Navigation
http://www.businessweek.com/ap/2013...
http://www.usatoday.com/story/news/...
http://docs.justia.com/cases/federa...
http://www.facebook.com/pages/The-K...
Réponse de Sonova : http://www.sonova.com/
Staefa (Switzerland), 17.04.2013 - Sonova Holding AG, the world’s leading provider of hearing solutions, acknowledges today the verdict of the Kentucky Western District Court. The case was brought by a patient whose cochlear implant malfunctioned as a result of moisture ingress. The device in question was part of a voluntary recall issued by Advanced Bionics in March 2006. A jury yesterday awarded the plaintiff damages totaling USD 7.25 million. Sonova will carefully review the verdict and considers an appeal.
In light of the verdict, Sonova will reassess its provisions for claims of this category which can affect the financial year 2012/13 results due to be reported in May. The financial impact of such reassessment has not been included in the current guidance for financial year 2012/13.
In 2006, Advanced Bionics identified an issue related to the feedthrough assembly provided by one (commonly referred to as Vendor B) of two approved vendors, affecting some, but not all HiRes 90K devices manufactured prior to March 2006. The company promptly initiated a voluntary recall of all unimplanted devices that contained the Vendor B feedthrough component and immediately ceased the use of feedthroughs from Vendor B.
The recall was already resolved prior to the acquisition of Advanced Bionics by Sonova in 2009. The HiRes 90K implant manufactured today is the most reliable device ever manufactured by Advanced Bionics leading the industry with a 99.8%1 reliability rate. Advanced Bionics is a global leader in cochlear implants firmly committed to the continuous improvement of the quality of its products and the reliability of its implants.
1 Advanced Bionics Reliability Update 2012.
Advanced Bionics Announces Voluntary Recall of the HiRes 90K Cochlear Implant
Device will be Recalled from the Market while the Company Works with the US Food & Drug Administration to Address the Issue
Valencia, CA, November 23, 2010 - Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.
AB is continuing to evaluate the root cause(s) of the problem and is working closely with the FDA to address their questions and concerns, and institute changes to the product to ensure that the HiRes 90K has the highest quality for patients who use the device. This voluntary action is being taken to ensure continued patient safety and product quality. The risk of any significant adverse medical events appears to be remote at present.
http://www.advancedbionics.com/com/...
L’administration américaine (Food and Drug Administration) a requis une peine de 2,2 millions de dollars contre Advanced Bionics, fabricant d’implants cochléaires.
Ces implants cochléaires font courir un risque pour la santé publique, dû à un fort taux d’humidité, exposant les patients à des risques d’échec du dispositif pouvant entraîner une perte d’audition supplémentaire.
La FDA a également accusé l’entreprise d’avoir expédié des appareils auditifs à des clients américains avant de les informer du changement de dispositif qui affectait la sécurité et l’efficacité de leur matériel.
http://www.fda.gov/bbs/topics/NEWS/...
FDA Seeks Civil Penalties from Calif. Device Maker
This press release contains revisions posted April 8, 2008, to include additional information on the March 2006 recall [1].
The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing device manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.
The cochlear implants pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.
The agency’s complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.
The complaint alleges that Advanced Bionics shipped cochlear implants to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The cochlear implant is considered a Class III device by the FDA-the most stringent regulatory category for devices.
The complaint alleges that the company failed to comply with the FDA’s current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.
Advanced Bionic’s alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the cochlear implant by testing lots under actual or simulated use when the unapproved vendor’s component was used.
The complaint also states that Advanced Bionics shipped cochlear implants in violation of the law between January 2005 and July 2006. Two cochlear implants shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
In addition to conducting a March 2006 recall of unimplanted devices containing the component from the unapproved vendor, Advanced Bionics also notified patients with such implants and instructed them to contact their health care providers if they suffered symptoms of device failure.
FDA’s complaint states that the company’s failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.
Advanced Bionics, LLC, is located in Sylmar, Calif.
Réponse du P.D.G. d’Advanced Bionics, sur son site internet :
Chers tous,
Vous êtes nombreux à avoir entendu parler de l’intention de la FDA d’infliger une amende à Advanced Bionics. Cette annonce concerne une affaire vieille de cinq ans, survenue en 2003. Il s’agit donc d’une histoire ancienne ! Nous sommes en train de trouver une solution avec la FDA, mais le processus est complexe et prend du temps. En attendant, nous souhaitons vous communiquer quelques éléments importants :
1. L’amende concerne principalement des jugements de la FDA sur notre système d’assurance qualité de l’époque, c’est-à-dire en 2003.
2. Nous collaborons activement avec la FDA pour essayer de trouver une solution à ces problèmes.
3. Le processus est complexe et prend du temps.
4. L’amende prévue par la FDA n’a aucune conséquence sur la capacité d’Advanced Bionics à exercer son activité.
5. Le HiRes90K est un produit extrêmement fiable et, avec le Harmony, il constitue le système d’implant le plus résistant du marché.
Jeffrey H. Greiner
Président Directeur Général
Advanced Bionics LLC
http://www.bionicear-europe.com/fr/...
Autres plaintes...
MOCHI et al v. Advanced Bionics Corporation et al
Plaintiffs : LINDA MOCHI and NICHOLAS MOCHI
Defendants : Advanced Bionics Corporation, Advanced Bionics, LLC and Astro Seal, Inc.
Case Number : 1:2013cv10730
Filed : March 29, 2013
Court : Massachusetts District Court
Office : Boston Office
County : Suffolk
Presiding Judge : Edward F. Harrington
Nature of Suit : Other - Personal Injury : Health Care/Pharmaceutical Personal Injury Product Liability
Rarus et al v. Advanced Bionics Corporation et al
Plaintiffs : Tim Rarus and Brandi Rarus
Defendants : Advanced Bionics Corporation, Advanced Bionics, LLC, Astro Seal, Inc. and Boston Scientific Corporation
Case Number : 8:2012cv01664
Filed : July 26, 2012
Court : Florida Middle District Court
Office : Tampa Office
County : XX Outside US
Presiding Judge : Elizabeth A. Kovachevich
Referring Judge : Mark A. Pizzo
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Cardinale et al v. Advanced Bionics Corporation et al
Plaintiffs : Meredith Cardinale , Vincent Cardinale and Jeremy Cardinale
Defendants : Advanced Bionics Corporation, Advanced Bionics, LLC, Astro Seal, Inc. and Boston Scientific Corporation
Case Number : 1:2012cv05595
Filed : July 20, 2012
Court : New York Southern District Court
Office : Foley Square Office
County : Richmond
Presiding Judge : George B. Daniels
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Wear v. Advanced Bionics Corporation et al
Plaintiff : Courtney Wear
Defendants : Advanced Bionics Corporation, Advanced Bionics, LLC and Astro Seal, Inc.
Case Number : 4:2012cv00896
Filed : July 11, 2012
Court : Missouri Western District Court
Office : Kansas City Office
County : Jackson
Presiding Judge : Gary A. Fenner
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Hasselbring et al v. Advanced Bionics Corporation et al
Plaintiffs : Guy Hasselbring and Rosemary Hasselbring
Defendants : Advanced Bionics Corporation, Advanced Bionics, LLC and Astro Seal, Inc.
Case Number : 4:2012cv00616
Filed : May 23, 2012
Court : Missouri Western District Court
Office : Kansas City Office
County : Jackson
Presiding Judge : Greg Kays
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Hicks v. Advanced Bionics Corporation et al
Plaintiff : Jo Ann Hicks
Defendants : Advanced Bionics Corporation, Advanced Bionics, LLC, Advanced Bionics Holding Corporation and Astro Seal, Inc.
Case Number : 1:2012cv00275
Filed : January 27, 2012
Court : Maryland District Court
Office : Baltimore Office
County : 88888
Presiding Judge : Richard D Bennett
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Barnett et al v. Advanced Bionics Corporation et al
Plaintiffs : Lewis Barnett and Sandra Barnett
Defendants : Advanced Bionics Corporation, Advanced Bionics, LLC, Advanced Bionics Holding Corporation and Astro Seal, Inc.
Case Number : 1:2012cv00193
Filed : January 19, 2012
Court : Maryland District Court
Office : Baltimore Office
County : Talbot
Presiding Judge : Richard D Bennett
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
V.B., a minor b/n/f TRINA D. LINDBLOM v. ADVANCED BIONICS, LLC
Plaintiff : V.B., a minor b/n/f TRINA D. LINDBLOM
Defendant : ADVANCED BIONICS, LLC,
Case Number : 1:2011cv24496
Filed : December 14, 2011
Court : Florida Southern District Court
Office : Miami Office
County : Miami-Dade
Presiding Judge : Ursula Ungaro
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Eggerling et al v. Advanced Bionics, LLC
Plaintiffs : Dennis Eggerling and Melissa Eggerling
Defendant : Advanced Bionics, LLC
Case Number : 5:2011cv04104
Filed : November 28, 2011
Court : Iowa Northern District Court
Office : Western Division Office
County : Monona
Presiding Judge : Mark W Bennett
Referring Judge : Paul A Zoss
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Plaintiffs filed this action on November 28, 2011, on behalf of themselves and their minor daughter, “A.E.” Their complaint alleges that A.E. suffered permanent hearing loss and was forced to undergo open-head surgery due to an allegedly-defective medical device supplied by defendant Advanced Bionics, LLC.
Hurdt v. Advanced Bionics LLC
Plaintiff : Stephanie Hurdt
Defendant : Advanced Bionics LLC
Case Number : 3:2011cv02309
Filed : September 7, 2011
Court : Texas Northern District Court
Office : Dallas Office
County : Lubbock
Presiding Judge : Sam A Lindsay
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
STOUT et al v. ADVANCED BIONICS, LLC
Plaintiffs : REBECCA STOUT and JOHN STOUT
Defendant : ADVANCED BIONICS, LLC
Case Number : 2:2011cv01061
Filed : August 16, 2011
Court : Pennsylvania Western District Court
Office : Pittsburgh Office
County : Allegheny
Presiding Judge : David S. Cercone
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
J.R. et al v. Advanced Bionics, LLC et al
Plaintiffs : J.R. , David Reid and Corinne Reid
Defendants : Advanced Bionics, LLC , Advanced Bionics Corporation , Astro Seal, Inc. and Does 1-10
Case Number : 5:2011cv00843
Filed : July 19, 2011
Court : New York Northern District Court
Office : Syracuse Office
County : Onondaga
Presiding Judge : Gary L. Sharpe
Referring Judge : George H. Lowe
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Littlebear v. Advanced Bionics, LLC
Plaintiff : Paul Littlebear
Defendant : Advanced Bionics, LLC
Case Number : 4:2011cv00418
Filed : July 1, 2011
Court : Oklahoma Northern District Court
Office : Tulsa Office
County : XX US, Outside State
Presiding Judge : Gregory K Frizzell
Referring Judge : Paul J Cleary
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Paul Littlebear had a HiRes90K utilizing an AstroSeal feedthru implanted on July 26, 2004. The HiRes90K was explanted on July 29, 2010. Littlebear’s device contained 46% water vapor when explanted and failed due to excessive moisture leaking through the AstroSeal feedthru.
Estep et al v. Advanced Bionics, LLC
Plaintiffs : Carl Estep and Melanie Estep
Defendant : Advanced Bionics, LLC
Case Number : 2:2009cv00119
Filed : December 10, 2009
Court : Tennessee Middle District Court
Office : Cookeville Office
County : Putnam
Presiding Judge : District Judge William J. Haynes Jr.
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Shelyubskiy et al v. Advanced Bionics, LLC et al
Case Number : 1:2009cv05118
Filed : November 20, 2009
Court : New York Eastern District Court
Office : Personal Inj. Prod. Liability Office
Presiding Judge : Senior Judge I. Leo Glasser
Referring Judge : Magistrate Judge James Orenstein
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
E.O. v. Advanced Bionics LLC et al
Plaintiff : E.O.
Defendants : Advanced Bionics LLC and Advanced Bionics Holding Corporation
Case Number : 1:2009cv01021
Filed : January 15, 2009
Court : Illinois Central District Court
Office : Personal Inj. Prod. Liability Office
County : McLean
Presiding Judge : Judge Joe Billy McDade
Referring Judge : Magistrate Judge Byron G. Cudmore
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Bonifazi v. Advanced Bionics, LLC et al
Plaintiff : Coleen Bonifazi
Defendants : Advanced Bionics, LLC and Boston Scientific Corporation
Case Number : 1:2008cv07402
Filed : December 29, 2008
Court : Illinois Northern District Court
Office : Personal Inj. Prod. Liability Office
County : Cook
Presiding Judge : Honorable William T. Hart
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Badore et al v. Advanced Bionics, LLC
Plaintiffs : Jayne A. Badore and Advanced Bionics Holding Corporation
Defendant : Advanced Bionics, LLC
Case Number : 1:2008cv11963
Filed : November 25, 2008
Court : Massachusetts District Court
Office : Personal Inj. Prod. Liability Office
County : Suffolk
Presiding Judge : Judge Douglas P. Woodlock
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Purchase v. Advanced Bionics, LLC et al
Plaintiff : Christine Purchase
Defendants : Advanced Bionics, LLC, Advanced Bionics Holding Corporation and Astro Seal, Inc.
Miscellaneous : Jimmy Moore
Case Number : 2:2008cv02442
Filed : July 9, 2008
Court : Tennessee Western District Court
Office : Memphis Office
County : Shelby
Presiding Judge : Chief Judge Jon Phipps McCalla
Referring Judge : Magistrate Judge Diane K. Vescovo
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
Cause : 28:1441 Petition for Removal- Product Liability
Johnson v. Advanced Bionics, LLC et al
Plaintiff : Terra Johnson
Defendants : Advanced Bionics, LLC, Advanced Bionics Holding Corporation and Astro Seal, Inc.
Miscellaneous : Jimmy Moore
Case Number : 2:2008cv02376
Filed : June 9, 2008
Court : Tennessee Western District Court
Office : Personal Inj. Prod. Liability Office
County : Shelby
Presiding Judge : Chief Judge Jon Phipps McCalla
Referring Judge : Magistrate Judge Diane K. Vescovo
Nature of Suit : Torts - Injury - Personal Injury- Product Liability
This products liability case involves two cochlear implants manufactured by Advanced Bionics. Plaintiffs claim the cochlear implants that Chase Purchase-Weatherly (“Chase”) received in June 2004, and that Tamario Miller (“Tamario”) received in December 2005, contained a faulty component called a feedthru that allowed moisture to get into the implants, causing failure.
Selon le cabinet d’avocats Glassman, Edwards, Wyatt, Tuttle & Cox, Sonova (Advanced Bionics) fait l’objet de plus de 60 plaintes aux Etats-Unis pour des implants auditifs défectueux.
http://www.gewwlaw.com/
http://www.romandie.com/news/n/PRES...
