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From Products Liability Law Daily, July 30, 2013

Inadequate warning labels and monograph claims alleging injuries for long-term usage of metoclopramide survive dismissal motions

By Anthony H. Nguyen, J.D.

Claims alleging injuries from the use of a generic prescription drug were permitted to continue in part because (1) preemption of state law was not apparent; (2) issues of triable fact pertaining to protected speech were still to be determined; (3) privity existed for state consumer protection laws; and (4) allegations were sufficiently pled (Neeley v Wolters Kluwer Health, Inc., July 29, 2013, Ross, J). A consumer of metoclopramide alleged that she suffered injuries over long-term usage of the drug. The district court denied the generic drug manufacturers’ and patient education monograph providers’ motions to dismiss because the current stage of litigation would not resolve factual issues pertaining to preemption and First Amendment defenses. The brand name drug manufacturers’ motion for summary judgment was granted because the injured party could not demonstrate that she consumed a brand-name drug that caused her injuries.

Background. Under 21 U.S.C. sec. 355(j)(2)(A), in order to obtain approval for a generic drug, a manufacturer must generally show that the generic drug is bioequivalent to the brand name drug and has the same active ingredients, route of administration, dosage and strength. Moreover, pharmacies dispensing prescription drugs provide written information, known as patient education monographs (PEM) to customers for each prescription dispensed.

Currently, PEM authors are not regulated by the FDA; instead, PEM authors provide assurances of self-regulation of their conduct as to the form and substance of consumer medical information. As part of these assurances, a guideline was developed and established. Pursuant to the guidelines, pharmacies and PEM authors are to provide PEMs that are (1) scientifically accurate; (2) unbiased in content and tone; (3) sufficiently specific and comprehensive; (4) presented in an understandable and legible format that is readily comprehensible to consumers; (5) timely and up-to-date; and (6) useful, that is, enables the consumer to use the medicine properly and appropriately, receive the maximum benefit, and avoid harm.

In a lawsuit filed against (1) Wyeth, LLC, Wyeth Pharmaceuticals, Inc., and Schwarz Pharma, Inc. (collectively, brand defendants); (2) Barr Laboratories, Inc.; Barr Pharmaceuticals, LLC; Watson Laboratories, Inc., and Watson Pharma, Inc. (generic defendants); and (3) Wolters Kluwer Health, Inc. and Wolters Kluwer United States, Inc. (PEM defendants), Denise Neeley (Neeley) alleged that the defendants failed to update their warnings or monographs relating to the prescription drug Reglan® and its generic version of metoclopramide. Neeley, a Kentucky resident, was prescribed metoclopramide to be taken three times a day to treat her gastroesophageal reflux disease from November 2006 through February 2008. In 2010, Neeley was diagnosed with tardive dyskinesia, a disorder resulting in involuntary, repetitive movements, and alleged to have been caused by her use of metoclopramide.

Neeley alleged various claims against the generic and brand defendants for failing to update drug information and warnings, including labels, package inserts, drug databases and PEMs, distributed to doctors and patients, regarding the safety of metoclopramide for long-term usage. Her claims included actions of negligence, breach of warranty, misrepresentation and fraud, strict product liability, violations of Missouri and Kentucky consumer protection acts, certain liabilities theories, loss of consortium, and damages. She also alleged similar claims against the PEM defendants, asserting that the PEM defendants, as authors and not merely independent publishers, failed to warn of Reglan’s or metoclopramide’s dangers when they published monograph information pertaining to the drug and any potential increased risks.

Claims against generic defendants. The generic defendants moved to have the matter dismissed for lack of jurisdiction arguing that they committed no acts in Missouri that would give rise to Neeley’s alleged injuries. Additionally, the generic defendants contended that the U.S. Supreme Court’s decision in Pliva v Mensing (131 S.Ct. 2567 (2011)) preempted Neeley’s failure to warn claims and that her claims for negligence that encompassed more than just failure to warn claims were barred because they were based upon federal law and no private cause of action existed for such under 21 U.S.C. sec. 337.

Although the district court agreed that it did not have specific jurisdiction over the claims, it held that the generic defendants had sufficient contact with the state of Missouri to establish general jurisdiction. One generic defendant distributed metoclopramide that was manufactured by a generic defendant in the state of Missouri. Additionally, the generic defendants were all registered to do business in the state. The court held that at this stage of litigation Neeley had demonstrated that the generic defendants had sufficient “continuous and systematic” contacts with Missouri for general jurisdiction to apply.

Preemption. In Pliva v Mensing, the Supreme Court held that FDA regulations only permitted changes to generic drug labels when a generic drug manufacturer changed the label (1) to match an updated brand-name label or (2) to follow the FDA’s instructions. However, in rejecting the generic defendants’ preemption arguments, the district court distinguished Neeley’s claims from the determination in Mensing. The court noted that the generic defendants failed to include the following language: “Therapy should not exceed 12 weeks in duration” from the updated 2004 Reglan label. Moreover, the generic defendants failed to conform their own labels to the 2004 FDA-mandated label change. The court found that Neeley’s claims could be distinguished from the analysis in Mensing because her claims were based on violation of state duty when the generic defendants failed to update the metoclopramide warnings. Thus, Neeley’s claims were not attempts to enforce violations of the Food, Drug and Cosmetic Act.

The district court also declined to bar Neeley’s design defect claims. Under 21 U.S.C. sec. 352(j), a manufacturer must pull an FDA-approved drug from the market when it is dangerous to health even if used in the prescribed manner. In Kentucky, defective design claims focus on consumer expectations. As such, the claims were not preempted because it was not immediately clear whether Kentucky offered generic drug manufacturers an opportunity, consistent with federal obligations, to somehow alter an otherwise unreasonably dangerous drug.

Claims against PEM defendants. The PEM defendants argued that Neeley’s allegations stemmed from constitutionally protected speech. The PEM defendants asserted that the First Amendment precluded tort liability against publishers for non-defamatory and non-commercial speech. Moreover, the defendants argued that under Kentucky law, no duty was owed as they were publishers of general information. The defendants also argued that the monograph for metoclopramide could not establish liability, nor did the PEM defendants have a relationship with Neeley in order to support the negligence or warranty claims.

The PEM defendants argued that they had no legal duty to the readers of PEM pamphlets such as Neeley because they had no relationship to readers as mere publishers of the monograph. The guidelines did not describe a set of rules for any specific warnings that needed to be included in a PEM. In denying the PEM defendants’ motion to dismiss, the district court noted that the PEM defendants did not provide any Missouri or Kentucky authority declining to find a duty on behalf of the PEM defendants; the PEM defendants instead relied upon out-of-state cases decided on different grounds or standards. Although the PEM defendants did not have a direct relationship with Neeley, the court found that Neeley had sufficiently stated a duty owed to her because she was a foreseeable recipient of information.

Moreover, the court found a factual dispute regarding the First Amendment protection claimed by the PEM defendants. It was unclear to the court whether the PEM defendants were publishers or authors; the PEM defendants’ supporting case law did not mandate that the motion to dismiss be granted on First Amendment grounds. Likewise, the court declined to dismiss Neeley’s claims on statute of limitations grounds because the determination of when Neeley’s causes of action began to accrue was an issue of fact for a jury to decide.

State laws. The district court dismissed Neeley’s claims that the PEM defendants violated Missouri consumer protection laws because the PEM defendants’ activities had no connection to the state of Missouri. Claims arising under Kentucky consumer protection law could be maintained, however, because privity existed between Neeley and the PEM defendants. The Kentucky consumer protection law only required that Neeley prove she suffered an ascertainable loss that was the result of allegedly deceitful practice. The court found that the PEM defendants’ actions fell within the scope of activities to be protected against by the Kentucky law and that Neeley was the intended beneficiary of that protection.

Claims against brand defendants. The court found that Kentucky law mandated product identification before liability could be ascribed against the brand defendants. The threshold requirement for a product liability plaintiff in Kentucky was proof that the defendant’s product caused the plaintiff’s injury. Neeley did not take the branded version of metoclopramide, Reglan, and thus to impose a duty on the brand defendants would stretch the concept of foreseeability under the Kentucky consumer protection law too far. Neeley’s public policy argument was of no avail to her as it was not in the court’s province to dictate public policy. The court granted the brand defendants’ motion for summary judgment.

Other claims. Neeley’s claims contending that all defendants acted in concert to design and manufacture Reglan/metoclopramide and conceal dangerous side effects were dismissed because she did not provide evidence that an agreement existed between the defendants.

The generic, brand, and PEM defendants also argued that barring other motions and defenses, Neeley failed to allege sufficient facts to meet the pleading requirements under Fed.R.Civ.P. 8(a)(2). The court disagreed noting that Neeley provided numerous pharmacy records that outlined her use of metoclopramide. Neeley’s allegations that the drug information was false and misleading and caused her to ingest metoclopramide for longer than 12 weeks was pled with sufficient particularity for the Kentucky consumer protection law. However, the action based on Missouri law had to be dismissed because of lack of connection to the state of Missouri.

The case number is 4:11-CV-325 JAR.

Attorneys: Lawrence L. Jones, II (Jones Ward PLC) for Dessie Neeley and Harold Neeley. Sandra Jane Wunderlich (Stinson and Morrison) for Watson Pharma, Inc. James W. Childress (Childress and Ahlheim, LLC) for Wolters Kluwer Health, Inc. and Wolters Kluwer U.S. Corporation. Beth A. Bauer (Hepler Broom) for Wyeth, Inc. and Wyeth Pharmaceuticals. Andrew J. Calica (Mayer Brown) for Schwarz Pharma, Inc. Jacqueline R. Sheridan (Ulmer and Berne LLP) for Barr Pharmaceuticals, Inc., Barr Laboratories, Inc., and Watson Laboratories, Inc.

Companies: Watson Pharma, Inc.; Wolters Kluwer Health, Inc.; Wolters Kluwer U.S. Corporation; Wyeth, Inc.; Wyeth Pharmaceuticals; Schwarz Pharma, Inc.; Barr Pharmaceuticals, Inc.; Barr Laboratories, Inc.; Watson Laboratories, Inc.

MainStory: TopStory PreemptionNews WarningsNews JurisdictionNews DrugsNews MissouriNews

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