Denver Defective Drug and Medical Device Attorneys
We expect all the products we use to function properly, but none are more important than medical devices and drugs. When a patient is harmed by a dangerous device or drug, the manufacturers may be to blame.
If something went wrong with your medical treatment, all of your focus should be on resting and recovering. An experienced attorney can take the legal burden off your shoulders, so you don't have to worry about deadlines, filing paperwork, or arguing with a powerful insurance company to get the compensation you need to heal. At Leventhal Puga Braley P.C., our Denver product liability attorneys take care of that so you don’t have to. Call us today at (303) 759-9945 or toll-free (877) 433-3906 for a no-cost consultation.
A medical device is used to diagnose, prevent, or treat a medical disease or condition. The Food and Drug Administration (FDA) regulates all medical devices distributed in the United States, which is the largest medical device market in the world. Even small items such as bandages and eyeglasses are considered medical devices.
There are three FDA classifications of medical devices, which is determined by the extent of the device’s risk and invasiveness. Medical device malfunction that leads to product liability usually involves Class 2 or Class 3 devices.
Class 1 Medical Devices are “not intended for use in supporting or maintaining life.” They don’t come into contact with the patient’s internal organs, cardiovascular system, or internal organs, so they are subject to the fewest regulatory requirements. Examples include hospital beds, tongue depressors, and electric toothbrushes.
Class 2 Medical Devices are more sophisticated than Class 1 devices and more likely to come into contact with the patient’s internal organs or cardiovascular system. Examples include syringes, contact lenses, and catheters.
Class 3 Medical Devices “usually sustain or support life, are implanted, or present a potential risk of illness or injury” These are often the most innovative devices. Examples include pacemakers, implanted prosthetics, and breast implants.
The FDA monitors the manufacture of medical devices, which are subject to current Good Manufacturing Practice (cGMP). But devices are not always tested in real life situations before they go to market.
The overwhelming number of new devices that enter the market each year leaves a lot of room for error. Manufacturers are required to submit a Medical Devices Report (MDR) to the FDA when a device causes illness, injury or death. The FDA receives over 100,000 MDRs every year.
When a medical device does not work correctly, doctors and nurses are often left scrambling, and the results can be catastrophic, even fatal. Manufacturers of medical devices have to ensure thorough testing and quality control for what they make; otherwise, they put patients in danger - and can be held liable in court.
Some medical devices that are often faulty or defective include:
- Heart valves
- Prosthetic knees
- Resuscitation equipment
- Crutches, walking frames, and canes
The FDA does not have the authority to regulate doctors, only products. The role of medical device defect lawyers is to make sure medical devices are safe and doctors are using them properly.
The production and sale of medications, including prescription and non-prescription drugs, is a multi-billion dollar industry. When pharmaceutical companies perform clinical trials and receive FDA approval, they can develop remarkable drugs that greatly improve the lives of millions of people.
However, these companies sometimes cut corners in order to maximize profits, and when that happens patients can be seriously harmed or killed by adverse drug events. We often see claims arise over adverse events associated with these types of drugs:
- Type 2 Diabetes
- Blood Thinners
- Birth Control
- Sleep Aids
If you believe your injury or medical condition arose because of a faulty drug or device, we want to talk to you.
Often, people suffer catastrophic injury through no fault of their own. When that’s the case, we at Leventhal Puga Braley P.C. don’t believe that the victims should be stuck paying for those injuries.
Manufacturers have a duty to make products that work in the way they are intended. When these products fail or cause adverse reactions, the manufacturer – who often rushed the design or production process – should be held accountable. Like any other civil lawsuit, a lawsuit over a defective drug or medical device comes down to establishing liability, causation, and damages. Liability means that the company did something that another reasonable company would not have done while manufacturing or marketing a medical device. Causation means that the company's act of negligence was a cause of some type of harm to a consumer. Damages mean losses or injuries to the patient.
Establishing liability, causation, and damages is not simple. It often takes a great deal of research, testing, and expert testimony to demonstrate. At Leventhal Puga Braley P.C. our experienced and knowledgeable Denver medical product liability lawyers will go up against any pharmaceutical company or medical device manufacturer that caused harm to our clients.
Call (303) 759-9945 or toll-free (877) 433-3906 to set up a no-cost consultation so we can review your situation. We will let you know if you have a valid claim, and if so, we will handle your claim for no upfront cost, only taking our fee if we get you fair compensation. There are time limits in every state for filing a claim, so the sooner you speak to us, the better.
- How Does A Medical Device Wind Up In Your Body?
- Medical Devices - FDA
- Drugs - FDA
- Adverse Drug Events in Adults - CDC