Medical Technology and the Law

on August 27, 2015


Every year countless Americans undergo some type of medical procedure. Procedures are now less invasive and recovery time has been drastically reduced. This change can be attributed, in part, to advances in medical technology, including the increased utilization of medical devices. Technology is becoming “smarter” and devices used in surgery and other procedures are designed with outstanding intricacy. Sophisticated as this technology may be, the possibility for fault remains.

The recent outbreaks of a highly resistant bacteria in hospitals around the country has been blamed on a single medical device, a scope used in procedures to diagnose diseases of the liver, the bile duct, and the pancreas. The bacteria, Carbapenem Resistant Enterobacteriaceae or CRE, is called a “superbug” because of its difficulty to treat and high fatality rate.

The duodenoscope in question is designed in such a way that a thorough cleaning is difficult, if not, impossible. The highly resistant bacteria involved in the most recent outbreaks, it is said, was allowed to harbor in hard to reach areas inside the scope. Bacteria that is harbored can be transmitted during endoscopic procedures. Various manufacturers produce the same device. Criticism has been aimed not only at Olympus but at regulators including the Federal Drug Administration {FDA} for failure to act more promptly when warnings surfaced about this and other questionable medical instruments.

Some lawmakers have questioned the FDA’s regulatory practice. In a startling admission the FDA confirmed that this particular model has been on the market since 2010 without government approval. It is not uncommon for Medical devices such as the aforementioned scope to reach the market stage without first undergoing the type of in depth scrutiny that would likely detect inherent design flaws or other problems with a device.

It appears that efficacy is being put ahead of safety. Numerous other faulty medical devices have caused substantial harm, even death, to many. Power morcellators, used for fibroid removal and hysterectomies, have been implicated in the spread of uterine cancer. Subsequent to reports of this, the FDA issued a warning against the use of the device, and many hospitals, including Temple University in Philadelphia, have outright banned the instrument.

The Journal of the American Medical Association {JAMA} Oncology claims that women who undergo morcellation for hysterectomies have increased risk for undetected cancer than women who undergo fibroid removal. Morcellators shred fibroid tissue, and the shredded tissue is disseminated throughout the body, potentially spreading cancer.

Implants have also been implicated in a number of cases. An expansive recall of artificial knee implants was prompted when it was discovered that the implants were flawed. A recent 9.2 million-dollar verdict was awarded to a man who suffered permanent injury due to a faulty hip implant. Argument in this case reiterated that more adequate testing would have exposed the faulty design that caused such an injury.

If part of the aim of medical innovation is to produce more expeditious results, the safety and well being of the patient must not be compromised in the process. Along with faulty medical devices, improperly administered medications can be harmful, if not, fatal. Albert Einstein noted the danger of technology when technology exceeds our humanity. The benefit of mankind should always be the goal of technology and the goal of medicine. Once this aim is relinquished, the fault is availed to others to remedy. The Law and its noble representatives have always answered the call of the injured and harmed. The efforts of lawyers whose clients have been harmed by faulty medical products and medical negligence will be the spark that brings about the change that will protect others from future harm.

Call Pasquale E. Bianculli, Esquire PC personal injury lawyer in Philadelphia at (215) 339-5222 for a free confidential consultation.

Visit my website for additional information.



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