Subject: Medical Devices

FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

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FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.

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It’s an MDL World: The JPML issues its first orders of the year, creating two new MDLs

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Centralization of claims in multidistrict litigation has become the new normal—so much so, that MDL proceedings now comprise more than 50 percent of the federal civil caseload. But has MDL practice in the United States peaked? Only time will tell. While the total number of MDL cases remains high (424,720 cases as of mid-February), the vast majority of these cases are concentrated in just a few of the more crowded MDL dockets. And as the annual MDL statistics in recent years show, the total number of new MDL petitions submitted, and granted, has been in decline. In 2021, for example, the Judicial Panel on Multidistrict Litigation received 33 total MDL petitions, granting only 19—compared with 44 petitions (26 granted) the year before.

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Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

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By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering food to taking the bus to work could be achieved and tracked through a simple app. During the pandemic, the reliance on electronic mediums went from preferable to necessary, as many businesses shut down and transitioned to a remote or online-only presence.

The escalation of the digital age has led some manufacturers to consider electronic warnings for their products, through the manufacturer’s website, by providing a QR code, or by recommending (or requiring) the consumer to download an app. Even the American National Standards Institute (ANSI) has bought into digital warnings. ANSI’s Z535 standards provide guidance for product manufacturers related to the size, content, and location of warnings. Recently, ANSI created a subcommittee on warnings in electronic media and is in the process of developing a new standard, ANSI Z535.7, for safety information in electronic media. This new standard is expected to be published by December 2022. The FDA has also recently utilized electronic means to communicate information regarding the COVID-19 vaccines. In October 2021, the FDA published three Consumer Fact Sheets for the three currently authorized vaccines on its website and included a QR Code linked to the “most recent” COVID-19 Vaccine Fact Sheets.

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510(k) Clearance Precludes Punitive Damages in Arizona

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We know the plaintiffs’ bar’s feelings about the FDA’s 510(k) clearance process. They tell the jury and the court it is antiquated. They say it does not constitute a finding of safety or efficacy. They do all they can to paint the FDA’s regulatory clearance process as meaningless and not worthy of consideration by a judge or jury. Such arguments may have some vitality in some jurisdictions. But, as we learned twice again in the last month, not in Arizona.

Back in 2012, the Arizona legislature passed a law stating that a manufacturer may not be held liable for exemplary or punitive damages if “[t]he product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented . . . according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.” A.R.S. § 12-689(A)(1). The statute broadly defined “manufacturer” to include those engaged in designing, manufacturing, or formulating a product. A.R.S. § 12-689(D)(3). And it further defined “government agency” to mean any federal or Arizona agency with authority “to issue rules, regulations, orders or standards concerning the design, manufacture, packaging, labeling or advertising of a product[.]” A.R.S. § 12-689(D)(2).

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Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device Manufacturer

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A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively prune a plaintiff’s ambitious product defect claims. Conn v. C.R. Bard, Inc., No. 4:14-CV-298.

In 2006, plaintiff’s physicians discovered a blood clot in his inferior vena cava. An IVC filter was inserted to prevent the blood clot from causing potentially fatal further injury. Because of plaintiff’s young age, the physician chose a removable filter. Plaintiff reported abdominal pain just four days after the IVC filter was placed. The blood clot was found to have moved and extended through and above the recently placed filter, and the physicians initiated anticoagulant therapy.

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New Phthalates Study Garnering Media Attention Purports to Show Only an Association – Not Causation – with Certain Mortalities

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A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations.  Some media coverage of this study blurs the important distinction between “association” and “causation.”

What Are Phthalates?

Phthalates, sometimes called plasticizers, are a group of chemicals generally used to make plastics more durable, or to dissolve other materials.  Phthalates may be found in products such as vinyl flooring, food wraps, intravenous tubing, lubricating oils, and some personal care products such as shampoos, soaps, and hairsprays.

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