Massive Drug Recall and Whistleblower (False Claims) Lawsuit Impact Pharmaceutical Giant Johnson & Johnson
Stomach sickness and a strange smell forced Johnson and Johnson (J&J) division McNeil Consumer Healthcare to finally recall from market a total of 27 products, including Tylenol, Benadryl, Rolaids and Motrin, their second recall this month. The company claims the recalled medicines, manufactured in a Puerto Rico plant, became tainted by the wood storage pallets where it was stored. Pallet manufacturers have openly and aggressively challenged this claim that chemical treatment 2,4,6-tribromoanisole (TBA) could, as J&J claims, permeate the boxes, packaging, and bottles to taint the recalled medication.
Moldy-smelling, musty bottles of Tylenol Arthritis Relief caplets were first reported 20 months ago, and since people have complained of digestive problems, including nausea, vomiting and stomach pain. Apparently FDA officials knew about the odor in 2008, having received over 100 complaints by August 2009, but only took critical action recently.
Kickbacks were the cause of a False Claims lawsuit against nursing home pharmaceutical provider Omnicare for which J&J was implicated. The $98 million settlement was based on allegations that the nursing home pharmacists were unnecessarily, and dangerously, prescribing nursing home residents with dementia the antipsychotic drug Risperdal. Unfortunate for the nursing home resident, Risperdal isn't approved to treat agitated patients with dementia, but, according to the Justice Department (DOJ), this kickback scheme worked extremely well for J&J, tripling Omnicare’s sales of J&J drugs, from $100 million to $280 million with Risperdal making up $100 million of the latter sales figure.