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

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

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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Old Habits Die Hard: First Circuit Cites Newly Amended Language of FRE 702 But Follows Abrogated Precedent Instead

The longer and more frequently a principle is repeated by the courts, the more difficult it can be for courts to acknowledge change.  As illustrated by the First Circuit’s opinion in Rodriguez v. Hospital San Cristobal, Inc., 91 F.4th 59 (1st Cir. 2024) – the first reported appellate decision to cite the language of the newly-amended Federal Rule of Evidence 702 since it took effect in December 2023 – even a change to the Federal Rules of Evidence themselves might not be enough for a court to stop citing outdated but familiar precedents.

Some background is in order.  In 1993, Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) ushered in a new paradigm for evaluating the admissibility of expert opinion evidence.  Courts seized on Daubert’s comment that a court’s “focus, of course, must be solely on [an expert’s] principles and methodology, not on the conclusions that they generate.”  But just four years after Daubert was decided, the Supreme Court rejected an argument that a lower court had erred by evaluating an expert’s conclusions.  Because “conclusions and methodology are not entirely distinct from one another,” the lower court had not abused its discretion in evaluating whether the expert’s opinion was warranted by the data on which it was based.  General Electric Co. v. Joiner, 522 U.S. 136 (1997).

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How to Succeed in Business (in Philadelphia) Without Really Trying (Your Case There, Because Venue Isn’t Proper)

Venue rulings in Pennsylvania affect many defendants in products cases.  Those incorporated here, and those sued on allegations that their products caused harm here, of course.  And, for now at least, it includes corporate defendants registered to do business in Pennsylvania.  They are subject to general jurisdiction, including for claims unrelated to the Commonwealth, under Pennsylvania’s unique “consent to jurisdiction” statute.  That statute was upheld as consistent with due process in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023).

And with many serious personal injury cases being filed in Philadelphia – a venue described in a Mallory concurring opinion as “reputed to be especially favorable to tort plaintiffs” – the stakes involved in venue disputes are higher than ever.  That is even more evident after several recently reported verdicts in product cases, one approaching $1 billion and one exceeding $2 billion.

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Michigan Repeals Pharma Immunity Provision

Michigan recently signed into law a repeal of the immunity provision under its Product Liability Act, presenting a new litigation risk in Michigan for pharmaceutical companies. The provision had granted near-complete immunity to pharma for the past 30 years, as the only of its kind nationwide.  Michigan’s new law—Senate Bill 410 (SB 410)—removes this immunity, leaving intact a rebuttable presumption of non-liability and caps on non-economic damages.

SB 410 goes into effect on February 13, 2024, and is likely non-retroactive, meaning alleged injuries would have to occur after that date for the new law to apply.  Commentators predict increased Michigan litigation relating to opioid use, insulin price gouging, and Medicaid fraud.

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Pennsylvania Stays in a Minority of Two States in Prohibiting Evidence of Compliance With Government and Industry Standards in Products Liability Design Defect Cases

Just before Christmas, the Pennsylvania Supreme Court delivered a lump of coal to products liability defendants: Sullivan v. Werner Co., 2023 WL 8859656 (Pa. Dec. 22, 2023), affirming a lower court ruling that barred evidence of a product manufacturer’s compliance with government and industry standards in a strict liability design defect case. The lower courts held that such evidence goes to due care and is relevant only to negligence, not strict liability. The affirmance appears to support the exclusion of such evidence in design defect cases based on a risk-utility theory, but leaves uncertainty for the future because only three justices joined the principal opinion; a fourth justice concurred with the result but concluded the record was inadequate to resolve the legal issue, while two others dissented.

Plaintiff sued the maker of a mobile scaffold which collapsed. Defendant served an expert report that relied in part on government (OSHA) and industry (ANSI) standards. Plaintiff filed a motion in limine to exclude evidence of compliance with those standards, relying mainly on Lewis v. Coffing Hoist Div., 528 A.2d 590 (Pa. 1987), which excluded such evidence in strict liability cases. But Defendant argued the Supreme Court’s later ruling in Tincher v. Omega Flex, 104 A.3d 328 (Pa. 2014), undermined Lewis by overruling Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), a decision that had taken an extremely narrow view of the relevant facts in strict liability claims under section 402A of the Second Restatement of Torts. Tincher held that section 402A remained Pennsylvania law but “overruled Azzarello’s narrow construction . . . that prevented the jury from considering negligence-related rhetoric and concepts . . . .” Nevertheless, the trial court in Sullivan granted the motion in limine and an appellate court affirmed. Sullivan v. Werner Co., 253 A.3d 730 (Pa. Super. 2021).

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