Defective Medication Under Scrutiny After Supreme Court Ruling

A recent Supreme Court ruling is limiting court actions by injured patients who have filed claims against manufacturers of generic drugs.

The ruling was issued last year and said generic drugmakers do not have control over their labels and therefore cannot be sued for failing to alert the public. Under the 1984 Hatch-Waxman Act, generic drugmakers were not required to undergo the Food and Drug Administration’s (FDA) lengthy approval process if they could prove the generic drug was equivalent to the brand-name medicine.

In most cases, the Henry-Waxman Act requires generic manufacturers use the same labels as brand-name drugs, with dosing instructions and risks for injury. For this reason, judges have started to dismiss many product liability lawsuits against generic manufacturers while allowing those against brand-name drugs to move ahead.

In a March 20, 2012 article, The New York Times reported that a woman who had received the brand name for an anti-nausea medication had suffered gangrene – or a condition that results in dead or weakening body tissue. She sued the manufacturer Wyeth and won $6.8 million.

Another woman took the generic version of the defective drug, known as promethazine, and had to have her arm and forearm amputated because of complications from gangrene. Her case was dismissed last fall following the Supreme Court ruling.

The Supreme Court ruling comes as Americans are increasingly turning to generic medicines. As prices skyrocket and the economy struggles, many health insurance companies are requiring generics be filled before brand-name drugs. Doctors are required to show medical needs for the brand name over generic.

As a result, nearly 80 percent of prescriptions in the United States are filled generic and most states permit pharmacists to dispense a generic in place of a brand name.

What Can Consumers Do:
Support efforts to change the law. Public Citizen, a consumer advocacy group, has petitioned the FDA to give generic companies greater control over their labels. The move may allow generic drug users to sue. U.S. Rep. Henry A. Waxman, D-California, is also exploring ways to address the issue.

Talk to your doctor. Ask your doctor about the medicine being prescribed, the generic and potential side effects. If you are still concerned about potential injuries, ask your doctor to call your insurance company and request a brand-name.

Research any medication you use. Write down the name of the medicine you are prescribed, the medicine you receive at the pharmacy and research both drugs. Discuss any side effects with your physician.

Consider foregoing insurance. If you are really concerned and can afford the brand-name prescription, consider purchasing it. There are many discount drug programs which may help you reduce your costs. Check with any groups you are affiliated with, including AAA and AARP.

Contact your health insurance company. If the company has required you to use generic medications, ask if it has changed its policy and is now allowing use of brand-name medications.

Massachusetts Patients’ Bill of Rights and Preventing Medical Errors.

If You Are Injured by a Defective Drug.
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What Accutane Users Need to Know

Accutane is an acne medication that was once widely used, but withdrawn from the market in June 2009. The manufacturer, Hoffman-LaRoche, discontinued the drug as it faced Accutane lawsuits related to the drug’s powerful side effects.

Accutane is also known as isotretinoin. Approved for use in 1982, the medicine was originally manufactured to treat certain types of cancer. Later marketed as an acne medication, it proved effective at treating severe nodular acne, a chronic condition characterized by large, red, swollen lumps on the skin. Left untreated, severe nodular acne can cause permanent scarring.

Between 1982 and 2009, Accutane was used by more than 13 million patients, including those in Massachusetts. Additionally, many other individuals used generic equivalents, such as Amnesteem, Claravis and Sotret. The generic equivalents are still being prescribed.

The drug has long faced government scrutiny for its side effects, including birth defects, inflammatory bowel disease, ulcerative colitis, Crohn’s disease, liver damage, suicidal thoughts and depression. In many cases, patients have required extensive medical treatment and surgery to correct Accutane injuries.

The FDA has issued several warnings about Accutane over the years. In 2005, it warned users to watch out for symptoms of depression, suicidal thoughts and mood disturbance. The government agency has worked with Hoffman-LaRoche for many years on its iPledge program to reduce the risk of birth defects among female users. In 2007, the FDA warned consumers not to purchase Accutane or its generic equivalents over the Internet without consulting a doctor.

If you have taken Accutane, it is important to be informed of your rights. If you have taken the defective drug and suffered personal injuries as a result, you may be able to file a claim against the manufacturer.

Breakstone, White & Gluck of Boston, Massachusetts is skilled at handling product liability cases involving defective drugs such as Accutane.

Click to learn more about our Massachusetts Accutane lawyers. Or if you have a case, contact us today at 617.723.7676 or use our form.
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