Ex-employee alleges Baxter fired her for whistleblowing
A former employee alleges that Baxter Healthcare Corp. fired her because she raised concerns that the company was marketing a new drug prematurely.
Dr. Carol M. Gaines worked for the Deerfield-based company as a medical director from January to April 2014, when the company fired her, according to a lawsuit filed last month in Cook County Circuit Court.
The lawsuit accuses Baxter of firing her in retaliation and violating the Illinois Whistleblower Act, which prohibits firing an employee for disclosing information that could be a violation of state or federal law.
Baxter denies the allegations “will vigorously defend,” a company spokeswoman said in an email.
'UNACCEPTABLE PERFORMANCE'
“The plaintiff was employed at Baxter for a very short period of time and was terminated as a result of unacceptable performance,” she said. “Her termination was not related to any alleged compliance issues she claims to have raised.”
Dr. Gaines, of Mount Pleasant, Wis., says in her lawsuit that she raised concerns with Baxter that it presented materials for branding and marketing of the drug HyQvia to advisory boards before the materials were legally reviewed and approved, according to the lawsuit. The suit alleges that Baxter ignored her concerns.
The materials for HyQvia, used to treat immunodeficiency, “did not provide the balanced review of safety data required” and made efficacy claims that “cannot be made prior to a drug receiving FDA approval,” the lawsuit says.
Pharmaceutical companies can present drugs to physician advisory boards without violating FDA laws, said Richard Wood, an FDA lawyer at the Wood Burditt Group in Lake Bluff who is not involved in the case. Pre-selling a drug to doctors at the advisory board meetings violates the law, he said.
It is unclear from the lawsuit what was presented at the meetings. The FDA approved the drug in September.
NOT SEEKING JOB BACK
Baxter fired Dr. Gaines on April 9, saying she was not a “people person,” according to the lawsuit. Dr. Gaines alleges she was terminated in retaliation for her internal complaints and whistleblowing on Baxter's alleged illegal marketing and her refusal to participate or remain silent.
Baxter denies violating the law. “The alleged compliance issues she (Dr. Gaines) raises in her suit have been determined to be without substance,” the company spokeswoman said via email. The company declined to comment further.
Dr. Gaines is seeking monetary damages but not re-employment at Baxter, said Michael Leonard, her Chicago-based lawyer.
“This is an outrageous example of retaliation,” Mr. Leonard said. “We have seen companies do this before, but they are usually a lot more subtle and less obvious than this. This was a blatant attempt to silence her and ignore the law.”
Dr. Gaines works, Mr. Leonard said, but he did not disclose where.
A former employee alleges that Baxter Healthcare Corp. fired her because she raised concerns that the company was marketing a new drug prematurely.
Dr. Carol M. Gaines worked for the Deerfield-based company as a medical director from January to April 2014, when the company fired her, according to a lawsuit filed last month in Cook County Circuit Court.
The lawsuit accuses Baxter of firing her in retaliation and violating the Illinois Whistleblower Act, which prohibits firing an employee for disclosing information that could be a violation of state or federal law.
Baxter denies the allegations “will vigorously defend,” a company spokeswoman said in an email.
'UNACCEPTABLE PERFORMANCE'
“The plaintiff was employed at Baxter for a very short period of time and was terminated as a result of unacceptable performance,” she said. “Her termination was not related to any alleged compliance issues she claims to have raised.”
Dr. Gaines, of Mount Pleasant, Wis., says in her lawsuit that she raised concerns with Baxter that it presented materials for branding and marketing of the drug HyQvia to advisory boards before the materials were legally reviewed and approved, according to the lawsuit. The suit alleges that Baxter ignored her concerns.
The materials for HyQvia, used to treat immunodeficiency, “did not provide the balanced review of safety data required” and made efficacy claims that “cannot be made prior to a drug receiving FDA approval,” the lawsuit says.
Pharmaceutical companies can present drugs to physician advisory boards without violating FDA laws, said Richard Wood, an FDA lawyer at the Wood Burditt Group in Lake Bluff who is not involved in the case. Pre-selling a drug to doctors at the advisory board meetings violates the law, he said.
It is unclear from the lawsuit what was presented at the meetings. The FDA approved the drug in September.
NOT SEEKING JOB BACK
Baxter fired Dr. Gaines on April 9, saying she was not a “people person,” according to the lawsuit. Dr. Gaines alleges she was terminated in retaliation for her internal complaints and whistleblowing on Baxter's alleged illegal marketing and her refusal to participate or remain silent.
Baxter denies violating the law. “The alleged compliance issues she (Dr. Gaines) raises in her suit have been determined to be without substance,” the company spokeswoman said via email. The company declined to comment further.
Dr. Gaines is seeking monetary damages but not re-employment at Baxter, said Michael Leonard, her Chicago-based lawyer.
“This is an outrageous example of retaliation,” Mr. Leonard said. “We have seen companies do this before, but they are usually a lot more subtle and less obvious than this. This was a blatant attempt to silence her and ignore the law.”
Dr. Gaines works, Mr. Leonard said, but he did not disclose where.