ALEXANDRIA, Va. – A fundamental of our legal system is that each person is responsible for his or her own conduct, not that of another person. This same principle applies in the area of product liability law in that a manufacturer should only be responsible for its own product, not that of a competitor.
It may surprise readers to learn that West Virginia’s high court is presently considering whether to depart from this basic legal principle. A federal appellate court asked the state high court to clarify West Virginia law with respect to whether a branded drug company may be subject to liability for harms caused by a competitor’s generic drug product.
Most courts around the country have wisely rejected such a liability theory, but a few courts have accepted it. The driving force behind such acceptance is the fact that the U.S. Supreme Court determined in an earlier case that product liability claims generally cannot be brought against manufacturers of generic drugs because the manufacturer is not free to change the warnings on a generic drug without permission from the federal Food and Drug Administration (FDA). The Court reached the opposite conclusion with respect to branded drug manufacturers, finding product liability claims can generally be brought because the branded drug manufacturer can change its warnings without prior FDA approval.
As a result, plaintiffs’ lawyers have sought to make a branded drug manufacturer pay for alleged harm to persons taking a generic drug made by another company. The liability theory is that the branded drug manufacturer (i.e. the drug’s “innovator”) should be responsible for any and all liability stemming from the drug, including a generic version of the drug made by one of the branded manufacturer’s direct competitors.
Courts such as the Iowa Supreme Court have rejected this “innovator liability” theory, referring to it as unsound “deep pocket jurisprudence” that is “law without principle.” Courts rejecting this liability theory have also appreciated that subjecting a drug company to liability for its competitor’s products does not benefit public health and safety. A generic drug manufacturer produces a generic version of a drug after the branded drug manufacturer’s patent expires. At that time, the branded drug manufacturer typically sees its market share overtaken by generic versions of the drug and may even discontinue making the “off-patent” drug.
What is left is a situation in which the generic drug makers often become the main resource for new information about anything wrong with the drug they choose to manufacture and sell. The generic drug manufacturer is also not helpless if a potential new risk is discovered; it can ask the FDA to modify the drug’s warnings.
Public policy supports placing the responsibility to make the FDA aware of potential issues about a generic drug’s warnings with the companies that are actually making and selling these products. Public health is not served by imposing a virtually unbounded duty on a branded drug’s manufacturer to police the entire pharmaceutical industry in perpetuity with respect to generic versions of a drug made by its competitors. The “solution” is not to have Peter pay for the sins of Paul. West Virginia’s high court should follow, and reaffirm, this basic principle of liability law.
Cohen is former executive director of West Virginia Citizens Against Lawsuit Abuse.