News

In response to a request from the U.S. District Court for the Northern District of Florida, CCL today submitted a legal memorandum in Pye v. Fifth Generation, Inc. distinguishing misrepresentation claims brought against the manufacturers of Tito’s Handmade Vodka, based on the product’s claim to be “Handmade,” from similar claims against the makers of Maker’s Mark Bourbon. District Court Judge Robert Hinkle had recently dismissed such claims against Maker’s Mark and asked plaintiffs to explain why the same reasoning shouldn’t lead to dismissal of their claims. In its memorandum, CCL Chief Litigation Counsel Louis Bograd explained that there were important factual distinctions between the two cases, which have already led at least one other court to uphold misrepresentation claims against Tito’s Vodka. In particular, the Maker’s Mark bottle gives content to its claim to be “Handmade” by explaining that it was distilled in small batches under close supervision, assertions that plaintiffs in the Maker’s Mark case had not disputed. By contrast, the Tito’s Vodka label claims suggests that it is “Handmade” because it is “Crafted in an Old Fashioned Pot Still,” but plaintiffs allege that that representation is also false and misleading. Thus, a reasonable consumer may be misled by the claim on Tito’s label to be handmade, even if a consumer of Maker’s Mark cannot be.

This week, the Supreme Court denied a petition for writ of certiorari in Teva Pharmaceuticals, USA v. Hassett, the last in a series of petitions by generic drug companies seeking Supreme Court review of lower court decisions permitting plaintiffs to pursue products liability claims against manufacturers of generic metoclopramide, on the grounds that such claims were preempted under Pliva, Inc. v. Mensing. CCL Chief Litigation Counsel Louis Bograd opposed each of these petitions, asserting that the lower courts properly held that plaintiffs’ claims fell into exceptions from Mensing preemption because, under the facts in each case, it would not have been impossible for the generic manufacturer to have provided stronger warnings about the risks of long-term use of metoclopramide to plaintiffs and their prescribing physicians at the time metoclopramide was prescribed to the plaintiffs. Hassett is the fourth and final pending petition for certiorari in such circumstances that the Supreme Court has declined to hear. In each of these cases, plaintiffs may now proceed with their claims before state courts.

In a case argued by CCL’s Andre M. Mura, a federal district court in Florida refused to dismiss a class action complaint seeking damages for deceptive food labeling. The case concerns Wal-Mart’s Great Value “100% Cranberry Pomegranate” juice blend, which contains far less cranberry or pomegranate juice than labeling suggests. Wal-Mart argued that the suit was preempted because its labeling complied with federal law, and it sought dismissal because, it said, plaintiffs lacked standing. The district court here agreed with plaintiffs that their suit is not preempted and that they have standing to sue. The 37-page ruling, issued on April 23, is highly detailed in its analysis of preemption in this context, and is a great precedent for plaintiffs.

Plaintiffs are also represented by Tim Howard of Howard & Associates, PA of Tallahassee, Florida.

The Center for Constitutional Litigation today filed a brief in the United States Supreme Court in opposition to the petition for a writ of certiorari filed by Teva Pharmaceuticals USA and Pliva, Inc. in Teva Pharmaceuticals USA, Inc. and Pliva, Inc. v. Hassett, the third cert petition to arise out of the mass tort litigation in Philadelphia on behalf of persons injured by generic metoclopramide, In re Reglan/Metoclopramide Litigation.

In Pliva, Inc. v. Mensing, the Supreme Court ruled that federal food and drug law preempts state tort claims against generic drug manufacturers where federal law prohibits a drug company from complying with its duties under state law. Despite this clear holding, generic drug companies have argued that Mensing is a “get out of jail free” card for all state tort claims against them, even claims involving state law duties that do not conflict with federal requirements. Numerous courts, including the Pennsylvania Superior Court here, have rejected these arguments. Generic drug companies have now sought Supreme Court review of these rulings on four separate occasions. CCL has consistently opposed these efforts on behalf of persons injured by dangerous generic drugs. In the brief filed today in opposition to the petition for certiorari in Hassett, CCL Chief Litigation Counsel Louis Bograd argues, inter alia, that the Supreme Court lacks jurisdiction to review an interlocutory decision by the Pennsylvania state courts; that there is no split of appellate authority warranting the Supreme Court’s intervention; that the FDA has expressly rejected Teva and Pliva’s arguments and that the agency’s position is entitled to deference; and that, for numerous reasons, the Hassett case would be a poor vehicle for Supreme Court consideration of the questions presented. Bograd was assisted on the brief by CCL’s Jeffrey White. The Supreme Court will decide whether to grant the petition and hear this case near the end of May.

On Monday, March 23, the Supreme Court denied generic drug company Morton Grove Pharmaceuticals' petition for certiorari in Morton Grove v. Adams, an appeal arising out of the In re Reglan/metoclopramide Cases, mass tort proceedings in Philadelphia. CCL Chief Litigation Counsel Louis Bograd represented Plaintiff-Respondent Adams before the Court. Reuters covered the denial here. 

The Pennsylvania Superior Court had ruled that Adams' product liability claims against Morton Grove for injuries caused by long-term use of its metoclopramide syrup were not preempted, because Morton Grove, as the manufacturer of the Reference Listed Drug for metoclopramide syrup, could have strengthened the warnings on its product without prior FDA approval. Morton Grove contended that that ruling was in error because, as a generic drug company, claims against it were preempted under the Supreme Court decision in Pliva Inc. v. Mensing. This was incorrect, Bograd explained, because the test for preemption under Mensing is impossibility, whether federal law prohibited the company from doing what state law required. It was not impossible for Morton Grove to strengthen its warnings because, as the RLD, it could not violate the duty to match RLD labeling, which was the basis for the preemption ruling in Mensing. 

The case will now return to the Pennsylvania state courts for further proceedings.

CCL, on behalf of respondent Theresa Huck, recently opposed the filing of an amicus brief in support of a petition for certiorari in Pliva, Inc. v. Huck. The amicus brief was submitted on behalf of the Generic Pharmaceutical Association (GPhA) by the law firm of Ulmer & Berne. Although CCL normally, as a matter of professional courtesy, does not object to reasonable requests to appear as amicus curiae, CCL opposed this request because the law firm that filed the amicus brief also represents the petitioner, Pliva, Inc., in this and related cases. CCL therefore believes that the submission of this amicus brief violates Supreme Court rule 37.6, which requires amici to certify whether counsel for a party authored the amicus brief in whole or in part. GPhA asserted in its proposed brief that “no counsel for a party in this Court wrote this brief in whole or in part.” The “in this Court” language departed from the usual Rule 37.6 language. CCL contends that this representation was false, given Ulmer & Berne’s representation of the petitioner, and therefore opposed submission of the amicus brief in support of the petition.

On February 23^rd, CCL filed a brief in the U.S. Supreme Court to oppose to the petition for a writ of certiorari in Pliva, Inc. v. Huck, No. 14-544, on behalf of the plaintiffs. The case involves a failure-to-warn claim against the manufacturer of generic metoclopramide based on its failure to provide a warning against longterm use of the drug that had already been approved by the FDA. The Iowa Supreme Court recognized that such a claim escaped federal preemption under the reasoning of Fulgenzi v. Pliva, Inc., 711 F.3d 578 (6th Cir. 2013), another case that CCL handled. The failure to provide the updated warning that the name-brand manufacturer utilizes takes the case outside the scope of Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011), where the Supreme Court ruled it impossible for the generic manufacturer to update warnings on its own. Pliva petitioned for Supreme Court review, contending that plaintiff’s claim was impliedly preempted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), as an attempt at private enforcement of the FDCA. The brief was written by CCL Chief Counsel Lou Bograd on behalf of Theresa Huck and argued that that question Pliva put forth was not actually presented in this case, that the question actually decided by the Iowa Supreme Court had already been answered by the U.S. Supreme Court, that the FDA had rejected Pliva’s interpretation of federal regulatory requirements, and that the issue—which largely affects a single company—would largely be mooted by a new labeling regulation proposed by the FDA.

On January 15, CCL’s Andre M. Mura argued in federal district court in Florida on behalf of consumers who purchased multiple-juice products sold by Wal-Mart. In this suit, filed as a class action, consumers argue that Wal-Mart’s juice labeling is false and misleading in violation of Florida law, because the products are being advertised as 100% Cranberry Pomegranate when in reality they consist primarily of white grape juice and apple juice. Wal-Mart moved to dismiss the suit, arguing that federal law immunizes it from all liability under state law even if its labels mislead, and even if its labeling does not comply with federal law. The district court held a hearing on the motion, which lasted nearly two hours. Appearing alongside co-counsel Tim Howard and Ankur Mehta of Howard and Associates, P.A, Andre M. Mura explained why this consumer suit is actionable, that federal law does not preempt the field, and urged the district court to deny Wal-Mart’s motion. A ruling is expected shortly.

The Appellate Division of the New Jersey Superior Court handed down its decision today in an interlocutory appeal from a ruling denying generic drug manufacturers’ motions to dismiss certain failure to warn claims in the consolidated Reglan/metoclopramide mass tort litigation in that state. In In re: Reglan Litigation, an appeal argued by CCL Chief Litigation Counsel Louis Bograd, the appellate court unanimously affirmed trial court rulings that failure to warn claims based upon the generic defendants’ failure to timely update their product labeling to reflect new warnings approved by the FDA for the brand Reglan label are not preempted by federal law governing generic drugs, distinguishing Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011).

The Court found persuasive and adopted the reasoning of the U.S. Court of Appeals for the Sixth Circuit in Fulgenzi v. Pliva, Inc., 711 F.3d 578 (6th Cir. 2013), another appeal handled by CCL.  In Mensing, the Supreme Court found failure to warn lawsuits preempted by a 5-4 vote, because it determined that it was impossible for the generic manufacturers to make label changes without FDA approval, a disability that is not true of brand-name manufacturers. However, in Fulgenzi and the new New Jersey decision, the situation was quite different. Generic manufacturers are not prohibited from making changes that have already been approved by the FDA and, in fact, are required to mimic the labeling used by the name-brand product. Thus, the New Jersey court held that “plaintiffs' claims based on the Generic Defendants' failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.”

On October 15, CCL Chief Litigation Counsel Louis Bograd appeared in New Jersey Superior Court, Appellate Division, in Newark to argue for affirmance of an order denying motions to dismiss or for summary judgment in the consolidated In re Reglan Litigation. In both May 2012 and May 2013, Judge Carol Higbee, who was in charge of the consolidated litigation, denied dispositive motions filed by numerous manufacturers of generic metoclopramide on grounds of federal preemption. Judge Higbee ruled that generic drug manufacturers that had not revised their labeling to include warnings approved by the FDA for the Reglan label in 2004 were subject to failure-to-warn claims and that such claims were not preempted. Defendants successfully applied for interlocutory review of those orders, claiming that the trial court’s rulings were incorrect under Buckman Co. v. Plaintiffs’ Legal Committee. CCL Attorney Bograd explained to the Appellate Division that defendants’ arguments were based on a false characterization of plaintiffs’ claims: Plaintiffs were not suing because the labeling on generic metoclopramide violated the federal duty of “sameness” (that the labeling match that of Reglan), but rather for violation of the state law duty to provide consumers of the drugs, and their doctors, with adequate warnings of metoclopramide’s risks. A decision is expected within a few months.