Category: Medical Devices
FDA Knew About Endoscope “Superbug” Risk in 2009
February 20, 2015 -- Reuters reports that contaminated endoscopes have been linked to at least five major outbreaks of infection since 2009, but no new safety requirements have been imposed on manufacturers by the FDA. The outbreaks raise concern that...
Texas CRE Infection Lawyer
CRE infections are blamed on 9,000 infections and 600 deaths a year in the United States. Up to 50% of infections are fatal because the bacteria can resist treatment with virtually every antibiotic. UPDATE: New "Superbug" Infections Reported in Virginia...
Texas ERCP Endoscope Infection Lawyer
Deadly outbreaks of “superbug” infections have been linked to endoscopes that cannot be effectively sterilized. Lawsuits are now being filed by victims who claim the design is defective and unreasonably unsafe UPDATE: Gas Relief Drops Linked to Infection Risk August...
Olympus ERCP Endoscope Linked to Infection Outbreak
February 19, 2015 -- The FDA has warned doctors and hospitals that ERCP endoscopes have a design flaw that “may facilitate the spread of deadly bacteria.” The warnings were issued after a drug-resistant “superbug” on contaminated endoscopes caused a deadly...
C.R. Bard Settles IVC Filter Lawsuit 6 Days Into Trial
A man who was injured by an IVC Filter has been paid a confidential settlement.
Gynecare Morcellex Lawsuit Filed in South Carolina
February 11, 2015 -- A lawsuit has been filed against Ethicon Inc. on behalf of a woman who died of cancer after a Gynecare Morcellex morcellator was used during her hysterectomy. The woman, Cynthia Ostrander of Greenville, South Carolina, underwent...
Woman Seriously Injured by OtisMed Knee Implant
February 9, 2015 -- The OtisMed knee implant is responsible for complications, including early failure and revision surgery in several dozen patients, according to the New York Times. The Times highlighted the case of Carla Muss-Jacobs, a woman who needed...
Medtronic Pays $2.8M Fine for SubQ Stimulation Marketing
February 6, 2015 -- Medtronic has agreed to pay $2.8 million to resolve a whistleblower lawsuit accusing the device-maker of illegal “off-label” promotion of a device for “SubQ stimulation.” Medtronic sells spinal cord stimulation devices that are implanted just beneath...