The legal and regulatory framework for medical device manufacturers is complex. It comprises a patchwork of laws, regulations, and restrictions that can differ from state to state. For instance, under the US Department of Health and Human Services (HHS), the FDA regulates medical device safety and proper utilization. FDA’s Center for Devices and Radiological Health primarily regulates medical devices.
As such, manufacturers of orthopedic implant products need to understand the implications of using these implants on their patients. One of the most crucial aspects of medical implants is if they have any adverse effects on patients. This is the part where Exactech is facing lawsuits.
Understanding the Exactech Lawsuits
Exactech is a knee, ankle, and hip replacement device manufacturer. According to TorHoerman Law, thousands of Exactech devices have been recalled due to the harmful impact they can have on patients. Defective packaging for these devices can lead to the oxidation of polyethylene components. This can result in injuries, requiring patients to undergo revision surgery.
The lawsuits against Exactech are based on the premise that the company knew about potential product problems but failed to disclose them.
In some cases, patients claim that their surgeons told them their implants were safe and effective. However, they weren’t fully aware of the risks involved in using these devices. In other instances, patients allege that Exactech failed to adequately warn patients about specific risks associated with its products.
All the Exactech lawsuits are now consolidated into multidistrict litigation (MDL). This is done to ensure smooth handling of all the lawsuits. The Exactech MDL results from all the lawsuits filed due to the negative impact of implant devices on patients.
Exactech has recalled most of its products now. According to the FDA, Exactech recalled 80% of knee and ankle replacement devices manufactured since 2004 in February 2022. Although the products are recalled, many people have already suffered the injury.
Legal and Regulatory Framework
Given below are some legal and regulatory framework details related to the Exactech lawsuits:
- Medical devices are subject to regulation by the FDA, which guides how to ensure their safety and effectiveness.
- State laws govern the legal framework for medical malpractice lawsuits. Many states have adopted some version of the American Bar Association’s Model Medical Professional Liability Act (MPLA).
- To bring a lawsuit based on medical device liability, you must prove that the manufacturer acted irresponsibly and the products caused harm.
The Defense Perspective
The defense perspective is that implants are safe. According to an article by the FDA, most devices work as expected. Exactech has a long history of providing high-quality products to patients. However, the company cannot deny that the implants are causing injuries, as there have been several such cases.
Exactech has been working with the FDA to resolve product concerns, including submitting clinical data and research findings. The company maintains confidence in its safety and efficacy, so it has discontinued selling these devices today.
Exactech has accepted its fault and is working on it. This is good news for plaintiffs, as they can expect the judgment to go in their favor. The lawsuits have impacted the brand image of Exactech. However, the company is taking all measures to maintain a good reputation by accepting its faults and reworking the products’ packaging.
Patient Rights and Recourse
Here are some patient rights you need to know to file the Exactech lawsuit in the right context and win it.
- You have the right to be fully informed about the risks and benefits of any medical device or procedure. This includes understanding the potential complications and alternatives. If a patient was not adequately informed and suffered harm, they may have a basis for legal action.
- ​​Patients may have the right to pursue a product liability lawsuit if a medical device is found to be defective or dangerous. Product liability claims can be based on design defects, manufacturing defects, or failure to warn about potential risks.
- You should receive services in a safe environment by qualified practitioners. The practitioners should be free from conflicts of interest or other influences that may compromise their objectivity.
- You have the right to be informed before you agree to any procedure and throughout its course.
Exactech Lawsuits Settlement Amounts
The settlement amounts vary depending on various factors. For example, Exactech lawsuit settlement amounts can range from $50,000 to $300,000 and more. This huge difference in settlement is largely associated with the severity and longevity of the injury.
The settlement amount will be high if you have faced severe damages leading to surgery and health problems. Similarly, various other factors like medical expenses, lost wages, etc., can all influence the Exactech settlement amounts.
However, not all patients are eligible for a settlement payout due to their particular circumstances or incomplete medical records. Hence, proving the connection between your injury and the Exactech implant is vital. You can use medical receipts, surgery bills, etc., as proof to build your case.
Ongoing Developments
The lawsuit landscape has changed a lot over the years. The number of lawsuits has increased, and the Exactech defendants have filed motions to dismiss some. In May 2023, at least 373 Exactech lawsuits were due in New York MDL.
In May 2023, the FDA re-issued a safety communication regarding the Exactech products. The article states that if a patient is experiencing no complications, there’s no need to do surgery to remove the implant. However, contact your healthcare provider quickly if you feel pain or discomfort.
The Exactech lawsuits are currently in the pretrial discovery stage. This means that both sides’ legal representatives exchange information about evidence and witnesses. The cases are expected to move to trial soon, and new information will be available.
Conclusion
It’s clear that Exactech has a lot on its plate right now. The company faces multiple lawsuits alleging that its products are defective, and those cases are likely to drag on for years before they’re resolved. In addition, the FDA recently issued an alert about potential problems with Exactech’s replacement devices. This is another blow for the company as it tries to rebuild trust among patients and doctors.
