Medical Devices

//Medical Devices
Medical Devices 2017-09-11T22:29:12+00:00

Defective medical devices can devastate an individual hoping to rely on these devices to recover from injuries, or to save a life. Many defective medical devices are the result of product defects: for example, a company rushing to deliver a new product to the market without sufficiently testing the product for safety or long-term use. Common examples of defective medical devices in California that were the subject of litigation include defective hip and knee replacement devices, defective cochlear implants, defective pacemakers, defective contraceptive devices, and defective heart valve replacements. Although injuries that result from defective medical devices are the subject of product liability actions, injured patients may also have additional claims against their doctors, medical professionals, and hospitals.

Importantly, in California, injured parties can bring claims for defective medical devices against any entity in the so-called “stream of commerce” for a given medical device, even if that party was not negligent in the creation or design of the product. This means, for example, that an injured patient might be able to bring suit simultaneously against many parties: the drug or device designer, the manufacturer, laboratories involved in testing the drug or device, sales representatives, doctors, pharmacists, hospitals, clinics, or even retail suppliers. To do so, an injured patient must show that that the defective medical device or drug was used in an “intended or reasonably foreseeable manner” (which can include reasonably foreseeable misuse), that the device or drug was in a defective condition when it left the possession of the party being sued, and that the device or drug was the “legal cause” of the injuries suffered.

For example, if a patient is implanted with a defective hip replacement, and argues that the hip replacement was defectively designed, all parties later in the stream of commerce, such as the hip replacement manufacturer, laboratory, doctor, and so on, may be liable. Alternatively, if a patient’s defective hip was damaged when the hip was shipped from the supplier to the doctor, the hip designer, manufacturer, testing laboratory, and so on will not be liable, though the shipping company, doctor, hospital, and nurse may be.

In California, most defective medical device or drug cases are brought under a theory of law known as “strict liability.” See Greenman v. Yuba Power Products, 377 P.2d 897 (Cal. 1963). Under this theory, the defective device or drug can either be the defective due to a design defect, due to a manufacturing defect, or be defective because it does not contain adequate instructions or warnings of potential safety hazards.

Medical devices or drugs that are defective due to a design defect are often defective because the manufacturer has failed to understand the risks involved in the materials or chemicals used. For example, a medical device manufacturer may have chosen to use a cheaper material to design a pacemaker as a means to save money, however, the cheaper material may unexpectedly cease functioning, when a more expensive alternative would not have. Similarly, a drug company may design a drug using an experimental compound that results in detrimental effects years later, when a safer compound capable of accomplishing the same result was also available.

In contrast, manufacturing defects in defective medical devices or drugs are defects in the device or drug that deviate from the manufacturer’s intended or designed end product, or possibly from other, identical, products that are part of the same product line. For example, if the manufacturer of a hip replacement failed to attach a necessary screw to the replacement, even though this screw was specified in the design, the hip replacement would be guilty of a manufacturing defect. As discussed previously, the hip replacement designer would not be liable for the defect, however the manufacturer and all others in the chain of commerce may be.

Finally, a medical device or drug may be defective because it lacks adequate warnings or instructions. In general, these are devices or drugs that could be used safely, but, because they lack sufficient warnings or instructions, create an “unreasonable risk” to the user. See DeLeon v. Commercial Manufacturing & Supply Co., 148 Cal. App. 3d 337 (Cal. Ct. App. 1983). For example, if a chemotherapy drug prescribed to treat cancer should not be taken more than once per day (and, if taken multiple times per day, could cause death), but lacks instructions informing the patient of this, that chemotherapy drug may be defective because it lacks adequate warnings for its use and the risks of misuse are extremely high.

A patient who has been impacted by a defective medical device or drug may also be able to sue his or her doctor, medical professional, or hospital separately under a medical malpractice claim. In these cases, a patient must show that the doctor, for example, was negligent in selecting the device to be used in the patient. For example, if a doctor decided to implant a medical device in a patient that was known to be defective, or the doctor might have reasonable determined that it was, the patient may be able to pursue simultaneous claims under a product liability and medical malpractice theory.

Many defective medical device or drug claims are pursued as class actions in California. In these circumstances, a device or drug suffering from a design, manufacturing, or warning defect may have impacted many individuals over a long period of time. Class actions attorney will consolidate many cases together and bring suit on behalf of many victims against the guilty parties in one trial. Oftentimes, these types of cases are beneficial for victims because, so long as the victims were the recipient of the device or drug, they may be entitled to compensation, frequently without the hassle of hiring independent attorneys, doctors, and investigators. Recently, for example, Glaxo Smith-Kline, a major drug manufacturer, paid out over $3 billion to settle a class action lawsuit resulting from defective drugs in California.

Many medical devices and drugs are governed by state and federal agencies, such as the Food and Drug Administration (FDA). As a result, litigation against medical device and drug companies can be complicated due to the complex licensing and regulatory approaches deployed by the FDA. Moreover, the FDA’s rules change over time, further complicating recovery that might stem from a defective device or drug manufactured used or manufactured years before. A skilled attorney and medical professional, knowledgeable in defective medical device or drug issues, can help to navigate this complex legal field.

At the Thompson Law Offices, we understand that your ability to receive the medical care you need, your ability to support your family during your recovery and beyond, and even your peace of mind may depend on receiving the compensation you deserve. Our goal is always to recover the full value of your claim.

If you’re ready to start fighting for your rights, request a free consultation.