Subject: Medical Devices

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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FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

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The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.

The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.

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Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

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A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer.  Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”).   Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

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FDA Solicits Feedback to Create Consistent Process for Labeling Devices

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The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20, 2021, the FDA published a discussion paper titled Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework. With a goal of stimulating discussion among stakeholders, the paper outlines several factors to consider for labeling devices so that providers can make well-informed decisions about which devices may be most appropriate for their patients.

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Summary of HB1125: Deceptive Lead Generation

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Lawsuit advertisements—specifically ones that target prescription drugs and medical devices—can be dangerous.  Nationwide, dramatized and exaggerated legal ads have flooded both televisions and the internet, often masquerading as “medical alerts.”  Some estimates have total spending on legal advertisements at around $1 billion annually.  As a result, state legislatures are beginning to take action to combat deceptive advertising and come up with solutions, including in Indiana, which recently passed House Bill 1125.  House Bill 1125 places several limitations on the practice of lead generation – the use of commercial communications to initiate consumer interest or inquiry into legal services intended to redress an alleged injury from a medical device or legend drug – and provides a private right of action for manufacturers and sellers of medical devices and legend drugs against deceptive lead generators.

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Eleventh Circuit Holds Expert Qualified in Surgical Tool Suit Despite Lack of Experience Using the Product

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The Eleventh Circuit recently reinstated a case alleging a surgical tool caused internal burns during a hysterectomy surgery, holding that the district court erred in disqualifying an expert on the basis that he had never before used the tool.  The decision is a reminder of the importance of asserting and maintaining precise and strategic Daubert challenges.

In Moore v. Intuitive Surgical, Inc., No. 19-10869, the plaintiff underwent a laparoscopic hysterectomy in which her surgeon used a robotic miniature electrified scissor tool manufactured by the defendant.  Following surgery, the plaintiff experienced, among other things, abdominal pain and eventually learned she had sustained internal burns to her left ureter during the surgical procedure.  The tool was recalled by the manufacturer a few months after the plaintiff’s procedure, and the plaintiff filed suit.

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