Supreme Court seeks White House opinion in Medtronic pain pump case

Supreme Court seeks White House opinion in Medtronic pain pump case

Medtronic (NYSE:MDT) has had a lot of action in the courts today, with the Supreme Court sending a negligence lawsuit against the company up to the federal government for a 2nd opinion.

The Justices asked the White House to weigh in on a lawsuit that questions preemption laws for medical devices, which have shielded many companies by immunizing FDA-approved devices from patient complaints.

The lawsuit, Medtronic v. Stengel, has gone circles in the court system for years, with the latest coming to the attention of the Supreme Court after an appeals court ruled that preemption laws don’t protect Medtronic from negligence claims.

Preemption holds that patients can’t sue medical device makers in state courts over products that went through the FDA’s most stringent review process, called pre-market approval. But the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.

In 2000, plaintiff Richard Stengel began using Medtronic’s SynchroMed EL pain pump, an implanted device that delivers medication directly to the spine via an intrathecal catheter. In 2005, Stengel began developing symptoms of paralysis from an inflammation in his spine around the catheter tip. The device and most of the inflammation were removed, "but not in time to prevent the granuloma from rendering Stengel permanently paraplegic," according to court documents.

The FDA approved the first SynchroMed pump in 1998 and later granted approval for the iteration used to treat Stengel. Medtronic recalled that device in 2008.

Medtronic last year won a preemption ruling, but the case resurfaced with Stengel’s lawyers claiming that Medtronic was negligent in reporting issues with the implantable pain pump. Medtronic asked the Supreme Court to hear the case after a judge in January ruled that Stengel can proceed with his claims.

The lawsuit is part of a growing trend, with patients and their lawyers making negligence claims in order to get around preemption laws. The same strategy arose in plaintiffs seeking damages in cases over Medtronic’s troubled Infuse bone-growth protein, with judges in 2 states so far issuing seemingly conflicting rulings about the validity of such lawsuits.

The Minnesota medical device titan has had a lot of high-profile court action lately, with the Supreme Court ruling this week that it won’t hear Medtronic’s (NYSE:MDT) appeal of a $74 million win scored by Edwards Lifesciences (NYSE:EW) in their patent war over heart valve technology.

Medtronic had some better luck in August, when the U.S. Solicitor General filed an amicus brief effectively siding with Medtronic, arguing that Boston Scientific (NYSE:BSX) bears the burden of proof in a long-running patent infringement beef that’s also headed for the Supreme Court.

MDT shares were down 1.2%, trading at $52.72 as of about 4:15 p.m. today.

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