By Saranac Hale Spencer, From The Legal Intelligencer
The Johnson & Johnson subsidiary that makes children’s Tylenol has pleaded guilty to a criminal charge for its failure to correct faulty manufacturing practices, agreeing to pay $25 million to resolve the matter.
McNeil, the Johnson & Johnson subsidiary that had made the over-the-counter medicine in its Fort Washington plant, agreed to pay a $20 million criminal fine and a $5 million criminal forfeiture to settle a misdemeanor charge for violating the Federal Food, Drug, and Cosmetic Act by introducing adulterated drugs into interstate commerce, according to the guilty plea filed in federal court in Philadelphia on Tuesday.
The company had distributed bottles of liquid Tylenol with metallic pieces in them for about a year after first becoming aware of the problem, according to the plea agreement.
In May 2009, a consumer returned a bottle of infants’ Tylenol since it had “black specks” in it, according to the agreement. McNeil identified the specks as having nickel- and chromium-rich components that were not supposed to be in the medicine.
Part of the machinery used to make children’s and infants’ Tylenol and Motrin includes a metal composite called Waukesha 88 that is composed primarily of nickel and also has tin, iron, bismuth and chromium, according to the agreement.
At the time, McNeil didn’t connect the particles in the medicine to the manufacturing plant’s equipment and didn’t initiate a corrective and preventive action, or CAPA, as is required by the company’s standard operating procedures, according to the plea agreement.
McNeil found more metallic pieces in medicines manufactured in January and March 2010, but, again, didn’t link the contamination to its machinery or initiate a CAPA.
In April, McNeil began connecting the incidents to its machinery and had an inspection by the U.S. Food and Drug Administration, which “determined that McNeil lacked a CAPA plan covering the particles and other foreign material found in the infants’ and children’s OTC liquid drugs,” according to the plea agreement.
The FDA found that McNeil wasn’t conforming to current good manufacturing practices, or cGMP, which renders the drugs adulterated, according to the plea agreement.
Later that April, McNeil recalled certain batches of children’s and infants’ Tylenol and Motrin.
The maximum statutory penalty for misdemeanor with which McNeil was charged is $200,000 or twice the gross gain or loss, whichever is greater, according to the plea agreement.
Here, the total of $25 million that McNeil agreed to pay “is based on a percentage of the sales of specific infants’ and children’s OTC liquid medicines between May 2009 and April 2010,” according to the plea agreement.
“The law requires that drugs be produced under the most rigorous of quality standards. When companies fail to exercise the vigilance that the law demands, they will be held accountable,” First Assistant U.S. Attorney Louis D. Lappen said in a prepared statement. “Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution.”
McNeil issued a statement highlighting its recall and noting that the problem didn’t pose a health risk to consumers.
“This plea agreement fully and finally resolves the federal government’s investigation, and closes a chapter on actions that led the company to review and significantly improve its procedures,” said Carol Goodrich, a McNeil spokeswoman, in a prepared statement. “McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are best able to meet our commitment to consumers, patients and doctors who rely on our products.”
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