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From Health Law Daily, September 1, 2016

Claims that Invokana® maker should have adopted alternative design before seeking FDA approval not preempted

By Pamela C. Maloney, J.D.

A patient’s design defect claim against the manufacturers of a diabetes medication was not preempted to the extent she alleged that the companies should have adopted a safer alternative design before seeking FDA approval of the drug, a federal court in Louisiana ruled. Only the portion of the design defect claim based on post-FDA-approval of the drug was preempted. Thus, the patient was allowed to proceed on her claims for defective design and inadequate warnings (Guidry v. Janssen Pharmaceuticals, Inc., August 29, 2016, Feldman, M.).

In 2013, the patient took Invokana®, part of a new class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which are designed to block the reabsorption of glucose by the kidney, increase glucose excretion, and lower blood glucose levels. Six months later, she was hospitalized with ketoacidosis, acute kidney injury, and acute renal failure. In 2015, the FDA issued a safety announcement stating that SGLT2 inhibitors may lead to ketoacidosis. She filed suit against Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, Johnson & Johnson Services, Inc., Johnson & Johnson Company (collectively, Janssen), and two foreign manufacturers that were dismissed for lack of personal jurisdiction, alleging 10 causes of action under the Louisiana Products Liability Act, common law claims, and state unfair trade practice law violations. On February 17, 2016, the court granted the companies’ motion to dismiss on the grounds that that the non-LPLA claims were barred by the exclusivity provision of the LPLA, and that the LPLA claims were not adequately pleaded (see Products Liability Law Daily’s February 18, 2016 analysis).

Pending before the court was a motion to dismiss for failure to allege sufficient facts to satisfy federal pleading standards and because the patient’s state law claims were preempted by federal law.

Manufacturing defect claim. None of the facts alleged in the complaint suggested that the Invokana ingested by the patient deviated from the specifications or intended design of the drug. Instead, she only claimed that Invokana deviated from performance standards and other identical products because it caused dehydration and osmatic diuresis that forced the kidneys to overwork and eventually fail. These allegations were not sufficient to meet the pleading requirements for a manufacturing defect claim and, therefore, Janssen’s motion to dismiss this claim was granted.

Design defect claim. Although the patient explained at length her theory of how Invokana was defectively designed, she did not offer a specific alternative design that would have prevented her injury. However, she did offer a general theory that Invokana could have been designed to put less strain on the kidneys. Whether she could demonstrate the existence of the availability of such a design raised a question of fact that could only be assessed upon discovery. Thus, even though the court agreed with Janssen’s argument that the mere fact that alternative medications might have different side effects did not validate the patient’s defective design claim, the court concluded that the patient had asserted the minimum level of facts to survive the motion to dismiss.

Adequacy of warnings. Similarly, the patient’s allegations supporting her failure-to-warn claim also contained plausible facts that were sufficient to overcome the Janssen defendants’ motion to dismiss. Citing medical statistics and research that showed an alleged correlation between Invokana and kidney injury or failure, the patient alleged that the defendants intentionally downplayed the seriousness and likelihood of these adverse side effects. In addition, she contended that the defendants promoted the drug to physicians and consumers without adequately disclosing these potential risks. Although Janssen countered that it provided multiple warnings of the adverse side effects associated with the drug, these contentions raised issues of fact that could not be resolved at the pleading stage. Whether the warnings were adequate was a question of fact that could not be resolved under a motion to dismiss.

Preemption. Turning to the defendants’ argument that the patient’s design defect was preempted, the court clarified that the design defect claim was premised on the contention that the drug should have been designed differently. According to the defendants, federal law prohibits a drug manufacturer from changing the chemical composition of a prescription drug without FDA approval. Because it would be impossible for them to change the design of Invokana unilaterally, application of Louisiana tort law would impose a duty that is prohibited by federal law, thus invoking the doctrine of implied conflict preemption.

According to the district court, only the U.S. Court of Appeals for the Sixth Circuit has addressed the exact issue presented here, i.e., whether a patient’s state law defective design claim against a brand-name drug manufacturer was preempted by federal drug regulations. In Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., the Sixth Circuit found that a patient’s state law defective design claim against a brand name drug manufacturer was preempted by federal drug regulations (see Sufferer of known, warned-of side effect finds no relief on appeal, December 14, 2015). The federal court agreed, finding that to the extent the patient’s claim that Janssen should have adopted a new design for Invokana after it was approved by the FDA, her defective design claim was preempted.

However, Yates left unanswered the question of whether the patient’s defective design claim against a brand name drug manufacturer was preempted even on a theory that the manufacturer should have adopted a safer, alternative design before seeking FDA approval.

In response, Janssen argued that preemption specifically applied to the patient’s design defect claims because under the Louisiana Products Liability Act, the relevant question was whether the product was unreasonably dangerous at the time it left the manufacturer’s control. Because prescription drugs could not be sold to the public until after FDA approval, the "unreasonably dangerous" analysis always occurs post-FDA-approval.

The court rejected this view, explaining that the dispositive question in this case was whether a drug manufacturer could independently design a reasonably safe drug in compliance with its state-law duties before seeking FDA approval. Thus, the unreasonably dangerous analysis in the defective design context would occur prior to FDA approval. It was not "too attenuated to assume that the FDA would approve a safer, alternative design of a drug that it has already approved."

In this case, the patient stated in her complaint that Janssen knew Invokana’s design posed an unreasonably dangerous risk of kidney injury before it was approved by the FDA, yet nonetheless sought FDA approval for the drug. Louisiana law imposes a duty on all manufacturers to consider feasible, alternative designs and to weigh the risks and utility of the final product before it left the manufacturer’s control. Federal law does not prevent a drug maker from complying with this state-imposed duty before seeking FDA approval. Thus, in the narrow, pre-FDA approval context, the patient’s design defect claim was not preempted by federal drug law.

The case is Civil Action No. 15-4591.

Attorneys: Richard J. Arsenault (Neblett, Beard & Arsenault) for Gloria Guidry. James B. Irwin, V (Irwin Fritchie Urquhart & Moore, LLC) and John Q. Lewis (Tucker Ellis LLP) for Janssen Pharmaceuticals, Inc., Janssen Ortho LLC, and Janssen Research & Development LLC.

Companies: Janssen Pharmaceuticals, Inc.; Janssen Ortho LLC; Janssen Research & Development LLC; Johnson & Johnson; Mitsubishi Tanabe Pharma Corporation; Mitsubishi Tanabe Pharma Development America, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PreemptionNews PLDrugNews LouisianaNews

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