The FDA says that laparoscopic power morcellators—surgical devices commonly used to remove fibroid tumors from the uterus or the entire uterus—should not be used to perform these procedures in the vast majority of women because they can spread unsuspected cancer. The FDA’s Immediately in Effect (IIE) guidance, issued November 24, updates a safety communication issued […]
Andrus Wagstaff Law Blog
The results of preliminary lawsuits against transvaginal mesh manufacturers seems to indicate that the legal tide is turning in favor of women who claim that the devices cause injuries such as pain, bleeding and infection. Seven mesh device makers, including Boston Scientific, Johnson & Johnson, C.R. Bard and Endo International, are facing thousands of lawsuits […]
Pharmaceutical companies drive demand for their drugs through direct-to-consumer advertising on television, the Internet, the radio and in print. An AARP poll found that 90% of Americans have seen or heard one such advertisement, most commonly on television. In fact, a study published in the Annals of Family Medicine notes that Americans see as many […]
$3 billion: that’s how much GlaxoSmithKline agreed to pay the U.S. Department of Justice in 2012 to settle civil and criminal charges related to its misbranding of the drugs Paxil and Wellbutrin and its failure to disclose safety information about the diabetes drug Avandia. Although the $3 billion fine was the largest fine ever levied […]
Fresenius Medical Care, the Waltham, Massachusetts-based manufacturer of dialysis solutions GranuFlo and NaturaLyte, is now facing approximately 6,000 lawsuits alleging that patients suffered severe injuries and were not warned about the risks associated with the products. The filing of lawsuits against Fresenius are preceded by a 2012 Food and Drug Administration (FDA) Class I recall […]
Two studies published recently in the prestigious medical journal JAMA Internal Medicine say that many of the medical devices approved by the Food and Drug Administration (FDA) lack evidence verifying their safety and effectiveness. One study, led by Dr. Diana Zuckerman, president of the National Center for Health Research, looked at moderate to high-risk medical […]
Have you experienced a serious reaction to a medical device or drug? Use the link below to report these occurrences directly to the FDA. Then contact our law firm for legal advice. Click here for the FDA website.
Despite the publication of a study that confirms an earlier government assessment that the use of laparoscopic power morcellators—devices used in minimally invasive uterine procedures—is risky, some gynecologists continue to use them. A number of health insurers, meanwhile, are no longer paying for morcellation, citing patient safety risks. The Food and Drug Administration (FDA) in […]
Pelvic mesh is a medical device originally designed for hernia repair that was repurposed for use in women suffering from conditions including pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, the device was not tested by the FDA for this use. Thousands of injured women allege that the mesh erodes prematurely, causing injuries including severe pain, sexual dysfunction […]
Injuries to the head and spine are among the most debilitating and costly that a person can suffer. They’re also much more prevalent than you might think, affecting millions of Americans each year. Common causes of both traumatic brain injury (TBI) and spinal cord injury (SCI) are preventable accidents such as motor vehicle accidents, falls, […]
