Defective Drugs and Medical Devices

The U.S. Food and Drug Administration (FDA) is taking on medication errors by changing drug packaging and labeling. Medication errors are a massive problem in the healthcare systems of the United States. The Institute of Medicine reports that as many as 98,000 Americans die each year because of medical errors, and up to 7,000 of…

You have likely heard of, and may well have been a victim of, a cyber security breach where sensitive, personal information was hacked from the servers of a bank, a credit bureau or even a major health care insurer. Medical devices such as pacemakers and insulin pumps are now connected to wireless networks so that…

Medication errors are a significant problem in modern health care. Also called adverse drug events (ADE), the Agency for Healthcare Research and Quality (AHRQ) reports that ADE’s account for nearly 700,000 emergency department visits and 100,000 hospitalizations each year. The AHRQ also reports that approximately 5% of hospitalized patients will experience an ADE making them…

A pacemaker is a medical device, first used in Sweden in the 1950s, for patients with heart problems. The device sends electrical impulses that help stabilize patients who have irregular heartbeats. Implanting a pacemaker is usually performed by a cardiologist or a surgeon. Unfortunately, some pacemakers have flaws which can cause death, heart attacks, or…

U.S. Food and Drug Administration (FDA) in 1998 to treat cancer breakthrough pain, but with additional safety measures. The dangerous drug was prescribed and dispensed in the form of transdermal patches and lozenges. Today, however, many of the cases of fentanyl-related injuries may be attributed to counterfeit fentanyl, which is sold on the black market…

On November 1, 2016, a California woman named Chrystal Austin filed a lawsuit against Bristol Meyers-Squibb after having suffered excessive financial losses linked to a compulsive gambling problem caused by the drug Abilify. Ms. Austin claims that the drug maker failed to warn consumers about the impulse control side-effects before it caused her significant financial…

An estimated 15 million Americans use proton pump inhibitors (PPIs), which are sold by prescription and over-the-counter under a variety of brand names, including Nexium, Prilosec and Prevacid. The PPIs lower the acid in your body and help fight off heartburn or acid reflux disease. A study was published on Jan 11 2016 in JAMA…

The Zika virus has been all over the news lately as concerns about the spread of the mosquito-borne virus move towards full-blown panic, as the virus has been linked anecdotally to microcephaly, a frightening birth defect. Symptoms of the Zika virus are mild and last for a few days to week and include fever, rash,…

Last September, we discussed how defective IVC filters were linked with as many as 27 deaths and thousands of problems that required surgery. The manufacturer knew that the IVC filter could cause potentially fatal problems soon after it was released for sale, but they kept it on the market for five more years. In December…

The U.S. Food and Drug Administration (FDA) has taken action to warn consumers about the risks involved with surgical mesh devices that are implanted to repair pelvic organ prolapse (POP). On January 4, 2016, the FDA issued two final order to manufacturers of these devices. The first was to re-classify transvaginal mesh devices from class…