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Ohio Defective Medical Device Lawyers
Experienced representation when medical devices cause harm to Ohio patients
Manufacturers of implants, stents, defibrillators, ventilators, and other types of medical devices generally must obtain approval from the Food and Drug Administration (FDA). These companies need to comply with any FDA recalls and their own recalls. At Crandall & Pera Law, our personal injury and wrongful death lawyers file product liability claims when medical devices cause injuries or deaths. Our Ohio defective medical device attorneys have the skills and experience to show that a medical device was defective, whether it was subject to a recall or that it caused a patient or your loved one harm. We demand compensation for all your medical bills, pain and suffering, and other damages.
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How does the FDA regulate medical devices?
The FDA's Center for Devices and Radiological Health (CDRH) regulates the manufacturing and importation of medical devices sold in the United States. “Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III.” The classification levels affect the type of approval required for all medical devices. The classification levels also impact clinical studies, labeling requirements, and many other conditions.
The following entities must register their devices with the FDA:
- Manufacturers
- Re-packagers
- Re-labelers
- Specification developers
- Re-processors of single-use devices
- Manufacturers of accessories and components sold directly to the end user
- Other entities
According to the FDA, medical devices “range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems.” Other examples of medical devices include diagnostic ultrasound products, X-ray machines and medical lasers.
Medical devices that have been involved in FDA or manufacturer recalls include hip replacements, IVC filters, defibrillators, drug-coated stents, contraceptive devices, bone graft implants, hernia mesh, CPAP machines, and artificial heart valves.
A medical device is:
“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- (A) Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
- (B) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or”
- Meets other definitions
More complicated questions about medical device classification are involved when software is involved.
What types of injuries do defective medical devices cause in Ohio?
Harm includes any device that causes pain, distress, bleeding, or discomfort, causes diseases or infections, prevents the patient’s health from improving, prevents proper medical devices from being used, causes psychological harm, or causes any other type of injury.
Other injuries from defective medical devices include rejection of the device, perforation of organs and tissues, allergic reactions, and other harmful consequences.
Sadly, in some cases, defective medical devices may be fatal.
What types of medical defect claims do you handle in Ohio?
Medical device manufacturers make huge profits. Some medical devices are used by millions of people nationwide. The price that these companies must pay for these profits is to ensure that their products are safe. Manufacturers are in the best position to ensure that their medical devices are properly designed and made with quality parts, that the instructions for use are clear, and that there are warnings about the risks and dangers of using the devices.
Our Ohio dangerous device lawyers file product liability claims against the manufacturers and all other responsible parties when their devices cause harm to a patient or cause the death of a loved one.
Product liability claims include:
- Strict liability claims. With these claims, the manufacturer is liable if the medical device is defective when the device is installed, the doctor uses it, or the patient uses it – and the defective device causes a patient’s injuries or the death of a loved one. There is no need to prove that the manufacturer should have done certain things or refrained from doing certain things. As long as we can show the product is defective and the defect caused harm, the manufacturer should be liable.
At Crandall & Pera Law, we work with medical device experts who can report and testify about why medical devices are defective. We also review whether the medical device was subject to an FDA recall or a manufacturer recall. The FDA and the manufacturers themselves should monitor the medical devices for safety and effectiveness (how well the medical devices work). If there are concerns about either the device’s safety or effectiveness, the medical device may be recalled. A recall essentially means that the device is taken off the market, and the doctors and patients are advised on what steps they should take, such as removing any implanted devices and obtaining any approved replacement devices.
- Negligence. Manufacturers may also be liable if the design, manufacture, and marketing of their product were negligent. For example, the manufacturer failed to run specific safety tests or clinical studies.
- Breach of warranty. Manufacturers may also be liable for medical devices that cause harm based on the warranties (express or implied) that they make about the benefits and use of their products.
In many cases involving defective medical devices, there are many other patients who suffer from the use of the device too. In this situation, the cases are often combined into a class action lawsuit. We can explain how a class action lawsuit works and protect your right to compensation.
How do you fight for defective medical device victims?
Our Ohio dangerous medical devices file product liability claims against every company involved in the sale of the product, including the manufacturer, distributor, and seller.
We may also file medical malpractice claims against the doctor, hospital, or clinic that recommends the medical device if they fail to warn you or a loved one about the dangers and risks of using the device or fail to give proper instructions about how to use the medical device.
Do you have an Ohio lawyer near me who can handle my defective medical device case?
At Crandall & Pera Law, we represent patients who suffer harm due to medical devices. We handle cases for injury victims in Ohio from our office at 850 Euclid Ave #1122, Cleveland, OH 44114. We also have offices in Cincinnati, Columbus, Chesterland and Chagrin Falls. If you can’t come to our office because of your injuries, we can meet you at your home or a nearby healthcare facility. We also speak with clients by phone and through online discussions.
We understand how upset you are. Medical devices should help you, not hurt you. We’re prepared to fight for all the compensation you deserve.
Talk with our accomplished Ohio medical malpractice lawyers now
Manufacturers should never put their profits ahead of public safety. At Crandall & Pera Law, we’ve earned the respect of former clients, insurance companies, and defense lawyers for our ability to show medical devices are defective, are causing you harm, and are preventing your conditions from being treated properly. Call us now or complete our contact form to schedule a free consultation.