Lawsuits pile up over DePuy hip implant

DePuy logo

Lawsuits over an allegedly faulty hip implant are piling up for DePuy Orthopaedics, with three more patients suing the Johnson & Johnson (NYSE:JNJ) subsidiary over its ASR acetabular cup.

Cynthia Magowan, Harold Schoening and Katherin Balestra-Walter each received the device, according to a lawsuit filed in the California Superior Court for San Francisco, and each had to have revision surgery after the cup partially detached from their hip sockets.

The trio accuse DePuy of liability for manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product.

It’s the latest of what’s likely to become an avalanche of liability lawsuits over the implant, after a Florida woman, Kathleen Margenau, sued on similar grounds earlier this month. Spencer Pahlke, a lawyer for the firm representing Magowan, Schoening and Balestra-Walter, told MassDevice that his firm, Walkup, Melodia, Kelly & Schoenberger, has several more suits in the works.

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 lawsuits.

"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]," according to Margenau’s lawsuit. "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."

Magowan, Schoening and Balestra-Walter make similar claims in their lawsuit, according to court documents.

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. A DePuy spokeswoman said the company does not comment on pending legal matters.

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

Leave a Reply