Defective Drug and Medical Device Litigation Blog

By now, many Americans have probably heard about New Jersey Governor Chris Christie's recent weight loss surgery. Bariatric procedures have become one of the most popular and effective ways for obese Americans to lose weight and address or cure weight-related medical issues; some of which include type II diabetes, high blood pressure, high cholesterol and heart disease.

There are several bariatric procedures available, and some are wondering why Christie chose the lap-band procedure. Experience has shown that while many patients have had success with a lap-band procedure, the lap band can be a dangerous medical device that often causes complications later on.

We have previously written about the dangerous drug Fosamax, which was first patented and manufactured by Merck & Co. The drug is in a class of medications called bisphosphonates, which help prevent the loss of bone mass and related conditions such as osteoporosis.

Fosamax seemed to work well and was wildly popular. Unfortunately, however, many patients were not adequately warned about the risks associated with this dangerous drug; including femur fractures and a condition known as osteonecrosis of the jaw (or jaw death).

Pregnant women have a lot of restrictions placed on them. In addition to worrying about eating right, getting plenty of rest and generally taking care of themselves, pregnant women also have to abstain from alcohol and try to stay away from second-hand smoke.

There are also a number of prescription medications that shouldn't be taken during pregnancy. While these are not otherwise dangerous drugs, certain medications taken during pregnancy can cause damage to the fetus or birth defects. Recently, the Food and Drug Administration added another drug to the list of meds for pregnant mothers to avoid.

Women choose to undergo breast implant surgery for a variety of reasons. But regardless of whether a woman entrusts her body to a plastic surgeon for reconstructive surgery after cancer, reconstructive surgery after an accident or because she simply feels that such surgery will benefit her in some way, she deserves quality care and safe implants. Unfortunately, not every woman receives the quality care and safe implants she deserves.

Earlier this month, five Poly Implant Prothese (PIP) manufacturing executives began standing trial in France for producing defective medical devices. Over 300,000 women have been implanted with the company’s defective breast implants globally. Approximately 5,000 women have filed suit against the pharmaceutical giant so far.

Some of our recent posts have been focused on the dangers of certain medical products labeled and sold as "dietary supplements." The Food and Drug Administration no longer has pre-market regulatory power over dietary supplements, which are defined as orally ingested products containing "dietary ingredients." Common examples include vitamins, minerals, amino acids and other things the body needs to maintain health.

But because the FDA does not have regulatory power over dietary supplements before they hit the market, a lot of dangerous drugs are put on store shelves because their manufacturers market them as dietary supplements. Unfortunately, this causes a lot of extra work for the FDA after the products are released; and it also puts consumers in danger. According to a recent study, the majority of drugs subject to a Class I recall since 2004 have been dietary supplements. 

As we have previously discussed, federal officials have turned their focus to compounding pharmacies across the country. In the wake of the meningitis outbreak - caused by unsanitary conditions at a compounding pharmacy in Massachusetts - the Food and Drug Administration increased its efforts to inspect these facilities.

Recently, the FDA conducted an investigation at a compounding pharmacy located in Indianapolis. During the inspection, the FDA noted issues with quality control within the facility that could have led to products being contaminated. When the environment in a compounding pharmacy is not sterile, the drugs being manufactured at the location can be compromised, which could lead to serious health risks for patients who use them.

One of the most glaring regulatory gaps in our healthcare system was exposed during the 2012 meningitis outbreak. Unlike ordinary pharmacies, compounding pharmacies have long been largely exempt from regulatory oversight by the Food and Drug Administration. As a result, defective drugs produced by these manufacturers can more easily slip into the stream of patient commerce. Thankfully, this critical regulatory gap is currently being addressed by Congress.

Under a new bipartisan bill drafted under the powers granted to congress by the Constitution's Commerce Clause, compounding pharmacies shipping drugs across state lines would become newly subject to FDA authority. This power will allow the FDA to hold compounding pharmacies to various safety and quality standards aimed at preventing injury to patients.

Knowledge is a powerful tool; and one that is crucial to patient safety. That's why most of our blog posts focus on the harm and side effects patients suffer because they did not know enough about a dangerous drug before taking it.

But there are times when patients put themselves and their family members at risk by refusing to participate in medical treatments that can prevent serious diseases; usually due to unfounded fears about the safety of a given drug. Perhaps the most potent example of this is the debate over the safety of early childhood vaccinations.