The 2008 Supreme Court ruling in Riegel v. Medtronic held that if a medical device passed the Food and Drug Administration’s (FDA’s) safety review and received premarket approval, federal law barred common-law state claims that challenge the device’s saftey and effectiveness or whether it was being marketed consistent with FDA premarket approval. Since this ruling, some plaintiff personal injury lawyers have successfully argued their manufacturing defect state case claims by claiming that since the state has similar requirements to the FDA’s requirements and the manufacturer failed to follow the FDA requirements, the manufacturer violated both state and federal law. This is a type of “parallel claim”, as the state requirements are arguably similar or parallel to federal requirements.
More recently, another parallel claim that is quickly gaining popularity with personal injury lawyers is the “off-label promotion” claim. If a medical device’s manufacturer promotes uses of the device that are not FDA approved, plaintiff personal injury lawyers argue this “off-label promotion” is a parallel claim; thus, it is not barred by federal law. These claims are found in hundreds of recent personal injury lawsuits filed against Medtronic Inc. alleging that its Infuse Bone Graft was promoted for uses other than those approved by FDA. These unapproved uses allegedly caused patients various personal injuries. Because these cases are recent, it is not yet clear how these “off-label promotion” claims will turn out. Medical device manufacturers may quickly have even more litigation worries.
