Alabama No Longer An Outlier State: Legislature Says 'No' To Innovator Liability

1. INTRODUCTION

   Since the United States Supreme Court's decision in Pliva, Inc. v. Mensing1, the plaintiffs' bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic prescription drug. One of those alternate theories is "innovator liability," which posits that the brand manufacturer should be liable for injuries caused by the generic equivalent even if the claimant did not ingest the brand manufacturer's product. Plaintiffs rationalize that because the FDA requires the generic manufacturer to copy the brand's label and warnings, the brand manufacturer should be liable.

   The innovator theory contravenes a principal foundation of product liability law: that a manufacturer is not liable for injuries resulting from use of another manufacturer's product. Indeed, the logic is undeniable - if a manufacturer did not make the product, it cannot be liable for damages allegedly caused by its use.

   In the context of pharmaceutical litigation, this foundational rule was set forth in Foster v. American Home Products,2 which required product identification - a direct evidentiary link between the allegedly harmful product and the allegedly liable defendant-manufacturer.3 The Foster court reasoned that making brand-name drug manufacturers liable for generic manufacturers' activities was unfair and stretched the boundaries of legal foreseeability in product liability law.4

   This established law took a step backward with the first mention of innovator liability in Conte v. Wyeth, Inc.5 In Conte, the court concluded that Foster's analysis was flawed because it did not consider concurrent liability, rationalizing that it was reasonable to require brand-name manufacturers to put correct information on their labels or be held liable for its failure to warn.6 The Conte court held that it would not protect the brand-name manufacturer from foreseeable injuries caused by its allegedly inadequate warnings that the generic manufacturers are required to replicate.7

   In addition to California, Alabama and Vermont are the only other jurisdictions to apply the innovator liability theory to hold a brand-name manufacturer liable for misstatement or omission for an injury caused by a generic drug manufactured by a different company.8 However, Alabama recently took swift action to curtail the potential Pandora's box of litigation created by the Wyeth v. Weeks decision. In doing so, the Alabama legislature reduced the number of innovator liability states to just two, a considerable minority to the number of states addressing the issue and holding otherwise.9

2. WEEKS: THE "WORST PRESCRIPTION DRUG/MEDICAL DEVICE DECISION OF 2014"

   In our July 2013 Pro Te article, "What Do California, Vermont and Alabama Have In Common?,"10 we reported on what had been deemed the "worst prescription drug/medical device decision of 2014."11 To recap, in Wyeth, Inc. v. Weeks, the Alabama Supreme Court allowed a plaintiff claiming injury from a generic product to maintain a misrepresentation claim against the brand manufacturer. The original Weeks decision garnered widespread negative press, thus causing the Alabama Supreme Court to reconsider its original opinion, en banc.

   At rehearing, Wyeth argued - supported by the majority of states - that it had no relationship with the Weeks plaintiffs and, thus, it owed them no duty to warn. However, the Alabama Supreme Court emphatically rejected this notion and admonished Wyeth's argument, holding:

   Wyeth's argument completely ignores the nature of prescription medication. The Weekses cannot obtain Reglan or any other prescription medication directly from a prescription-drug manufacturer. The only way for a consumer to obtain a prescription medication is for a physician or other medical professional authorized to write prescriptions (i.e. a learned intermediary) to prescribe the medication to his or her patient. When the warning to the prescribing health-care professional is inadequate, however, the manufacturer is directly liable to the patient for damage resulting from that failure. 12

   Although one would think - as the majority of states have previously held - that the above rationale would prevent brand-name manufacturer liability in the case of generic ingestion, the Supreme Court rejected such a conclusion, rationalizing:

   The substitution of a generic drug for its brandname equivalent is not fatal to Weekses' claim because the Weekses are not claiming that the drug Danny ingested was defective; instead, the Weekses' claim is that Wyeth fraudulently misrepresented or suppressed information concerning the way the drug was to be taken and, as discussed, the FDA mandates that the warning on a generic-drug label be the same as the warning on the brand-namedrug label and only the brand-name manufacturer may make unilateral changes to the label.13

   The Alabama Supreme Court again relied heavily...