Articles in Medical Devices
Zimmer Hip Recall Lawsuits: Patients Seek Compensation For Injuries From Faulty Hip Implant
First sold in the United States in 2006, the Zimmer Durom cup was implanted in more than 12,000 patients prior to its recall in in July 2008 due to a high failure rate. Now patients are filing lawsuits against Zimmer for being forced to undergo a second hip replacement surgery.
Medtronic Subpoenaed Over Heart Devices
On December 9th, Medtronic Inc. said that it had earlier received a subpoena from the Department of Health and Human Services seeking production of documents on a range of issues relating to the company’s heart-rhythm devices
Medtronic gets FDA warning on documentation, responses, quality control in heart implant unit
The FDA found problems with procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues
Pain Killer Pumps May Themselves Cause Irreversible Joint Damage
Federal regulators are demanding changes to labels on devices that deliver pain killers directly to joints after surgery, in response to numerous reports of irreversible cartilage damage
250 million Accusure insulin syringes recalled
A Huntsville, Ala., company is recalling about 250 million Accusure insulin syringes it has distributed nationwide since January 2002 because the products’ needles could detach from the syringes
Firm charged with fraudulently marketing spinal medical device
A medical technology company has been accused by federal prosecutors of fraudulently marketing devices used during spinal and bone surgeries
Patient exposed to radiation at LA hospital sues
A patient who was exposed to an overdose of radiation during a CT scan on Monday sued Cedars-Sinai Medical Center and the maker of the scanner.
United States has no good system to track medical implants
Experts say deaths are the result of a major weakness in the nation’s system for recalling thousands of medical devices routinely implanted in people’s bodies, ranging from screws and plates to artificial knees and hips.
Philips Healthcare recalls 5,400 defibrillators
As reported in the San Francisco Chronicle, Philips Healthcare said Saturday it is recalling about 5,400 automated external defibrillators after receiving reports of a memory chip failure in a small number of some models that could make them inoperable.
Beleagured Food and Drug Administration Reveals It Succumbed to a Push by “Paid-For Lawmakers”
As noted in our Medtronic heart lead recall blog, the New York Times has issued a story that the U.S. FDA “has revealed that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees,” an approval it is now revisiting.
Much-criticised FDA medical device approvals get external review
The Food and Drug Administration is asking the government’s top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.
Child Seeks to Convince Congress to Restore Patient Rights
Six year-old Avery deGroh of McHenry, Illinois, and her parents have traveled to Washington, D.C. not once but twice in 2009 to share her story with Congress and to ask for passage of the Medical Device Safety Act.
Medtronic warns about heart device battery
Reuters reports that Medtronic Inc has said it is warning doctors about problems with 6,300 implantable heart devices because the batteries in the devices drain sooner than normal. Medtronic spokesman Christopher Garland noted that patient safety was not at risk because the affected devices, called Concerto CRT-D and Virtuoso ICD, will provide three months’ warning before their batteries run down.
Ghostwriting “Rife” in Medical Journals
The New York Times reports that six of the top medical journals published a significant number of articles in 2008 that were written by ghostwriters financed by drug companies, according to a study released Thursday by editors of The Journal of the American Medical Association.
August 2009 Updates for Claimants in Silicone Gel Breast Implant Litigation
Lieff Cabraser has posted several important silicone gel breast implant-related updates this year with regard to both the Dow Settlement and the Revised Settlement Program.
