This week, Illinois Attorney General Lisa Madigan announced that the lawsuit that she was spearheading along with the Oregon Attorney General to find justice for those who had been injured by the drug Avandia had been settled. Illinois AG Madigan’s press release appears below with all the details.
This settlement is a settlement of potential claims by the various states involved in the negotiations and the manufacturer of this drug, GlaxoSmithKline. Notice that the State of Indiana is not involved here. Also, notice that these are claims that the states would make against the drug maker; this settlement does not involve private causes of action based upon personal injury or product liability laws as they stand on the books of the State of Illinois or the State of Indiana or any other state.
The Attorneys General here are settling the state allegations of deceptive and unfair trade — this is not a settlement of any personal injury negligence claims by an individual who has been hurt or killed after taking Avandia. In particular, the State of Illinois sued GlaxoSmithKline for violating the Illinois Consumer Fraud and Deceptive Business Practices Act and the Uniform Deceptive Trade Practices Act in a Cook County court. You can read the complaint online here.
What is Avandia? It’s a Drug Used for Type 2 Diabetes Sufferers
According to the U.S. National Library of Medicine, Avandia is the brand name for rosiglitazone, a drug that was been given to treat Type 2 Diabetes. However, it’s dangerous and the following warning as been issued by the federal government:
Rosiglitazone may cause fluid retention (a condition where the body keeps excess fluid) that may lead to or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take rosiglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease, high blood pressure; coronary artery disease (narrowing of the blood vessels that lead to the heart); a heart attack; an irregular heartbeat; or high cholesterol or fats in the blood. Your doctor may tell you not to take rosiglitazone or may monitor you carefully during your treatment.
If you develop congestive heart failure or other heart problems, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking rosiglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; the need to sleep with extra pillows in order to breathe while lying down; frequent dry cough; or increased tiredness.
Taking rosiglitazone may increase the risk that you will experience a heart attack. This risk may be higher if you take insulin along with rosiglitazone. Your doctor may tell you not to take rosiglitazone if you are taking insulin. Tell your doctor or get emergency medical care immediately if you experience any of the following symptoms: shortness of breath; pain in the jaw, arm, back, neck, or stomach; pain in the center of the chest that lasts for a more than a few minutes or that goes away and comes back; uncomfortable pressure, fullness, or squeezing in the chest; breaking out in a cold sweat; nausea or vomiting; or lightheadedness.
A program has been set up to limit the use of rosiglitazone and to inform people about the increased the risk of heart attack while taking this medication. Only people are already taking rosiglitazone and people whose blood sugar cannot be controlled by other medications should consider taking rosiglitazone. The program also makes sure that everyone who takes rosiglitazone understands the risks and benefits of taking the medication and has talked to his or her doctor about these risks.
You will be able to take rosiglitazone only if you and the doctor who prescribes your medication have enrolled in the program. You will receive your medication by mail from a participating pharmacy; you will not be able to get your medication from a local retail pharmacy. Ask your doctor if you have any questions about participating in the program or receiving your medication.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with rosiglitazone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer’s website to obtain the Medication Guide.
Talk to your doctor about the risks of taking rosiglitazone.
Avandia Linked to Over 100,000 Heart Attacks by Food and Drug Administration
This once-popular diabetes drug has been linked to over 100,000 heart attacks here in the United States according to the FDA. Studies show that Avandia can up the chances of having a heart attack by 43% and it can DOUBLE the risk of heart failure if you take it consistently over a one year time period.
Still, Avandia has not been recalled from the market. You can buy it today.
If you or a loved one has been hurt by taking the diabetes drug Avandia, then you may have a legal claim under your state’s personal injury laws for damages. The Attorney General settlement does not block that avenue for justice.
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Avandia Settlement Press Release by Lisa Madigan, Illinois Attorney General, on November 15, 2012:
Chicago — Attorney General Lisa Madigan today announced a $90 million settlement with pharmaceutical company GlaxoSmithKline reached with 37 of her counterparts over allegations that the company unlawfully promoted its diabetes drug, Avandia. Illinois will receive more than $5 million under the settlement.
In filing a joint complaint and settlement today, Madigan and the other attorneys general allege that GlaxoSmithKline engaged in unfair and deceptive marketing practices when it misrepresented the safety of Avandia and the effects it would have on a patient’s cholesterol levels and cardiovascular health.
Madigan and the other attorneys general alleged the company promoted Avandia using false and misleading representations on the safety of the drug for diabetic patients. The attorneys general also alleged GlaxoSmithKline lacked scientific evidence to back up its claim that Avandia would lower a patient’s cholesterol and falsely promoted the drug’s cardiovascular benefits when Avandia may instead increase a patient’s cardiovascular risks.
“Our investigation demonstrated that GlaxoSmithKline had little regard for the facts or for the health and safety of the patients it targeted with its misleading marketing,” Madigan said.
As part of the settlement, GlaxoSmithKline will reform how it markets and promotes diabetes drugs. The company is prohibited from:
Making false, misleading or deceptive claims about diabetes drugs;
Making safety claims not supported by substantial evidence or substantial clinical experience;
Presenting favorable information of drugs that have been proven invalid;
Promoting drugs before they have received approval from the U.S. Food and Drug Administration; or
Misusing statistics or otherwise misrepresenting the nature, applicability or significance of clinical trials.
Under the settlement, for a period of at least eight years, GlaxoSmithKline must post summaries of all company-sponsored observational studies and company-sponsored clinical trials of diabetes products. GlaxoSmithKline must also follow requirements under federal law on registering and posting such clinical trials and comply with International Committee of Medical Journal Editors Uniform Requirements for Manuscripts submitted to biomedical journals.
The investigation was led by Madigan and the Oregon Attorney General’s office. Also participating in the settlement are attorneys general in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.
