Blistering Complaint Against Drugmaker

(CN) - Johnson & Johnson lied to government inspectors, faked clinical data, shipped falsely labeled products around the world, and abused the credentials of the M.D. Ph.D. it hired as its director of global clinical research, the doctor says. Dr. Margaret Cobb says the pharmaceutical giant fired her because she "voiced strong objections and complaints about and refused to engage in" the illegal behavior.

Cobb claims accuses Johnson & Johnson of "fraudulently and falsely using [her] name and medical credentials, without her authorization or knowledge, in misrepresenting to the federal government that the company had complied with due diligence ethics procedures."

In her complaint in Union County Court, Elizabeth, N.J., Cobb claims Johnson & Johnson did that from 2005 to 2008.

She also claims that co-defendant Kristine Barone, senior director for Medical Knowledge Management, engaged in insider trading while "knowingly submitting unvalidated and inaccurate clinical data for safety reporting to domestic and international health authorities."

Cobb claims that Barone and others "knowingly submit[ed] unvalidated clinical data for public clinical trial disclosure," and "knowingly provided false and inaccurate information to government inspectors regarding the company's clinical registry system in an effort to deceive and mislead inspector.

Cobb claims that Johnson & Johnson "misrepresent[ed] to government agencies that due diligence had been performed for patient protection prior to recruiting patients for clinical studies;" and "knowingly permitt[ed] false or misleading labeling information to be included with pharmaceutical products for distribution to worldwide markets."

The blistering, 15-page complaint adds that Johnson & Johnson failed to "maintain requisite internal controls concerning financial, ethical, contractual, and regulatory oversight matters, in violation of federal laws governing public companies;" and that it "knowingly submitt[ed] false and unreliable blinded data [sic] to government health authorities regarding multiple products."

Cobb says that "as a result of her whistle-blowing, [she] became the victim of malicious harassment and retaliation by Barone and other management employees". She says Johnson & Johnson "failed to fulfill its legal duty" to investigate her complaint, but ran only "shams and cover-ups," and eventually fired her under the pretext of a departmental reorganization.

Cobb seeks punitive damages from Johnson & Johnson, Barone, and Dirk Gille, the head of Quality Management & Training.

She wants to be re-employed at the senior director level.

She is represented by Gary Roth with Javerbaum Wurgaft of Springfield, N.J.

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