Segal McCambridge Attorneys Jeff Singer, Kim Kayiwa, and Mitch Morinec Gain Dismissal on Behalf of Generic Drug Manufacturer in High Damages Products Liability Case


February 17, 2012

Segal McCambridge attorneys Jeff Singer, Kim Kayiwa, and Mitch Morinec gained dismissal on behalf of an international generic drug manufacturer in a high damages products liability case in Illinois state court. At hearing, Jeff Singer successfully argued that the plaintiff's state law "failure to warn" and "design defect" claims were pre-empted by federal law and, as a result, rendered plaintiff's lawsuit meritless against Segal McCambridge's client.

This argument was based on a recent United States Supreme Court decision barring such state law actions against generic drug manufacturers because they conflict with, and are pre-empted by, regulations of the United States Food and Drug Administration ("FDA"). Under FDA regulations, generic drug warning labels must mirror warning labels approved by the FDA for use with "name brand" prescription drugs. Because of this, a generic drug manufacturer has no duty to change its labels from the labels on a "name brand" drug even if it is intended to promote patient safety.

Essentially, because a generic drug's labeling must be identical to those labels on its "name brand" counterpart, a generic drug manufacturer cannot be sued under state law for an alleged failure to warn consumers about its product. Likewise, because a generic drug by nature must be identical to its "name brand" counterpart, a generic drug manufacturer cannot be subject to a state court lawsuit for defective design.

Jeff Singer argued the motion before Judge Daniel Fish in the Circuit Court of Lee County, Illinois on January 6, 2012. The decision (which can be read by clicking here) was handed down on February 16, 2012.