This post is from the non-Reed Smith side of the blog.
If you know this blog, you know we leave no stone unturned when it comes to preemption. As far as we know, Greager v. McNeil-PPC, Inc., 2019 WL 5549524 (N.D. Ill. Oct. 28, 2019) is a preemption issue of first impression. Plaintiff alleged she suffered an injury from her use of name-brand and generic ibuprofen products. Id. at *1. The manufacturer and distributor of the generic product moved to dismiss on the basis of preemption asking the court to apply the conflict preemption rule established by Mensing and Bartlett. The court agreed.
The analysis is pretty straightforward. Generic drugs receive FDA approval via abbreviated new drug applications (ANDA) and upon a showing that the generic drug is equivalent to a previously approved branded drug. Federal law then applies a “duty of sameness” to generic drugs. A generic drug and its labeling must be identical to those approved for the brand drug. Id. at *2. This process applies to both prescription and over-the-counter (OTC) drugs. Because of this “sameness” requirement, the Supreme Court has held that it would be impossible for generic manufacturers to comply with both federal law and any state tort law that held that the product or its labeling was defective. Unlike brand drugs which, under certain circumstances, have a process that allow them to change their labeling without FDA approval, generic manufacturers have no such option. So claims against generics are preempted.
Plaintiff argued that OTC drugs are different because of the savings clause in 21 U.S.C. §379r. This regulation that applies to OTC drugs contains a provision expressly preempting any state law that is “different from or in addition to, or that is otherwise not identical with, a requirement under this chapter.” Id. at *3. But the regulation goes on to provide: “Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.” §379r(e). Plaintiff argues, therefore, that it was Congress’ intent to preserve products liability claims like hers.
The court, adopting defendants’ argument, focused its analysis on the “nothing in this section” language. The savings clause applies solely to the express preemption established in §379r but does not apply to the conflict preemption on which defendants are relying and the court is applying. So, while the plaintiff was drawing attention to the fact that OTC and prescription drugs are governed by different regulations:
The key distinction in the relevant regulatory structure and case law in not between prescription and non-prescription drugs but between NDA holders and ANDA holders.
Id. at *4. All of the cases cited by plaintiffs turned on the availability of the CBE process. Since it is undisputed that that process is not available to the generic manufacturer in this case and since all of the claims are premised on either failure to warn or improve the product – they are all dismissed.