Products Liability Medical Malpractice Lawsuits

The United States Supreme Court has made new rulings which may affect future product defect cases. Each case looks at the role of the United States Food and Drug Administration (FDA) and state law in controlling the quality of products. Specifically, these rulings could alter the ability of consumers to raise claims against drug manufacturers and medical device manufacturers for injuries suffered due to product defects.

Drug Warning Labels

In March 2009, the U.S. Supreme Court reviewed the case of Diana Levine (a former guitarist). Ms. Levine lost her arm after she visited a Vermont health clinic in April 2000 seeking medical assistance for a migraine. A physician’s assistant injected Ms. Levine with Wyeth's Phenergan drug (an anti-nausea drug). The injection in Ms. Levine’s case was made directly into her vein, using what is known as the IV-push method. Unfortunately, this injection immediately caused gangrene in Ms. Levine’s arm.

Medical personnel have several options for injecting this particular drug:

A slow intravenous drip into a vein
Intramuscular injection
IV-push method (in which the drug is injected into a vein)*

*Note: The IV-push method is considered the most risky method of injection, while the other two options are comparatively less dangerous.

Originally, a jury in Vermont found that Wyeth's label had inadequate warnings addressing the dangers associated with injecting the drug through the IV-push method. The jury then awarded Ms. Levine $6.7 million. In 2006, the Vermont Supreme Court upheld the jury’s ruling, prior to the U.S. Supreme Court upholding the jury’s determination.

After hearing arguments and reviewing the case, the U.S. Supreme Court determined in a six to three decision that patients injured by such a drug may pursue a state liability lawsuit against drug companies, even if a drug has undergone FDA review.

While arguing before the U.S. Supreme Court, Wyeth had asserted that the warning on the drug was sufficient because it had received FDA approval. The company also argued that it could not change the drug’s label after the FDA approved it. Furthermore, Wyeth contended that allowing lawsuits based on the each state’s liability laws would limit the government’s ability to regulate the drug industry. The U.S. Supreme Court rejected these arguments.

The effect of this ruling remains unclear. However, this decision will likely eliminate one argument that drug companies often use to get lawsuits dismissed. Drug companies, like Wyeth, will likely fail in asserting that a claim raised by an injured individual should be dismissed simply because the FDA approved of the warnings placed on the drug’s packaging. Many states, such as California, Illinois and Vermont have laws in place to protect consumers against companies who fail to sufficiently warn consumers about hazardous products.

Medical Devices

In February 2008, the U.S. Supreme Court considered the case of Charles Riegel. Mr. Riegel died in 1996, after a balloon catheter burst, after it had been inserted during an angioplasty.

The U.S. Supreme Court ruled eight to one that medical device manufacturers are protected from state lawsuits, even if the devices do not function properly, as long as the devices have undergone FDA review and approval. The decision applies specifically to Class III medical devices, such as pacemakers or heart valves. These devices go through the highest level of FDA scrutiny before approval. As stated on the FDA’s website, “Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” In this case, Medtronic had made the catheter that burst. The catheter is considered a Class III medical device, which had been approved by the FDA after considerable testing.

The effect of the U.S. Supreme Court’s decision in this case is still unfolding. However, the outcome in this case will likely limit the avenues of legal recourse available for consumers injured by medical devices approved by the FDA. Effectively, a company that gains FDA approval for their medical device will seemingly have a great deal of protection against a lawsuit should the device cause an injury to a patient. The decision also appears to fall in line with existing federal law governing the FDA, which prevented state law from pre-empting the FDA’s approval process for medical devices.

Medical Product Defects Lawsuits

Defective medical products can include any of the following:

Prescription drugs (such as painkillers, anti-depressants, or anti-nausea drugs)
Over the counter drugs (such as contact lens cleaner or cold medications)
Surgical products (such as silicone breast implants or catheters)
Medical devices (such as pacemakers)

For an injured party to successfully bring a lawsuit against a medical device or drug manufacturer, an experienced attorney is needed to make an initial determination, as to whether the lawsuit should be raised as a products liability or medical malpractice lawsuit. Properly making this decision requires that an attorney have a strong understanding of the facts of the case, as well as an extensive knowledge of both product liability and medical malpractice law.

Attorneys must also consider the applicable statute of limitations in medical injury cases. In the above cases decided by the U.S. Supreme Court, the injured parties knew within a short period of time after receiving treatment that they had suffered an injury. Other injured parties, however, may not learn of their injury until some period of time passes from the time of the individual’s treatment. The statute of limitations for some states is based upon when an individual suffers an injury, while other states consider the moment when an individual learns of their injury to initiate the statute of limitations. Such important distinctions demand knowledgeable, experienced counsel to help an individual protect his or her legal rights.

Seek Qualified Legal Advice

Injuries caused by medical device and drug manufacturers can occur for a variety of reasons. The success of your case depends on both the merits of the case and your attorney’s understanding of the laws applicable to medical product defects. The impact of the above U.S. Supreme Court decisions is still not clear. However, any case involving either area of the law will demand that an attorney consider the importance of each decision when determining how to proceed with a case.

If you or a loved one has suffered injuries from a medical device or drug defect, please contact us at the National Justice Coalition for a confidential evaluation by a qualified attorney experienced in product defect injury litigation.