It has been a while since we’ve written about a case delivering a one-two punch against a plaintiff suing both brand and generic drug manufacturers for alleged injuries from ingesting generic drugs. Punch One is rejection of the claims against the brand manufacturers because they did not make or sell the products at issue in the product liability case. That is, the courts (the sane ones, anyway) turn thumbs down on innovator liability. Punch Two is rejection of failure to warn claims against the generics because, per the SCOTUS Mensing decision, such claims are preempted on the theory that the generic manufacturer was powerless to fiddle with the drug label.

In Johnson. v. Novartis, 2020 WL 2300139 (W.D. Texas May 7, 2020), the court actually delivered a one-two-three punch. The plaintiff had ingested two generic drugs and claimed that they gave him Peyronie’s Disease (PD). He asserted the usual battery of claims (strict liability, negligence, fraud, warranty), as well as a violation of the Texas Deceptive Practices Act. The Johnson court dispensed with the multiplicity of actions and treated the entire case as a products liability claim based on an alleged failure to warn.

    Punch One: Innovator Liability – Brand Name Manufacturers

The two brand name defendants each moved to dismiss the plaintiff’s claims as relying on innovator liability — i.e., claims against a brand name manufacturer for injuries caused by a generic drug. The plaintiff did not ingest the brand name drugs. His claims against the brand manufacturers relied on the other defendants’ generic drugs copying the information from the brand name labels.

Texas law rejects this theory of liability for the simple fact that “products liability law generally requires allegations that the defendant supplied the allegedly defective product to the plaintiff.” In Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674 (5th Cir. 2014), the Fifth Circuit upheld the district court’s dismissal of the plaintiff’s negligence, products liability, and fraud claims against the brand name manufacturers, reasoning that brand name manufacturers do not owe a duty to consumers of generic drugs. The Johnson court followed this ruling and dismissed the plaintiff’s claims against the brand manufacturers.

    Punch Two: Federal Preemption – Generic Manufacturers

The plaintiff’s state law claims against the generic manufacturers were preempted by federal law. This preemption stems from the Supreme Court’s decision in Mensing, which held that federal law preempted state law causes of action related to a generic drug manufacturers failure to warn. PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (holding it impossible for generic manufacturers to abide by state warning laws while also abiding by federal law mandating that they match brand name labels). The Fifth Circuit precedent followed Supreme Court precedent (because that is what lower courts are supposed to do) and interpreted Mensing as preempting Texas law claims such as those the plaintiff asserted in Johnson. The Johnson court followed both the SCOTUS and Fifth Circuit precedents (because that is what lower courts are supposed to do), and held that the plaintiff’s claims against the generic manufacturers based on their alleged failure to warn of the risk of PD were preempted.

    Punch Three: FDA Approval

All the defendants pointed to Texas law’s presumption of no liability for FDA-approved labels. Indeed, Texas Civil Practice & Remedies Code Section 82.007(a)(1) provides that FDA approval “presumptively insulates from liability, for failure to warn, defendants who made, prescribe, or sell drugs in accord with FDA standards.”

Texas law provides five ways this presumption of no liability can be rebutted: (1) “fraud on the FDA”; (2) the product was sold after the FDA ordered the product removed from the market; (3) if the manufacturer promoted the product for a use not approved by the FDA; (4) off-label prescriptions; and (5) bribery of a public official.

The plaintiff in Johnson went the usual route and pleaded the “Fraud on the FDA” exception. Specifically, the plaintiff alleged that the defendants withheld from the FDA information related to the connection between the drugs and PD. But the “Fraud on the FDA” exception is preempted by federal law unless the FDA has found fraud. Thanks again, Buckman. Because the plaintiff could not allege that the FDA had found fraud on behalf of the defendants related to these drugs, this exception was preempted and could not provide the basis for liability.

The plaintiff sought to avail himself of another exception by contending that the defendants “recommended, promoted or advertised” these drugs “for an indication not approved by the [FDA].” But pleading this exception requires alleging that (a) the defendants marketed and promoted the unauthorized use of the drugs to the prescribing doctors, that (b) the plaintiff relied on that specifically promoted use, and that (c) the plaintiff’s injuries were caused by that off-label promotion. And yet the plaintiff in Johnson utterly failed to to allege any facts related to “off-label” marketing. The Johnson court therefore concluded that the plaintiff had not alleged any facts rebutting Texas law’s presumption of no liability resulting from FDA approval.

    Knock-out Punch: No Leave to Amend

Not surprisingly, the plaintiff moved for leave to amend his complaint. Federal Rule of Civil Procedure 15(a) governs amending pleadings, stating that Courts “should freely give leave when justice so requires.” But justice did not so require in Johnson. The plaintiff’s proposed amended complaint did not solve his problems. Instead, he reiterated that he ingested only the generic drugs, and thus his amendment would be futile as to the brand manufacturers. Nor could he get around Mensing preemption as to the generic manufacturers. Nor could he rebut Texas law’s presumption of no liability for drugs approved by the FDA. Accordingly, the Johnson court denied the plaintiff’s motion for leave to amend, and dismissed all of the claims with prejudice.

    Ain’t Gonna Be No Rematch

The Fifth Circuit subsequently affirmed the trial court’s decision, and the Supreme Court recently denied certification and a rehearing. Johnson v. Novartis Pharms. Corp., 845 F. App’x 305, 307 (5th Cir.), cert. denied, 142 S. Ct. 83 (2021), reh’g denied sub nom. JOHNSON, RAMON D. v. NOVARTIS PHARMACEUTICALS, ET AL., No. 20-1572, 2021 WL 5763397 (U.S. Dec. 6, 2021).