In this article, the authors discuss new updates from the UK’s Medicines and Healthcare products Regulatory Agency on how software and artificial intelligence medical devices will be regulated in the United Kingdom after Brexit. Read and learn more!
Guest Writer Does the European Union Commission’s Proposal on AI Liability Act as a Game Changer for Fault-Based Liability Regimes in the EU? By Nils Lölfing Abstract: In this article, the author discusses increasing risks that artificial intelligence system providers, developers, and users will face from a liability directive proposed by the European Union Commission. The AI Liability Directive proposed by the European Union Commission puts additional liability risks on providers, developers and users of specifically high-risk artificial intelligence (AI) systems. If enacted, it could become a game changer for fault-based liability regimes in the European Union, as it introduces a presumption of causality to prove fault and a right of access to evidence from companies and suppliers regarding high-risk AI systems. This will help victims enforce non-contractual civil law claims for damages caused by an AI system. What this is about and how it increases the liability risk exposure of actors in the AI systems supply chain will be discussed in this article. Background On September 28, 2022, the EU Commission published its proposal for a Directive to establish new fault-based liability rules for AI systems (AI Liability Directive), along with a reform for the existing rules on the strict liability of manufacturers for defective products. The current article focuses on [...]
Authors Peter Schildkraut is a co-leader of the firm's Technology, Media & Telecommunications industry team and provides strategic counsel on artificial intelligence, spectrum use, broadband, and other TMT regulatory matters. Mr. Schildkraut helps clients navigate the ever-changing opportunities and challenges of technology, policy, and law to achieve their business objectives at the US Federal Communications Commission (FCC) and elsewhere. He is the author of "AI Regulation: What You Need To Know To Stay Ahead of the Curve. James W. Kim is a nationally recognized expert in procurement law that regularly advises companies that do business with the US government, with a focus on professional services organizations and the life sciences industry. He is a regular speaker and author on procurement and drug pricing matters and his work is regularly featured in nationally-distributed industry print and digital media. Mr. Kim provides clients with strategic counsel related to US government funding and US market access, including assistance with more than $5 billion in procurement and grant awards and regulatory counsel related to more than $40 billion in successful M&A transactions. Marne Marotta works with clients facing complex challenges to develop and implement dynamic government relations strategies. Drawing from her experience in the Senate and the executive branch, she provides clients with strategic guidance and counseling, devises and implements comprehensive advocacy campaigns, [...]
Mental Health Platform's Data Sharing Practices Challenged. BetterHelp allegedly shared personal identifiable info with third parties. FTC files administrative complaint asserting "years of deception." Days later, two class actions were filed in the Northern District of California. Online mental health company BetterHelp, Inc. is facing allegations on two fronts for allegedly sharing personal identifiable information with third parties and breaching consumer privacy. The Federal Trade Commission (“FTC”) initiated an administrative complaint against the California-based online mental health company on March 2, 2023, after what they call years of deceptive practices and blatant denial of a media report published by Jezebel in February 2020. The article cited evidence that BetterHelp shares sensitive patient information and email account information with third parties such as Facebook, Snapchat, Criteo, and Pinterest. Days after the FTC filed its complaint, consumers filed two class actions in the Northern District of California’s San Jose Division (C.M. v. BetterHelp, Inc., March 7, 2023, 5:23-cv-01033 and Jane Doe v. BetterHelp, Inc., March 11, 2023, 5:23-cv-01096). Both consumer privacy lawsuits state that their facts are largely supported by experts in the field of data privacy. BetterHelp is a Delaware corporation with its principal office or place of business in Mountain View, Calif. On its website the company claims it is the “world’s largest therapy platform” with more [...]
Sysco and Burford Capital Butting Heads Over Litigation Control. Food giant claims funder is interfering with antitrust litigation. Funder says its client is settling for too little. Public dustups over litigation funding are rare. Leading litigation funder Burford Capital LLC and food distribution giant Sysco Corp. are locking horns over the control and use of litigation funds. Burford says Sysco is settling Burford-funded antitrust litigation for amounts that deny the financial company optimal return on its investment. Sysco says the funder has overstepped its bounds and interfered with Sysco’s litigation oversight. Sysco received $140 million from Burford in part to fund price-fixing lawsuits against poultry, pork and beef producers – complex multidistrict litigation involving hundreds of plaintiffs, dozens of defendants, and related criminal suits brought by the Department of Justice (DOJ). So far, settlements of private antitrust litigation have reached into the hundreds of millions, and DOJ has levied more than $100 million in fines. Burford, which gets a share of any settlements in the antitrust litigation, says Sysco is settling for too little. Sysco has sued companies associated with Burford – Glaz LLC, Posen Investments LP, and Kenosha Investments LP – claiming they are meddling in Sysco’s settlement efforts. Glaz, Posen, and Kenosha are all companies which have Burford Capital Limited as the only direct or [...]
L’Oréal Among Defendants in Litigation Over Hair Products. Dozens of hair straightener cases allege higher incidence of cancers and other diseases. Plaintiffs in dry shampoo litigation say products contain benzene. Seven companies control the U.S. hair product industry. L’Oréal has been hit hard in recent hair care litigation related to straighteners, relaxants, and dry shampoos. L’Oréal was named a defendant in nearly sixty complaints alleging that straightening products manufactured by the beauty giant have caused cancer in its consumers. L’Oréal has also been named a defendant in a proposed class-action for its Redken dry shampoo that allegedly contains the carcinogen benzene. Other large industry players such as Johnson and Johnson and Unilever have also been accused of selling dry shampoos with dangerous levels of benzene. Straighteners and Relaxers Litigation Dozens of cases have been consolidated in multidistrict litigation against L’Oréal for its potentially cancerous hair straighteners and relaxers. Mitchell v. L’Oréal USA Inc. is a typical case. It was filed by Missourian Jennifer Mitchell, a black woman, after her diagnosis of uterine cancer which she claims was caused by endocrine disrupting chemicals (EDCs) in L’Oréal’s hair straighteners and relaxers. Jennifer Mitchell was diagnosed with her cancer on August 10, 2018. “Ms. Mitchell was first exposed to EDCs and/or phthalate-based products around 2000, at or around the age [...]
Meta, Google Face Barrage of Pixel Lawsuits in Digital Privacy War META PLATFORMS INC. AND GOOGLE are currently facing nearly 70 lawsuits involving large companies and some hospital systems or individual health care providers utilizing Pixel tracking tools embedded on their websites and applications. Sensitive private data such as financial information gathered from filing tax returns online or patient healthcare information stored on patient portals is being actively tracked and sent to Meta and Google for both analytical and advertising purposes. Tracking pixels are a 1x1 Pixel graphic that serves as a snippet of code used for tracking user behavior, site conversions, web traffic, and other metrics generated from a site’s server. In 2018, Meta told Congress that there were more than 2 million Pixels across the web, which at the time, was one of the largest data-harvesting operations most internet users had ever seen. Meta makes their Pixel code freely available to anyone and any business – thus the amount of Pixel tracking has exponentially grown since Meta testified before Congress. The analytical information that companies gleam from Pixel tracking is paying off and is featured on everything from fast food companies such as Chick-Fil-A, media companies like iHeart Radio, and even tax-filing websites such as Tax Slayer or TaxAct. Pixel Tax Data On November 22, 2022, [...]
Legal News: Ohio AG Sues Norfolk Southern Over East Palestine Train Spill. Legal News On March 14, 2023, Ohio filed a lawsuit against Norfolk Southern Railway Company, a multi-billion dollar entity, in the U.S. District Court for the Northern District of Ohio. The lawsuit stems from the East Palestine train derailment (the “Derailment”), which took place on February 3, 2023. The lawsuit seeks to “recover response costs, redress damages to natural resources, and receive an order for injunctive relief, civil penalties, and damages.” The Derailment The Derailment of train 32N occurred at approximately 9 PM in East Palestine, Ohio—roughly fifty miles northwest of Pittsburgh, Pennsylvania. The accident is believed to have been caused by the overheating and failure of at least one wheel bearing. Twenty of the derailed cars contained hazardous materials, including vinyl chloride, butyl acrylate, ethylhexyl, acrylate, and ethylene glycol monobutyl ether. Chief among the substance concerns was vinyl chloride, which emits toxic substances when it burns. The Environmental Protection Agency (EPA) states that it was notified of the Derailment about two hours after it occurred, and personnel were on site five hours after the accident. The surrounding downwind area was evacuated. Reports were made of health and safety hazards to people and animals in the affected region. Three days after the crash, emergency responders intitiated a controlled [...]
Guest Writer Victoria is a third-year student at the University of Miami School of Law, Juris Doctorate Candidate 2023, Law Review Staff Editor, and soon-to-be associate at Jones Day. European Court of Human Rights to Hear Case on Climate Change By Victoria Kline The European Court of Human Rights (ECHR) is hearing a landmark case brought forward by the Senior Women for Climate Protection Switzerland, who are suing the Swiss government (the “State”) for human rights violations related to climate change. Verein KlimaSeniorinnen Schweiz and others v. Switzerland (“KlimaSeniorinnen”) is one of the first climate change matters the court has taken up. On Wednesday, March 29, 2023, the ECHR held a public hearing. History of the Case KlimaSeniorinnen began back in 2016, ignited by a group of women called KlimaSeniorinnen Schweiz, the Senior Women for Climate Protection Switzerland. The group filed suit in Swiss court against a variety of Swiss federal government bodies alleging violations of obligations set forth in the Swiss Constitution and the European Convention on Human Rights (the “Convention”). The heart of the suit is the State’s shortcomings in progress being made towards the adopted Paris Agreement’s goal to keep “the increase in the global average temperature to well below 2°C above pre-industrial levels.” The elderly plaintiffs purport that their demographic is especially [...]
Environmentalists Argue Federal Government Failed to Analyze Social Costs of Fossil Fuel Emissions from Drilling Leases “Federal public lands used for fossil fuel extraction contribute 24% of the United States’ Greenhouse Emissions,” according to 10 environmental groups in their ongoing lawsuit against the U.S. Department of the Interior, Secretary of the Interior Debra Haaland, the Bureau of Land Management (BoLM), and BoLM Director Tracy Stone-Manning (Dakota Resource or Council, et al, v. U.S. Department of the Interior, et al., D. D.C., No. 1:22-cv-1853 ). Their lawsuit seeks to invalidate 173 oil and gas leases approved in June 2022 across eight states: Colorado, Montana, Nevada, New Mexico, North Dakota, Oklahoma, and Utah, and Wyoming. Plaintiffs include: Dakota Resource Center, Center for Biological Diversity, Citizens for a Healthy Community, Living Rivers & Colorado Riverkeeper, Montana Environmental Information Center, Rio Grande Waterkeeper, Sierra Club, Waterkeeper Alliance, Western Waterheads Project, and WildEarth Guardians. The environmental groups argue the BoLM is in violation of the National Environmental Policy Act (NEPA) 42 U.S.C. § 4321, for failing to make efforts to prevent or eliminate damage to the environment and biosphere. The groups also argue that Secretary Haaland failed to follow the instructions of the Federal Land Policy and Management Act (FLPMA) 43 U.S.C. § 1701, which requires her office to “take any action necessary to prevent [...]
Willow II: Conservation Groups Sue Again to Stop Oil Project in Alaska’s Western Arctic Several conservation groups filed a lawsuit in the U.S. District Court for the District of Alaska against the federal government in another effort to halt the Willow Master Development Plan (Willow Oil Project), a proposed oil and gas development in Alaska’s Western Arctic. Spearheading the development is ConocoPhillips Alaska Incorporated. The project was approved for a second time by the Biden Administration only a day before the filing of the plaintiffs’ complaint. The Willow Oil Project The Willow Oil Project is a multi-billion dollar project that would involve the construction of drilling pads, pipelines, and other infrastructure in the National Petroleum Reserve-Alaska (Reserve). The project involves drilling up to 250 wells for the purpose of generating 586 million barrels of oil within its 30-year lifespan. As a direct result of the activity, roughly 258 million metric tons of greenhouse gas emissions would be released into the atmosphere. The project has been controversial due to concerns over its potential impacts on the environment and wildlife in the area. Willow II Case History ConocoPhillips first proposed the Willow Oil Project to the Bureau of Land Management (BoLM) in May of 2018. After determining that the project was a major federally-involved action that would significantly affect the [...]
The judicial system is overburdened for a number of reasons, and greater efficiency is a must if court systems are to achieve their important objectives. Technology and openness to all that it offers is a key solution, something that was tried, tested and proven during the Covid pandemic which closed courthouses and law offices around the nation. Along with technology, improvements can be made by reexamining their orthodoxies about how things should be done based on decades of "that's how we've always done it." This is a matter of importance to judges, lawyers, plaintiffs, defendants, and numerous others whose lives are impacted directly or indirectly when either the civil or criminal justice systems are inefficient, cumbersome, costly, confusing, slow, and even inaccessible. If only we had an example of at least one judge who is trying to do something about it. But wait ... Listen to my interview with the Hon. Scott Schlegel who presides over criminal civil and domestic matters in Louisiana's 24th Judicial District Court in Jefferson Parish. Judge Schlegel was elected to the bench in 2013, and quickly earned a reputation as a modern judge using technology to bring his court into the digital age, even before the pandemic forced the change on other jurists. He partnered with tech companies to develop efficiency tools like chat bots and [...]
