Defective Drugs: Are You Afraid of Your Medication?

Minneapolis, MNWith the recent focus on defective drugs and drug recalls, you can be forgiven for hesitating for a moment before you take your medication. After all, lately it seems as though it is not a case of IF a drug will be recalled, but WHEN the recall will occur. Bad drugs have been in the news a lot—from overdoses of active ingredients to tendon ruptures to increased risk of heart attacks. The makers of these medications face a variety of drug lawsuits, alleging that they have put profits before people.

The good news is that the Supreme Court has sided with consumers, finding that federal approval of a warning label does not pre-empt a patient's right to sue under state law for failure to adequately warn. The bad news is that for every lawsuit like this one, there is a patient (or many patients) who had to suffer terrible side effects from the drug.

Everyone knows that medications can cause side effects and in some cases, those side effects are worth the benefits from taking the drug. But the usually accepted side effects include headaches, nausea and dizziness, not heart attacks, strokes and liver failure.

Yet this is exactly what patients are being asked to endure: serious side effects for drugs that do not seem to do much to help them. And, if that weren't enough, patients are being subjected to drugs that are improperly manufactured, contain contaminants or contain high doses of active ingredients—all things they are not warned about on a drug's labeling.

Meanwhile, the one agency that consumers rely on to protect them from defective drugs, the FDA may not be acting quickly enough to protect people. According to a report in the News and Observer, the FDA received reports about debris and sediment in medicine shipped from AM2PAT in 2005, but did not issue a recall on the company's products until December 2007.

AM2PAT is now involved in a criminal investigation after 5 deaths and 100 illnesses were linked to the company's heparin and saline products. Patients were exposed to the contaminated products during chemotherapy, kidney dialysis and other procedures that required an IV. Claims against the company include falsifying documents so that it would appear that sterility tests were conducted, operating with broken lab equipment and using an ordinary fan to ventilate a "clean room," in which the air is controlled so that germs do not spread.

Shockingly, the company has also been accused of hiring a teenage high-school dropout as its chief microbiologist. Despite repeated red flags about problems with AM2PAT's heparin, the FDA did not take immediate action against the company, putting more patients at risk of serious complications, according to patient advocates.

Even when drugs appear to have been properly manufactured, there is a risk that the studies that found the drugs to be beneficial were actually fabricated. According to an MSNBC article, an anesthesiologist has been accused of faking data for 12 years in studies that suggested benefits from painkillers. The anesthesiologist is alleged to have fabricated some or all of the data included in 21 papers published between 1996 and 2008.

The published studies reported favorable results from Bextra, Celebrex, Lyrica and Vioxx. Furthermore, some studies reported that Effexor, an antidepressant, could be used as a painkiller. Since those papers were published, some of the medications have been pulled from the market because they were linked to a risk of heart attack, stroke and death. Some of the studies have now been retracted.

One doctor noted that the anesthesiologist's findings were used widely and had "a huge impact on the field." Some of the clinical trials may now be repeated.

Faced with news like this, how are patients supposed to have faith that their drugs are safe and tested and manufactured properly? They really cannot. All they can do is take their medicine and hope that they will not be one of the ones who suffer a "rare but serious" side effect. They can only hope that one day the medication they take will not be recalled.

And, if their medication is found to be defective, they can contact an attorney to discuss their legal options.