In the 59-page published opinion, the three-judge appellate panel found that the claims ran parallel to regulations under the Food, Drug and Cosmetic Act, not in conflict to them, and that Genentech had failed to show that it would have been impossible to comply with the plaintiffs’ request without approval from the Food and Drug Administration.
In the case, which was consolidated into a multidistrict litigation from 14 separate actions, a group of cancer treatment providers allege that while the labeling of Herceptin states that it can produce up440 milligrams of its active ingredient, trastuzumab, when reconstituted, in practice it produces substantially less.
Last year, the Oklahoma federal court hearing the case granted summary judgment to Genentech, finding that as a “solid drug,” the medication could be packaged and sold with variations allowed for things like loss or gain of moisture and other packaging and distribution issues. As such, the district court found that requiring Genentech to ensure that each package had a minimum of 440 milligrams of the drug conflicted with federal law.
But the Tenth Circuit on Friday ruled that Herceptin is considered a liquid drug under federal law. According to the opinion, the FDA’s regulations include the phrase “intended for injection” in reference to liquid — but not solid — drugs, so despite being distributed in a solid block to be reconstituted by physicians, Herceptin is a liquid drug because its use is via injection.
Liquid drug manufacturers are required to label their packages to express the minimum amount in the package, according to the opinion, which puts the regulation directly in line with the claims made by the plaintiffs in the MDL, and not an obstacle to federal regulations.
The Tenth Circuit also shot down Genentech’s arguments that it would be impossible to comply with both the state law claims in the cases and federal regulation because it could not change the manufacturing process of Herceptin without FDA approval.
In Friday’s opinion, the court noted that the FDCA does not include an express preemption, but could be preempted in a case such as this under the obstacle preemption and impossibility preemption doctrines.
Under the obstacle doctrine, state law is preempted when it conflicts with federal law. In this case, the district court found that the state law claim that that the packaging must reflect the minimum amount in the package conflicted with federal law allowing for variation in the amount. Meanwhile, under the impossibility doctrine, state law claims are preempted if a company can’t comply with both state law claims and federal regulations.
In this case, the district court had sided with Genentech when it argued that it couldn’t comply with the plaintiffs’ claims without getting approval from the FDA to change how it makes the drug.
The panel wrote that between 1998 and 2009, Genentech did ship the drug with an average fill that met or exceeded 440 milligrams, and the average only dipped below 440 milligrams starting in 2010.
According to the opinion, evidence and testimony in the case suggests that Genentech either intentionally or knowingly allowed the average amount of medicine to decline, and thus would be able to ensure each package contained the amount on the label if it went back to its pre-2010manufacturing practices.
The Tenth Circuit further noted that Genentech failed to explain why it did not need FDA approval to allow the amount of Herceptin in each package to decline, but would need the agency’s approval to increase it back to the levels it had been before 2010.
“We’re pleased the Tenth Circuit recognized that implied preemption, in all its forms, must be applied narrowly and only in situations where it is absolutely clear that Congress intended to foreclose state law claims,” Matthew W.H. Wessler of Gupta Wessler PLLC, representing the plaintiffs, told Law360on Friday. “We look forward to continuing to litigate this important case on behalf of our clients.”
“Genentech’s preemption arguments were a case of smoke and mirrors, supported neither by the Supreme Court’s precedent nor the facts of the case,” Tara Tabatabaie of Fulmer Sill PLC, also representing the plaintiffs, told Law360 on Friday.
James D. Sill, also of Fulmer Sill, added he looks forward to moving the case forward toward class certification in district court.
“The well-reasoned opinion speaks for itself,” he said. “Facts supporting certification are compelling, and we look forward to a trial on the merits for the class in 2021.”
Representatives for Genentech could not immediately be reached for comment Friday. U.S. Circuit Judges Mary Briscoe, Carolyn McHugh and Nancy Moritz sat on the panel for the Tenth Circuit.
The plaintiffs are represented by Matthew W.H. Wessler of Gupta Wessler PLLC, David L. Bryant,Amelia A. Fogleman, Steven J. Adams, Adam C. Doverspike and James Wesley Scott Pebsworth of GableGotwals, James D. Sill, Matthew J. Sill, Kathryn Eidson Griffin, Tara Tabatabaie and Christopher J. Bergin and Simone Fulmer of Fulmer Sill PLC, and Janaki Hannah Nair of Elias Meginnes & Seghetti PC.
Genentech is represented by Alicia J. Donahue and James P. Muehlberger of Shook Hardy & BaconLLP, Paul W. Schmidt and Emily Ullman of Covington & Burling LLP and William W. O’Connor of HallEstill Hardwick Gable Golden & Nelson PC.
The case is In re: MDL 2700 Genentech, case number 19-5035, in the U.S. Court of Appeals for theTenth Circuit.
–Editing by Alanna Weissman
In the case, which was consolidated into a multidistrict litigation from 14 separate actions, a group of cancer treatment providers allege that while the labeling of Herceptin states that it can produce up440 milligrams of its active ingredient, trastuzumab, when reconstituted, in practice it produces substantially less.