• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Stryker, Medtronic lose preemption bids in OP-1, Calstrux and Infuse lawsuit

Stryker, Medtronic lose preemption bids in OP-1, Calstrux and Infuse lawsuit

September 25, 2013 By Brad Perriello

Stryker, Medtronic lose preemption bids to toss bone protein case

A California state court ruled out a series of motions seeking to dismiss a lawsuit filed over bone proteins made by Stryker and Medtronic, ruling that federal law does not preempt the case from going forward.

April Cabana sued the medical device companies for alleged off-label promotion of the bone growth products, as well as a hospital and surgeon Dr. Ali Mesiwala for failing to inform her that they were using the experimental products. Cabana allegedly received Stryker’s OP-1 Putty in combination with its Calstrux bone-filler during surgery to relieve her back pain. Stryker’s OP-1 Putty had clearance under a humanitarian-use exemption, which requires hospital board authorization prior to use. The combination of the putty and Calstrux bone-filler had never been examined or approved by the FDA, according to the complaint.

In a 2nd, corrective procedure, surgeons removed the excess bone and fused the remainder using Medtronic’s Infuse bone graft, again in an off-label manner, according to legal documents. Infuse had FDA clearance for use during an anterior procedure, but Cabana claims her surgeon opted for a posterior procedure.

Cabana claims the mixture of the 2 products caused excessive bone growth in her lower back, resulting in nerve compression and debilitating pain that required additional surgery.

After a Sept. 9 hearing, Judge Terry Green of the California Superior Court for Los Angeles County shot down the companies’ motions to dismiss on preemption grounds, ruling that Cabana presented adequate evidence that Stryker promoted the off-label combination of the OP-1 and Calstrux putties strong enough to allow a trial on her claims of liability failure to warn, negligence, negligence per se, breach of warranty and fraud, according to court documents. Citing evidence produced that Medtronic allegedly knew of but did not disclose problems with the Infuse product, Green also allowed Cabana’s claims of negligence, negligence per se, breach of warranty and fraud against that company to go to trial, slated for Feb. 10, 2014, according to the documents.

Last year Stryker copped to a misdemeanor and paid $15 million to settle charges that the company ran an off-label promotion scheme, including falsifying hospital records to authorize use of the OP-1 products, which were cleared only for humanitarian use. Stryker later sold its OP-1 assets to Olympus (TYO:7733).

Medtronic was cleared of wrong-doing just months later, when the U.S. Justice Dept. closed the books on its investigation into Infuse.

Filed Under: Legal News, News Well, Product Liability Tagged With: Minnesota, Resorbable bone materials, Stryker

More recent news

  • Medtronic partners with IRCAD on Hugo, Affera surgical training
  • 23andMe co-founder wins bid to take back control of company
  • Neurent Medical opens new manufacturing facility in Ireland
  • Brain Navi wins FDA nod for neurosurgical robot
  • Adona Medical completes enrollment in first-in-human interatrial shunt trial

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy