The Conte decision is well known by brand and generic manufacturers alike. 85 Cal.Rptr.3d 299 (Cal.App. 2008).  There, one panel of the California Court of Appeal allowed the plaintiff to pursue a claim against a brand manufacturer, even though the record was clear that she had taken only generic manufacturers’ products.  At the time, counsel and our brand manufacturer clients questioned whether the decision signaled the beginning of the end of product identification requirements or whether the Conte decision would stand alone as an isolated incident of unfortunate reasoning.   

In the three years following Conte, courts throughout the country rejected its reasoning and refused to find that brand manufacturers owe a duty to individuals who take generic bioequivalents.  

Then came Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011), and the glimmer of hope for plaintiffs for broader application of Conte doctrine.  In Mensing, the United States Supreme Court held that federal law preempts state laws that require stronger warnings on the generic product’s label and therefore barred plaintiffs’ state law tort claims against generic manufacturers.  As a result of the Court’s decision, many brand name counsel and clients expected plaintiffs’ lawyers to rigorously pursue the argument that the brand manufacturers should be held liable for injuries caused by the use of generic products because their clients would be left without recourse simply because a pharmacy dispensed a generic product rather than a brand product.

The Sixth Circuit Court of Appeals quickly thwarted plaintiffs’ hopes.  In Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), the court explicitly rejected Conte and affirmed the district court’s dismissal of all claims against the brand manufacturer. Plaintiffs Lala Smith, Alice Wilson and Dennis Morris were prescribed Reglan, which is a medication used to treat gastroesophageal reflux.  Id. at 422.  Reglan was manufactured by Wyeth from 1989 to 2001 and by Schwarz Pharma. Inc. from 2002 to 2005.  Id.  Pursuant to Kentucky’s generic-substitution law, which requires pharmacies to fill prescriptions with generic products unless the prescribing physician specifically instructs otherwise, all three plaintiffs received generic metoclopramide, but never received Reglan manufactured by Wyeth or Schwarz.  Id.  As a result of their long-term use of metoclopramide, the plaintiffs claimed that they developed tardive dyskinesia, a neurological disorder that resembles Parkinson’s disease.  Id.

Like the plaintiff in Conte, the plaintiffs brought state-law failure to warn claims against the generic manufacturers and asserted state-law fraud, fraudulent concealment and negligent misrepresentation claims against the brand manufacturers.  Id.  As to the brand manufacturers, the plaintiffs alleged that Reglan’s label “falsely and misleadingly represented the risks associated with long-term use of metoclopramide.”  Id.  The district court granted summary judgment to the brand manufacturers and held that “Kentucky law does not permit a cause of action for misrepresentation about a product against anyone other than the product’s manufacturer or distributor.”  Id.  Additionally, the district court granted summary judgment to the generic manufacturers based on federal preemption.  Id.

The Sixth Circuit affirmed the dismissal of the generic manufacturers, finding the decision compelled by the plain language of Mensing:  “The Supreme Court held unequivocally . . . that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug’s label, thus barring the plaintiffs’ state-law tort claims.”  Id. at 423.

As to plaintiffs’ fraud-based claims against the brand manufacturers, the Court made the following unequivocal statement regarding product identification: “A threshold requirement of any product-liability claim is that the plaintiff assert that the defendant’s product caused the plaintiff’s injury.”  Id. (citing Holbrook v. Rose, 458 S.W.2d 155, 157 (Ky. 1970)).  The court concluded that plaintiffs’ theory of liability “fails to satisfy the threshold requirement of a products-liability action – that the defendant’s product have injured the plaintiff.”  Id. (emphasis in original).  The court specifically rejected the plaintiffs’ Conte-based arguments:  “As have the majority of courts to address this question, we reject the argument that a name-brand drug manufacturer owes a duty of care to individuals who have never taken the drug actually manufactured by that company.”  Id. at 424.

Conclusion

Of course, Kentucky does not stand alone in requiring plaintiffs to establish that the harm they complain of was caused by a product manufactured by the defendant.  Indeed, product identification is widely accepted as a threshold requirement in product liability claims, although surprisingly this proposition is not often clearly stated in case law involving drugs and devices. Nonetheless, this decision by the Sixth Circuit in the post-Mensing and post-Conteenvironment hopefully will encourage other courts to likewise prevent recovery of  damages from a brand manufacturer for harm allegedly caused by a product manufactured by one of its generic competitors, and will confirm that Conte remains an aberration.