Long-awaited ruling in Medtronic Infuse lawsuit could have ripple effect on industry

Medtronic logo

Federal pre-emption statutes have thus far stalled personal injury complaints over Medtronic’s (NYSE:MDT) troubled Infuse bone-growth protein, but new lawsuits may find their way to trial by claiming that the medtech titan is liable for injuries because it engaged in off-label marketing.

Such a complaint is pending before Minnesota Hennepin County District Judge Laurie Miller. A ruling is expected this summer, and the decision could have a ripple effect that reaches beyond Medtronic. If Miller rules against Medtronic, the decision could set a precedent that would have major implications for the way courts judge liability of medical device companies, possibly twisting a 5-year-old precedent that also involved a lawsuit against Medtronic.

In 2008 the U.S. Supreme Court ruled 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. The decision has helped block lawsuits against many medtech companies, including some Infuse complaints, but the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.

Lawyers representing patients with complaints against Medtronic may stake their arguments on allegations the the medical device company illegally marketed the Infuse product for uses that were not explicitly cleared by the FDA, the Star Tribune reported.

Medtronic in 2002 won limited approval to market Infuse for use in the lower spine, but other "off-label" uses make up about 85% of Infuse use, according to the Tribune. Physicians are free to use approved medical devices in off-label ways, but the manufacturers are prohibited from promoting those types of practices. Prior lawsuits have accused Medtronic of illegally marketing Infuse for use in the neck, but a years-long criminal and civil investigation closed in May 2012 without finding evidence of wrongdoing.

Ultimately, the new complaints may hinge on a matter of who is liable when a patient is injured by a product that is used in a way other than what has been specified by the FDA, American Assn. for Justice spokesperson Jennifer Fuson told the paper. For lawyers representing patients, the high amount of off-label use is a sign that Medtronic encouraged off-label use.

Minnesota lawyers Lou Bograd and Stuart Goldenberg of the Center for Constitutional Litigation are representing the plaintiff in the lawsuit before Judge Miller, as well as 35 other Infuse patient injury complaints. Thus far decisions in lower courts and gone both ways, and the case is likely to land Medtronic back in the Supreme Court.

The controversy over the Infuse product, which recently included a shareholder lawsuit accusing Medtronic and its leadership of misleading investors, blew up over the summer of 2011 when the Spine Journal dedicated its entire June issue (PDF) to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse.

The journal’s investigation concluded that 13 studies (published by authors who collectively received millions from Medtronic) downplayed or omitted entirely evidence of safety risks from Infuse. The actual rate of "frequent and occasionally catastrophic complications" associated with the product was between "10% to 50% depending on approach."

The ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks. In the fall of 2012 a U.S. Senate report blasted Medtronic over its handling of the Infuse product, saying the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies, charges that the company "vigorously" denied.

RSS From Medical Design & Outsourcing

  • Albright Technologies expands their silicone offerings
    Albright Technologies, a rapid silicone prototyper, has added silicone injection molding tooling and services to its product lineup. Liquid silicone injection molding became a suitable product offering as Albright expanded its offerings to better serve the silicone molding market. While silicone prototypes are commonly manufactured with low volumes in mind; injection molded liquid silicone rubber parts are […]
  • Applied Silver launches SilvaClean, silver treatment for textiles
    Applied Silver, Inc, is launching SilvaClean, a state-of-the-art silver treatment for textiles, at the Association for Professionals in Infection Control and Epidemiology’s (APIC) forty-second Annual Conference taking place at the Music City Center in Nashville, from June 27 through June 29. Hospitals have invested significantly in reducing the potential of infection through products and processes designed […]
  • Two-Component technology for improved quality of life
    In the field of injection molding and mold making, toolcraft covers all processes within the added value chain–from the design and selection of materials through to the creation of finished and qualified products. Complete solutions offered include injection molding for parts in the small and extremely small component areas, e.g. for medical technology. Utilizing two-component […]
  • GDS security protects medical devices from hackers
    As data breaches become more commonplace with serious consequences to personal, corporate and national security, it is clear that there is no shortage of accomplished and effective hackers ready to steal data and trade it on the open market. Global Data Sentinel (GDS) has the ability to provide retroactive security to remove access to email […]
  • BRAEBON and SomnoMed combine products to combat sleep apnea
    BRAEBON Medical Corporation announces that the DentiTrac oral appliance compliance system has passed a regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent oral device. BRAEBON congratulates SomnoMed for being the first company to achieve this milestone. “We are pleased DentiTrac is launching in the US market. Accurate oral appliance […]
  • For advanced shielded plastic connector solution, ODU delivers with latest product
    ODU, a company which designs and manufactures connector solutions and cable assemblies, is announcing ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions, to the US market. ODU MEDI-SNAP EMC is the latest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable […]
  • LifeVac steps towards availability on European markets
    On June 16, 2015, LifeVac Europe received confirmation from the UK Ministry of Health that LifeVac is now registered in the Medicines and Healthcare products Regulatory Agency public access data base. This is the final step towards acquiring the CE mark and making LifeVac available to the entire European market. “We are very excited to […]
  • A few ideas for improving productivity in medical processes
    Drive-based vibration and slosh control can help improve throughput in machines that assemble medical devices and products. Bipin Sen • Ed Lasch Bosch Rexroth Corporation www.boschrexroth-us.com Simply increasing the speed of a system that assembles medical devices, or packages medical products, seems like an easy way to boost throughput – until unwanted vibration (either induced […]
  • ODU announces MEDI-SNAP EMC for next generation medical applications
    ODU, announced ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions to the US market. ODU MEDI-SNAP EMC is the newest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable EMI protection at the same time. ODU MEDI-SNAP EMC is available in […]
  • Evaluating the risk of device misconnections: Designing for medical devices with ISO 80369 in mind
    Beginning in the 1990s, concerns grew regarding the proliferation of medical devices fitted with luer connectors and the reports of patient injuries and deaths arising from misconnections. Thus began a many-years process to develop new industry standards for the small-bore connectors used in medical device applications. The much-anticipated ISO 80369 series of standards for small-bore […]
  • Custom molded filter screen assemblies limit contamination and reduce product failure
    Molded screen insert assemblies from Minnesota Rubber and Plastics are custom designed for water, beverage, off-highway and transportation applications to filter out fluid contaminants and reduce product failure. A wide range of screen options are available in many materials for difficult filtration applications allowing use with different fluids. Filter assembly orifice sizes available range from .71 […]

Leave a Reply