Making its presence felt as an early contender for a 2019 Top Ten DDL case, it's In re: Genentech, Inc., Herceptin (Trastuzumab) Marketing and Sales Practices Litigation, 2019 WL 1284176 (N.D. Okla. Mar. 20, 2019). The challengers came in swinging, but they were no match for federal preemption. Down go plaintiffs! (We hear that in Howard Cosell's voice, but you do you).
Plaintiffs, cancer treatment providers, brought economic loss claims under California law against the manufacturer of a biologic used in the treatment of breast cancer. There is no allegation that the biologic product is ineffective or unsafe. Plaintiffs' sole claim is that not every vial of the product contained the same weight. Id. at *1. Briefly, the biologic goes through a freeze-drying process so that the end product is a dry solid protein in a vial. Each vial is accompanied by a vial of sterile water used to reconstitute the product back to a liquid which can then be injected. Id. at *2-3.
Before a biologic can go to market, the FDA must approve its biologic license application ("BLA"). The BLA "contains specifications for the product, which establish criteria for determining whether each lot of the biologic satisfactorily conforms to the drug product, as approved by the FDA." Id. at *1. Sound familiar? Think PMA. A biologic's labeling also has to conform to federal law, including that it not be false or misleading, and prior FDA approval is "usually required" for labeling changes. Id. at *2.
The labeling for Herceptin, as approved by the FDA in 1998 and re-approved more than 10 times since, provides that each vial of Herceptin "nominally" contain 440 mg of the solid powder. The BLA specifications for Herceptin, also approved by the FDA, provide that each vial contain 440 mg ± 35 mg. In other words, there is an allowable variability in weight permitted by the FDA. The undisputed facts of the case are that Herceptin levels were always within the FDA-approved range. Id. at *3-4.
Despite being fully FDA-compliant, Plaintiffs' brought breach of warranty and consumer protection claims premised on allegations that the product's labeling was inaccurate because the vials did not contain at least 440 mg. Essentially plaintiffs were trying either to force a change in the amount of product contained in each vial by requiring defendant to change its manufacturing process, to force a label change as to the stated concentration, or to force defendant to stop selling vials that have less than 440 mg. No matter how you slice it, their claims are preempted.
Plaintiffs' first argument was an attempt to eliminate FDA's "reasonable variation" regulations. Package size, weight or number, must be on all food and drug labels. The federal regulations, however, permit "reasonable variations caused by loss or gain of moisture . . . or by unavoidable deviations in good manufacturing practice." Id. at *7 (citing 21 C.F.R. §201.51(g). Therefore, plaintiffs' claim requiring each vial of Herceptin to contain a minimum of 440 mg directly conflicts with express federal law. Id. at *8.
Plaintiffs next tried to argue that Herceptin should be considered a liquid drug rather than a solid because the weight requirements for prescription drugs vary depending on how the drug is supplied. Herceptin is classified by the FDA as a "dry solid," therefore its label "shall be considered to express the accurate net weight" subject to allowable variations. Id. This differs from the requirement for liquid drugs whose labeling must state the "minimum quantity." Id. So while the requirements for liquids fit better with plaintiffs' arguments, plaintiffs can't just change the category of the product from solid to liquid on their own say so. The entire regulatory history of the product confirms that the FDA has always considered and treated Herceptin as a solid.
Plaintiffs' next argument was an attempt to retroactively apply a draft FDA Guidance. In 2014, the FDA published a Draft Guidance providing "that the labeling of all injectable products, including those reconstituted from a solid, must reflect the minimum quantity of drug product that can be withdrawn from the vial." Id. at *9. But that wasn't the law from 1998 to 2014. "[F]rom a legal standpoint, Guidances are prospective in nature absent a contrary instruction from the FDA." Id. In fact, this Draft Guidance stated "when finalized, [it] will represent the [FDA's] current thinking on this topic, it does not create or confer any right for or on any person and does not operate to bind FDA or the public." Id. at *12 n.10.
Nor can plaintiffs treat a compliant product as "adulterated" by applying FDA requirements differently than the FDA. As stated above, it is undisputed that Herceptin 440 mg vials have always contained between 405 mg and 475 mg of the biologic, the FDA approved range of variation. But plaintiffs tried to argue, relying on FDC Compliance Policy Guide §420.100, that Herceptin was adulterated because "its strength differs from . . . that which it purports or is represented to possess." Id. at *10. But that section also provides that a drug's quality standards can be determined from the labeling. The FDA-approved labeling for Herceptin has always stated the each vial "nominally" contains 440 mg. Plaintiffs' can't read into FDA regulations a requirement that the label contain "exactly" 440 mg when the FDA has itself not imposed such a requirement. Id.
For all of the above reasons, the court determined plaintiffs' claims were barred by obstacle preemption. If that was enough to put plaintiffs on the ropes, impossibility preemption dealt the fatal blow. To comply with plaintiffs' demand for a weight of "at least" 440 mg per vial, defendant would have to change its manufacturing process – a process that is specified in the BLA and which therefore requires prior FDA approval of any changes. Id. at *11. If defendant couldn't change the product, Plaintiffs' alternative demand was that defendant change the label to state the "accurate" concentration for the reconstituted biologic (as defined by plaintiffs). But a change in concentration on the label would also require FDA approval because it relates to "strength and potency" which affect "safety or effectiveness." Id. Defendant could not comply with plaintiffs' state-law claims and not run afoul of FDA regulations.
Finally, in the first application of Mensing/Bartlett preemption to a biologic, the court dismissed plaintiffs' stop-selling claims. If defendant couldn't change the product or the label, plaintiffs contended that it could comply with state law by simply not selling any vials containing less than 440 mg – something defendant was expressly allowed to do under federal law. The court quoted heavily from Bartlett in concluding that "Genentech cannot be forced to stop selling its vials that comply with FDA requirements in order to avoid liability under state claims." Id. at *12.
Summary judgment across the board in favor of defendant. That's the DDL blog "telling it like it is."
This article is presented for informational purposes only and is not intended to constitute legal advice.
