Defective Medical Device Information

A guide to understanding Defective Medical Device Accidents, including a list an explanation of the types of defective medical devices, an overview of the Food and Drug Administration (FDA), an explanation of Product Liability Law as it pertains to Defective or Dangerous Medical Devices, a guide to determining fault, and the statute of limitations.

Understanding Defective Medical Devices · Types of Defective Medical Products · FDA-Food and Drug Administration · Center for Devices and Radiological Health · Product Liability Law · Determining Liability · Statute of Limitations

Understanding Defective Medical Devices

All types of Defective Medical Devices can cause accidents, including:

Medical appliances and equipment Organ transplants Prosthetic devices Surgical implants and equipment Hospital supplies Diagnostic equipment Hearing and visual aids.

If any of these products proves to be defective or dangerous and causes harm, it can be subject to a medical products liability lawsuit.

The Food and Drug Administration (FDA) and specificaly, the Center for Devices and Radiological Heath (CDRH), regulates the safety of medical devices. Depending on how dangerous a product might be, the FDA may exert more control over the manufacturer of the medical device. Manufacturers must compy with the standards, regulations, and accept practices that are outlined by the FDA. Consequently, if a manufacturer can prove that it complied with the FDA standards, then it is less likely to be found negligent. Conversely, if an injured party can prove that the manufacturer did not comply with FDA regulations, then the class is more likely to be successful. However, it should be noted that even if a manufacturer complies with all FDA guidelnes, this does not mean that they are free of liability for accidents caused by defective medical products.

A Supreme Court Decision in February of 2008 may make it more difficult for injured persons filing filing state court lawsuits to win, if the cases are contesting the safety of federally-approved medical devices. This is because in the case (Riegel v. Medtronic, Inc.) the Supreme Court ruled that the Medical Device Amendments of 1976 prevent the majority of state law claims challenging the safety or effectiveness of a medical device that received FDA approval. This, however, should not stop you from consulting a defective medical device lawyer if your or someone you loved has been injured by an dangerous medical product.

Types of Defective Medical Products

People can be injured by a wide range of dangerous and defective medical devices, including:

Inhalers Defibrillators Pacemakers Catheters Feeding tubes Arthroscopic pumps Percutaneous closure devices Knee implants Power Wheelchairs Stents Orthopedic bone screws Blood plasma products Latex gloves Prosthetics Intrauterine devices (IUDs) used for birth control Silicone gel breast implants (ruptures were associated with the development of fibromyalgia) Heart valve implants (leakage and strut fractures caused repeated surgeries or heart failure) Hip replacement parts (defects led to severe hip pain and loss of balance) Improperly sterilized gynecological devices such as curettes, uterine dilators, and biopsy pipettes marketed as sterile. Video bronchoscopes. (A bronchoscope is a flexible tube with a small light and camera used to evaluate the lungs for disease.) Kidney dialysis filters used to cleanse patients’ blood

FDA-Food and Drug Administration

The Food and Drug Administration (FDA) a branch of the Department of Health and Human Services (HHS) and is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The FDA does not develop, manufacture or test medical devices. Products found to be unfit for consumers are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. These products usually are destroyed, or in some cases, they are reconditioned to be in compliance with FDA regulations.

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it

Recalls the device (through correction or removal); and Notifies FDA.

Legally, FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, FDA has rarely needed to require a medical device recall.

When a company recalls a medical device, it

Contacts directly the customers who received the product from them, and takes steps to reach others who need to be notified (for example, by issuing press releases or providing detailed instructions); Supplies information to help users identify the product and take steps to minimize health consequences; and Takes action to prevent the problem from happening again.

FDA oversees each recall to make sure that the actions the company takes are adequate to protect the public health. During a medical device recall, FDA

Works with the recalling firm to obtain information about the product, the problem, the recall strategy, and the steps to prevent the problem from happening again; Conducts audits to make sure the recall efforts are appropriate and effective; Makes sure the company takes necessary actions to prevent the problem from happening again.

Center for Devices and Radiological Health

The Center for Devices and Radiological Health (CDRH), part of the U.S. Food and Drug Administration (FDA), helps ensure that medical devices are safe and effective as authorized by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act and helps reduce unnecessary exposure to radiation from medical, occupational, and consumer products as authorized by the Radiation Control for Health and Safety Act of 1968.

Product Liability Law

Defective and unreasonably dangerous medical products can cause serious injuries or death to patients. These products have manufacturers, distributors, and end users who can be held accountable when something goes wrong with the product. Medical and pharmaceutical companies have a responsibility to take the utmost care when researching and developing a product before it is released to the public. When they fail to uphold these responsibilities and a defective medical device causes injury, they can be held liable for damages under products liability laws. The federal government regulates some aspects of consumer product safety, but the laws affecting products liability litigation exist at the state level and the complexities of these laws vary from state to state. Defects can be traced to three main stages: when the product is designed, when the product is manufactured, and when the consumer should receive instructions or warnings. Product liability lawsuits are built upon the legal doctrine of "strict liability," which means that the injured person does not need to prove that the medical device company was negligent. Rather, all that needs to be proven is that the device was directly responsible for the ensuing injury, and that the manufacturer could have known and done something about this. These lawsuits can be extremely complex and often involve a considerable amount of expert testimony, so it is best to hire an experienced defective medical device attorney.

Determining Liability

When a person uses a medical product or device in a reasonable manner and that product causes injury, the manufacturer, wholesaler or seller may be liable. The liability for a drug of medical device defect differs depending on the individual facts of each case. If the defect is in the design, development or manufacturing of the medical product, the manufacturer may be liable. In addition, if the manufacturer did not comply with Food and Drug Administration (FDA) regulations, the plaintiff may recover damages. in most cases, claims against the manufacturer will be for strict liability or negligence. Strict liability focuses on whether the medical product is unreasonably unsafe to consumers. Negligence cases focus on development, manufacturing and quality control of a medical product. It must be determined that the manufacturer was responsible for the defect and the injury that occurred in order to be held liable. If the medical product is not shown to be defective or unreasonably unsafe due to manufacturing, the treating physician may be at fault. Physicians have a duty to explain manufacturers’ warnings to their patients or consumers when it is necessary and appropriate to avoid consumer injuries. Determining liabilty in a defective medical device case is a complex task. An experienced defective medical device lawyer will have the knowledge and resources to handle this process.

Statute of Limitations

Defective Medical Device Accident Lawsuits must be filed within a certain amount of time or the injured person is no longer entitled to compensation for injuries. This legal time limit within which a lawsuit must be filed is referred to as the statute of limitations. The statute of limitations begins at the time of injury, or the discovery of the injury (or the time when the injury, reasonably should have been discovered). For Defective Medical Device Accidents, the statute of limitations varies from state to state. Furthermore, the statute of limitations for dangerous medical products depends on what type of lawsuit is being filed. This is because Defective Medical Device Lawsuits can be filed for medical malpractice (personal injury) or, more commonly, for product liability, though sometimes the statute of limitations is the same. These issues can get complicated, so it is best to consult an defective medical product lawyer, so you know how to best proceed in order to protect your rights. Also, keep in mind that, it is usually the case that the longer you wait to file a Dangerous Medical Device Lawsuit, the harder it becomes to win your case.

All content on Accidents.com is for informational purposes only and is NOT intended as legal or medical advice. Please seek advice from a professional on any related topics.

Tags: Defective Medical Devices · Legal Help · Product Liability Accidents