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Recall

In vitro fertilization (IVF) is one of the most common types of fertility treatment, but the process is also extremely sensitive, invasive, and expensive. All of these factors come into play in a series of recent lawsuits following CooperSurgical’s December 5, 2023 recall of three lots of its embryo culture media—a substance that allows for the development of fertilized embryos. According to the company’s announcement, CooperSurgical had received a high number of customer complaints indicating that its embryo culture media caused impaired embryo development.

Continue Reading Recall Litigation Report: CooperSurgical Faces Multiple Lawsuits Following Recall of IVF Embryo Culture Media
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Just over a month after the Food and Drug Administration (FDA) announced its intent to delay enforcement of facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Government Accountability Office (GAO) issued a report, “COSMETIC SAFETY: Better Planning Would Enhance FDA Efforts to Implement New Law,” with seven recommendations to strengthen FDA efforts to implement its new cosmetic oversight responsibilities.

Continue Reading GAO Report Concludes that the FDA Needs to Strengthen its Efforts to Implement MoCRA
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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.

Continue Reading FDA Seeks Comments on COSMETICS Direct for MoCRA Facility Registration and Product Listing
Recall

Consumer-driven lawsuits that follow a product recall often focus on what the company knew, when it knew it, and how it acted in response. And for companies who are hoping to avoid such a lawsuit, one of the biggest questions is what do they need to disclose to consumers and how far does that obligation reach? Certainly, companies cannot disclose what they did not know, and manufacturers are not required to warn for every conceivable risk, regardless of how remote. A recent class action, Gurkov v. Real Kosher Ice Cream Inc., No. 1:23-cv-06128 (E.D.N.Y Aug. 14, 2023), brings these issues into focus.

Continue Reading Recall Litigation Report: Real Kosher Ice Cream Sued Over Listeria Contamination
Recall

The second half of 2022 proceeded much like the first, with manufacturers busy navigating recalls and related litigation, although not necessarily in that order.

Philips CPAP/ BiPAP Machines Still Under Fire

Philips is still battling an onslaught of cases stemming from a June 2021 recall of CPAP and BiPAP breathing machines, including a consolidated consumer class action, In re Philips Recalled CPAP, Bi-Level PAP, & Mechanical Ventilator Products Liability Litigation, No. 2:21-mc-01230 (W.D. Pa.), MDL No. 3014, and a medical device supplier suit, Baird Respiratory Therapy, Inc. v. Philips, 2:22-cv-00886 (E.D. Pa.). Since early 2021, there have been reports of over 260 deaths and thousands of health problems associated with the degrading polyurethane foam found in these devices, which was used inside millions of CPAP and BiPAP machines for over a decade. Philips claims that it has produced over 3.95 million repair kits and replacement devices to date and continues to research potential health risks to users from its machines. Despite these efforts, its legal troubles will continue into 2023, with even more consumer-facing lawsuits, including Braverman v. Koninklijke Philips N.V., No. 2:22-cv-7927, which was first filed at the end of December 2022 in the U.S. District Court for the Eastern District of New York and is one of the first CPAP/BiPAP suits to allege the inhalation of the toxic foam particles caused mouth and tongue cancer.

Continue Reading Recall Litigation Report: Year in Review (2022)

When a product is recalled, class action lawsuits are not the only threat. Recalled products can also give rise to droves of individual actions. This is the case for Exactech, Inc., a manufacturer of implants, instruments, and technologies for joint replacement.

Following an initial pause in elective procedures at the start of the COVID-19 pandemic, the number of hip arthroplasty surgeries has grown at a steady pace. These procedures commonly use acetabular liners to increase the stability of the total hip arthroplasty. Now, Exactech, a manufacturer of acetabular liners, is under fire nine months after the U.S. Food and Drug Administration (“FDA”) announced a Class II recall of the Exactech Connexion GXL acetabular polyethylene liner in June 2021. A Class II recall involves situations in which consumers may experience temporary or medically reversible health consequences or the likelihood of serious adverse health consequences is remote.
Continue Reading Recall Litigation Report: Exactech Joint Replacement Products

For the first time in nearly two decades, China is revamping its export control regime and issuing its first unified Export Control Law, which combines concepts from more than a dozen existing Chinese laws and related regulations. This alert summarizes the most significant changes from current Chinese export control practice, highlights what may be…

Both have recently brought legal actions against video game makers alleging that their rights of privacy or publicity have been violated by characters in video games. The lawsuits are the latest in a series of high profile disputes that pit an individual’s personality rights against a game maker’s First Amendment rights.

Various states have enacted statutes that protect an individual’s right to “publicity” or “privacy.” The statutes differ from state-to-state but the basic idea is that an individual should have some right to prevent unauthorized commercial use of his or her name, likeness and identity by a third party. This is sometimes referred to as “personality rights.”

The expressive content of video games, on the other hand, is subject to protection under the First Amendment. The extent to which the First Amendment rights of a video game manufacturer may permit the use of real people as characters in video games without violating the individual’s personality rights has been the subject of much interest and discussion in the recent past.

The discussion resumed in earnest in early July when Ms. Lohan brought an action in New York state court alleging that the maker of the video game Grand Theft Auto V had violated her right of privacy under New York state law by the use of her image, likeness, “screen persona” and details from her personal life in depicting a character in the game named Lacey Jonas. A few weeks later, Mr. Noriega brought an action in California state court alleging that the maker of the video game Call of Duty: Black Ops II violated his right of publicity under California state law by illegally using his image and likeness in connection with a character described “as a kidnapper, murderer and enemy of the state.” The lawsuits have been treated by some in the media and by some commentators with a certain degree of amusement and in Mr. Noriega’s case – whose colorful resume includes convictions for drug trafficking, racketeering and money laundering as well as a lengthy stint as a U.S. Prisoner of War – outright disbelief, but they raise serious issues regarding the interplay between the First Amendment and the rights of privacy and publicity.Continue Reading What Do Actress Lindsay Lohan and Former Panamanian Strongman Manuel Noriega Have in Common?

On September 3, 2013, the U.S. District Court for the Northern District of Illinois dismissed a class action complaint against Barnes & Noble seeking damages based on a data security incident, finding that the plaintiffs lacked standing to bring the claims. This decision reaffirms that retailers may be able to avoid damages for data breaches…

On March 6, 2013, the United States District Court for the Northern District of California held that a putative class of LinkedIn premium users lacked standing to pursue state law unfair competition, breach of contract, and negligence claims resulting from a hacking incident. The court dismissed the complaint, concluding that the plaintiffs failed to establish any legally cognizable injury and any causation between the alleged incident and any alleged economic harm.

LinkedIn, the online community for professional networking, offers both free and premium paid accounts to consumers. The Privacy Policy applicable to both types of accounts provides that user information will be protected with “industry standard protocols and technology,” but notes that it provides no guarantee that LinkedIn’s security will be able to prevent all security breaches. On June 6, 2012, hackers infiltrated LinkedIn’s computer systems and posted 6.5 million user passwords and email addresses. LinkedIn subsequently updated its password encryption method to prevent future breaches.

A putative class of premium LinkedIn users filed an amended complaint alleging unfair competition, breach of contract, and negligence claims. LinkedIn filed a motion to dismiss for lack of standing, which the court granted.Continue Reading Allegation of Data Breach Alone Insufficient to Sustain Claims Based on Inadequate Cybersecurity Under California Law