Defective Drug and Medical Device Litigation Blog

We frequently write about how federal regulation plays a key role in maintaining the safety of the nation's drugs and medical devices. Specifically, we have highlighted the decisions of the Food and Drug Administration (FDA) as particularly important to the safety of American patients.

However, the ability of the FDA to keep dangerous drugs off the shelves and critically important drugs in the hands of patients may soon be compromised. If not reauthorized by September, the FDA will lose its ability to function at a particularly high level due to loss of "user-fee" funding.

There has been a lot of news over the last several months related to the dangerous contraceptive drugs Yasmin and Yaz, which are manufactured by Bayer. The FDA recently voted to require stronger warnings about blood-clot risks on labels for Yasmin/Yaz and similar birth control products.

But there has also been significant news regarding Yaz litigation. As of last month, the company had settled 651 lawsuits alleging blood-clot injuries and fatalities caused by the dangerous drug. The settlement total so far has reached $124 million.

Some prescription drugs are dangerous, not necessarily because of their side effects but because they are only safe for particular conditions. When the drugs are marketed for conditions other than those for which they are approved, disastrous consequences can result. We have previously written that doctors are allowed to prescribe FDA-approved medications for off-label uses, but drug companies are only allowed to market drugs to treat conditions for which they have been approved.

When drug manufacturers try to increase their profits by disobeying safety regulations, patients are put at risk. Potentially dangerous drugs marketed to the wrong patients can be a recipe for disaster.

We have previously discussed the ways in which adequate safety regulation is imperative to ensure that the nation's pharmaceutical and medical supplies are safe for patients. However, one glaring regulatory gap is contributing to the proliferation of defective medical devices, specifically those implanted within patients' bodies.

The Food and Drug Administration (FDA) requires each pharmaceutical to be imprinted with a unique code. This code enables the FDA to track defective and dangerous shipments of given medications and otherwise monitor their safety.

Nearly every prescription drug comes with some risk of side effects while the drug is being taken. Patients who experience those side effects can often simply stop taking the drug.

But with some dangerous drugs, patients may continue to suffer side effects even after they have stopped taking the medication. Recently, the FDA announced that this could be the case with Propecia (a hair-loss treatment) and Proscar, a drug that treats enlarged prostates. As a result, the labels will now warn that some men may continue to experience adverse sexual side effects even after quitting the drug treatment.

In our last post we began a discussion related to safety protocols within the medical device manufacturing industry. Following a scandal seven years ago, the industry pledged to promptly and thoroughly investigate any potentially defective medical devices for safety. However, alleged breaches in this protocol may be costing patients their lives.

Experts have noted that the key to these protocols is that manufacturers explore each severe adverse event and patient fatality linked to its products to see whether or not a defect or flaw in the device is present. If one is found, other patients can be prevented from suffering the same fate.

When news of a defective drug or product grips the media, governmental regulators and the medical community all at once, the hope is that whatever problem has surfaced will be properly investigated, fixed and laid to rest.

Unfortunately, flaws in certain defective medical devices which plagued the market seven years ago have recently reappeared. Evidence suggests that if safety protocols had been properly followed, these flawed devices could have been kept away from patients.

In February, we wrote about counterfeit injectable cancer drugs which are plaguing the American market. We discussed that because of their unregulated nature, these counterfeits could certainly be classified as dangerous drugs, defective drugs or both. Unfortunately, the threats that these counterfeit cancer drugs pose have yet to pass.

In fact, the Food and Drug Administration (FDA) announced earlier this month that an additional counterfeit variation of the popular cancer pharmaceutical Avastin has been circulating in the United States.