Florida woman sues DePuy Orthopedics over hip implant

June 15, 2010 By MassDevice staff Leave a Comment

DePuy Orthopaedics is facing the first of what might be an avalanche of lawsuits over one of its hip implants, after a Florida woman sued the company over an allegedly faulty hip implant.

Kathleen Margenau was implanted with a DePuy ASR acetabular cup in March 2008, according to court documents. Following the surgery, Margenau began experiencing pain and "extreme weakness in her hip and quadriceps," according to the lawsuit. Little more than a year later, her surgeon explanted the device and found that the device had "catastrophically failed." Another device made by one of the Johnson & Johnson (NYSE:JNJ) subsidiary’s competitors was implanted and Margenau returned to her active lifestyle, according to the document.

DePuy, which introduced the ASR in the U.S. in 2005 after winning 510(k) clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuit.

"During this time, defendant DePuy was aware of a high rate of failures of its ASR cups, but did not provide this information to [Margenau’s surgeon]," the lawsuit alleged. "As a result of defendant DePuy failing to provide this crucial information to plaintiff’s orthopedic surgeon, [he] had little reason to suspect that the source of plaintiff’s ongoing pain and weakness was the result of the failure of the ASR cup."

DePuy discontinued the cup and had phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a "higher-than-expected" failure rate in traditional hip replacements, especially in smaller patients or those with weak bones.

Those moves followed two years of reports that the implant was prone to early failure, according to the New York Times. Dr. Stephen Graves, the director of the Australian database, told the newspaper that the company was too slow in pulling the device from the market. The FDA received about 300 complaints about the ASR cup since 2008, according to the Times, with most complainants undergoing revision surgeries to replace the device. And the device’s co-developer, Dr. Thomas Schmalzried, said he and DePuy officials realized that the ASR cup might be more of a challenge to implant properly than competing cups.

“The window for component position that is consistent for good, long-term clinical function is smaller for the ASR,” than other cups, Schmalzried told the newspaper, which reported that he received $3.4 million from DePuy for his work on the ASR and other devices.

DePuy acceded that the device posed "a theoretical potential" to "be more sensitive to component position," but cited data from other studies and examinations of explanted devices that contradicted that finding.

Margenau is seeking a jury trial, compensatory damages and legal fees. The consortium of law firms that’s representing her said it believes the lawsuit is the first to involve the ASR device.

January 2020 Issue: The Leadership in Medical Technology Issue
The next Roaring ’20s The medtech industry received one of the best holiday gifts it could have hoped for just before Congress adjourned for its year-end break: the repeal of the 2.3% medical device excise tax. The tax was part of the Affordable Care Act of 2010 and was one of a number of funding… […]
Integer adds IPG manufacturing and testing tech to Mexico plant
Integer Holdings (NYSE:ITGR) announced it has added implantable pulse generator (IPG) cleanroom assembly and testing capabilities at its Tijuana-North facility The plant is the first Class III active-implantable medtech manufacturing site in Mexico to receive FDA approval, according to the Plano, Texas-based company. Integer has added Class 7 and 8 cleanrooms, and manufacturing and capital… […]
FDA issues draft guidance on multi-use arthroscopy tubing sets
The FDA has issued draft guidance on arthroscopy pump tubing sets intended for multiple-patient use. Clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing/reprocessing the irrigation tubing system between patients. These devices are designed to deliver irrigation to the surgical site, these devices… […]
How LED light can break down ingestible medical devices
Researchers at the Massachusetts Institute of Technology have developed an approach to break down ingestible medical devices in the gastrointestinal tract. Medical devices can be inserted in the gastrointestinal tract to treat, diagnose or monitor a number of GI disorders. However, the devices have to removed through endoscopic surgery once completed. The MIT researchers developed… […]
New 510(k) boosts iRhythm, Verily efforts for AFib screening
The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC) to improve atrial fibrillation treatment. Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. “We’ve worked carefully to meet the FDA’s stringent… […]
Argon Medical debuts IVC filter retrieval kits
Argon Medical Devices (Frisco, Texas) said this week that it has launched single-loop and triple-loop retrieval kits for percutaneous removal of inferior vena cava (IVC) filters that are no longer medically required. The kits are indicated for use via a jugular approach and offer the following features: A coil-reinforced outer sheath with the strength needed… […]
NANS 2020: Neuromodulation news you need to know
Neuromodulation devices from companies including Medtronic (NYSE:MDT), Abbott (NYSE:ABT) and SPR Therapeutics are showing promise treating pain. That’s one of the initial takeaways from study results that medical device companies in the neuromodulation space are touting this weekend at NANS 2020 in Las Vegas. NANS is a joint conference of Congress of Neurological Surgeons and the North American Neuromodulation… […]
Injection Molding Principles
Optimizing custom part designs for injection molding requires a thorough understanding of the process and outcomes. In this e-book, you’ll learn about common molding resins, special molding terms you should know, and most importantly, how to optimize your part with undercuts, even walls, drafts, and more. Download this e-book from Xometry to learn more… The […]
GW Plastics expands Vermont manufacturing and tech center
GW Plastics announced that it has completed a $10 million expansion of its Royalton, Vt., manufacturing and technology center. The company said it has added a 30,000 ft2 to the building to accommodate the growth of its thermoplastic injection molding and medical device contract assembly business. The expansion includes a new 13,000 ft2, Class 8… […]
Certain GE Healthcare patient-monitoring devices vulnerable to cyberattack
The federal government and GE Healthcare (NYSE:GE) announced today that the certain of the company’s patient monitoring devices are vulnerable to cyberattack. If attacked, some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems could stop monitoring patients, silence alarms or produce unnecessary alarms during… […]
Cardinal Health recalls 9 million surgical gowns, sends hospitals scrambling
Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns produced by an unnamed contract manufacturer after discovering quality issues with the product. The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also… […]