Health Law Daily Preemption wont spare Genentech from biologic lawsuit
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Monday, June 1, 2020

Preemption wont spare Genentech from biologic lawsuit

By Jeffrey H. Brochin, J.D.

District court erred in granting summary judgment to a cancer drug manufacturer based on the doctrines of obstacle pre-emption and impossibility pre-emption, where neither applied in the case of the labeling of drug concentrations for a biologic.

A federal appeals court in Oklahoma has reversed the trial court’s grant of summary judgment to Genentech, Inc., (Genentech) manufacturer of the cancer treatment drug Herceptin, after determining that nothing in the federal regulatory scheme required the FDA to ensure that Genentech’s proposed label for Herceptin fully complied with all of the statements contained in the Biologic License Application (BLA). Additionally, the court held, nothing in the federal regulatory scheme required the FDA to police Genentech’s distribution practices and ensure that the amount of Herceptin per vial complied with the product label or with federal regulations (Tulsa Cancer Institute, PLLC v. Genentech, Inc., May 29, 2020, Briscoe, J.).

Complaints over fill weight. Genentech manufactured Herceptin from the cells of a Chinese hamster ovary (CHO) cell line that were genetically modified to produce trastuzumab, the active ingredient. The trastuzumab is ultimately harvested from the CHO cells and the resulting protein solution is referred to as the "drug substance." It is freeze dried into a cake comprised of the dry solid protein and some inactive ingredients. The vials are then sealed, and because the drug substance protein concentration and fill weight vary to some degree from batch to batch, the result is that the weight of the Herceptin cake in each multi-dose vial also varies to some degree in a range around 440 mg. The FDA-approved content specification for each multi-dose vial of Herceptin is 440 mg ± 35 mg, resulting in an FDA-approved range of 405 to 475 mg per multi-dose vial. When a vial of Herceptin is shipped to a health care provider, the Herceptin cake inside of the vial must be reconstituted before the drug can be administered to patients.

In 2014, the FDA received complaints from various health providers regarding their inability of providers to withdraw the requisite volume of the drug from each vial of Herceptin. In October, 2014, the FDA noted that the original BLA stated that the vial contained 440 mg of trastuzumab, but after reconstitution, the vial allowed for recovery of 400 mg of drug product.

District court summary judgment. A group of fourteen cancer treatment providers filed suit over the discrepancy between the drug’s label and the amount derived from the reconstituted vial contents, and their cases were consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Northern District of Oklahoma. The trial court granted summary judgment to Genentech after finding both obstacle pre-emption and impossibility pre-emption as bars to the plaintiffs’ claims of mislabeling. The instant appeal followed.

PHSA and FDA approvals. The appeals court noted that Congress, by way of the Public Health Service Act (PHSA), expressly regulates biological products such as Herceptin, and that the PHSA directs the HHS Secretary to oversee the approval of biologic licenses, and outlines the standards for the approval of such licenses, and HHS in turn, has delegated that authority to the FDA. Consequently, a manufacturer of a biologic must file, with the FDA, a BLA, and FDA approval of a BLA constitutes a determination that the product meets applicable requirements to ensure safety, purity, and potency.

No express pre-emption. It was undisputed that Congress did not include an express pre-emption provision in either the PHSA or the federal Food, Drug, and Cosmetic Act (FDC Act). Furthermore, there was no assertion by Genentech that Congress intended the federal government to exclusively occupy the field of prescription drugs in general, or biologics in particular. That left only the issues of obstacle pre-emption and impossibility pre-emption to be considered by the appeals court. However, for those pre-emptions too, the appeals court found that Genentech failed to establish that either of those doctrines applied to the plaintiffs’ claims.

No label policing by the FDA. The court again examined congressional intent, and found that Congress did not intend the FDA—whose primary job is to ensure drug safety and effectiveness—to have sole authority to police drug companies’ compliance with commercial terms and promises. Nothing in the federal regulatory scheme required the FDA to ensure that Genentech’s proposed label for Herceptin fully complied with all of the statements contained in the BLA. Further, nothing in the federal regulatory scheme required the FDA to police Genentech’s distribution practices and ensure that the amount of Herceptin per vial complied with the product label or with federal regulations. Although the FDA establishes general labeling standards, it does not appear to routinely police manufacturers afterwards to ensure that they are fully complying with those standards, and that leaves room for states to impose their own requirements, so long as those requirements do not conflict with the federal regulatory scheme.

Based on the foregoing, the appeals court ruled that neither obstacle pre-emption nor impossibility pre-emption applied in the case, and the district court therefore erred in granting summary judgment to Genentech. The decision was reversed and the case remanded.

The case is No. 19-5035.

Attorneys: Adam C. Doverspike (Gable & Gotwals) for Tulsa Cancer Institute, PLLC n/k/a Oklahoma Cancer Specialists Management Co., LLC., Oklahoma Oncology & Hematology, Inc. d/b/a Cancer Care Associates., State of Oklahoma., Florida Cancer Specialists, P.L., Hematology-Oncology Associates of Central New York, PC and Tennessee Oncology, PLLC. Alicia Jane Donahue (Shook Hardy & Bacon LLP) for Genentech, Inc.

Companies: Tulsa Cancer Institute, PLLC n/k/a Oklahoma Cancer Specialists Management Co., LLC; Oklahoma Oncology & Hematology, Inc. d/b/a Cancer Care Associates; Hematology-Oncology Associates of Central New York, PC; Florida Cancer Specialists, P.L.; Tennessee Oncology, PLLC; Genentech, Inc.; Roche Holding AG; Roche Holding Ltd.; Roche Holdings, Inc.

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