Medical devices have truly revolutionized healthcare around the world, making it possible for many to live longer, better quality lives. Unfortunately, each year a large number of devices prove faulty and defective, thereby causing substantial harm, and even death to the patient. A person who has suffered injury often does have legal recourse, and in some cases may even be able to join a class action lawsuit against a manufacturer, although this is not always the most financially advantageous means of obtaining compensation. It is important for anyone whose health has been damaged by a defective medical device to seek legal representation.
Medical Device Recalls & Defects We Are Currently Investigating:
- Bair Hugger Warming Blanket
- Breast Implants
- DePuy Synthes Attune Knees
- Ethicon Morcellator Hysterectomy
- Exactech® Optetrak® Knee Replacement
- Gastric Bypass & Balloon
- Hernia Mesh
- IVC Filter Lawsuit
- Mirena Birth Control
- NuVasive MAGEC System
- Paragard IUD
- Stryker LFIT Femoral Heads
- Stryker Rejuvenate Hip Replacement
- Surgical Stapler
- Terumo Heater-Cooler Device
Definition and Classes of Medical Devices
The term “medical device” refers to various devices that are meant to do one of the following:
- To diagnose a medical condition
- To treat or cure a medical condition
- To prevent a medical condition
- To correct a function of the body that is not working properly for its intended purpose
- To prevent a function of the body from its purpose, such as with contraceptives
These can include machines, instruments, in vitro reagents, and other devices as defined under the Food, Drug and Cosmetic Act. Among these are defibrillators, stents, implants, and contraceptives.
The Food and Drug Administration classifies medical devices as follows:
- Class One. The potential for risk is lowest with these, with minimal chance of the patient suffering harm if they fail.
- Class Two. These devices carry a greater risk of harm to the patient should they become or prove defective. These are often released with a 510(k) application.
- Class Three. Devices in this class pose the greatest risk of injury. Serious injury or death is typical. The FDA usually requires Pre-Market Approval (PMA) with these.
FDA Regulations and Medical Devices
FDA regulations appear to be stringent, often requiring extensive clinical testing and evaluation, and no small amount of research before a product is approved for release in the U.S. to be used on humans or animals. Unfortunately, this is not enough, for every year a great number of individuals suffer injuries due to defective medical devices. One problem is that, given a large number of applications for FDA approval every year, there is a substantial backlog, and manufacturers often have to wait years for approval. As a result, manufacturers have sought ways to circumvent the system of approval. Section 510(k) of the Food, Drug and Cosmetic Act establishes substantial requirements for registration and notification of an intention to release a new product. Many new devices, however, are being released under a provision which eases the process of approval if the said component is “substantially equivalent” to one that has already been approved and marketed. The results are alarming: 1% of Class 3 devices were recalled during the years 2005-2009 for safety issues. Indeed, the transvaginal mesh was approved through this process and has proven to cause serious health issues in women.
MAUDE Reporting of Medical Device Failures
The FDA has also set up a database, MAUDE (Manufacturer and User Facility Device Experience) which reflects information reported about defective medical device failures. Every year medical device reports of malfunctions, deaths and serious injuries believed to be linked to medical devices are reported through MAUDE. However, this database is far from accurate and therefore is of little help. Problems associated with MAUDE include:
- There is no way to verify reports.
- The accuracy of reports cannot be ascertained.
- The failure of devices might be substantially underreported.
- It is difficult to verify a cause and effect link between the device and reported the result.
- Searches of the system only yield information based on search terms used and therefore are not comprehensive.
Types of Defects and Potential Defendants in a Case
Defective medical device claims fall into several basic categories: defective manufacturing, defective design, and defective marketing. Depending upon the nature of the case and type of defect, the potential defendants may include one or more of the following:
- The manufacturer
- Facilities and laboratories that conducted testing of the device
- The sales representative, if he made false claims.
- The doctor who recommended the device
- The hospital or clinic where the device was administered/implanted
- The retail supplier
It is very important that anyone filing a claim understand that there is a statute of limitations for doing so. You should consult with an attorney to determine how long this is, but generally, the clock begins to run when the device is first administered, prescribed, or implanted.
How do I make a claim for a recalled or defective Medical Device?
Medical device claims are often highly complex, and as mentioned, may involve multiple defendants. In order to prove a claim, the injury victim will need to show that injury did occur, that the device in question is flawed in design, manufacture or marketing, and that this defect directly led to the injuries. It is important for anyone seeking legal remedy in such a case to work with a highly skilled and knowledgeable personal injury attorney who will fight aggressively on his/her behalf. Nadrich & Cohen, LLP have represented clients successfully for decades. Call us today.