Manufacturers of medical devises can be responsible for harm caused by their products. There are a large percentage of medical malpractice cases, which don’t primarily target healthcare professionals. Those cases usually involve a defective medical device or a dangerous drugs. It is important to note, however, that a product or pill’s failure to work doesn’t necessarily mean it is defective or harmful.
Common reasons for defective drugs and devices
Drugs and medical devices are supposed to go through a testing system before they’re released for use by the public. However, not all drugs and devices are tested equally, and not all drug/device manufacturers are subject to the same Food & Drug Administration guidelines. More often than not, a drug or medical device is labeled harmful or defective because:
- It’s being used off-label. When people use pills in an off-label way – for example, taking Wellbutrin (an anti-depressant) to help you quit smoking – then the side effects may not be clearly noted, or the drug may not work as intended. Transvaginal mesh (TVM) is a good example of this, as the device was originally designed for hernias, and can have catastrophic effects on a woman’s body when used for a prolapsed uterus.
- The warning label is unclear. We all know that cigarettes are bad – but until 1938, they were not required to carry a warning label that said so, and thousands of people died from smoking-related causes because of it. Drugs and medical devices need the same warning labels. When the potential side effects aren’t revealed – like they weren’t for the diabetes drug Actos, which has been linked to bladder cancer – then the manufacturing companies and distributors can be held accountable in a malpractice suit.
- The testing wasn’t rigorous enough. The materials used in TVM were never tested in that capacity – and it was perfectly legal, because the FDA didn’t require additional testing. Inadequate testing often leads to faulty products.
- The materials are defective. When Stryker and DePuy put their hip and knee replacement devices (respectively) on the market, they used materials that actually corroded inside the human body. Because of the process they used for submitting their newer products (the FDA’s 510(k) Premarket Notification Process) they did not undergo any clinical trials that could have alerted them to a potential problem.
- The profit margin is too high for companies to shelve a product. If ten young men take Risperdal and only one of the ten develops gynecomastia, then the cost of recalling the drug and fixing it is assumed to be greater than the cost of one lawsuit for every ten users. Drug companies and manufacturers aren’t alone in this practice, either; almost every company with a product to sell behaves in this way.
Defective medical devices and dangerous drugs injure, maim and kill thousands of people every single year, and most of those injuries and deaths are avoidable. If you have questions about defective medical devices and dangerous drugs, we invite you to visit Plaxen & Adler, P.A.