FDA Warns of Problems with Heart Pump; Patients Receive it Anyway

HeartWare heart pumpEight years ago, the Food and Drug Administration (FDA) found problems and concerns with the HeartWare heart pump. Even with this information, the pump was implanted into patients for years following. The problem was found back in 2014 and a warning letter was sent to the manufacturer by the FDA. However, this did not stop the heart pump from being implanted in patients without any of the original issues being addressed.

One of the biggest concerns is why was this allowed, especially if the FDA issued a warning. The reason may be a lack of communication. The Food and Drug Administration is not required to inform other branches of government or agencies of their findings. This means lawmakers and those who approve these devices are not informed of the risks or breakdowns.

While the FDA maintains a public database, and this is where they claim other agencies should have checked before implanting the device, it is cleared out every five years. This means that the warning regarding these medical devices was removed from the database five years later, even though the product still had the original defect. The Centers for Medicare & Medicaid were one of the agencies that continued to implant these devices in patients even after the defect was made public. This also indicates that our tax dollars were being used to implant defective devices into unsuspecting patients.

The issue all stems back to the FDA and their lack of communication. The agency only sent a warning letter to the manufacturer, but did not call for a product recall or inform agencies that the heart pump was a dangerous device. This cost many people their lives and someone should be held liable. To make matters worse, the FDA received reports of deaths and injuries that may have been related to the heart pump. While sales did stop in June of last year, this does not take back the damage that has already been done. If you have been injured by a defective medical device, contact a Maryland defective medical device attorney.

Other common defective medical devices

While this is an example of one medical device, there are many others out there that can cause severe injury or death. Other common defective products include:

  • Pacemakers
  • DePuy hip replacements
  • Faulty coated heart valves
  • Ineffectual glucose meters
  • Stryker knee replacements
  • Broken LASIK eye surgery technology
  • Defective birth control implants
  • Defective transvaginal mesh

There are several reasons a medical device can be defective, and your Maryland defective medical device attorney can determine why, as well as the best legal options for your particular case.

Common defective medications

Not only are you at risk of injury from defective products, but you may also be at risk of defective medications. If a medication is not properly tested or is incorrectly administered, it can cause catastrophic harm to patients. There are a few class action lawsuits already filed for the following medications:

  • Diabetes medication
  • Antidepressants
  • Anti-psychotics
  • Birth control
  • Seizure medications
  • Osteoporosis
  • Testosterone replacement therapies

These are just the generic types of medications, but specific brands are under fire. You may need to discuss your symptoms and medications with an attorney to see if your medication is currently under a class-action lawsuit.

What to do if you have a defective medical product

Liability can be tricky for defective products, especially after the 2008 U.S Supreme Court ruling stating that if a defective product is FDA approved, then the manufacturer is immune from liability. There is a caveat, however, since the FDA tests products each year and monitors others. This means that manufacturers may still be held liable in many cases.

If a product is found to be defective, then the manufacturer must inform all consumers who use the product of the defect and what to do next. They must do so in a timely manner, so that injury and harm do not befall the consumer. Your doctor may also hold liability if they knowingly prescribe you a dangerous medical device. You should also make sure you are using any medical product as directed. If you are, and suffer injury, contact a Maryland defective medical device attorney.

You may be able to obtain compensation for your injuries or the death of a loved one from a defective medical device. Contact Plaxen Adler Muncy at 410-730-7737, or complete our contact form to schedule a consultation with a Maryland defective medical device attorney at one of our locations throughout the state.