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

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 of future antitrust challenges to settlements in which the generic defendant: (1) receives a payment as part of a settlement, and (2) does not come onto the market immediately. Moreover, the decision probably makes more likely that we will see in the future more trials-of-a-patent-case-within-an-antitrust-case, because assessing (as the Rule of Reason calls for) whether the procompetitive aspects of an agreement outweigh the anticompetitive aspects of the agreement, would seem to require an assessment of the strength of the patent case

The Supreme Court reversed the decision of the Eleventh Circuit, which had affirmed the dismissal of a complaint brought by the FTC alleging that a reverse payment settlement between brand and generic pharmaceutical companies violated the antitrust laws. The Eleventh Circuit had held that a reverse settlement does not violate antitrust law “absent sham litigation or fraud in obtaining the patent” so long as the settlement’s “anticompetitive effects fall within the scope of the exclusionary potential of the patent.” FTC v. Watson, 677 F.3d 1298 (11 Cir. 2012). The Supreme Court disagreed, stating that reverse payment settlements “can sometimes violate the antitrust laws,” holding that the Eleventh Circuit should have allowed the FTC to proceed with its lawsuit, and remanding the case for further proceedings consistent with its opinion. Majority Opinion at 2, 21.

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

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

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,

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

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

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 would directly advance the stated goal of reducing smoking rates.
Continue Reading FDA Rule Mandating Graphic Images on Cigarette Labels Struck Down by D.C. Circuit under the First Amendment

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 preempted by the Medical Device Amendments to the Federal Food, Drug & Cosmetic Act (“FDCA”).
Continue Reading California Court Allows State Law Claims Against Medtronic to Proceed; Rejects Preemption Argument

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”).

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 lawsuit was authorized by the Administrative Procedure Act (“APA”) because the new animal drug withdrawal process is a discrete action that FDA was required by statute to take. In addition, the court found that when FDA determines that there are “serious questions” about the safety of a drug, then FDA is required under § 360b(e)(1) to withdraw approval of the drug unless the drug sponsors can prove that the drug is safe. Therefore, the court ordered FDA to re-issue a notice of withdrawal for penicillin and tetracyclines (chlortetracycline and oxytetracycline) in animal feed and provide an opportunity for a hearing to the relevant drug sponsors. If the drug sponsors fail to show that the drug use is safe, FDA must issue a withdrawal order.
Continue Reading FDA Ordered to Continue Withdrawal Proceedings for Antibiotics in Food Animals