Our bodies are amazing creations. The bones, muscles, nerves and organs work together in harmony to keep us breathing, digesting and moving seamlessly. Sometimes, though, that harmony isn’t so perfect. Conditions like arthritis or osteoporosis, or serious injuries, can mean that we need to replace one of our original parts with a man-made medical device. […]
Category Archives: Drugs And Medical Devices
In the last 11 years over 600 medical devices have been approved for use in humans by a procedure referred to as 501(k). The 501(k) is a process whereby devices used in cardiovascular care, neurology, obstetrics and gynecology, and most areas of medical device production can be approved with very little oversight. The benefit of […]
Texan’s injured by medical errors are very often denied access to the Courts. Texas voters have allowed the Texas Legislature to cap non-economic recoveries in medical malpractice cases at a maximum of $250,000.00. Therefore, when a non-employed, retired or young Texan is killed by the negligence of a medical provider the most that can be […]
On March 6, 2009 in an article entitled “Political Lobbying Drove FDA Process” the Wall Street Journal chronicled how a medical device manufacturer had its product that is intended to be implanted into patients knees quickly approved because of its lobbying efforts. The medical device had the normal review and investigation short circuited. Medical devices […]
The Food and Drug Administration (FDA) is responsible for researching and approving new medicines, staying abreast of those medicines on the market, regulating medical devices, and monitoring and ensuring the safety of approximately 80% of our food supply. Most people don’t realize the FDA also regulates many devices that emit radiation such as cell phones, […]
Drug Companies appear to have too much influence over the regulatory governmental agencies that are supposed to determine whether a drug is effective and safe. Federal Regulators with the Food and Drug Administration (the “FDA”) admitted that they should not have “uninvited” a leading cardiologist to a panel that was going to decide whether to […]
Federal regulatory agencies have become increasingly lax in their enforcement of rules and regulation that have been enacted to protect consumers. Many agencies have relied upon self regulation and enforcement which is essentially no regulation. The recent meltdown in the United States financial sector is some evidence that companies and individuals cannot be left to […]
The Food and Drug Administration (FDA) has recently classified a “warning” sent out by Medtronic, Inc. to health professionals as a Class 1 recall. A Class 1 recall is the most serious type of recall order issued and involves situations in which there is a reasonable probability that use of the product will cause serious […]
We were excited to learn about the new Food and Drug Administration (FDA) list of drugs being investigated. We often get calls from medical patients who suffered severe injuries potentially from prescription medicines. Often it is impossible to determine whether the FDA is investigating the adverse event or even whether the medical issue was an […]
The Food and Drug Administration (FDA) is obligated to monitor our nation’s food supply for safety as well as evaluate and approve for sale in the United States prescription drugs and medical devices. However, recent reports of large scale outbreaks of food poisoning, dangerous drugs causing death and injury as well as tampering with chemicals […]