Medical Device Claims Archives - Page 13 of 20

Arizona Supreme Court Applies Federal Preemption To Preclude State Law Failure To Warn Claim Involving Pain Pump

December 20, 2018

The Supreme Court of the State of Arizona (“Arizona Supreme Court”) held in its opinion filed on December 18, 2018 that the plaintiff’s pain pump failure to warn state law claims were preempted under federal law (i.e., federal law preempts a failure-to-warn claim predicated on a me[...]

FDA Issues Safety Communication For Pain Pump Medications

December 9, 2018

On November 14, 2018, the FDA issued a safety communication in which it warned that patients undergoing treatment or management of pain who are given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump may be subjected to addition[...]

Defective Medical Devices Caused 1.7 Million Injuries, 83,000 Deaths In U.S.

November 29, 2018

The Implant Files, which is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all, analyzed more than 8 million device-related health records, including death and injury reports and recalls, and found “more than 1.7 million injur[...]

FDA Issues Proposed Cybersecurity Recommendations For Medical Devices

November 11, 2018

Imagine you or a loved one has an implanted medical device, such as a heart pacemaker, that may be hacked and controlled by someone other than the manufacturer or your doctor. Someone could conceivably control the device such that you or your loved may be seriously harmed (or worse). On October 17, [...]

Study Finds Silicone Breast Implants Associated With Autoimmune Complications

October 5, 2018

A study published in the Annals of Surgery on September 14, 2018 entitled, “US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients” concluded: “Silicone implants are associated with an increased risk of certain rare harms; associations need to be further [...]

Philadelphia Medical Malpractice Case Filed For Death Of Premature Baby Who Contracted Virus In NICU

September 21, 2018

A medical malpractice wrongful death lawsuit reportedly was filed in August 2018 against Children’s Hospital of Philadelphia (“CHOP”), alleging that a premature baby treated at the hospital in 2016 was one of 23 infants who contracted a virus while being treated in the hospitalR[...]

MAUDE Adverse Event Reports For Filshie Clips

August 23, 2018

A Filshie clip is a silicone-lined, titanium occlusive device, originally designed for surgical contraception that was approved by the FDA in September 1996 for permanent contraception in women. The Filshie clip is placed with a reusable applicator and designed to permanently occlude the mid-isthmic[...]

Where Is My Filshie Clip?

August 10, 2018

A major manufacturer of Filshie clips, which is a method of permanent female sterilization, describes the medical device on its website as follows: “The Filshie Clip is manufactured from titanium and is lined on the inner surface with silicone rubber (both materials are implantable grade). At [...]

Report Finds Pharmaceutical Recalls And Medical Device Recalls Were Up In First Quarter 2018

July 10, 2018

The First Quarter 2018 “Recall Index” published by Stericycle Expert Solutions (“Stericylce,” which “provides global and local expertise before, during, and after a recall threat” and each quarter of the year analyzes cumulative recall data across five product cat[...]

California Appellate Court Reduces Punitive Damages Award From $70M To $19.6M In Malfunctioning Surgical Stapler Case

July 8, 2018

The Court of Appeal of the State of California First Appellate District Division Five (“California Appellate Court”), in its opinion filed on June 13, 2018, reduced the punitive damages award by a California jury from $70 million to $19.7 million (i.e., two-times the amount of the compen[...]

FDA Warns About Deaths In Patients With Liquid-Filled Intragastric Balloon Systems Used To Treat Obesity

June 27, 2018

The FDA issued a warning letter to health care providers in the United States on June 4, 2018 regarding reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity. Since 2016, the FDA has received reports of a total of 12 deaths that occurred in patients with[...]

Misplaced/Displaced (Migrated) Filshie Clips

June 9, 2018

We have been receiving an increasing number of inquiries from women throughout the United States who had Filshie clips used during tubal ligation who subsequently got pregnant because the Filshie clips were improperly placed or the Filshie clips migrated, causing unwanted pregnancies and/or severe p[...]

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Category: Medical Device Claims