Senate Bill 80 (SB80) was passed and is now law. The purpose of this legislation was to “provide that a manufacturer is not liable . . . for damages resulting from a product it did not design, manufacture, sell, or lease; and to provide that a manufacturer is not liable for damages if its design is copied without its express authorization.” That sounds reasonable enough at first blush, that is, until you consider the realities of the pharmaceutical industry and federal labeling rules for prescription drugs.
Most folks are very familiar with generic pharmaceutical drugs. When a branded drug’s patent expires, generic manufacturers may seek FDA approval for the generic versions of brand-name drugs by way of an abbreviated new drug application process. Instead of having to duplicate the extensive animal and human testing already conducted by the brand-name manufacturer, the generic manufacturer may instead rely on the brand-name manufacturer’s data and submit only bioequivalence data.
Because they do not incur the costs of clinical trials, generic medications are significantly cheaper than their brand-name counterparts. The use of generic drugs is so ubiquitous that all 50 states have some form of generic substitution law — allowing a pharmacist to provide a generic drug in place of a brand-name drug, unless the prescribing physician indicates otherwise on the prescription.
Both brand-name and generic manufacturers must monitor adverse reactions suffered by users of a drug and provide post-marketing reports to the FDA. However, only the brand-name manufacturer remains responsible for the accuracy and adequacy of its drug’s label, while the generic manufacturer is to simply make sure that its label matches the branded drug’s. These rules are very strictly enforced. Even if a generic manufacturer believes that a warning should be added or strengthened, actually doing so would violate federal laws and regulations requiring the label of the generic drug to match the brand-name manufacturer’s label. Brand-name manufacturers are well-aware that after their patents expire, generic versions of the drug will be made, with those manufacturers distributing the brand-name manufacturer’s label.
Because generic manufacturers do not have the authority to add or strengthen warnings in the label, they are generally immune from liability for failure to warn, leaving victims injured by generic medications without a remedy. Last year, the Alabama Supreme Court recognized that these nuances make prescription drugs “unlike any other product on the market,” and upheld its 2013 ruling that brand-name drug manufacturers can be held liable for inadequate warnings in its label, even where the victim actually took a generic version of the drug, produced by another manufacturer. This ruling provided much-needed relief for Alabamians harmed by generic drugs with outdated labels.
Reaction to the Wyeth v. Weeks decision was extreme and largely ignored the text of the ruling itself. The Court specified in its opinion that it was “not . . . creating a new tort of ‘innovator liability.’” The pharmaceutical industry acted quickly and, as a result, Alabama legislators and business organizations called for a quick end to “innovator liability.” SB80 was introduced, a great deal of misleading information put out, and, the bill passed in record time. The Alabama Supreme Court emphasized repeatedly that the Weeks decision was based on the unique regulatory environment of prescription medications and detailed:
Nothing in this opinion suggests that a plaintiff can sue Black & Decker for injuries caused by a power tool manufactured by Skil based on labeling or otherwise.
The report by AL.com that said Alabama’s Supreme Court had “put the state back on the highway to tort hell,” was totally untrue. If companies are to be held responsible for only their own products, shouldn’t that mean that brand-name drug manufacturers are responsible for the content of the warnings found in the labels they design and put out for public consumption? The Alabama Supreme Court had ruled correctly in its opinion on the liability of a drug company. This new law is a classic example of “over-reacting” by a legislative body.
Sources: Alabama Senate Bill 180 (2015), Wyeth v. Weeks (Ala. Aug. 15, 2014), Law360.com, AL.com
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