Articles Posted in Medical Devices

The U.S. Food and Drug Administration (FDA) plays a critical role in keeping consumers safe. There is a reasonable expectation that a product that is bought at a store will be safe for use. That expectation is even more secure when it comes to products that are used by medical professionals in critical health care processes. A patient does not wander through a store to select which medical products are used in their care. From hip implants and needles, to medication and IV pumps, patients rely on the choices of their doctors and care of regulatory agencies like the FDA to ensure that dangerous products are not allowed.

Our entire caregiving process is based on this trust. That is why we must be incredibly vigilant about holding designers and manufacturers accountable when products actually harm patients unnecessarily. In the aftermath of dangerous products, medical device lawsuits are common to ensure that accountability is provided and those affect receive redress.

Yet, ideally the damage would be prevented altogether. That is where regulatory agencies are in control. It is critical that the FDA act aggressively to ensure product manufacturers make choices, if necessary, so that dangerous products are pulled from use in a timely manner.

There is always a critical balancing act that must be performed with so many technological advances in the medical field. On the one hand, there is a desire to get these new products and procedures in place as soon as possible so as to help as many medical patients as possible. We lose people each and every day who might have been saved by earlier use of advances or specialized tools. Of course, on the flip side, just as these tech tools can save lives, they can also take them away. Medical care is an incredibly delicate process, and any errors, imperfections, or slip ups can literally be the difference of life and death.

This inherent tension is why federal regulators have created various layers of oversight and a formalized approval process for most medical advances–from new devices to drugs. This ensures that medical patients do not unknowingly suffer the consequences of being an unwanted guinea pig for something that doesn’t yet have all the kinks worked out. As those who have followed various mass recalls and medical malpractice cases in the medical field appreciate, even when the approval process is followed, serious harm can still result. One need look no further than the thousands of medical patients suffering as a result of defective DePuy hip implants to understand what can happen when defective products are on the market.

Robotic Surgical Tool Injuries

Defective medical devices pose incredible risks, because the possibility exists that they may harm hundreds or thousands of patients before being pulled from the market. Unlike individual cases of malpractice, when the products used by doctor (or consumers directly) are unsafe, the costs can be staggering. That is why there are clear standards that must be followed by all those who play a role in designing, manufacturing, and using medical products. Failure to act carefully may result in significant legal liability.

Mirena Lawsuits

That seems to be the case with the inter-uterine device known as Mirena. Over two million women have had the device implanted. Multiple sources are reporting on the many women have come forward suggesting that they have suffered serious injury as a result of the device. Considering the significant number of women who use Mirena, tens of thousands may ultimately suffer serious injury as a result of these complications.

As reported recently in the New York Times, the U.S. Supreme Court is set to hear a new case that will further clarify legal liability rules as they relate to drug errors and pharmaceutical companies. At the heart of the case is whether a generic drug manufacturer can be held liable for the harm caused by a defectively designed drug.

The original case was filed by a woman who was given a prescription for the pain pill known as sulindac by her doctor. The mild medication was intended to provide some relief for her shoulder pain. In reality, it totally changed the woman’s life–and not for the better. The patient suffered from a reaction to the drug which caused severe burning. Here skin literally “sloughed” off. Ultimately she needed to spend months in a burn unit and was in a coma for even longer. By the end of it all the woman was legally blind and had suffered permanent damage to her lungs and esophagus.

Defective Drug Legal Case

If you enter a hospital even once you will recognize it: the beeps, buzzing, hums, and ringing that make-up the hospital safety alarm system. These sounds are used for safety, set to make noise and alert caregivers when something might be amiss with a patient. When used properly, alarms are clearly a critical tool that can ensure fast action in the response to changes in conditions that might save lives.

But managing alarms is not necessarily a straight forward process. Identifying where alarms should be added or where some need to be taken away requires careful thought and planning. Too few alarms might mean that doctors and nurses do not react quickly enough to help a struggling patient. On the other hand, too many alarms could result in alarm fatigue such that there are so many sounds that no alert actually seems urgent. Alarm overload must be considered closely to understand the exact balance that is best for patients.

Goals for Future Years

All medical operations are somewhat delicate procedures. That is why it is obvious that the devices used in those procedures–from medical tools to implants–need to be safe and secure. Most medical patients assume that there are regulations in place so that not just any device is used when they go in for medical treatment or an operation. One assumes that there will be testing and trials for most products so medical professionals know that they are safe before they are used in a way which might harm thousands of patients.

Sadly, many of those assumptions are incorrect. Often is is not until a product causes significant harm that its lack of safety is verified. That was evidenced vividly over the last few years with the recall of thousands of metal-on-metal hip implants which were discovered to cause serious harm to thousands of patients. Readers are likely familiar with the two most high-profile cases, the Stryker hip implant recall and the Depuy recall. Our attorneys work with residents who were harmed by these products. Thousands of medical patients across the country, including in Illinois, were forced to endure painful revision surgeries and deal with other medical complications as a result of receiving these faulty devices.

The 501(k) Approval Process

Our attorneys often explain the difference between medical malpractice (professional negligence) issues and ordinary negligence. While professional negligence refers to mistakes made in specialized medical care, ordinary negligence refers to general safety lapses. For example, while giving a patient an overdose of a medication is professional negligence, failing to properly monitor a wandering patient is ordinary negligence. The difference has legal ramifications, often with different procedural and evidentiary rules.

One similar split exists between products and regulation of those products. There are medical products and regular consumer goods. While all products need to be safe, the rules for use of these devices and the governmental entity that is charged with ensuring their safety differs between them. In many cases, it is easy to differentiate between the two. A Tiffany lamp is obviously a consumer good, while a DePuy hip implant is a medical device. However, at times the line between whether a device is a medical product or an ordinary consumer item is not clear.

Where Do Bed Rails Fit In?

Surgical errors may be the prototypical form of medical malpractice. That is because they involve the classic scenario of a patient who is in the complete control of the medical professional (often under anesthesia) with complex bodily invasions that often include life and death issues. Of course, attorneys working on these cases appreciate that patients are at their most vulnerable during surgeries, and all medical practitioners must abide by aprropriate standards of care at those times.

A recent story in the Star Exponent is an example of this type of case. According to the reports, a medical professional was sued by a former patient who claimed that problems during surgery left her deformed and with chronic pain in one arm. The problems, the plaintiff alleged, stemmed from inadequate care during a collarbone surgery on the left side of her body. According to the complaint filed with the court that initiated the suit, the defendant-doctor performed a “carpal tunnel release” and an “open reduction internal fixation” on the plaintiff’s left clavicle. The idea was that the work would help relieve pressue and pain along the nerve in the wrist. The operation also involved repairing bones in the area with artificial implants.

Unfortunately, instead of improving her situation and relieving pain, according to the patient the operation only made things worse. And she suggests that probems during the operation are the cause. In particular, the complaint explains that, in the middle of the procedure the doctor determined that there was a problem with one of the bones. To correct this he attempted to screw in a six inch metal plate into the left side of the woman’s upper body. Unfortunately, because of poor bone condition, he was unable to screw the plate to the clavicle. Instead of recogonzing the lack of feasibility of completing the operation in this case, the doctor plunged ahead. He kept the metal plate in the body and tried to keep it in place with sutures instead of screws.

It goes without saying that there is little room for error when it comes to medical products that are inserted inside a patient body. It is absolutely imperative that all mistakes be avoided when patients agree to have a device surgically installed in their body to treat a certain ailment. Unfortunately, there are many cases of various objects their either do not work as intended or actually cause more harm. In those cases, lawyers often fight hard to ensure the affected families have their legal rights respected.

Spinal Implants Problems

One of the more recent examples of this scenario involves BMP spinal implants–like one known as Infuse. Some “off label” uses of the device may actually cause injuries and harm to patients.

In August of 2010, DePuy Orthopedics, a division of Johnson & Johnson, issued a recall for two of its widely used hip replacement products, ASR™ XL Acetabular Hip System and the DePuy ASR™ Hip Resurfacing System, after it was determined that the metal-on-metal design of the prosthetic hip could be harmful to the individual recipients. The metal-on-metal devices have caused issues for thousands of recipients because of the deterioration of the metal once implanted in a patient’s body. The metal-on-metal design can lead to the release of small metal particles into the recipient’s body. This can lead to a slew of health problems including infection, necrosis, allergic problems or even heart and neurological system problems.

The company estimated that between 2003 and 2009 over 90,000 patients received one of the now recalled DePuy hip replacement systems. Research has shown that nearly one in eight recipients of a DePuy Hip Replacement required a revision surgery to correct the issues associated with the faulty hip replacements.

With approximately 90,000 faulty hip replacements used and a one in eight chance of issues occurring, it is safe to assume that well over 11,000 patients will require a revision surgery to correct the problems suffered because of the faulty metal-on-metal design. “Anyone who received a recalled DePuy hip implant may be eligible to receive compensation for these defective products, even if they have not yet experienced pain or symptoms,” said attorney Steven Levin of Levin & Perconti.

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