Regulatory and Industry Standards Archives - Page 2 of 8

Category: Regulatory and Industry Standards

EU’s Proposed Product Liability Directive – More Trick than Treat?

Americans love a good scare on Halloween. But, of course – with ancient castles, centuries of folklore, and actual Transylvania, our friends in the European Union know how to celebrate the spooky season just as well as we do. Unfortunately, there’s more than ghost stories to send a shiver down your spine in the EU these days. This month, a joint committee of the European Parliament voted on new amendments to the proposed “digital age” update of the Product Liability Directive, which was initially enacted in the 1980s. On the one hand, the proposal seems like a treat with its efforts to modernize the product liability framework to account for the changing product landscape and to address access issues for consumers. But many European business leaders caution that this is more trick than treat. Among other things, there are concerns that the traditional burden of proof requirements and safeguards on evidentiary disclosures will vanish into thin air. Concerns abound that the proposals won’t benefit consumers or industry, but rather lawyers and litigation funders. Scary stuff, indeed.

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Experts Who Cannot Articulate a Standard Cannot Opine that a Defendant Failed to Meet the Standard

If you don’t know where a line is, you can’t say whether someone has crossed it. That principle applies in spades to expert witnesses, particularly when their role in the case calls on them to help the jury understand where the lines are drawn in their field. Thus, for example, a toxicology expert who cannot say how much chemical exposure is required to produce a toxic effect cannot opine that the plaintiff’s exposure was sufficient to cause that effect. Likewise, an expert who criticizes a product’s warnings but cannot articulate an adequate warning does not pass muster under Federal Rule of Evidence 702. See, e.g., Bourelle v. Crown Equip. Corp., 220 F.3d 532, 538-39 (7th Cir. 2000).

The Seventh Circuit recently gave yet another illustration of this principle at work. In Burns v. Sherwin-Williams Co., — F.4th —, 2023 WL 5210857 (7th Cir. 2023), a plaintiff truck driver was injured while making a delivery at defendant’s store using a “walkie” (i.e., an electric forklift that the operator walks behind) owned by defendant. Plaintiff was backing the walkie down a ramp and toward a dumpster with pallets laying on the ground nearby. Unfortunately, he underestimated the walkie’s stopping distance. He tried “plugging” – i.e., pushing the thumb switch in the opposite direction to slow and then reverse the walkie – and then engaged the emergency brake, but it was too late. He trapped his foot against the pallets, then fell over and broke his ankle.

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Ethylene Oxide Alert: Where Is Your Warehouse?

For over a year now, the U.S. Environmental Protection Agency (EPA) has been focused on reducing or eliminating ethylene oxide (EtO) emissions from industrial sites, commercial sterilizing facilities, and even hospitals. After a brief extension, the comment period for new proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and National Emission Standards for Hazardous Air Pollutants (NESHAP) regulations closed at the end of June with over 1,000 unique written comments. It is anticipated that EPA is going to take some time to sort through those comments before issuing final rules, which are expected in March 2024. At the same time, EPA has forecasted releasing a proposed rule specific to hospital sterilizers in early 2024.

Next up on EPA’s agenda appears to be warehouses that store products sterilized with EtO. The looming question appears to be “where is your warehouse?” Onsite warehouses are the first to be in EPA’s crosshairs, but in classic agency style they are leaving the option to expand that focus open for the time being. Meanwhile, environmental groups are asking EPA not to wait to expand that focus, and states like California and Georgia are taking matters into their own regulatory hands.

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EU Publishes General Product Safety Regulation – Full Enforcement to Commence in December 2024

On May 23, 2023, the European Commission formally published the new General Product Safety Regulation, which reforms a variety of product safety regulations for manufacturers doing business in the European Union (EU) and its 27 member states. The European Parliament adopted the text of the regulation on March 30, 2023, and the European Council adopted it on April 25, 2023, but its official publication yesterday triggers the implementation and enforcement deadlines. Specifically, the regulation takes effect on June 12, 2023 (20 days from yesterday) and will include an 18-month transitionary period for EU member states, companies subject to the regulation and other actors to implement the new and revised regulations. Full enforcement begins December 13, 2024, after the conclusion of the transition period.

The regulations have been under consideration for many years and represent a major overhaul of product safety regulation in Europe. Product manufacturers should review the full set of regulations carefully and make any necessary adjustments to their procedures and processes to be in compliance with the new regulations before full enforcement takes effect on December 13, 2024. Among other things, the new General Product Safety Regulations include new requirements related to adverse event reporting, pre-market risk assessments, safety recalls, and product labeling and documentation. For example, manufacturers will be required to report “accidents caused by a product” “without delay” if the product is involved in an incident resulting in death or “serious adverse effects on health and safety.” Meanwhile, operators of online marketplaces are subject to an even more broadly worded requirement to report “accidents caused by a product … resulting in serious risk or actual damage of the health or safety of a consumer,” which extends the reporting requirement beyond incidents of actual injury.

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The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show no sign of slowing, as the number and type of medical device products that are connected to the cloud increase (thereby increasing the attack surface for hackers), and as hackers become more sophisticated. Indeed, in a September 2022 FBI Private Industry Notification, the FBI noted that around 53% of connected medical devices and other internet of things (IoT) devices in hospitals had known critical vulnerabilities. These vulnerabilities could allow hackers to direct medical devices to give inaccurate readings, administer drug overdoses, or otherwise endanger patient health.

In the past, the U.S. Food & Drug Administration (FDA) has urged manufacturers to take measures to ensure the cybersecurity of their products through non-binding guidance. On December 29, 2022, President Biden signed into law the $1.7 trillion Omnibus Appropriations Act, which provided the FDA with authority to require manufacturers to take cybersecurity protection measures as to medical devices that are brought to market through future pre-market submissions. See H.R. 2617 (117th Congress, 2021-2022), text available here.

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5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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