Infuse lawsuits pile up for Medtronic | Legal News

Infuse

Personal injury lawsuits over its controversial Infuse bone-growth protein are beginning to pile up for Medtronic Inc. (NYSE:MDT), after the Spine Journal revealed serious concerns about the device’s safety this summer.

In June, the journal took the unprecedented step of devoting an entire issue to the Infuse controversy. Its investigation found problems with 13 studies by MDT-sponsored physicians, all of which downplayed or omitted the rates of adverse events associated with the protein, known as recombinant human bone morphogenetic protein-2.

Although the furor ignited by the study eventually died down on Wall Street (where analysts warned of a possible 3-cent-per-share dip in overall profits), Medtronic and Infuse are under intense scrutiny elsewhere. The U.S. Justice Dept. and the U.S. Senate are each conducting probes into the bone morphogenetic compound and its Fridley, Minn.-based maker’s marketing practices.

Sign up to get our free newsletters delivered straight to your inbox

Now Jennifer English is the latest in what’s likely to become a long line of plaintiffs to file personal injury suits against the Fridley, Minn.-based medical device colossus. The of Lake Worth, Fla., woman was implanted with an Infuse device in August 2007, according to court documents. But the rhBMP-2 embedded in the device allegedly caused ectopic bone growth that compressed nerves and required two revision surgeries to remove the out-of-control bone growth.

“I trusted Medtronic with my life,” English said in prepared remarks. “It is disappointing to find out Medtronic is not looking out for the best interests of the patient, but for own its financial interests.”
English’s complaint accuses Medtronic of fraudulently misrepresenting the device’s risks and of improperly promoting and marketing Infuse for off-label uses, according to documents filed with the U.S. District Court for Southern Florida.

Medtronic spokesman Steve Cragle told MassDevice in July that the company hasn’t “heard any feedback from our customers that they are reducing their expected use.” Infuse, Cragle told us, is a “physician-pull product,” meaning that Medtronic reps don’t actively promote it and aren’t compensated for any Infuse sales.

“So it’s up to the physician to determine when to use our product,” Cragle wrote in an email.

Medtronic pulls down between $700 million and $750 million from Infuse alone, analysts estimate.

Read more medical device legal news from MassDevice.com

Beckman Coulter settles class-action shareholders’ suit for $5.5 million

Beckman Coulter Inc. agreed to pony up $5.5 million to settle a class-action shareholders’ lawsuit accusing it of failing to disclose regulatory and quality issues in time to prevent damage to its share price.

The Brea, Calif.-based company, which was acquired by Danaher Corp. (NYSE:DHR) for $6.8 billion in February, asked Judge Josephine Tucker of the U.S. District Court for Central California to approve the settlement agreement between Beckman and the plaintiffs, led by the Arkansas Teacher Retirement System and the Iron Workers District Counsel of New England Pension Fund.

The securities fraud class action alleged that Beckman and its management made “material misstatements and omissions regarding product quality, safety, United States Food and Drug Administration regulatory compliance and the company’s troponin test kits, as well as likely customer retention, recurring revenue, business prospects, and earnings forecasts and guidance,” according to court documents.

“Lead plaintiff alleges that defendants failed to make earlier disclosure of alleged non-compliance with FDA pre-market notification requirements concerning modifications made to the company’s troponin tests, and failed to make earlier disclosure of the effects of noncompliance on the company’s operations, products and prospects,” according to the documents.

If approved by Tucker, would see the plaintiffs receive $ 5 million in cash; Beckamn would pay another $500,000 “for the expenses incurred in providing notice to the class and administering the settlement,” according to the documents.

RSS From Medical Design & Outsourcing

  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]
  • FDA seeks public input on Quality Metrics guidance
    by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation […]
  • First ‘Ear Wear’ for Active Adults Debuts with MDHearingAid FIT
    If you’ve burned out your ears with earbuds, headphones or decades of other audio abuse but aren’t ready for your grandmother’s hearing aids, not to worry! The new MDHearingAid FIT gets you back in the game with a tiny, FDA-registered, one-size-fits-most solution that doesn’t block your ear canal like old-fashioned in-the-ear hearing aids. The FIT feels […]
  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]

Leave a Reply