Drug Safety

The drug industry is a major component of American society. There are more than 12 prescriptions filled each year for every man, woman, and child in the US. These prescriptions have the ability to save lives, but they also have the ability to cause permanent injury and death when the drugs in question are dangerous.

The US is a very profitable market for drug companies, and lawsuits over dangerous drugs target drug companies’ profits directly, penalizing drug manufacturers that put these drugs on the market.

Possible Dangers Not Evaluated

One important role that jury trials play is penalizing drug manufacturers when they do not properly evaluate the dangers of drugs during pre-market evaluation. One example of this is the anti-acne medication Accutane. During early studies, there were indications that the drug might adversely affect the intestines, but this effect was not evaluated. It was only many years later that we would understand the drug’s role in causing inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis.

Another failure to evaluate potential dangers of a drug was in the case of Posicor, which was dangerous or even deadly when taken with at least 25 different drugs. The manufacturer knew that the drug would result in increased drug concentrations in the blood and listed three specific examples, they did not evaluate other drugs that might be adversely affected. In less than one year on the market, with only about 200,000 prescriptions filled, the drug resulted in more than 100 deaths while offer, according to the FDA, no “special benefits” over other drugs already on the market.

Known Dangers Concealed

There have also been many cases where drug manufacturers have been shown to know about the dangers drugs posed, but worked actively to conceal them. Vioxx was a pain reliever prescribed to arthritis victims. The drug was approved in 1999, and evidence suggests that its manufacturer knew by 2000 that the drug increased risks of heart attack and stroke. However, it continued to deny the link—and intimidate doctors and researchers who talked about it–until 2004 when, in response to increasing evidence, it withdrew the drug from the market. In the five years it was on the market, researchers estimate the drug may have caused up to 140,000 heart attacks in the US, resulting in more than 61,000 heart attack deaths.

Another case of known dangers concealed was Avandia. Avandia was approved in 1999, and almost immediately some researchers were concerned about its impact on the heart. In response, the manufacturer intimidated researchers into keeping silent about the potential risks, even though internal memos showed that the manufacturer knew about these risks. When forced to perform a study on these risks, they designed one that was unable to give clear statistical evidence one way or the other. By the time these risks were fully evident, the drug likely resulted in 83,000 heart attacks, although we do not know how many of these were fatal.

Generic Drugs: Justice Denied

Unfortunately, although lawsuits have been able to get compensation for victims of name brand drugs like Accutane, Posicor, Vioxx, and Avandia, the Supreme Court recently ruled that people could not get compensation for injuries caused by generic versions of a drug. The June 2011 ruling in Pliva Inc. v. Mensing, stated that generic drug manufacturers cannot be held responsible for inadequate labeling on their drugs because they are required to have the same label as the name-brand drugs that they are based on. Previous rulings have shown that people could not sue a name-brand drug manufacturer if they only took a generic version of the drug.

Since 80% of all prescriptions are filled with generic drugs, this means that most people who suffer injury as a result of drugs will be unable to get compensation for their life-changing or even life-ending drug injuries.

This judicial gridlock means that legislative action is required to ensure justice for victims of dangerous generic drugs. Join the fight today to restore these victims’ access to justice.