Manufacturers of medical devices have a legal duty to ensure that their marketed products are safe and effective when used as directed. Medical devices are supposed to be extensively tested and scientifically designed to be safe. This is not always the case and defective medical products can lead to more intensive surgeries to correct the damage caused by the defect than were originally necessary. In fact, many people recover from the procedure and feel fine, only to later experience pain or adverse effects because the medical device was defective. Some patients actually suffer irreversible injury or die because the medical device was poorly designed or manufactured, because of doctor error during the procedure, or because of an infection caused by the device.
Consumers do not discover that the medical devices have caused short-term or permanent damage until it is too late. The related costs including medical expenses, lost income and rehabilitation can run into the millions of dollars. You have a right to recover your losses. Bonsignore Trial Lawyers were pioneers in the earliest class actions against the manufacturers of bad medical devices and have had an exceptional success rate ever since. If you or a family member have suffered harm from a medical device Bonsignore Trial Lawyers will can help.
As recent recalls have established, FDA approval doesn’t guarantee that a drug is safe. Recent defective medical devices include vaginal and hernia Mesh Pain Pumps; Hip Replacements; Knee Replacements; Dialysis Machines; Defibrillators; Heart Valves; Stents, Breast Implants and Power Morcillators.
Unfortunately, device makers sometimes use loopholes in the U.S. Food and Drug Administration’s regulations to gain clearance for their products. For example, one common loophole they utilize involves a claim that their device is “substantially equivalent” in safety and effectiveness to another device that is already on the market. Another involves claim to the FDA that their device is being used for the same purpose as another device already on the market when in reality the actual use the manufacturer intends for the device is entirely different.
The disturbing truth is that to start selling a product that can rack up many millions of dollars in revenue, medical device manufacturers often do nothing more than file paperwork and pay the Food and Drug Administration a user fee of roughly $4,000. When this occurs, the only safety “testing” is in the bodies of patients.
Typically defects in medical devices result from inadequate testing or rushing the approval process a product on the market. Consumer complaints are supported by the facts. According to an article in the Washington Post nearly 2,500 medical devices were recalled for potential safety problems in 2008. The Wall Street Journal has reported that the number of medical device recalls doubled in the decade from 2003 through 2012 rising from 604 in 2003 to 1,190 in 2012. The increase in recalls where a defect in a medical device carried a reasonable probability of death rose from 7 in 203 to 57. These numbers are expected to rise sharply given the developing scandal surrounding power morcellators.
Compounding this already disturbing backdrop is the fact that the medical device industry is highly competitive. Pressure from executives to increase profits sometimes results in medical products being rushed to market. When a product is rushed to market adequate testing and proper consideration of the potential harm and serious consequences gets pushed aside. Government rules that require the smaller number of high-risk products to undergo mandatory safety studies before being marketed to the public mandate studies that are smaller and less rigorous than those required for prescription drugs. Keep in mind the studies for prescription drugs are not that great.
Calls for improvement by highly respected experts in the field add clarity and place this big national health care problem in context. For example, Diana Zuckerman, Ph.D. has publically stated that “standards for devices exist, they just don’t make sense”. Dr. Zuckerman is president of the nonprofit National Research Center for Women & Families.
An investigation by Consumer Reports revealed medical devices often aren’t tested before they come on the market. The in depth investigation included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA. Consumer Reports found that medical devices often aren’t tested before they come on the market and there is no systematic way for the government, researchers, or patients to identify or learn about problems with specific devices. In context, your toaster and coffeemaker carry unique serial numbers. Artificial hips and heart valves don’t. On the bright side, Bonsignore Trial Lawyers have cut through these roadblocks and held the manufactures of bad medical devices accountable for many years.
The prestigious Institute of Medicine released a panel report that found the FDA should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market. This never happened. Instead Congress is debating a new law that would keep the present system virtually intact and ratify an agreement between the FDA and industry to get devices on the market even faster.
BONSIGNORE HOLD MANUFACTURERS OF BAD MEDICAL DEVICES ACCOUNTABLE
Bonsignore Trial Lawyers have held manufacturers of bad medical devices liable for injury and death caused by the failure to exercise ordinary care. The most common theories we use include:
- Defective manufacture including use of the wrong materials, missed manufacturing steps;
- Failure to institute adequately quality controls or to test and inspect;
- Failure to insure safe and secure shipping which results in a contaminated product;
- Defective design;
- Failure to provide adequate instructions, warnings and labels including a failure to provide adequate or accurate warnings or failure to provide adequate instructions concerning safe usage or the failure to advise doctors how to use or store the product;
- Failure to issue an adequately recall notice.
When medical device companies’ market devices that cause injuries to many Bonsignore Trial Lawyers will insure your rights are protected and obtain reasonable and just compensation for the victims.
WHAT IS A MEDICAL DEVICES
Common medical devices include:
- Heart Valves
- Artificial Joints
- Jaw Implants
- Breast Implants
- Dialysis Machines
- Cosmetic Implants
- Heart Monitors
WHO DOES BONSIGNORE HOLD ACCOUNTABLE FOR BAD MEDICAL DEVICES
Who Bonsignore Trial Lawyers will hold accountable depends on the unique circumstances of each case. In the past, Bonsignore has brought claims against the manufacturer and others in the chain of distribution. Defendants may include:
Testing Laboratories -that performed tests on the medical device;
Medical Device Manufacturers’ Sales Representatives who met with doctors and other members of the medical community to sell and make recommendations for uses and applications;
Shipping Companies that improperly transported the device from the manufacturer to the doctor
Hospitals and Clinics that are part of the chain of distribution; and
Retailers: Products obtained from a pharmacy, drug store, or other retail supplier may also be liable.
BONSIGNORE TRIAL LAWYERS AND THEIR CLIENTS MAKE A DIFFERENCE
The FDA relies on consumer victims to play an active role in the health care system. MedWatch is a safety voluntary adverse effect reporting system and information source sponsored by the FDA. Through MedWatch consumer victims can quickly and easily report adverse events online. As a part of our representation, we will report your adverse event for you. All consumers who are injured or suffer a bad reaction or know side effect to a medical device (or drug) should file a MedWatch Consumer Voluntary Reporting form (Form FDA 3500B). The form can is located at the following link: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery.
In addition to prescription and over-the-counter drugs and medical devices, consumers should report vitamins and other nutrition products, infant formulas and specialized nutrition products that treat a specific disease or condition. Also make-up, cosmetics products, foods and beverages and Biologics used for transplant like tendons or bone.
Claims can be brought against the manufacturer and anyone else in the chain of distribution. Organizations and people involved in this chain may include:
Laboratories: any testing laboratories that performed tests on the medical device or drug.
Sales representatives: pharmaceutical and medical device manufacturers often use sales representatives who meet with doctors and other members of the medical community to sell drugs and devices and make recommendations for uses and applications.
Doctors and pharmacists: the doctors (and pharmacists if a drug) who recommended the drug or medical device may be liable based on their failure to warn you about potential dangers or to provide adequate instructions regarding the proper use of the medical device.
Hospitals and clinics: hospitals and clinics that are part of the chain of distribution between the manufacturer of the medical device and drug and the consumer may be liable for your injuries.
Retailer: Products obtained from a pharmacy, drug store, or other retail supplier may also be liable.
WHAT SHOULD I DO IF I HAVE FALLEN VICTIM TO A BAD MEDICAL DEVICE
If you suspect your medical device or implant has been recalled or is otherwise defective there are a series of steps that you should consider taking in addition to reporting your problem to MedWatch:
- always talk to your doctor first;
- continue receiving treatment for your illness;
- explore any opportunities that you may have to recover your costs and seek damages from the device manufacturer;
More specifically, if your medical device has been recalled, the first thing that you should do after being notified is to contact your doctor and ask her to check the device against the list of know recalled devices. If you do not feel comfortable with the advise your doctor gives you, seek a second opinion. While following your doctors advise, keep a written record of any out of pocket costs that you incur. Do not sign any legal releases without first consulting with an experienced lawyer.
TYPES OF MEDICAL DEVICE RECALLS
Determining the type of medical recall your medical device is part of will give you an indication of the type of legal recourse available to you. There are three different classes of FDA medical device recalls:
Class I Recall – This is the most serious recall that the FDA can assign. When the FDA issues a Class I recall use of the involved device could result in serious injury or even death.
Class II Recall – A Class II is also very serious. When the FDA issues a Class II recall use of the involved device could result in temporary health complications or there may a small chance of incurring a serious injury.
Class III Recall – A Class III FDA recalls should also be taken very seriously. When the FDA issues a Class II recall use of the involved device violates the FDA’s medical device laws.