Oklahoma Court Rejects Conte and Concludes Innovators Not Liable for Injuries Arising from Use of Generic Competitors' Products
Drug & Medical Device Practice Alert
The Western District of Oklahoma recently refused to expand the California First District Court of Appeal's decision in Conte v. Wyeth and instead, like the majority of other jurisdictions having considered the issue, concluded that innovators can not be held liable for harm caused from use of a generic version of a brand-name product. The court also found that claims against generic drug manufacturers are not preempted under the federal Food, Drug, and Cosmetic Act (FDCA) under the reasoning set forth in the United States Supreme Court's decision in Wyeth v. Levine.
Schrock v. Wyeth
In Schrock v. Wyeth, Susan Schrock claimed she developed an irreversible neurological condition after long-term use of generic versions of Wyeth's Reglan, a drug used to treat acid reflux. Although she only took the generic version of the drug, Schrock argued that Wyeth should be held liable because the company:
failed to warn of the serious risks associated with long-term use of the brand-name version of the drug; failed to request a labeling change revision with the Food and Drug Administration (FDA) under the Changes Being Effected (CBE) provisions of the FDCA; and failed to report safety information directly to the medical community. Schrock filed a lawsuit against Wyeth, as well as the drug distributor Schwarz Pharm, Inc., and generic manufacturers Actavis, Inc., Actavis-Elizabeth, L.L.C., and Pliva U.S.A., Inc.
Wyeth and Schwarz obtained summary judgment in the District Court on the basis that, as the brand-name manufacturer and distributor they should not be liable for harm allegedly caused by the generic manufacturers of the prescription drug. The court reasoned that Wyeth's product information had no causal relationship to Schrock's injuries, and that Wyeth owed no duty to her as a user of a generic version of its brand-name drug, stating that "twenty[-]four courts in fourteen different states have rejected the assertion that defendants have a duty to warn about products they did not manufacture. Given these defendants have no relationship with plaintiffs in the instant case, the Court finds that holding defendants Wyeth and Schwarz liable under the circumstances would 'extend the concept of duty beyond reason and good sense as a matter of public policy.'"
The generic manufacturers, however, were unsuccessful on their motions to dismiss based on federal preemption. Despite regulations to the contrary, the District Court, citing the United States Supreme Court's recent decision in Wyeth v. Levine, concluded that generic manufacturers have the same ability and duty to add and strengthen warnings as do brand-name manufacturers under the CBE provisions of the FDCA. The court's reliance on Levine was improper. The drug at issue in Levine was a brand-name drug, not a generic drug. As the FDA and several courts have repeatedly recognized, generic manufacturers do not have the same duty to add and strengthen warnings as do brand-name manufacturers under the CBE procedure. The District Court also failed to address the United States Supreme Court's recent decision to accept certiorari in Colacicco v. Apotex Inc.
Implications for Future Cases
This decision will likely have little impact on claims brought against innovators in California in the near future. However, the Oklahoma Court's ruling may support future claims against generic drug manufacturers for the time being.
It is anticipated that other courts across the country will also conclude that innovators are not the indemnitor for injuries caused by their generic competitors' products. Unfortunately, until the California Supreme Court addresses Conte and concludes that innovators should not be held liable for harm caused by their generic competitor's products, plaintiffs will continue venue shopping in an attempt to get their cases into California state court. Fortunately, innovators can avail themselves of motions to remove these cases to federal court or motions to transfer these actions to more appropriate venues where Conte is not binding precedent.
As for generic manufacturers, the Oklahoma court's reliance on Levine is misplaced and should not have an impact on future cases. The two are factually distinguishable on one key point: the drug at issue in Levine was a brand-name drug, not a generic drug. The FDA and several courts have repeatedly recognized that generic manufacturers do not have the same duty to add and strengthen warnings as do brand-name manufacturers under the CBE procedure. Levine does not suggest otherwise. For this reason, Schrock should not preclude a successful preemption argument against generic drug manufacturers in other cases.