A California appeals court has thrown a haymaker at Johnson & Johnson, deciding that the pharmaceutical company may be liable for punitive damages in a lawsuit challenging the adequacy of warnings provided with over-the-counter Motrin.
The lawsuit was brought by Christopher Trejo of Los Angeles.
In October 2005 when he was 15 years old, Trejo developed a rare and serious skin condition known as Stevens-Johnson Syndrome (SJS). Trejo has the more severe variant, Toxic Epidermal Necrolysis (TEN).
TEN is nasty business, potentially life threatening and characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body.
Researchers say that TEN is normally the result of a bad reaction to medication.
Trejo claims that his condition was the result of a severe adverse reaction to Motrin, an over-the-counter pain reliever containing ibuprofen, a non-steroidal anti-inflammatory drug (NSAID).
In 2008, Trejo sued Johnson & Johnson and McNeil Consumer Healthcare Division for strict products liability, negligence, and breach of warranty. McNeil makes over-the-counter Motrin and is a subsidiary of Johnson & Johnson.
According to Trejo’s complaint, Johnson & Johnson and McNeil have long known about the risks of SJS and TEN, yet failed to provide specific warnings about those risks with its Motrin product.
Moreover, Trejo alleged that Johnson & Johnson and McNeil misrepresented study results to the FDA in obtaining its approval for over-the-counter Motrin.
Trejo filed his lawsuit in Los Angeles County Superior Court. The trial court refused to strike Trejo’s claim for punitive damages and Johnson & Johnson appealed that ruling.
In an opinion certified for publication on Wednesday, the California Court of Appeal decided Trejo could submit his claim for punitive damages to a jury.
Johnson & Johnson tried to argue that Trejo could not possibly show that the company and its subsidiary acted with the requisite malice in light of the fact the FDA had approved its labeling for Motrin.
But the court decided that Johnson & Johnson could not hide behind the FDA stamp of approval.
First, there was evidence presented by Trejo that McNeil has known since the 1980s that ibuprofen is associated with SJS/TEN. Despite these allegedly known risks, the drug company never proposed to the FDA a specific warning, opting in the end to simply warn consumers of the general risk of severe allergic reactions.
On this issue, the court also made the point that foreign labels for Motrin have long contained more information about SJS/TEN.
In explaining that Johnson & Johnson and McNeil had a duty to be more proactive, the court observed that “federal regulations permit labeling changes without FDA approval to ‘add or strengthen a contraindication, warning, precaution, or adverse reaction’ or to ‘add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.'”
That being the case, the court concluded that “there are triable issues of fact regarding whether McNeil’s FDA-approved labeling could evidence despicable conduct or conscious disregard for safety. The relevant federal regulations place the burden on manufacturers to ensure their drug labeling is adequate at all times, regardless of FDA approval of existing labeling.” (Johnson & Johnson v. Superior Court)
– Pat Murphy