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BD Attempted Illegal Shipments to Iraq and Violated FDA Rules, Wrongful Termination Suit Alleges

NEW YORK, Nov. 30 (GenomeWeb News) - A former Becton Dickinson official is suing the company for wrongful termination after he refused to participate in certain BD-sanctioned activities that he felt were "unethical, illegal, fraudulent," according to a court document.


In the suit, filed with the Superior Court of New Jersey in BergenCounty, Zeil Rosenberg, BD's former worldwide immunization director, objected to four practices within the company. He claimed BD illegally shipped medical supplies to Iraq in 2001, falsely marketed its SoloMed syringe, withheld syringes during the 2004 flu vaccine shortage in the United States, and violated US Food and Drug Administration regulations governing clinical trials.


Rosenbergis seeking compensatory damages, including back pay and front pay, punitive damages, attorneys' fees, interest, and costs of the litigation. He said the company fired him on Dec. 8, 2004.


Under the New Jersey Superior Court rules, BD has 35 days to respond.


A BD spokeswoman told GenomeWeb News that Rosenberg's allegations are "untrue," "inaccurate," and "spurious."


In the complaint, Rosenbergsaid he refused twice to allow approximately 25 million no-stick SoloShot syringes to be shipped from Belgiumto Iraqin 2001 "because the company was not authorized by the United Nations under its Oil for Food Program and did not have a license from the US Treasury Department's Office of Foreign Assets Control." BD "eventually" obtained the proper authorizations and completed shipment," he said in his complaint.


The suit also claimed BD's revenue and profits for 2001 suffered as a result of Rosenberg's objections, leading the company to "retaliate" by downgrading his performance rating for not meeting his sales targets for the year.


The suit also said that, in 2004, BD developed the SoloMed syringe, a copy of the K1 syringe made by Britain's Star Syringe, which claimed an "auto-disable" feature designed to prevent the syringe from being reused. Rosenbergsaid when he "objected" to the claim -- he said the SoloMed in fact could be reused -- the company remarketed it as "reuse prevention," a move his lawyers called a "gimmick."


Also in 2004, BD secured expedited FDA approval to distribute its cheaper SoloShot syringes. Despite orders for the syringes, BD resisted to sell them citing fears they would "impair the more profitable market for no-stick Integra syringes," which the company didn't have in stock at the time, Rosenbergalleges. He said the 2004 flu vaccine shortage "could have been less severe" if BD had shipped the cheaper SoloShot syringes.


Also according to the complaint, BD's Medical Systems president, Gary Cohen, warned Rosenbergthat his continued employment at BD "was at stake" if he "continued to make additional objections."


Rosenbergsaid he and others raised concerns about the "integrity and legality" of the company's clinical trials in 2004, according to the complaint, citing "inadequacies of BD's data-management system used to track the progress and adverse events occurring during clinical trials." When Rosenbergattempted to develop a "reliable" data-management system, he was reprimanded and his efforts discontinued. Independent auditors were hired, who confirmed Rosenberg's concerns about the lack of quality control and FDA violations.


When Rosenbergtried to rectify the problems, he was fired, he claimed.


In a prepared statement, the BD spokeswoman said BD places "no greater value on anything we do than our commitment to public health and in continuing to earn the trust and confidence of those who look to us to meet their health-related needs worldwide. We are proud of our adherence to the strictest of standards in carrying out our corporate responsibilities and we will never compromise those standards." The statement said Rosenberg's "personal actions were inconsistent with this commitment and led to the decision to terminate our association with him."


BD "will be responding more fully" to Rosenberg's allegations "and will illuminate them for what they are when we answer his Complaint in writing with our responsive pleading, which we look forward to filing prior to the coming holiday season," the spokeswoman said.

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