California Becomes First State to Recognize Innovator Liability

Originally published January 26, 2009

Keywords: California Supreme Court, product

liability, duty to warn, generic drugs, brand name drugs, Conte v.

Wyeth, negligent misrepresentation

On January 21, 2009, the California Supreme Court declined

petitions to review the appellate court decision in Conte v. Wyeth, Inc., et al., 85 Cal.

Rptr. 3d 299 (Cal. Ct. App. 2008). In Conte, the appellate

court held that Wyeth, a name brand manufacturer of Reglan® (a

prescription drug used to treat gastroesophageal reflux disease),

has a duty to warn patients whose doctors allegedly rely on

Wyeth's labeling information for name brand Reglan® when

prescribing the drug, regardless of whether the patient's

prescription is filled with the name brand drug or a generic

version. In ruling this way, the court of appeals became the first

court in the United States to recognize the so-called

"innovator liability" theory of recovery.

Plaintiff alleged in Conte that she developed tardive

dyskinesia after ingesting generic Reglan® for four years to

treat her reflux disease. She further alleged that both Wyeth and

certain generic-drug manufacturers could be held liable for her

injuries because the warnings accompanying both the name brand and

the generic products failed to adequately warn about the true risk

of developing tardive dyskinesia beyond twelve weeks of

therapy.

Because plaintiff had not ingested Wyeth's product, the

Court of Appeal held that she could not assert traditional product

liability claims against Wyeth. Nonetheless, the court held that

plaintiff could assert a separate negligent misrepresentation claim

against Wyeth. Rejecting the reasoning of every previous decision

on the issue, the court stated:

The common law duty to use due care owed by a name-brand

prescription drug manufacturer when providing product warnings

extends not only to consumers of its own product, but also to those

whose doctors foreseeably rely on the name-brand manufacturer's

product information when prescribing a medication, even if the

prescription is filled with the generic version of the prescribed

drug.

By contrast, and notwithstanding evidence that the plaintiff

ingested generic Reglan®, the Conte court dismissed

all claims asserted against the generic manufacturers, including

traditional products liability claims, because the evidence

demonstrated that the plaintiff's physician did not rely on

those manufacturers' labels in prescribing the generic product.

Thus, under...