Drug Injury Attorney Blog

Federal legislators are introducing new bills that would allow patients to once again file lawsuits over injuries from flawed or unsafe medical devices, the New York Times reported Feb. 19. The bills are necessary because of a February 2008 Supreme Court decision in Riegel v. Medtronic Inc. (PDF), which found that defective medical device lawsuits based on state claims are preempted by explicit language in federal law. The decision barred most, if not all, medical device claims, leaving patients at the mercy of a flawed FDA approval process.

The article starts with the story of the Turnidge family, which lost father Mark Turnidge in January. Turnidge, 33, had an internal defibrillator implanted into his heart, which was intended to regulate his heartbeat. Because of a break in the device that could have caused random, repeated electric shocks to his heart, Turnidge decided to have it surgically removed -- but the surgery went wrong. Turnidge died, leaving wife Wendy and two young boys behind. Wendy Turnidge is considering a medical malpractice lawsuit as well as a dangerous medical device lawsuit against Medtronic, the maker of the flawed defibrillator that made the surgery necessary. But thanks to the Riegel decision, a Medtronic lawsuit would almost certainly be dismissed unless Congress takes action.

Preemption is a legal doctrine that says federal law trumps the laws of states and local governments. If a federal law preempts a state law, following that federal law should protect individuals and businesses from criminal or civil liability for not following state laws on the same subject, including state negligence claims. The Riegel decision found that language in the Medical Devices Amendments of 1976 explicitly preempted state claims. (This makes it distinct from the court’s more recent decision in Wyeth v. Levine, in which the pharmaceutical company argued that the law implied, but did not outright specify, preemption.)

As the Times reported, this decision left medical device patients to rely wholly on FDA regulators to prevent serious injuries or even deaths from medical device defects. That would be more reassuring if so many medications and medical devices had not been recalled in recent years due to serious safety flaws, and if we had not seen so many reports of political and industry influence trumping science at the agency. As a pharmaceutical liability attorney, I have seen patients killed, disabled or diagnosed with lifelong serious health conditions because of injuries from FDA-approved medicines and devices. I do not believe FDA approval is enough to ensure safety, at least at the moment.

Based in St. Louis, The Lowe Law Firm represents clients in Missouri and throughout the nation in defective medical device litigation and dangerous prescription drug claims. If you or someone you love has been hurt by a pharmaceutical product and you’d like to talk with us about legal action, please contact us online or call us toll-free at 1-877-678-3400.

An email sent by an official at drug maker AstraZeneca admits that the company suppressed three clinical trials of its drug Seroquel because of unfavorable results, Bloomberg News reported Feb. 27. The message was revealed as part of an ongoing series of pharmaceutical injury lawsuits alleging that AstraZeneca knowingly failed to warn customers that Seroquel could cause diabetes and related health problems. In the December 1999 message, AstraZeneca official John Tumas told colleagues that the company “cherry-picked” data from one Seroquel study and failed outright to publicize two others that were unfavorable to its product.

Seroquel, an “atypical” antipsychotic, is approved to treat schizophrenia and bipolar disorder. Originally thought of as a vast improvement over older psychiatric medications, it came under fire in 2004, when a group of medical research organizations named it as one of six antipsychotics (along with Risperdal and Zyprexa) that promote diabetes, high cholesterol and obesity. At least 9,000 lawsuits have been filed alleging that AstraZeneca failed to warn patients of this risk. Many also allege that the company promoted its drug for illegal off-label uses. Spokesman Tony Jewell told Bloomberg News that the company acted responsibly and appropriately in its research and marketing.

The unsealed documents suggest that not everyone agrees, according to Bloomberg. In the 1999 email, Tumas chastised company officials for not disclosing the full results of the “cherry-picked” study, suggesting that the company’s reputation for ethical behavior was in danger. In another unsealed message, AstraZeneca official Richard Lawrence said the company had engaged in a “great smoke-and-mirrors job” with U.S. and Canadian regulators. And documents from 2000 show that company officials knew that the drug was linked to high blood-sugar levels, even though a 2000 FDA filing from the company said it had no documented evidence of a relationship between Seroquel and diabetes.

The Lowe Law Firm is actively pursuing lawsuits over injuries from taking Zyprexa, another of the atypical antipsychotics under fire for its connection with diabetes. If you or someone you care about has developed diabetes, obesity or another serious health problem from taking Seroquel, we would like to hear from you. In a successful defective drug injury lawsuit, you can win compensation for all medical bills related to an injury from Seroquel, as well as compensation for living with a serious health condition caused in part by a company’s failure to warn you of the dangers. Based in St. Louis, Missouri, the firm represents people with serious defective drug injuries around the U.S. To set up a free, confidential consultation, please call toll-free at 1-877-678-3400 or contact us online.

As a pharmaceutical injury lawyer, I was delighted with the U.S. Supreme Court’s March 4 ruling that drug manufacturers may not escape legal liability simply because their warning labels comply with FDA regulations. Wyeth v. Levine (06-1249). As the New York Times reported, the court ruled 6-3 that there is no implied preemption in federal law that would stop state juries from hearing drug injury lawsuits. The case was closely watched by pharmaceutical companies as well as drug injury lawyers around the country, because it had the potential to stop all drug injury claims, no matter how valid the claim or serious the injury.

The case was brought by Vermont resident Diana Levine, who visited a health clinic for migraine headache treatment. For her nausea, she was given an injection of Phenergan, a drug made by Wyeth. Phenergan is safe when injected into a vein, but causes swift and irreversible gangrene when exposed to blood in arteries. The assistant at the clinic made a mistake, and Levine lost her hand and lower arm -- and her livelihood as a musician. She sued and settled with the clinic, but also sued Wyeth, arguing that the manufacturer failed to sufficiently warn users about the risks of administering Phenergan incorrectly.

At trial, Wyeth argued that it should not be held responsible for Levine’s injury because it had followed all of the FDA labeling regulations that applied to the drug. It said the court should find that federal law preempts state claims through implied, not explicit, language. The Supreme Court rejected that argument, saying that Congress had explicitly stated that several federal laws preempt state laws and had the opportunity to include such language in drug regulations -- but chose not to. In fact, wrote Justice John Paul Stevens, the FDA welcomed dangerous drug lawsuits as a complement to its own work until 2006, when it underwent “a dramatic change in position” under the Bush Administration. He also criticized the FDA at length for its toothlessness in recent years.

As a dangerous prescription drug lawyer, I am delighted with this ruling, which ensures that people who have suffered permanent injury or lost a loved one to a defective medication can continue to seek justice through state courts. If the court had found that federal law does preempt state claims, it would have eliminated many valid pharmaceutical liability lawsuits brought by seriously hurt people. The painkiller Vioxx, for example, became the subject of thousands of lawsuits after it was revealed to quadruple patients’ chances of serious heart attacks and withdrawn from the market amid allegations that drug maker Merck knew about the problem long before it took action. None of those people would be able to hold Merck responsible for their injuries, or the deaths of their loved ones, if the preemption argument had prevailed.

I can always practice a different kind of law. But for my clients, a ban on dangerous drug litigation leaves them with no recourse if they have been seriously harmed by a drug maker’s irresponsibility -- even if, as was alleged with Vioxx, the manufacturer knowingly exposed its customers to serious harm. Thanks to the Supreme Court, patients still have that option. If you or someone you love was seriously hurt by a defective prescription drug, The Lowe Law Firm can help. To set up a free consultation about your defective drug claim, please contact us through our Web site or call 1-877-678-3400.