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S.C. Supreme Court Doesn’t Mince Words

A recent opinion of the Supreme Court of South Carolina strongly censured the actions of one of America’s biggest pharmaceutical companies, even as it reduced the civil penalties that had been imposed against the drug-maker by the trial court.

Under the appellate court’s scrutiny was Ortho-McNeil-Janssen Pharmaceuticals, a division of Johnson & Johnson. Among the Court’s choice descriptions of this Big Pharma appellant:

  • Janssen’s unfettered desire for sales and market share led it to engage in a systematic pattern of intentional nondisclosure, false representations, and deceptive conduct
  • Janssen’s deceit was substantial.
  • Janssen’s furtive efforts to mislead prescribing physicians . . . were reprehensible and in callous disregard for the health and welfare of the public.
  • Janssen’s desire for market share and increased sales knew no bounds, leading to its egregious violation of South Carolina law.

What was all the fuss about?

Risperdal, an antipsychotic drug developed by Janssen Pharmaceuticals and approved by the FDA in 1994 for the treatment of schizophrenia in adults. Within three years, more than one million prescriptions had been dispensed. It was promoted as being more effective than the older antipsychotics and without their dangerous side effects.

Substantial Risk Uncovered

It wasn’t long, however, before studies found Risperdal posed a serious risk of substantial weight gain, increased the long-term risk of developing various kinds of cancer, osteoarthritis, cardiovascular disease, stroke, diabetes, cardiac arrest, and sudden death in the elderly. This was seriously bad news for Janssen/Johnson & Johnson. Risperdal was Johnson & Johnson’s best-selling drug, generating worldwide sales of $24.2 billion from 2003 to 2010.

A drug’s label “must contain a summary of the essential scientific information needed for the safe and effective use of the drug,” and the label “must be informative and accurate and neither promotional in tone nor false or misleading in any particular.”

Furthermore, as time goes by and new risks and side effects are discovered, the manufacturer must revise the label “to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug.”

Janssen chose not to disclose what it knew to be the dangers of taking Risperdal.

In fact, when the FDA asked manufacturers of antipsychotic drugs to submit the clinical data they had about the metabolic side effects of these products, Janssen told them only about positive studies and hid what they knew about negative effects. Nevertheless, the FDA decided the label on drugs in this class of antipsychotics needed to be changed. Janssen dragged their feet, waiting until February of 2005 to update Risperdal’s label to include a boxed warning regarding the risk of stroke, cardiac arrest, and sudden death in the elderly; and they didn’t add a warning about diabetes until August 2008. This became the first claim in the case of South Carolina v. Ortho-McNeill-Janssen, etc., filed on April 23, 2007.

Dear Doctor…

After the labels were changed, Janssen wanted to reassure physicians about the efficacy and safety of Risperdal, so they sent out what is known in the industry as a “Dear Doctor” letter. The problem is, they lied. And this became the second claim in the civil case accusing Janssen of violating the South Carolina Unfair Trade Practices Act (SCUTPA).

After a 12-day trial, a jury found Janssen guilty of willfully violating the provisions of SCUTPA both with regard to Risperdal labeling and in the Dear Doctor letter.

The Court imposed civil penalties totaling more than $32.7 million based on 553,055 separate violations of SCUTPA in connection with its deceptive conduct in the sales and marketing of Risperdal.

It was no surprise that Janssen appealed the case to the South Carolina Supreme Court. They’ve been hit right and left with state and federal lawsuits; the federal litigation has resulted in agreed upon penalties in excess of $2 billion. In the S.C. case, the drug company was successful in having the judgment reduced due to statute of limitations issues, but they are nevertheless on the hook for $136,025,400.

Legal Fallout Continues

Janssen tried to wriggle out of trouble by saying the Attorney General hadn’t proved actual injury, which the Supreme Court characterized as “nothing more than an ‘if we lied, nobody fell for it’ defense.” But when the AG files suit alleging violation of SCUTPA, he is not required to show that any injury actually resulted from the deceptive acts.

It is also possible for a private person to seek damages under SCUTPA, but a private claimant must suffer an actual loss, injury, or damages, and be able to demonstrate a causal connection between the injury and the complained-of unfair or deceptive acts or practices.

SCUTPA is only one of the statutes under which a pharmaceutical company can be called to task for the harm caused by a dangerous drug. And Risperdal is only one of the prescription drugs approved by the FDA which was later found to be associated with serious adverse effects. The Louthian Law Firm helps South Carolinians hurt by dangerous drugs. If you have questions about Risperdal, Xarelto, Paxil, Lipitor or any other drug you suspect has harmed you or your loved one, call us at (803) 454-1200.

We’ll tell you the truth, and we won’t mince words either.

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