Adrienne Franco Busby

Adrienne Franco Busby puts science and strategy to work for companies facing product liability litigation. She is an experienced litigator in product liability, commercial, employment, class action and mass tort matters.

View the full bio for Adrienne Franco Busby at the Faegre Drinker website.

Articles by Adrienne Franco Busby:


EPA’s Final EtO Rule Has Landed: What Now?

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The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.

The final rule differs significantly from EPA’s initial proposed rule. See initial proposal back in April 2023. The changes result in a still restrictive and costly rule, but with more time and options for compliance. These changes come after significant interagency discussions, including discussions with the U.S. Food and Drug Administration (FDA) about the impact of these rules on the medical devices, about half of which are currently sterilized by EtO. According to EPA, there will be no need for companies to revalidate their medical devices due to this final rule. It seems likely, however, that a facility’s ability to comply with the new regulation ultimately may affect sterility validation, so revalidation concerns should not be completely discounted just yet.

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California Appellate Court Upholds Federal Preemption of Negligent Undertaking Claim Under the Medical Device Amendments of 1976

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Federal preemption can be a very powerful defense.  For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et seq. (“MDA”).  In Regwan v. Abbott Laboratories, Case No. B319606, 2023 WL 8818748 (Cal. App. 2d Dec. 21, 2023), the California Court of Appeal relied on that principle in holding preempted a negligent failure to warn claim premised on a sales representative’s intraoperative communications and presented as a “negligent undertaking” claim.  This holding continues a California trend that federal law may preempt negligence-based claims regarding Class III PMA medical devices even if they are not presented as traditional design defect or failure to warn claims.

In Regwan, the plaintiff alleged she suffered serious injuries following implantation of a MitraClip that the defendant manufactured.  During the procedure, the saline bag ran dry, causing the plaintiff to allegedly suffer an air embolism and brain injuries.  The plaintiff asserted negligence and products liability causes of action against the defendant after discovering a defendant representative attended the surgery and was allegedly “responsible for the flow of saline.”  The defendant demurred, arguing federal law preempted the plaintiff’s products liability claims.

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EU Reaches Legislative Deal on Proposed ‘Digital Age’ Updates to Product Liability Directive

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Last week, the European Union made a significant breakthrough towards its goal of overhauling the 40-year-old Product Liability Directive for the demands of the “digital” age and modern economy. To amend the directive, the elected European Parliament and the European Council (comprised of government representatives of the 28 member states) must agree on final language and separately pass the draft legislation through their respective bodies. After extensive legislative efforts and negotiations, the European Council (currently led by the Government of Spain) and the European Parliament issued press releases announcing that they have reached a political agreement regarding the proposed updates to the directive.

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Something to Celebrate: A Brief Guide to the FRE 702 Amendments

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Fun fact:  There are 23 holidays that can be celebrated today, December 1st.  Some, like Rosa Parks Day and World AIDS Day, are solemn and serious.  Others are silly and fun, like National Peppermint Bark Day and National Christmas Lights Day.  And then there are those that are downright strange, like Bifocals at the Monitor Liberation Day.  (No, we didn’t make that up.)  But for those of us who practice in the federal courts, we can add one more celebration to this esteemed list.

Today, the long-anticipated amendments to Federal Rule of Evidence 702, governing admissibility of expert opinion evidence, finally take formal effect.  The amendments were unanimously approved by the Advisory Committee over two and a half years ago.  Courts have been citing the proposed amendments since shortly after they were first approved.  On the surface, the amendments to the text of Rule 702 itself may appear relatively modest.  Indeed, at least one court has observed that the new language “clearly echoes the existing law on the issue.”  Sardis v. Overhead Door Corp., 10 F.4th 268 (4th Cir. 2021).  But there is more to these new amendments than initially meets the eye.  In order to understand and effectively use the amendments, parties and litigators must understand and use the history and the Committee Note explaining the amendments.

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

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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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Ethylene Oxide Alert: Where Is Your Warehouse?

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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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