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Infant’s Tylenol Protests Kept In Federal Court

(CN) - Claims that Infant's Tylenol made a 2-week-old baby vomit blood until he died should not keep Johnson & Johnson and Wal-Mart in state court, a federal judge ruled.

Nevada resident Stacy Sherfey claims she gave her son Tracen a recommended dose of Infant's Tylenol based on his doctor's suggestion on Feb. 16, 2009, and gave him two more doses the next morning and evening as directed by the packaging instructions.

When Tracen began vomiting blood, Sherfey took him to the emergency room, and he was later airlifted to Children's Primary Hospital in Salt Lake City, Utah

Within days, the baby died from acute liver failure on Feb. 19, 2009, according to the complaint.

Stacy and her husband Neil sued the drug's manufacturers, distributors and retailers - Johnson & Johnson (J&J), McNeil-PPC Inc., Wal-Mart, and Inmar Inc. and its subsidiaries - and several of their senior officials in Philadelphia on June 27, 2012.

The Sherfeys allege that the officials "replaced salaried full-time scientists in the analytical laboratory with contract workers who lacked technical pharmaceutical experience," and then used the money saved to market and advertise the dangerous drugs.

"Despite knowledge of the manufacturing defects" and the growing number of adverse event reports, officials "insisted" on continuing to sell the defective products, the Sherfeys claim.

The couple said Inmar implemented a phantom recall and conducted "market assessments" to determine the risk the defective medicines posed "to prevent parents from switching permanently to less expensive acetaminophen products."

In 2007, despite "glaring warning signals" like a rebuke from the Food and Drug Administration and McNeil's recognition of quality control issues, J&J's officials "remarkably dismantled" its corporate compliance group and "de-emphasized the importance of quality control," according to the complaint.

Another couple, Daniel and Katy Moore, previously filed a similar suit in December 2011, stemming from the death of their 2-year-old son, River.

The defendant companies ultimately removed both suits to U.S. District Court for the Eastern District of Pennsylvania.

U.S. District Judge Mary McLaughlin refused to remand the Moores' suit on Nov. 1, 2012, and later declined to reconsider or let the couple appeal her ruling in September 2013, holding that McNeil was allowed to remove the suit, as its production plant is in Skillman, N.J.

Relying in part on McLaughlin's rulings, Senior U.S. District Judge Robert Kelly denied the Sherfeys' motion to remand their suit and dismissed the named officials on Jan. 29.

The Sherfeys' claims against J&J's Board Chairman and CEO William Weldon "may establish that Weldon set corporate priorities that he should have known would cause injury to the public," Kelly wrote. "They, however, do not amount to acts of misfeasance. Moreover, we agree with Moore in that Weldon was not alleged to have directed a particular act specifically connected to the manufacture and distribution of the purportedly defective Infant's Tylenol or any later improper recall of that product that caused or contributed to the death of Tracen."

Allegations of a "secret recall" are "merely conclusory," the judge ruled, finding that the individual defendants have all been fraudulently joined.

"At best, plaintiffs allege that defendants had notice or general knowledge of defects in the products, but failed to act in a way that would have prevented those specific products that allegedly harmed plaintiffs from being sold," Kelly wrote. "Moreover, none of these individual defendants are alleged to have manufactured, inspected, or released any contaminated medication, including Infant's Tylenol that allegedly caused the death of Tracen."

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