Contributing Author: Meghan A. McCaffrey
In a significant decision, the Supreme Court of Alabama ruled Friday that “it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce[.]” Rejecting the majority approach, Alabama now joins only two other courts — California and Vermont — in holding branded manufacturers liable for claims based on a generic drug.
The question certified by an Alabama federal court in August 2001 was “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?” With its 8-1 decision, Alabama answered with a resounding yes, finding that a branded drug manufacturer “could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug.”
The ruling seems to stretch the bounds of foreseeability well beyond its limit, holding that foreseeability exists just because there is a patient — somewhere down the line — whose doctor may rely on the labeling of a branded drug to prescribe medication; branded medication that the patient may not actually take, instead taking — by virtue of a patient’s choice, a pharmacist’s choice, or an insurance company’s choice — the generic version. By doing so, the court expands a branded manufacturers duty of care well beyond fundamental and well-established principles of tort and product liability law. In O’Neil v. Crane Co., a California court rejected the same pure foreseeability doctrine that Alabama adopted on Friday, stating that “duty is not an immutable fact of nature but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection.” O’Neil v. Crane Co., S177401, *30-31(Cal. Jan. 12, 2011). Indeed, the O’Neil court went on to hold that “foreseeability alone is not sufficient to create an independent tort duty. Instead, the recognition of a legal duty of care depends upon the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability.” Id. at 31.
How did the Alabama Supreme Court get to its ruling? Surprisingly, it did so relying on the Supreme Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Wyeth v. Levine, 555 U.S. 555 (2009), as well as the only other two lower court cases supporting its ruling, California’s Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (2008) and Vermont’s Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010). Using the Supreme Court’s opinions in Levine and PLIVA, Alabama reasoned that state-law claims against a manufacturer were not preempted and plaintiffs could hold a branded manufacturer liable for warnings on a generic product it did not produce because PLIVA had found that federal regulations prohibited generic manufacturers from changing warning labels on their generic drugs. Because a generic drug’s label must be the same as the brand-name drug, the court argued, “it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.”
While Alabama’s decision still appears to be an outlier, its extension of the foreseeability doctrine could have potentially vast implications not only for the pharmaceutical industry, but the larger products industry as a whole. For Wyeth and the Weekses, the battle will continue – the Alabama Supreme Court’s ruling was not on the merits, so the Weekses will still have to prove that their prescribing physician received and relied upon the branded manufacturer’s label and warnings and that those labels and warnings were inadequate or fraudulent. Nonetheless, it is clear that this was a results-driven analysis; PLIVA unequivocally proscribes recovery against generic manufacturers, but the Alabama Supreme Court still wanted to hold someone liable. It remains to be seen whether other courts will follow suit, but we’ll continue to follow these developments here at the Product-Liability Monitor.