A simple bandage that covers a scratch may not seem like it has much in common with a sophisticated pacemaker that helps a vital organ work normally, but, in fact, the law considers both to be medical devices.

The Food and Drug Administration (FDA) defines a medical device as an instrument that is used to diagnose, prevent or treat a disease or other condition. Every year, hundreds of new medical devices are manufactured, and all of them must be approved by the FDA before they can be sold to the public. Unfortunately, the FDA cannot carefully test all these products for safety and efficacy, and sometimes the agency chooses to approve a new device on the basis of its “substantial similarity” to an already existing device.

Regardless of how a medical device was approved for sale, many have turned out to be life-threatening for reasons ranging from design flaws to poor manufacturing quality, from insufficient testing to a misrepresentation of side effects.

An unsafe medical device can seriously harm the very people that expected the device to make their lives better. Some devices are found to be so dangerous they are recalled, which means they must have their flaws fixed if possible or be removed from the market.

Medical Device Recall Attorneys in Kentucky

Defective Medical Device AttorneyThe Kentucky defective medical device attorneys of the Johnson Law Firm represent patients who have been seriously hurt by unsafe medical products. Because cases involving faulty medical devices are complex and expensive, you should have an attorney who has experience in the area. We have the skills and resources to successfully pursue claims against all responsible parties, including the hospital, distributor, or seller that provided the device; the doctor that prescribed the device; and the manufacturer of the device.

Our lawyers can evaluate your possible claim relating to any medical device, including dangerous products for which there has already been a recall, such as:

  • Angioplasty Stents
  • Blood Pressure Cuffs
  • DePuy Hip Implants
  • HeartMate II Heart Pumps
  • Kugel Mesh Patches
  • Medical Lasers
  • Medtronic Pacemakers
  • Metal-on-Metal Hips
  • Shoulder Pain Pumps
  • Stryker Hip Implants
  • Transvaginal Mesh
  • Ultrasound Devices
  • Ventilators and Dialysis Machines
  • Zimmer Knee Implants.

Getting Worse – Not Better

A report issued by the FDA last year revealed that recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, rising from 604 to 1,190. There was also a considerable increase in recalls where the defective product carried a reasonable probability of death to the patient, rising to 57 from 7. The FDA publishes many recalls on its website. The list for 2014 is 60 items long, meaning recalls occurred on average more than once a week. This list includes only the most serious cases where use of the product could result in major health problems or even death.

More recalls going back as far as 2002 can be found by using the FDA Medical Device Recalls searchable database. Concerned consumers can also sign up to be alerted by email whenever an unsafe medical device or dangerous drug is recalled.

Although recalls are meant to protect the public and limit liability, thousands of people have already experienced injury before recalls are issued, and such recalls do not necessarily adequately address a person’s pain, suffering or medical treatment costs.

When a medical device does not work as promised, the effects can be damaging and extensive. Medical device manufacturers are legally obligated to make their devices safe, to meet FDA standards and to warn of any risks or side effects involved. Patients have a right to know the risks associated with a particular medical device.

Making Legal Claims

The Pikeville, Kentucky medical device recall attorneys of the Johnson Law Firm are dedicated to representing victims of negligently manufactured and marketed medical devices. We will carefully investigate all of the evidence, and we have the experience to hold accountable companies that may have put profits ahead of your health. If you or someone you love has been injured by a medical product, you may have valuable legal rights. Please contact us today for an evaluation of your case by calling 606-433-0682 or by filling out this form.