Articles Posted in Medical Devices

Last month’s lawsuit by a Birmingham man claiming his penis was partially amputated during a circumcision brings attention to the on-going problems related to medical negligence.   The American Medical Association recognizes that medical negligence is the third largest cause of death in the United States, following only heart disease and cancer in causes of death in the United States.

Between 2003 and 2013, adverse action was taken against over 10,100 providers for violations and there were 827 medical malpractice payments made to victims of medical negligence in Alabama alone. ( Nationwide, adverse action was taken against 377,081 providers and medical malpractice payments were made to 160,619 victims of medical negligence. (

Even with those alarming statistics, a lot of those claims are against the same doctors. A 1990 study by the National Practitioner Data Bank found that just 5.1 percent of doctors account for more than half of all medical malpractice payouts. Of the 35,000 doctors who had two or more malpractice payouts, only 7.6 percent of them were disciplined. More strikingly, only 13 percent of doctors with five medical malpractice payouts have ever been disciplined. (

With the announcement this week by the U.S. Consumer Product Safety Commission (CPSC) and Bed Handles Inc. of a voluntary recall of about 113,000 adult portable bed handles, our attention is once again drawn to how to help keep elderly people safe. The bed handles that are being recalled can shift out of place, creating a dangerous gap between the bed handle and the side of the mattress. This gap poses a serious risk of entrapment, strangulation and death. This defective product has already resulted in the death of three women.

Recalled models include the Original Bedside Assistant® (BA10W), the Travel Handles™ (BA11W) which is sold as a set of two bed handles, and the Adjustable Bedside Assistant® (AJ1). The bed handles are intended to assist adults with getting in and out of bed by giving them a bar to grip and were sold by home health care stores, drug stores and medical equipment stores nationwide and in home and health care catalogs from January 1994 through December 2007 for about $100.

This is just one example of a number of products that are designed for elderly users that can cause problems both in the home and in a commercial setting, such as a nursing home. Other examples include consumer goods that may be safe for younger users but can be dangerous for elderly users who have reduced reaction times and less strength.

Johnson & Johnson was ordered by a Texas jury to pay $1.2 million to a woman who was injured after being treated for incontinence with one of Johnson & Johnson’s vaginal-mesh implants.  Ms. Batiste obtained the first jury verdict against Johnson & Johnson in the vaginal-mesh litigation.  Ms. Batiste suffered pelvic pain when the device eroded inside her.

There are over 12,000 lawsuits against Johnson & Johnson related to the mesh implants, including the slings, which are alleged to damage women’s organs and make sex painful when they begin to deteriorate.

Transvaginal mesh gained in popularity as a treatment option for Pelvic Organ Prolapse and Stress Urinary Incontinence in the mid-2000s.  As that treatment option’s popularity grew, so did the manufacturers.  There are over 30 manufacturers of these types of devices, including Ethicon (a division of Johnson & Johnson), CR Bard, American Medical System and Boston Scientific.  The U.S. Food and Drug Administration (“FDA”) has ordered the manufacturers to study the rates of organ damage and complications linked to the implants.  There are other, similar products that have been the subject of litigation as well, such as the Prolift implant which is implanted to support sagging organs.

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