yearly training course mandated by FDA.

Livingston says he reported compliance problems to the plant’s managing director, then, to a corporate quality control auditor charged with auditing the GMP training system, then confirmed them during a teleconference with the firm’s senior vice president. He repeated the negative findings the following month at a meeting of site directors, and expressed doubt that the facility could meet FDA’s deadline for improving its training program. The directors, he says, used profanity and expressed outrage that he had reported noncompliance with QA and SCI plans. Livingstone didn’t complain to the company’s human resources department at the time, he claims, because these types of interactions had become common, and he figured that complaining would be futile.

In May, 2002, after another meeting with quality and manufacturing, he says he was issued a written reprimand for using "foul and abusive" language. Livingstone says he refused to sign the reprimand because the company had not attempted to document his version of the story.

In July, Livingston said that he could not sign off that the training program met GMP standards, as required by a September 30 FDA deadline. He says management then mocked his analysis, and tried to pressure him into retracting his analysis and position and threatened to dismiss him if he went beyond analyzing "training systems."

In October, he complained to the newly established Office of Compliance and corporate Office of Ethics and Business Conduct. Once it was disclosed to supervisors that he had complained to that office, Livingston said, the level of "resentment, tension and hostility" shown him by plant management increased. Over the next few months, the basic training program was brought into compliance, Livingston says, and he signed the approval form documenting compliance.

However, he continued to point out problems with batch recordkeeping and SOP. He was then placed on probation, and issued a corrective action program (CAP) with a thirty-day warning. Three weeks before that time, Livingston says, the site’s human resources director was dismissed and a new H.R. person brought on board. Livingston says he completed and documented all requirements in the CAP, but was dismissed in December via a written letter that, he says, "contained no grounds for the termination." The Government Accountability Office (www.whistleblower.org) has taken on Mr. Livingston’s case, which is being evaluated.

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