New Jersey Mass Tort Court Rejects Brand-Name Liability for Generic Drugs

In a long-awaited and important decision issued on June 26, 2012, New Jersey Superior Court Judge Carol E. Higbee joined dozens of other courts in dismissing pharmaceutical product liability claims against brand-name companies in cases in which plaintiffs had taken generic versions of the drug in question. Judge Higbee is one of three judges presiding over cases in New Jersey’s Mass Tort Program, in which there are pending approximately one thousand cases where plaintiffs claim they were injured by ingestion of generic versions of the prescription drug metoclopramide, originally marketed under the brand name Reglan®. In some cases, plaintiffs also ingested the branded version of the drug. In all of the cases, plaintiffs joined the brand-name manufacturers as defendants. The brand defendants moved to dismiss.

As they have done in other jurisdictions, largely without success, plaintiffs argued that, despite the fact that they ingested generic metoclopramide, the brand defendants should nonetheless be held liable because they negligently misrepresented to the medical profession the risks and benefits of Reglan®. Plaintiffs argued that their claims were not for product liability, which would be governed by the NJ Products Liability Act (PLA), but were instead negligence claims governed by common law.

Judge Higbee – who recently also largely granted motions to dismiss plaintiffs’ claims against the generic defendants on the grounds of Mensing preemption – disagreed. She found that the PLA covers “any claim or action brought by a claimant for harm caused by a product, irrespective of the theory underlying the claim,” that “harm” includes personal injury, and that the NJ Legislature intended the PLA to be expansive and inclusive.” She therefore determined that plaintiffs were asserting product liability claims.

Judge Higbee then found, again citing New Jersey precedent, that the Legislature intended the PLA to “limit liability to specific parties – namely the manufacturer or seller of a product” and that “it is a fundamental principle of products liability law that a plaintiff must prove as an essential element of his case that the defendant manufacturer actually made the particular product which caused injury.” Since plaintiffs could not prove this essential element of their prima facie case, she concluded that the brand defendants were entitled to dismissal.

Judge Higbee recognized the existence of other cases (e.g. Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Ct. App. 2008)) which extended a brand-name manufacturer’s duty to warn to patients whose doctors relied on the brand-name manufacturer’s product information, regardless of whether the patient ingested a generic equivalent. She noted, however, that these were not New Jersey cases, and that she is bound by the statutory and case law of New Jersey which required dismissal.

The judge did not cite the only other case that has followed Conte – Kellog v. Wyeth, 762 F.Supp.2d 694 (D. Vt. 2010) ­­– nor did she refer to the myriad of decisions from other state and federal courts that have also found that brand-name manufacturers are not liable to plaintiffs who ingested generic versions of their drugs.

Judge Higbee’s decision is likely to be appealed, but it is firmly grounded in New Jersey common law and statute and is in the mainstream of decisions nationally on the issue of Innovator liability. It is highly unlikely that her decision will be reversed by the New Jersey Appellate Division or the New Jersey Supreme Court.