C.R. Bard Archives - Medical Design Sourcing

These devices are the top targets of lawsuit-related advertisements

Surgical mesh products continue to drive medical device lawsuit spending. [Photo via Adobe Stock]

Spending on advertisements related to medical device lawsuits this year is on track to exceed last year’s tally.

That’s according to figures provided by Washington, D.C.-based X Ante, which uses data from ad intelligence firm Vivvix. X Ante supplies reports on medical device lawsuit ad spending to the Advanced Medical Technology Association (AdvaMed), which is calling for new federal regulations of mass tort advertising to protect device manufacturers from lawsuits bankrolled by third-party funders.

For the first half of 2023, $6.2 million worth of legal ads targeted five kinds of medical devices:

Pelvic mesh: $3.5 million Hernia mesh: $1.9 million CPAP machines: $532,000 Physiomesh: $262,000 Military earplugs: $54,000

Spending on the top five device categories totaled just under $11 mil…

What’s so special about Apollo Endosurgery’s stomach-shrinking weight loss tech?

The Apollo Endosurgery OverStitch Sx endoscopic suturing system [Image courtesy of Apollo Endosurgery]

Apollo Endosurgery — set to be purchased by Boston Scientific for $615 million — develops new devices and minimally invasive procedures for weight loss.

The procedure is called endoscopic sleeve gastroplasty (ESG) and the device that made it possible is the OverStitch endoscopic suturing system.

Austin, Texas-based Apollo Endosurgery first won 510(k) clearance for OverStitch in 2008, with successive clearances for improved designs over the years. Most recently, in July the FDA granted de novo clearance for Apollo Endosurgery’s Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx systems. They’re the first FDA-authorized devices for ESG and endoscopic bariatric revision procedures.

Medical Design & Outsourcing spoke with Apollo Endosurgery Chief Medical Officer Dr. Christo…

Report: BD’s Bard unit to pay $4.8M in hernia mesh lawsuit

The C.R. Bard unit of BD (NYSE:BDX) was ordered to pay $4.8 million in a lawsuit related to its hernia mesh, Reuters reports.

The news agency said the company must pay nearly $5 million in a lawsuit brought by a Hawaii man who said he suffered serious complications from the implanted hernia repair mesh. BD will appeal the decision, a spokesperson told Reuters.

Paul Trevino and his wife, Earlynn, alleged in a 2018 lawsuit that the Ventralex hernia repair mesh from BD’s Bard business dug into his tissue, causing pain and inflammation while eventually leading to required corrective surgery, according to the report.

A Rhode Island jury handed down the verdict following a month-long trial, Reuters said. BD faces more than 30,000 lawsuits of a similar kind related to hernia mesh devices.

Mesh devices have been the subject of legal challenges over the years, proving to potentially be one of medtech’s greatest modern failures. Pelvic mesh prod…

N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard

A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard.

In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according to the appeals court panel.

In the case against J&J’s Ethicon, a jury had awarded Elizabeth and Tadeusz Hrymoc $5 million in compensatory damages and $10 million in punitive damages after finding the companies liable for violating New Jersey laws on defective design of their ProLift pelvic mesh and failing to warn patients of product risk.

The jury in the case brought by Mary McGinnis and Thomas Walsh McGinnis found Bard liable for design and failure-to-warn defects under the product liability laws of North Carolina, the plaintiffs’ home state, …

DTW Podcast: Vizient on PPE, Vicarious on VR-aided robotics and let’s all hope for pumpernickel

This week’s episode of DeviceTalks Weekly is brought to you by the later V, as in Vizient and Vicarious Surgical.

Bharat Sundaram, COO and president of Vizient, will share how the healthcare supplier is strengthening the supply of PPE for hospitals. He’ll also reveal when the company expects to see US hospitals running at pre-COVID levels. Hint: It’ll be a while.

Adam Sachs, CEO of Vicarious Surgical, tells us how the company will put a new round of capital from high-powered investors including Bill Gates and Vinod Khosla to work in developing to develop a surgical system employing robotic and virtual reality technologies. How does the start-up expect to compete with the established leaders in the robotics space?

Co-host Chris Newmarker, executive editor, life sciences, will walk us through the five biggest newsmakers on the MassDevice site involving C.R. Bard, Theranos, and Medtronic. Number one may surprise you, but given the time, perhaps …

Federal appeals court rejects preemption argument from BD’s Bard

[Image from Unsplash]

The 9th U.S. Circuit Court of Appeals has handed down an important medical device preemption opinion as it affirmed a $3.6 million award against Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard in a bellwether lawsuit case over inferior vena cava filters.

Bard’s lawyers had argued that when FDA reclassified intravascular filters as Class II devices, the agency’s special controls for such devices provided preemption against lawsuits for Bard’s G2 IVC filter. A U.S. District Court judge in Arizona should have granted Bard’s summary judgment motion involving Sherr-Una Booker’s lawsuit, Bard said.

The 9th Circuit disagreed in the opinion it handed down yesterday: “We assume, without deciding, that the special controls are requirements, but we nevertheless conclude that they are not ‘specific’ requirements ‘applicable to a pa…