The Sixth Circuit Court of Appeals has a notable case coming up regarding product liability and generic drugs. In Miller v. Eli Lilly & Co., the court will consider whether those harmed by generic drugs have the right to file lawsuits against their manufacturers.
Recently, the United States Supreme Court held in Mutual Pharmaceutical Co. v. Bartlett that manufacturers of generic drugs enjoyed tort protections due to the fact that generic drugs shared the same label as drugs originally approved for use by the federal Food and Drug Administration (FDA). Because the FDA approved the original drug and drug label, individuals injured by side effects of the generic drug could not sue generic drug manufacturers under state product liability laws.
However, this ruling included a footnote that stated it did not apply to design defects in the generic drug that paralleled the federal misbranding statute. As such, plaintiffs in Miller used the footnote as the basis of their request that the Sixth Circuit determine whether makers of the generic version of Darvocet and Darvon painkillers can be found liable for causing severe heart damage. Darvocet was originally taken off of the market in 2010 after concerns that it was addictive and had side effects like irregular heartbeat and kidney problems.
In Miller, the plaintiffs have argued that the generic drugs were misbranded under federal law because when used as directed by their label, they were ineffective and even dangerous. Their case was later dismissed in a federal district court. Even if the Sixth Circuit upholds the dismissal, the plaintiffs and future users of generic drugs may have received a helping hand from the Obama administration. That is because the Obama administration has drafted regulations requiring generic drug manufacturers to update their labels without waiting for FDA permission in order to warn of any newly discovered dangers. Prior to this, generic drug manufacturers seemingly lacked the flexibility that brand-name drug manufacturers had to periodically update labels, so the Supreme Court held that they could not be held responsible for side effects that were not disclosed on the labeling. Under the new regulations, the generic manufacturers would no longer be given the benefit of the doubt.
Critics of any attempt to hold generic drug manufacturers responsible for their defects argue that if lawsuit against the manufacturers are permitted, generic drugs will no longer be cheap, because their manufacturers will need to create "pharmacovigilance groups" like the brand-name labels. Yet having drugs that are slightly less cheap — if that is ever really a danger — seems like a small price to pay to avoid situations where an individual is harmed seriously by a generic. Especially when the generic has side effects that may not be present in the brand-name drug. In the meantime, if you live in Kentucky or Indiana and have been injured by a product like a prescription drug, contact a Kentucky or Indiana product liability attorney right away.
Miller & Falkner is a plaintiffs law firm serving residents of Kentucky and Indiana. Located in Louisville, Kentucky, the firm provides representation in the areas of personal injury and employment law. Contact us today for a free consultation.