The attorney who sued over cold medicine last week is vowing to add a defendant based on new ownership of Johnson & Johnson Consumer Inc. (JJCI).
Jason Richards of the Aylstock, Witkin, Kreis & Overholtz law firm filed a complaint September 13 on behalf of Steve Audelo in the Northern District of Florida federal court accusing Procter & Gamble and JJCI of fraud and deception.
But Richards said he will amend the complaint to include Kenvue.
“Our client took the medications when it was still being manufactured by JJCI, so that’s why JJCI was named,” he said. “We anticipate amending to add Kenvue as a defendant too now that Kenvue appears to be the new manufacturer of the drugs.”
On August 23, Johnson & Johnson announced in a statement that it had accepted 190,955,436 shares of Johnson & Johnson common stock in exchange for 1,533,830,450 shares of Kenvue common stock.
“I would assume it was spun off for some strategic purpose but I can’t speculate as to the reason,” Richards told the Florida Record.
Thirteen other complaints were filed in federal courts in Louisiana, New York, North Dakota, Maryland, New Jersey, California, Minnesota, and Illinois.
“The approval history of over-the-counter cold and cough medications is a little convoluted but Phenylephrine was approved by the FDA for over the counter use in the mid-1970s, and was approved in the 10mg dosage in 1994,” Richards said in an interview.
Richards’ Florida complaint states that the consumer advocacy group Public Citizen expressed concerns to the FDA in 2007 that among decongestants, phenylephrine is not as effective as pseudoephedrine in many over-the-counter cold medicines.
“Because the ingredient phenylephrine had previously been approved by the FDA as safe and effective, the drug’s efficacy was not really on the public’s mind until the FDA advisory panel issued its report last week and said that phenylephrine actually doesn’t work as a nasal decongestant,” he said.
As previously reported in the Florida Record, data from 2018 was confirmed last week by the FDA that phenylephrine-based decongestants are ineffective or work as a placebo.
“It appears like the drug companies sat on their hands and relied on the FDA to monitor the efficacy of their own drugs,” Richards said. “However, it is the drug manufacturers’ responsibility to continually monitor and ensure the safety and efficacy of their own drugs and report any potential safety and efficacy issues to the FDA on an ongoing basis.”
Kenvue manufactures Sudafed and Benadryl Allergy Plus Congestion while P&G manufactures Vicks NyQuil, which are all allegedly phenylephrine-based.
“Discovery in the case should shed some light on what, if anything, the drug companies did over the years to notify the FDA about potential efficacy issues phenylephrine,” Richards added. “It is an economic loss class action, so the goal is a full refund of the purchase price for the products that consumers purchased.”
The complaint claims $5,000,000 or more is at issue but Richards foresees the case being assessed at significantly more.
“We will have to see going forward, if a class is certified, how many claims are made for refunds, and thus, how much in damages is ultimately at stake,” he said.