Determining Liability When a Patient Develops Tardive Dyskinesia

Facts of the Case

Louise Taylor was psychiatrically hospitalized for a psychotic episode in 1998. Her outpatient psychiatrist, Dr. Richard Rhoden, initially continued her hospital-initiated, first-generation antipsychotic, haloperidol. Dr. Rhoden later prescribed quetiapine, a second-generation antipsychotic. After a suicide attempt by an overdose with quetiapine, Dr. Rhoden prescribed Risperdal, another second-generation antipsychotic. Per Dr. Rhoden, Ms. Taylor and her daughter received information regarding possible side effects of Risperdal, including tardive dyskinesia (TD), which is a potentially irreversible, involuntary movement disorder linked to antipsychotic use. Like all other antipsychotic medications on the market, Risperdal had a Food and Drug Administration (FDA) class label warning for tardive dyskinesia.

Ms. Taylor was prescribed Risperdal from March 1999 until January 2001. At a January 2001 visit with Dr. Rhoden, Ms. Taylor was noted to have developed oral dyskinesia. Dr. Rhoden consequently decreased Risperdal and restarted quetiapine. In February 2001, Ms. Taylor was reported to have developed tardive dyskinesia.

Ms. Taylor filed a complaint (through her conservator and niece, Brenda Fortenberry) against Ortho-McNeil Janssen Pharmaceuticals, the manufacturer and distributor of Risperdal, as well as its parent company, Johnson & Johnson, Inc., claiming that the medication resulted in the development of tardive dyskinesia. (Ms. Taylor named Dr. Rhoden in the lawsuit, but that claim settled out of court.) The trial court jury found in Ms. Taylor's favor, noting Janssen's “failure to provide adequate warnings/instructions” and Janssen's “negligent marketing/misrepresentation” (Fortenberry, p 386). Ms. Taylor was awarded $650,000 in economic damages and $1.3 million in noneconomic damages.

Janssen appealed the decision on several grounds. Janssen argued that Ms. Taylor's failure-to-warn claim did not present evidence suggesting that the Risperdal warning was inadequate. Janssen also argued that they were entitled to judgment due to insufficient evidence on Ms. Taylor's negligent misrepresentation claim. Janssen argued that there was no proof that Dr. Rhoden, in prescribing Risperdal to Ms. Taylor, received or relied on misrepresentation from Janssen. Janssen further argued that the jury instructions regarding the claim of negligent misrepresentation were improper.

Ruling and Reasoning

As to Ms. Taylor's failure-to-warn claim, the Supreme Court of Mississippi reversed and rendered judgment in favor of Janssen. The court stated that Ms. Taylor's attempt to prove her failure to warn claim through Janssen's marketing materials went beyond the statutory scope of the 1993 Mississippi Products Liability Act (MPLA), in which the “only pertinent question is whether the prescription drug label contained adequate warnings or instructions” (Miss. Code Ann § 11-1-63(c)(i)-(ii) (2014)). The court found that Dr. Rhoden, the learned intermediary, was warned of the danger of tardive dyskinesia “in no uncertain terms” via the Risperdal package label and that the warning was sufficiently adequate (Fortenberry, p 393).

The court found that a jury question did exist, however, as to whether there was a “material misrepresentation or omission” in the marketing materials provided to Dr. Rhoden (Fortenberry, p 399). The court considered whether the Janssen marketing materials misrepresented Risperdal as having a lower tardive dyskinesia risk than other medications. The court reviewed expert testimony from an academic psychiatrist and a neurologist specializing in movement disorders. Testimony reflected that the meaning of “atypical” had shifted over time with the marketing of second-generation antipsychotics to a point where there was “no consensus definition of the term” (Fortenberry, p 396). The court held that a jury question did exist as to whether Dr. Rhoden relied on Janssen's alleged misrepresentation in prescribing Risperdal, and whether this reliance resulted in Ms. Taylor's damages. The court reversed and remanded for a new trial on grounds raised by Janssen regarding improper jury instructions on several matters, including a claim of negligent marketing. Regardless, the court held that negligent marketing and negligent advertising were both outside the scope of a misrepresentation claim.

Dissent

In contrast to the court's decision, the dissent, while concurring in part regarding the reversal and remand of the negligent misrepresentation claim, argued against the central holding of the majority opinion. The dissent stated that Risperdal's FDA class label was inadequate to warn Dr. Rhoden of the severity of the risk of tardive dyskinesia. The dissent cited “substantial evidence” of the inadequacy of the FDA warning label laid out at trial, including a psychiatrist's expert testimony that the class warning was “cookie cutter” and “meaningless.” The dissent also noted that if adequate warnings were provided to the physician, the learned intermediary doctrine could insulate the pharmaceutical company from liability.

The dissent said that the FDA warning's adequacy should be determined by a jury, and that “reasonable and fair-minded jurors” had heard the psychiatrist's expert testimony and concluded that the warning was inadequate to warn Dr. Rhoden of Risperdal's risk of tardive dyskinesia (Fortenberry, p 410). In addition, the dissent stated that a jury could have concluded that Janssen's “aggressive marketing and over-promotion” could have rendered the FDA warning inadequate by failing to adequately inform Dr. Rhoden (Fortenberry, p 410). The dissent argued that the jury's verdict should stand.