Mutual Pharmaceutical Company v. Bartlett: How the Decision Affects Us

In our previous blog post, we discussed the Supreme Court decision to prevent consumers from seeking legal recourse for injuries caused by defective generic drugs under preemption laws. The decision favors manufacturers and is conceptually in conflict with the 2009 Supreme Court ruling that brand-name manufacturers may be sued for damages caused by drug defects. If brand-name pharmaceutical manufacturers can be held accountable for unsafe drugs, then generic drug manufacturers should also be responsible for theirs.

The combination of the Mensing and Bartlett decisions make it extremely difficult for an injured consumer to pursue a valid lawsuit against a generic drug manufacturer, but the specific circumstances of each case will determine the actual impact of these decisions.

For example, the decision should not affect the California Court of Appeal’s Teva v. Superior Court decision – published roughly two weeks ago – which our firm helped brief and argue. The decision held that claims based on a generic’s failure to update a label to match the brand as well as the failure to adequately communicate the updated label changes to doctors are not preempt under Mensing. The Sixth Circuit’s Fulgenzi decision also held that Mensing does not preclude claims based on failure to update. The legal team at Robinson Calcagnie Robinson Shapiro Davis, Inc. strongly believes that these decisions still stand, and may even be buttressed by the Court’s decision.

While Mensing and Bartlett foreclose state law claims based on failure to change the generic label prior to a label change by the brand, once the label is changed, there are at least some duties on the part of generic manufacturers for which they may be held liable if their breach in duty caused harm to the plaintiff. Even so, the remedies available to those harmed by generic drugs are arguably more limited because the Supreme Court has interpreted the law to mean that there can be no state law claim where such a law requires generic manufacturers to unilaterally change their labels to include warning information not contained in the brand label, and has now extended that view to certain design defect claims.

UPDATE – The FDA has recently announced plans to give generic drug manufactures permission to update their labels.