Potentially Dangerous Medical Devices are Still Widely Used

February 21st, 2019 by Rieders Travis in Products Liability

Medical malpractice attorney

When patients have medical devices implanted in their bodies, they expect the device to better their lives, not kill them.  However, all too often, patients have been injured or have died due to problems with medical devices that proved to be defective.

These device-related injuries can occur during an implant procedure or after the device has been in the body for years. When devices have been in the body for a while, it may be difficult to point to them as the source of the problem; and there are times when the device cannot be removed without causing additional injury or even death.

According to the International Consortium of Investigative Journalists (ICIJ), defective devices have been associated with 1.7 million injuries and more than 80,000 deaths in the past ten years.

Examples include:

  • a neck implant to relieve pain that caused airway obstruction, trouble swallowing and respiratory failure
  • artificial hips that cause cobalt poisoning and can damage the heart and brain
  • surgical mesh that cuts through flesh and organs, causing infections and hemorrhage
  • defibrillators that repeatedly shock patients

If you or a loved one has suffered harm due to a faulty medical device, you should seek legal representation to determine whether you can be compensated for your loss. However, due to the complexity and issues involving medical malpractice, your case must be handled correctly and competently by an attorney experienced in medical device malpractice. 

The skilled and experienced Pennsylvania defective medical device malpractice attorney Clifford A. Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann has spent decades successfully representing Pennsylvania families who have suffered an injury or loss due to medical malpractice.  Our attorneys offer personal attention and loyalty to every client, aggressively fighting for their right to compensation.

We offer a free consultation to examine the facts of your case, so contact us online or call our offices to set up your free consultation.

Why Problems With Medical Devices?

Medical devices are cleared and monitored by the Food and Drug Administration (FDA), which approves devices and is supposed to examine and possibly recall faulty devices when incidents arise. However, a global investigation last year by the ICIJ found significant failings in the FDA’s oversight.

Reasons include:

* Loopholes that allow most products to be approved for sale without clinical trials in humans:

1) In 1976, the FDA grandfathered-in all devices that were already on the market.  Under the FDA 510(k) pathway provision, new artificial joints, cataract lens implants, and thousands of other devices developed after 1976 can be approved for sale if shown to have “substantial equivalence” to a previously cleared device. This means higher-risk devices can be cleared based on previous devices, even those that have been recalled for safety problems.

2) The supplement pathway loophole, which allows manufacturers to circumvent clinical trials by informing the FDA that they are marketing an “updated version” of a device with minor changes.

* Manufacturers may take shortcuts or cut down on the testing process to rush the distribution of their products.

In 2007, Congress passed the Medical Device User Fee Amendments (MDUFA), which require manufacturers to pay for device approvals.  To continue collecting user fees, the FDA has to meet “performance goals” for faster approvals, so it has less time to evaluate products. This is an inherent conflict of interest.

What Are the Types of Defective Medical Device Claims?

Faulty medical device claims fall under three categories:

  • Defective design — there are issues in the design of a device even if appropriately manufactured.
  • Defective marketing – product may have been marketed without informing the patient of the dangers involved.
  • Defective manufacture – product was damaged during manufacturing or distribution.

Who May Be Liable?

The following are possible defendants who may be held liable for defective products:

  • Manufacturer– if the process is defective
  • Doctor– for failure to give information regarding potential warnings or the product’s proper usage
  • Retail supplier
  • Medical sales representative– if they recommended the device that harmed you.

In one recent case, we obtained an out-of-court settlement against the manufacturer of a defective device.  We continued the case against the doctor, who then blamed the technicians employed by the manufacturer.  This case demonstrated well that both the doctor and the medical device manufacturer or its employed technicians may be responsible.  In fact, different laws may apply to the doctor as opposed to the manufacturer.  Products liability law may apply to the manufacturer and ordinary Pennsylvania negligence law may apply to the doctor.  There are also federal principles of preemption if a medical device has been approved for sale by the federal government.  These are very complex and intertwined areas of the law.

Contact an Attorney at Our Firm

If you or a loved one has been injured or someone has died due to a defective medical device, you may have a liability claim to be compensated for medical expenses, loss of life’s pleasures, lost wages and emotional anguish.  You should get immediate legal assistance from an attorney with in-depth knowledge of product liability law to make sure you get the compensation you deserve.

The skilled and experienced Pennsylvania defective medical device attorney Clifford A. Rieders of Rieders, Travis, Humphrey, Waters & Dohrmann has spent decades honing his skills and successfully representing Pennsylvania families who have suffered an injury or loss due to someone else’s negligence. We offer personal attention and loyalty to every client, aggressively fighting for their right to compensation. Whether in settlement negotiations or pursuing a favorable trial verdict, we are thoroughly prepared and committed to achieving a just outcome. With our competent staff, we offer strength in numbers while providing top-notch personal service.

Cliff Rieders is a Nationally Board-Certified specialist for Civil Trial and Civil Practice and Procedure, a cum laude Phi Beta Kappa graduate of New York University as well as Georgetown University Law Center.  Rieders is a life member of the American Law Institute, which publishes recommended legal principles utilized throughout the United States.  He is a Past President of the Pennsylvania Association for Justice, formerly Pennsylvania Trial Lawyers Association.  Rieders has won numerous awards and recognition from the Pennsylvania Association for Justice, and he received the Pennsylvania Patient Safety Authority recognition award.  Cliff Rieders was a founder of the Pennsylvania Patient Safety Authority and served on same for 15 years.  Rieders was a Law Clerk in the federal court system for one of the most well-known and longest serving federal judges in the country, the Honorable Malcolm Muir.  Cliff has received the George F. Douglas Amicus Curiae Award, as well as the Milton D. Rosenberg Award from the Pennsylvania Trial Lawyers.  Rieders is on committees and organizations that write the law in many fields of practice.  Cliff Rieders was involved in the writing of the Mcare Act, which governs medical liability actions in Pennsylvania, and he wrote the book on medical malpractice that lawyers use in the state.  Cliff has authored a number of other textbooks and articles and he frequently teaches the law to other experienced lawyers.   Cliff Rieders is admitted in state and federal courts, including the Supreme Court of the United States.  He is a Nationally Board-Certified specialist for Civil Trial and Civil Practice and Procedure and is admitted in state and federal courts, including the Supreme Court of the United States.

If you or your loved one has suffered harm from a defective medical device, your next step should be to consult Cliff Rieders at Rieders, Travis, Humphrey, Waters & Dohrmann by calling or using our online contact form.

Based in Williamsport, we serve clients throughout the state of Pennsylvania, offering a free consultation on all personal injury matters.  Cliff Rieders is also admitted in New York, the District of Columbia, and, as indicated above, numerous federal courts.  More than that, we offer you experience, knowledge, compassion, and a long history of results.

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