Duane Morris attorney Kelly A. Bonner was quoted in an article in The Business of Fashion titled “What Beauty Needs to Know About the Biggest New Regulations in 80 Years,” about the Modernization of Cosmetics Regulations Act (MoCRA) recently signed into law. To read the full text of this article, please visit the firm website.
Regulatory Compliance Checklist Post-MoCRA for Beauty and Personal Care Products
MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq., in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.
This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.
To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.
Pa. Supreme Court Can Finally Set Proper Venue Standards
In March, the Pennsylvania Supreme Court heard oral argument in Hangey v. Husqvarna on the standards governing venue in a product liability case.
The court’s decision, expected by the end of the year, may provide important guidance on just how much business a corporate defendant must undertake in a plaintiff’s chosen forum for venue to attach.
This article will describe the case on appeal, the venue issues it raises and the precedential context in which it finds itself. We will also suggest a few important takeaways as trial courts and litigants await the disposition of the appeal.
To read the full text of this article by Duane Morris attorneys Alan Klein and Ethan Feldman, please visit the firm website.
Following MOCRA’s Enactment, Unpacking Litigation and Regulatory Risk for Cosmetics Brands
On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.
Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products.
To read the full text of this article by Duane Morris attorneys Rick Ball, Alyson Walker Lotman and Kelly Bonner, please visit the Duane Morris website.
L’Oreal Case Highlights Legal Risks Of Anti-Aging Claims
It is a truth universally acknowledged that a woman over 30 must be in want of an eye cream. Or a serum. Or anything, really, so long as it recreates the appearance of youth, vitality or an actual night’s sleep.
The global market for anti-aging cosmetics is expected to reach $93.1 billion by 2027. But as illustrated by a recent decision from the U.S. District Court for the Southern District of New York, Lopez v. L’Oréal USA Inc., promises that a product can turn back time by “restoring skin” or “promot[ing] cell regeneration” can prove costly for brands looking to capitalize on this growing market.
Brands should be mindful of litigation and regulatory risk when making certain anti-aging claims.
To read the full text of this article by Duane Morris associate Kelly Bonner, which was originally published in Law360, please visit the firm website.
Blocking A Second Punitive Damages Award In Product Cases
Punitive damages awards in product liability matters have reached new heights in recent years. Traditionally, product liability defendants have sought to contest liability in the first instance, and establish that the alleged conduct does not warrant punitive damages specifically
Two recent decisions highlight a perhaps lesser-known defense available in some jurisdictions that can limit or even preclude punitive damages where they have previously been awarded for the same product or conduct.
To read the full text of this article, originally published in Law360, by Duane Morris attorneys Anne Gruner and Ethan Feldman, please visit the firm website.
California Appellate Court Permits Defense Expert Testimony Regarding Causation to Meet Lower Standard When Offered to Challenge Plaintiff’s Causation Evidence
Causation in personal injury actions, including product liability claims related to drugs and medical devices and toxic tort actions related to exposure to hazardous substances, must be proven within a reasonable degree of medical probability based upon competent expert testimony. That’s typically the plaintiff’s burden of proof. Do the defendants bear the same burden? In Kline v Zimmer, the California Court of Appeal recently held that, in challenging the plaintiff’s causation evidence, defense expert testimony should be held to a standard of “less than a reasonable medical probability.”
Kline involved the plaintiff’s claim that the Durom Cup hip implant, manufactured by defendant Zimmer, Inc. and utilized in his first hip replacement surgery, was defective and caused him to require an additional surgery, which resulted in further injury. Evidence presented by the plaintiff at trial included an expert who testified to a reasonable medical probability that the Durom Cup’s defects caused the plaintiff to need the additional surgery, which resulted in changes in his muscles and soft tissues causing him chronic pain.
To read the the full article by Duane Morris attorney Michael L. Fox, which originally appeared in the IADC Committee Newsletter, please visit the Duane Morris LLP website.
Oregon Cannabis Mislabeling Spurs Investigation and Recall
The Oregon Liquor and Cannabis Commission (OLCC) is conducting an ongoing investigation into Curaleaf regarding an alleged mislabeling of a nonpsychoactive cannabidiol (CBD) product, which actually contained psychoactive delta-9 tetrahydracannabinol (THC). Curaleaf operates 101 retail cannabis dispensaries in 16 states. The OLCC investigation revealed that the alleged mislabeling resulted from an employee’s confusing the CBD bottles with the THC bottles in preparing the Curaleaf cannabis products at issue. The incident caused consumers ingesting those products to have experienced a “high” they did not anticipate, and ultimately led to the recall of approximately 500 bottles of tincture from the Oregon market. At least three of those consumers went to the emergency room due to the high, one consumer was hospitalized and one consumer’s estate brought a claim for wrongful death.
To read the full text of this Duane Morris Alert, please visit the firm website.
Seth Goldberg is a Team Lead of Duane Morris’s Cannabis Industry Group, a cannabis business advisor, and a trial attorney with experience in products liability and consumer fraud claims. Ethan Feldman is an associate in the firm’s Trial department, with experience in products liability and consumer fraud.
The Importance of 510(k) Evidence to Ensuring a Fair Trial
Since the onset of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) has received more attention than perhaps ever before. While Americans anxiously awaited for approval of a COVID-19 vaccine, the FDA and its regulatory scheme were ever-present topics on the news and in social media. The American population’s newfound familiarity with the FDA is especially pertinent in a medical device litigation context. As litigators well know, jurors already enter a courtroom with preconceived notions of medical device companies, the FDA and the relationship between the two. So how will this newfound knowledge of the FDA influence juror opinions? Put another way, what would happen if a jury participating in a medical device trial failed to hear any reference to the FDA at all? Potentially, the results would be catastrophic to device manufacturers.
To read the full text of this article co-authored by Duane Morris partner Sean Burke, please visit the AdvaMed website.
3D Printing and its Implications for the Auto Industry
For as long as cars have existed, three fundamental truths appeared to be eternal. First, every car contains safety critical components, second these components are mostly metal and third, they are manufactured by one of two methods—stamping or cold forming. These eternal truths always led to an equally durable legal reality, that if the safety critical component fails the manufacturer will be liable to the injured party. It’s hard to think of a more trite and dependable set of principles. But these timeless precepts are about to become disrupted as the automotive industry continues to explore the innovation of 3D printing.
To read the full text of this article by Duane Morris partners Sean Burke and Alex Geisler, please visit the 3DPrint.com website.