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Generic Drug Companies Are Insulated from Liability When They Harm Patients

Posted on in Prescription Drugs

By Lindsay Proskey

Recently, the Seventh Circuit dismissed thousands of claims against Pfizer, the manufacturer of a generic testosterone drug, Depo-T, for inadequately warning consumers that Depo-T increased heart attacks in older men.[1] The consumers' right to relief hinged on Depo-T’s classification as a generic or brand name drug. The Seventh Circuit found the plaintiff’s claims preempted under federal law and barred by Supreme Court precedent, leaving these consumers without recourse. The controlling Supreme Court precedent and outdated FDA rules collectively frustrate state tort laws, impede on consumer rights, prevent injured consumers from judicial relief, and insulate generic drug companies from state product liability law under the guise of preemption.

Federal Preemption

Federal law “preempts” or displaces state law when state and federal law conflict. The doctrine of preemption derives from the Supremacy Clause[2] of the United States Constitution. Upon state ratification, federal law became superior over state law, within the realm of constitutionally delegated authority, thereby granting states the rights and powers “not delegated to the United States.”[3]  Traditionally, states have the power to establish and enforce laws protecting the welfare, safety, and health of the public. Since federal and state governments have both exclusive and concurrent powers, a problem exists when both levels of government regulate the same subject matter. Where preemption applies, federal law trumps state legislatures, courts, administrative agencies, and constitutions. Thus, the Supreme Court accepts the Supremacy Clause as a “basic constitutional command that all conflicting state provisions be without effect.”[4]

Forms of Preemption

Federal law can trump state law through express or implied preemption. To expressly preempt state law, Congress must explicitly state the terms in a statute. The Court has found implied preemption where comprehensive legislation occupies an entire field, or where state laws conflict with or create an obstacle to the accomplishment of federal objectives.

Federal Preemption Over Generics

Currently, federal law requires generic drug companies to maintain matching warning labels to that of its brand name equivalent. This prohibits independent label change irrespective of newly acquired adverse information, exactly opposite federal rights granted brand name companies. Consequently, preemption principles effectively eliminate failure to warn claims against generic drug manufacturers. In 2011, the Supreme Court drew public criticism after a 5-4 Court decision held that federal law preempted all state laws imposing a duty on generic drug companies to change a drug’s warning label. The Court found that the state duty conflicted with the federal requirement that generic warning labels “match” its branded equivalent.[5] Remarkably, the Court received a Brief of Amici Curiae on behalf of 40 states in support of imposing a duty. Additionally, it prompted the FDA’s 2013 proposed rule to allow unilateral generic label changes and if adopted, would eliminate preemption obstacles faced by generic drug consumers. However, the FDA has not taken further action, and the law remains unchanged.

“[A] drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with the brand-name drug or a generic.  If a consumer takes a brand-name drug, she can sue the manufacturer … If, however, she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue...”

PLIVA Inc. v. Mensing, 131 S. Ct. 2567, 2592-93 (2011).

(5-4) (Sotomayor, J., dissenting)

The Seventh Circuit's Recent Decision

To receive FDA approval, a brand name drug is subject to extensive safety and effectiveness testing, unlike a generic, which receives speedy approval by copying the composition and warning label of its brand name equivalent. The brand name drug then becomes the Reference Listed Drug, an approved drug product to which new generic versions are compared to show that they are bioequivalent.[6] A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its application. In this case, the FDA selected Depo-T as the successor Reference Listed Drug for testosterone therapy after its brand name equivalent was discontinued. The plaintiffs argued that federal law required Depo-T to match the warning label of the “Reference Listed Drug,” which in this case was Depo-T’s own label. Depo-T, therefore, would not violate federal law and create inconsistent labeling because its brand name counterpart was no longer on the market. Thus, the court should not find preemption applies to generic successor Reference Listed Drugs. The 7th Circuit stated that Congress, the FDA, and the Supreme Court find meaningful difference in the approval process of brand name and generic drugs, not the status as reference listed. The approval process allowed Depo-T’s bypassing of extensive safety and effectiveness testing by copying the composition and warning label of its brand name counterpart. Unilateral generic drug modifications would undermine the accelerated process that quickens newly developed drugs market access for the benefit of consumers. The court held that this approval process is decisive for federal preemption purposes notwithstanding the drug's status as reference listed.

Contact Our Chicago Product Liability Lawyers

Each year, pharmacies fill more than 2.6 billion generic prescriptions compared to 1.2 brand name.[7] According to the FDA, generic drugs saved consumers $824 billion in the last decade. But this figure fails to account for costs borne by consumers for generic drug injuries. In 2016, the FDA reported 3,783,913 adverse reactions to prescription drugs.[8]  Of these reactions, 766,784 were “serious reactions,” defined as life threatening, hospitalization, disability, congenital anomaly, “other serious”, and required intervention to prevent impairment. Tragically, 105,357 prescription drug reactions resulted in death. The experienced professionals at Tomasik Kotin Kasserman are committed to helping consumers in these cases. Tim Tomasik served on the ABA preemption task force and is committed to protecting consumers from the unfair preemption protection provided generic drug companies. If you or a loved one have experienced an adverse drug reaction resulting in injury or death, call the law offices of TKK at 312-605-8800 or contact us online.

[1] Guilbeau v. Pfizer Inc., 880 F.3d 304 (7th Cir. 2018)
[2] Art. VI, Cl. 2
[3] U. S. Const. amend. X
[4] Maryland v. Louisiana, 451 U. S. 725, 746 (1981)
[5] PLIVA Inc. v. Mensing, 131 S. Ct. 2567 (2011)
[6] https://www.fda.gov/drugs/informationondrugs/ucm079436.htm (last accessed April 23, 2018)
[7] https://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM226568.pdf. (Last accessed April 23, 2018)
[8] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/. (Last accessed April 23, 2018)
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