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

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Boston Scientific reveals California AG probe, whistleblower suit

Boston Scientific reveals California AG probe, whistleblower suit

November 7, 2012 By MassDevice staff

Boston Scientific

Boston Scientific (NYSE:BSX) said the office of California attorney general Kamala Harris launched a probe this month of its transvaginal surgical mesh sales.

The Natick, Mass.-based medical device company also said a whistleblower lawsuit was filed against its neuromodulation business alleging violations of the False Claims Act "through submission of fraudulent bills for implanted device," according to a regulatory filing.

Boston Scientific said Harris’ office and "several other state attorneys general offices intend to initiate a civil investigation into our sales of transvaginal surgical mesh products."

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

As of yesterday more than 2,500 product liability suits had been filed against BSX over the mesh devices, "alleging personal injury associated with use of our transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse," according to the filing.

"Generally, the plaintiffs allege design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims. Many of the cases have been specially assigned to 1 judge in state court in Massachusetts," Boston Scientific said, noting that lawsuits filed in federal courts have been consolidated into a single case before the U.S. District Court for Southern West Virginia.

Boston Scientific also said that a lawsuit unsealed in August alleges that its Valencia, Calif.-based neuromodulation business alleges that it ran a scheme to defraud Medicare and promote off-label use of its Precision Plus spinal cord stimulation system.

The lawsuit, filed in the U.S. District Court for New Jersey in March 2011, contains 29 counts alleging that the company sold the devices without certificates of medical necessity and faked diagnostic codes for the Precision Plus device. The suit also accuses Boston Scientific Neuromodulation Corp. of falsely certifying its truthfulness and compliance on claim forms. The company sometimes allegedly shipped the device before receiving orders from physicians, allegedly faking records to alter the shipping date.

The suit also alleges that BSNC also promoted the system for off-label uses, including treatment of phantom leg pain and urinary incontinence, and faked adverse event records "for the purpose of hiding such to [sic] the FDA," according to court documents.

Boston Scientific asked Judge Susan Wigenton in October to dismiss the qui tam case, which the U.S. government declined to join, according to the documents.

Filed Under: Legal News, Neuromodulation/Neurostimulation, News Well, Product Liability, Urology Tagged With: Boston Scientific

In case you missed it

  • iRhythm stays silent on federal grand jury subpoenas
  • Texas power grid struggles a year after cold stopped semiconductor plants
  • The road to a robot: Medtronic’s development process for Hugo RAS system
  • How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
  • Zimmer Biomet appoints new chief accounting officer
  • Cook Medical makes next-gen in vitro fertilization incubator available in U.S., Canada
  • Boston Scientific co-founder Peter Nicholas is dead at 80
  • How Boston Scientific uses clinical feedback to advance innovation
  • How Stryker includes users for product design in the digital age
  • DermaSensor wins MedTech Innovator Mid-Stage Companies Pitch Event
  • FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
  • Medtronic completes Intersect ENT acquisition
  • Steris rises on Street-beating Q4, sets fiscal 2023 guidance
  • Medtronic must sell Intersect ENT subsidiary to satisfy FTC concerns
  • Abbott partners with Women as One to help more underrepresented clinicians lead trials
  • Lucira Health asks FDA for EUA on molecular at-home COVID/flu test
  • Device commercialization platform AcuityMD raises $31M Series A to fund R&D engineer hiring

RSS From Medical Design & Outsourcing

  • iRhythm stays silent on federal grand jury subpoenas
    More than one year after receiving the first of two federal grand jury subpoenas seeking information about its products and communications with the FDA, iRhythm Technologies has said little publicly about the matter. It would have been easy to miss the San Francisco-based cardiac monitor maker’s initial disclosure last summer. iRhythm (Nasdaq:IRTC) was without a… […]
  • How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
    A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor. The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions next month. The company also presented… […]
  • Texas power grid struggles in heat one year after record cold stopped semiconductor plants
    A heat wave in Texas took at least six power plants offline Friday with high temperatures forecasted to blaze throughout this week. A record cold snap in February 2021 took NXP Semiconductors and Samsung chip fabrication facilities offline for weeks, contributing to a global semicondcutor shortage that is still throttling medical device production. There’s no… […]
  • How Stryker includes users for product design in the digital age
    Medical device developers and manufacturers like Stryker (NYSE:SYK) are changing how they approach design as digital technology becomes more crucial. Four Stryker executives shared how the Kalamazoo, Michigan–based orthopedic device giant is thinking differently about medical product development and how health care providers and patients will ultimately use them. The DeviceTalks Boston panel of Stryker… […]
  • DermaSensor wins MedTech Innovator Mid-Stage Companies Pitch Event
    DermaSensor Inc. — the creator of a handheld, point-and-click device to quickly assess skin lesions for cancer risk — is the winner of the MedTech Innovator Mid-Stage Companies Pitch Event.  The Miami-based mid-stage company beat out 1,000 applicants, more than 20 of which competed on-site May 10–11, 2022 at DeviceTalks Boston. DermaSensor walked away with… […]
  • Steris rises on Street-beating Q4, sets fiscal 2023 guidance
    Steris (NYSE:STE) shares ticked up today on fourth-quarter financial results that came in just ahead of the consensus forecast. The infection prevention technology company — headquartered in Dublin, Ireland, and run operationally out of Mentor, Ohio — posted profits of $52.3 million, or 52¢ per share, on sales of $1.2 billion for the three months… […]
  • Lucira Health asks FDA for EUA on molecular at-home COVID/flu test
    Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test. Emeryville, California–based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a… […]
  • Device commercialization platform AcuityMD raises $31M Series A to fund R&D engineer hiring
    AcuityMD said today it has raised $31 million in Series A funding for its medical device commercialization platform. “With our new funding, we plan to double down on R&D by growing our engineering team from 15 to over 40 over the next year,” AcuityMD co-founder and CEO Michael Monovoukas said in a blog post. “We’ll… […]
  • Rockley Photonics announces $81.5M private placement
    Rockley Photonics (NYSE:RKLY) announced today that it entered into agreements for an $81.5 million private placement. Participating investors agreed to purchase $81.5 million in convertible senior secured notes (due 2026) and warrants to purchase 26.5 million Rockley ordinary shares at an exercise price of $5 per share, subject to certain anti-dilution adjustments. Warrants purchased in… […]
  • Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’
    The first day of DeviceTalks Boston closed with a panel of Stryker (NYSE:SYK) executives discussing new tools, technologies and strategies in medtech. Digital VP Tracy Robertson, Digital, Robotics, and Enabling Technologies President Robert Cohen and Surgical Technologies VP of Digital Innovation Siddarth Satish offered their thoughts on industry trends in healthcare and at the Kalamazoo,… […]
  • Medtronic’s VC leader discusses risk, returns, strategy and an ‘ugly truth’
    A panel of medtech investors convened today for DeviceTalks Boston included David Neustaedter, VP of venture capital at Medtronic (NYSE: MDT). He’s spent 14 years in the role, including as director of venture capital at Covidien before Medtronic acquired the company. (Read more in his DeviceTalks speaker bio.) Medtronic has more than $500 million in… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MEDTECH 100 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.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

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

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS