Necrotizing enterocolitis (NEC) is a horrible disease that can affect premature infants. The condition is gastrointestinal and causes inflammation and infections in the intestines that can lead to the intestinal cells dying. If the inflammation gets severe,…
Vaccines are one of the most effective ways to prevent the spread of infectious diseases throughout the world. The overwhelming majority of people who receive vaccines do not experience serious problems, and the benefits greatly outweigh the threat of risk. However, similar to the risks associated with natural supplements and…
(NATIONAL RECALL: February 2020) The Food and Drug Administration (FDA) has issued a recall for an insulin pump that thousands of people use with Type 1 diabetes. The recall is centered around certain Medtronic MiniMed 600 series insulin pumps. One person has died, 2,175 people have received injuries and there…
Transvaginal mesh devices are designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to the Food and Drug Administration (FDA), in 2010, of the 300,000 women who had surgery for POP, 1 in 3 used transvaginal mesh devices. At the same time, of the 260,000 women…
According to the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research, a generic drug is a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Although generic drugs are generally cheaper,…
As previously reported by Carabin Shaw, there have been a number of hip replacement recalls in recent years, including recalls of the of the DePuy ASR Hip, the Biomet M2a Hip, the Stryker Rejuvenate and the ABG II, among others. These recalls brought attention to the potentially serious injuries that…
One key product liability issue to watch for in 2013 is reportedly the continued adoption of the learned intermediary doctrine by states. In June 2012, Texas joined 35 other states in holding that a sufficient warning to a treating doctor (the “learned intermediary”) satisfies a manufacturer’s duty to warn in…
Pradaxa was first released into the market in 2010 by German pharmaceutical giant Boehringer-Ingelheim. The drug immediately reached blockbuster status by notching over $1 billion dollars in sales. In its initial stages, Pradaxa was thought to be a next generation drug that would replace the most common drug used to…
Hip replacement surgery is a relatively common procedure for baby boomers and older adults who are restricted from their normal activities due to pain associated with severe arthritis. Usually, this option is entertained only after all non-surgical treatment has failed. Although the use of prosthetic hip implants date back into…
Johnson & Johnson has announced it will phase out the sale of four mesh surgical products used to treat pelvic prolapse, hernia, and bladder control problems in women. Johnson & Johnson’s Ethicon unit will reportedly stop selling Gynecare Prosima, Gynecare TVT Secur, Gynecare Prolift, and Gynecare Prolift+M by the end…