Category Archives: Litigation

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Judge Overseeing Opioid Lawsuits Takes Unorthodox Approach

Ohio Judge Dan A. Polster, who is handling the multi-district opioid litigation proceedings, is taking a very active hand in the management of the proceedings before him, the New York Times reports.  His methods are unorthodox: calling for minimal discovery, rapid settlement (if possible), and real-world solutions to “clean up this mess.”  Judge Polster’s distinctive … Continue Reading

Preparing for the Opioid Litigation Epidemic

One of the newer symptoms of this so-called “Opioid Epidemic,” is a rash of litigation targeting pharmaceutical manufacturers and distributors. Currently, there are actions underway in Texas, West Virginia, Alabama, Ohio, Mississippi, South Carolina, Kentucky, Washington, Illinois, California, New York and more new suits are being filed. In each of these claims, specific acts and … Continue Reading

Cattle Groups Sue USDA to Compel Country of Origin Labeling (COOL); Launching Newest Standoff in Longstanding COOL Dispute

Two groups representing U.S. cattle producers recently brought suit against the United States Department of Agriculture (USDA) based on the agency’s March 2016 decision to revoke regulations requiring that beef and pork products be labeled with their country of origin.  According to the plaintiffs, Ranchers-Cattlemen Action Legal Fund and Cattle Producers of Washington, USDA’s decision … Continue Reading

Dietary Supplement Advertising

Did you know Kelley Drye’s Advertising Law practice produces a newsletter, Dietary Supplement Advertising, to help marketers of dietary supplements stay out in front of regulatory challenges. Click here to access our Publication Sign Up and select Dietary Supplements to subscribe. Find contents from the latest issue below: Click here to view with images. STATE REGULATION State AGs and the New Administration … Continue Reading

Coalition Challenges National Marine Fisheries Service Rules for Regulating Offshore Aquaculture in the Gulf of Mexico

On February 12th, a coalition led by the Center for Food Safety filed suit in the U.S. District Court for the Eastern District of Louisiana challenging the National Marine Fisheries Service’s (“NMFS”) final rule implementing the Fishery Management Plan for Regulating Offshore Aquaculture in the Gulf of Mexico (“FMP”). The rule is the first FMP … Continue Reading

WLF Working Paper Assesses Ninth Circuit Preemption Decision

In Reid v. Johnson & Johnson, the Ninth Circuit heard an appeal of one of the many state law-based consumer class actions over food labeling. A new Washington Legal Foundation Working Paper by Sarah Roller assesses the Ninth Circuit’s refusal in Reid to grant preemptive effect to a 2003 FDA letter of enforcement discretion. Johnson & … Continue Reading

Bulk Drug Importer Sues FDA For Refusing Entry of 20,000-Kilogram API Shipment

Recently, H&M USA, an importer of  periodic bulk shipments of active pharmaceutical ingredients (API) turned to the courts in an effort to gain relief when the company’s efforts to resolve an unexpected import detention through FDA’s administrative process proved unsuccessful.  The FDA issued a Notice of Refusal, alerting the company that it had failed to … Continue Reading

Court’s Decision Over “Spreadable Butter” Claims Upheld On Appeal

The 2nd District Court of Appeals agreed with the lower court’s decision that no reasonable consumer would be misled into thinking that a product labeled as spreadable butter with canola oil was not 100% butter.  Mary Simpson sued Kelley Drye clients Kroger Corp. and Challenge Dairy Products alleging that the labeling of Challenge’s “Spreadable Butter … Continue Reading

FDA Announces Final Rule Banning BPA from Infant Formula Packaging

The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the … Continue Reading

Industry Groups Challenge USDA Mandatory Country of Origin Rule on First Amendment and Other Grounds

The American Meat Institute (AMI), along with seven other meat and livestock organizations representing the United States, Canada, and Mexico, filed an action this week challenging USDA’s recent mandatory country of origin rule. Issued by the Agricultural Marketing Service (AMS) on May 24, the final rule would revise existing regulations to require covered products to … Continue Reading

Supreme Court Ruling Increases Likelihood of Future Antitrust Challenges in Drug Patent Cases

On June 17, 2013, the Supreme Court issued its decision in FTC v. Actavis, Inc. et al. Justice Breyer delivered the majority decision, and was joined by Justices Kennedy, Ginsburg, Sotomayor, and Kagan. Chief Justice Roberts dissented, together with Justices Scalia and Thomas. Justice Alito was recused from the decision. This decision increases the likelihood … Continue Reading

Court Holds New York “Sugary Drink” Ban Violates State Constitution

A New York state court struck down today the New York City regulation that would have limited the size of certain “sugary drinks” to 16 ounces at select food service establishments. Initially proposed by Mayor Bloomberg’s Office and ultimately adopted by the New York City Board of Health, the ban was scheduled to begin at … Continue Reading

Ninth Circuit Rejects First Amendment Defense In Wire Fraud Case Regarding Drug Misbranding

This is a follow-up to our post late last year on the Second Circuit decision in US v. Caronia, which overturned a defendant’s off-label marketing conviction on First Amendment grounds (see our December 10, 2012 post, “Second Circuit Overturns Off-Label Marketing Conviction On First Amendment Grounds”). In United States v. Harkonen, the Ninth Circuit rejected … Continue Reading

Far-reaching PCA Criminal Indictments: A Harbinger for Things to Come Under the Food Safety Modernization Act?

Last week, the Department of Justice brought a sweeping indictment against several former Peanut Corporation of America executives alleging egregious, and intentional, violations of food safety laws that caused the salmonella peanut outbreak of 2008. The government charged four individuals who allegedly directed the scheme in an indictment that contains 76 counts of conspiracy, wire … Continue Reading

Second Circuit Overturns Off-Label Marketing Conviction On First Amendment Grounds

Applying the First Amendment in a way that could significantly alter the prosecutorial and regulatory landscape in Food and Drug cases, the United States Court of Appeals for the Second Circuit has overturned the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, where his prosecution and conviction … Continue Reading

FDA Rule Mandating Graphic Images on Cigarette Labels Struck Down by D.C. Circuit under the First Amendment

On Friday, August 24, 2012, the D.C. Circuit upheld an earlier ruling by the D.C. District Court invalidating an FDA rule that would have required one of nine images to be displayed on every cigarette package. The court held that the rule violated the First Amendment because the government failed to demonstrate that the regulation … Continue Reading

California Court Allows State Law Claims Against Medtronic to Proceed; Rejects Preemption Argument

The Superior Court for the County of Los Angeles ruled earlier this week in Cabana v. Stryker Biotech, LLC that a products liability action arising out of the off-label use of Medtronic’s INFUSE Bone Graft medical device could proceed by rejecting Medtronic’s summary judgment motion. Medtronic had argued that plaintiff’s claims were both expressly and impliedly … Continue Reading

California Federal Court Denies Federal Preemption for Cosmetics Labeled as Organic

A recent decision in the U.S. District Court of the Northern District of California, Brown v. Hain Celestial Group, Inc., provides important insights into cosmetic and food product organic claims. In 2011, a complaint filed against a cosmetic company alleged that the company’s organic claims violated the California Organic Products Act of 2003 (“COPA”). COPA … Continue Reading

FDA Ordered to Continue Withdrawal Proceedings for Antibiotics in Food Animals

On March 22, 2012, the United States District Court for the Southern District of New York issued an order that requires FDA to continue withdrawal proceedings under the Food Drug and Cosmetics Act, 21 U.S.C. § 360b(e), for sub-therapeutic use of certain antibiotics in livestock, including cattle, poultry, and seafood. The court found that the … Continue Reading

District Court Holds FDA Disclaimer Effectively “Negates” Qualified Health Claim and Violates First Amendment

A federal court in Connecticut recently held that the FDA could not require a green tea manufacturer to include a disclaimer that altogether negated the manufacturer’s qualified health claim linking green tea to a reduction in the risk of breast and prostate cancers. While upholding a portion of FDA’s required disclaimer under the First Amendment, … Continue Reading

D.C. District Court Invalidates FDA Rule Requiring Display of Images on Cigarette Packages on First Amendment Grounds

On February 29, 2012, the United States District Court for the District of Columbia held in R.J. Reynolds v. FDA that the Food & Drug Administration’s (FDA) final rule requiring the display of certain graphic images such as “diseased lungs” and a “cadaver bearing chest staples on an autopsy table” violated the First Amendment by … Continue Reading

Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices

The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are … Continue Reading

Supreme Court Unanimously Holds California Law Prohibiting Sale, Processing or Holding of Nonambulatory Pigs Expressly Preempted under the Federal Meat Inspection Act

In a unanimous opinion published on January 23, 2012, the Supreme Court reversed the Ninth Circuit Court of Appeals and held that a California law prohibiting the sale, processing or holding of a nonambulatory animal was expressly preempted by the Federal Meat Inspection Act (FMIA). The case, National Meat Association v. Harris, dealt with Section … Continue Reading

Supreme Court Rules on Generic Drug Labeling Preemption

On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic drug manufacturers to modify the FDA-authorized labeling for their products to provide “adequate warnings” as defined by state law. The Court … Continue Reading