A Michigan defective medical device lawyer can help if you or someone you care about was harmed by a medical product. These cases can be filed as individual lawsuits or as part of a class-action lawsuit. Settlements for victims of defective devices can be substantial.
Medical devices provide freedom and mobility to millions of Americans. From simple crutches that allow a patient to move around after breaking a leg, to pacemakers that help regulate a heartbeat after surgery, these devices are a key part of many peoples’ lives.
However, much like any other manufactured item, medical devices are prone to failure. This can result in catastrophic consequences for both your health and finances. However, manufacturers who are negligent in creating these objects may be held liable to provide compensation.
The state laws concerning liability in these cases are complex, however. Therefore, a Michigan medical devices lawyer may be able to help if you were injured after a device was defective. A compassionate and experienced attorney will work tirelessly to examine the root causes of the issue and fight to hold at-fault makers responsible for their actions.
- Understanding defective medical device liability
- Examples of defective medical device failure
- Difference between defective devices and dangerous drugs
- Defective medical device settlement example
- Get a free consultation from a medical device lawyer
Classifications of Medical Devices
The U.S. Food & Drug Administration has three primary classifications for medical devices. All devices manufactured, repackaged, or imported by any company for sale in the United States must meet FDA regulations. Every product, ranging from an electric toothbrush to a pacemaker is classified into a specific category.
The three classifications are:
Class I Medical Devices: medical devices that have a low to moderate risk to the patient and/or user. Examples include enema kits, elastic bandages, tongue depressors, manual stethoscopes, and bedpans.
Class II Medical Devices: those products that hose devices that have a moderate to high risk to the patient and/or user. This would include powered wheelchairs, air purifiers, surgical robots, some pregnancy kits, and acupuncture needles.
Class III Medical Devices: these are devices with a high risk to the patient and/or user. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples include artificial hip and knee implants, pacemakers, hernia mesh, transvaginal mesh, and breast implants. (including Biocell breast implants)
Understanding Medical Device Liability
Medical equipment must be approved by the U.S. Food and Drug Administration (FDA), but the manufacturer of the device is ultimately responsible to ensure the safety of the product. Large companies do not always disclose all of the potential dangers of the products they sell to the public and oftentimes, defective medical devices are put on the market even though they are at high risk of causing harm.
It is the responsibility of the manufacturer to inform the FDA and the public about the fault and the potential risks of the product, and if they do not, they can be held liable. When a manufacturer places a defective product on the market, and it is not safe for its intended use and causes injury to the prescribed patient, it can give rise to a defective medical device lawsuit. These cases seek fair compensation to patients who have been harmed or injured due to the defective device. Lawsuits filed against the device manufacturers might even result in significant settlements.
Furthermore, if a patient dies due to a defective product, a wrongful death lawsuit may be filed. Because of these nuances, navigating the claims process might be confusing and overwhelming, especially as a person recovers from their losses. A well-versed defective medical devices lawyer in Michigan could help to explain the complexities of this system and help to pursue a claim on an injured person’s behalf.
Common Examples of Medical Device Failure
Unfortunately, a medical device may fail at any time and for almost any reason. For example, there are simple failures with basic medical devices. This could be a crutch that may break as a patient goes down a flight of stairs or the brakes on a wheelchair may fail while a patient goes down a hill.
Other serious failures may involve devices that go inside a patient’s body. A defect in artificial joints, prosthetics, pacemakers, stents, or surgical pins may all cause a loss of function in a body part, an infection, or may even necessitate an additional surgery to correct. Other defective devices that could cause serious harm are defective bone cement, Bair Hugger, Philips CPAP, IVC filter, or power morcellator. Because of the potential severity of these issues, a well-versed Michigan attorney can help examine the facts that led to a person’s injuries to determine if a failing medical device is to blame.
Legal Difference Between Devices and Drugs
Michigan law makes it very difficult for any person to sue a product manufacturer for damages. According to Michigan Compiled Law §600.2946(2), makers of defective products are only liable if a plaintiff can prove that the product was not reasonably safe at the time it left the manufacturer’s control. This typically includes proving that an error in design or manufacture caused a failure. The same statute requires plaintiffs to submit alternative designs that retain the purpose of the failed item but mitigate any defects that caused the injury.
Furthermore, a subset of this law protects some makers of drugs from almost all liability. Mich. Comp. Law §600.2946(5) states that makers of drugs are only liable if they violate FDA laws—this may include instances of fraud or misrepresentation during the FDA approval process. Because of this, many medical device makers may argue that their product is not a medical device, but is instead a drug.
As a result, many dangerous drugs and defective device claims for residents of Michigan are filed in other states, where the laws are not as restrictive. In most circumstances, the claim will be a part of a class-action lawsuit and grouped together with similar claims against the same manufacturer.
In short, a product is a drug if the FDA has approved that product as such. Therefore, many items that a person may consider to be a medical device—such as an implanted item that releases medication over time, a medicine patch, or even products used for physical therapy—may, in fact, fall under the definition of a drug. This may make the potential for compensation almost impossible. Due to this, an experienced Michigan defective medical devices lawyer could help plaintiffs to understand the key legal distinction between devices and drugs for filing a claim.
Defective Medical Device Case Study
A consumer class action lawsuit was filed against the manufacturer of a hip replacement device. The medical device lawsuit alleged the company failed to properly design and manufacture the implant. As a result, it deteriorated, corroded, and caused metal toxicity in patients.
The device maker recalled over 50,000 of the products. However, many had already been implanted in patients who were suffering symptoms from metal toxicity. After disputing both liability and medical claims, the company agreed to pay a settlement of $1,430,000,000 to the patients.
How a Michigan Medical Devices Attorney Might Help
Many people rely on medical devices for their day-to-day activities. If these devices fail, a person may be unable to get around, may suffer from falls, or may even be denied essential medications. Because of how necessary these devices may be, all manufacturers must take responsibility for their products. However, state laws often limit the ability of an injured plaintiff to demand compensation.
If you were injured or suffered a worsened condition due to a defective medical device, a Michigan medical devices lawyer can help you. By explaining your legal rights and guiding you through the legal process. If you are eligible for compensation, we will file your claim.
Contact a legal professional today to schedule a consultation. There are no fees unless you win a settlement.
Michigan Defective Medical Devices References and Resources
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