The Legal Implications of the Exactech Recall for Patients and Hospitals

Searcy Denney Scarola Barnhart & Shipley
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Searcy Denney Scarola Barnhart & Shipley

Exactech is a manufacturer of medical implants, including ankle, knee, hip and shoulder replacement devices. Unfortunately, due to poor manufacturing practices and quality control issues, Exactech has been forced to recall hundreds of thousands of its implantable medical devices over the past few years. While some patients may receive news of Exactech’s recalls in time to protect themselves from serious complications, for many, the company’s recalls come too late.

In addition to the significant medical implications of the Exactech recalls, these recalls have significant legal implications as well. Patients affected by the company’s defective ankle, knee, hip and implant devices can—and should—seek just compensation for the costs and complications they suffer. Medical device manufacturers like Exactech have a legal duty to ensure that their products are safe for use as intended, and when they fail to do so, they can—and should—be held accountable.

The Legal Implications for Patients

As a patient, what are your legal rights if you received a defective Exactech ankle, knee, hip or shoulder replacement device?

When companies like Exactech sell defective medical devices, they can be held fully liable for the costs that patients and their families incur as a result of their devices’ defects. This includes both current and future costs, and it includes both out-of-pocket costs and non-financial losses. As a result, patients and families that have claims for defective Exactech ankle, knee, hip and shoulder implants can seek to recover just compensation for their:

  • Medical expenses (including diagnosis, treatment, revision surgery, and post-op therapy)
  • Prescriptions, medical supplies, transportation and other expenses
  • Loss of income due to inability to work (or needing to take time off of work to attend to medical needs)
  • Pain and suffering caused by defective Exactech ankle, knee, hip and shoulder implants and their complications
  • Emotional trauma caused by receiving a defective medical implant and being forced to deal with its consequences
  • Loss of companionship, consortium, enjoyment of life, society and support
  • Other financial and non-financial losses they suffer (or are likely to suffer in the future) as the result of receiving a defective Exactech implant

If you’ve ever been injured in a vehicle collision or slip-and-fall accident, you may be familiar with the concept of negligence. In these types of cases, proof of negligence is required to establish legal liability on the part of the at-fault party.

But, in cases involving defective medical devices, proof of negligence is not required. Instead, manufacturers like Exactech are “strictly liable” for putting dangerous medical devices on the market. This means that simply by selling medical devices that don’t meet the requisite standards for patient safety, Exactech is fully responsible for any losses that patients and their families are forced to endure.

With this in mind, if you or someone you love has experienced complications or undergone revision surgery after receiving an Exactech ankle, knee, hip or shoulder implant, you should speak with a lawyer about your legal rights. This costs nothing, and it could be the first step on your road to recovery. Most patients and families affected by defective Exactech implants experience significant financial and non-financial losses, and recovering these losses is critical for allowing them to move on.

Numerous patients and families have already filed lawsuits against Exactech—and won. At this point, there is no question that many of Exactech’s implantable medical devices are defective. The issues with Exactech’s implants are well-known, and the U.S. Food and Drug Administration (FDA) currently advises against implanting these devices in new patients.

The Legal Implications for Hospitals

While Exactech’s legal responsibility for selling defective medical devices is clear, what do the Exactech recalls mean for hospitals that implanted the company’s defective medical devices in patients for years?

The short answer is, “It depends.”

For a long time, hospitals had no reason to suspect that there were issues with Exactech’s devices. Exactech is a well-known medical device manufacturer that has been in business since 1985. As long as hospitals reasonably believed that Exactech’s devices were safe, as a general rule, this means that they are safe from liability for the harm these devices caused.

However, the Exactech recalls began in 2021, and, as a result of the recalls, the FDA now provides clear recommendations against implanting Exactech’s defective devices. If a hospital knew or should have known that Exactech’s medical implants were potentially dangerous, then it could be liable for continuing to implant these devices in patients’ bodies.

In these cases, in addition to having strict liability claims against Exactech, patients and their families may also have claims for medical malpractice. For obvious reasons, healthcare providers who perform implant surgeries are held to a high standard of care. As a result, implanting devices that are known to be defective against the FDA’s recommendations will expose hospitals to legal liability in many cases. 

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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