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J&J CEO Admits Lax Quality Standards Led to Recalls

The Los Angeles Times reports, “The head of pharmaceuticals giant Johnson & Johnson, testifying on the massive recall of its widely used children’s pain relievers, admitted Thursday that ‘we did not maintain our high quality standards,’” and consequently, “children do not have access to our important medicines,” Chief Executive William C. Weldon said. He also “told a congressional committee that the company is spending $100 million to fix quality problems that led to last spring’s recall of children’s over-the-counter medications, including children’s Tylenol,” and he “acknowledged mishandling two other recalls at his company’s McNeil Consumer Healthcare subsidiary.”

The AP reports that “Weldon told House lawmakers the company ‘made a mistake’ in conducting the so-called ‘phantom recall,’ which is one of a string of problems that have drawn congressional scrutiny.” During “the same committee hearing, the FDA’s deputy commissioner, Dr. Joshua Sharfstein, said his agency should have acted sooner to halt J&J’s plan. At the same time, though, he stressed that regulators were not aware of the deceptive nature of the recall.” Sharfstein explained that “J&J informed the FDA of its plan to repurchase the pills — which did not dissolve correctly — in April 2009,” and the agency urged J&J to conduct a recall in July. But, Sharfstein stated, “In my opinion, that message should have been given sooner.”

Nevertheless, Sharfstein emphasized that J&J “did not fully disclose the likely scale of the action or the way that the company was intending to proceed” in conducting the “phantom recall,” the Financial Times says. In addition, Sharfstein pointed out that the FDA “does not have legal authority to approve the manner in which the firm conducts the recall or to direct the firm to adopt a different recall strategy.”

From the American Association for Justice news release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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