Zocor (Simvastatin) Medical Malpractice

While medical malpractice often involves a surgeon making a mistake in the operating room and hurting his or her patient, or a doctor negligently misdiagnosing a patient or missing a diagnosis entirely, these are not the only ways for malpractice to happen. Doctors, surgeons, nurses, and the other healthcare professionals that you see in the doctor’s office or at the hospital are only the front line of medical workers in the vast healthcare system of the United States. There are many more that work behind the scene who can make a mistake or do something negligently or recklessly that ends up hurting you or someone you love.

Defective medical equipment or medicine is an excellent example. Large pharmaceutical companies only develop drugs in order to sell them and make as much profit as they possibly can. When problems or complications arise or are foreseen during the drug’s testing, the question is not whether those issues might hurt or even kill a patient, but whether it would impact the company’s profits as they market and sell the drug.

There are countless examples of this happening in the U.S. The drug Zocor is just one of them. A medicine that aims to lower a patient’s cholesterol, Zocor can have drastic effects on the muscle mass of those who take it, especially those who take it in high doses. Complications from this side-effect can be life-endangering.

The worst part about defective or dangerous drugs like Zocor is that you, as the patient and the end consumer, are almost powerless to avoid a potentially serious injury from the drug. Aggressive marketing campaigns and lobbying from pharmaceutical companies urge you to ask for the drug to deal with your medical problems and pushes your doctor to recommend it and to take it in higher doses. The medical malpractice attorneys at Gilman & Bedigian’s law office in Maryland fight to protect your rights to compensation if you or someone you love has been hurt in one of these terrible situations.

Zocor

Zocor, the trade name for a drug known as simvastatin, is a pill-based lipid-lowering medication. The drug was created and designed to help people lower their weight if they have already tried diet and exercise but to no avail. Zocor works by lowering the levels of lipid – a specific kind of fat – in a patient’s body. By lowering lipid levels, Zocor can also decrease the risk of heart attack in at-risk patients, as well.

Created by the pharmaceutical company Merck, Zocor was approved by the Food and Drug Administration (FDA) in 1991 and started being used medically in 1992. By 2015, the World Health Organization (WHO) deemed simvastatin one of the 410 most essential medications in the world, a designation that many developing countries pay attention to as they create and stabilize their healthcare systems.

The patent for Zocor expired in the United States on June 23, 2006, allowing other drug manufacturers to produce generic variations of the pill. This drastically reduced the price for the pill as competition stepped into the market, cutting into Merck’s profits. Before the patent expired and the drug could be generically produced, Zocor was recording $4.4 billion in worldwide sales. In order to prolong these profits, Merck was able to extend their U.S. patent, which had originally been set to expire in January 2006, an additional six months by showing – controversially – that it could help children.

Intended Use of Zocor

The purpose of Zocor is to help people lose weight who have been unable to do so through exercise and diet restrictions by lowering their lipid levels and reducing their cholesterol. However, there are also collateral uses for Zocor that come from its ability to help people reduce their lipid fats and cholesterol and lose weight. For example, by lowering a patient’s cholesterol, Zocor indirectly benefits a patient by reducing their risk for coronary heart disease.

Because of the significant risk of heart disease in developed countries, Zocor has become one of the most used drugs in the world, especially since it lost its patent protection in the U.S., allowing for the generic production of the drug that drastically reduced its price. In fact, in England, simvastatin was prescribed 39.9 million times in 2013, 9 million times more often than even aspirin.

Crucially, though, Zocor was only intended for use under a certain dosage. According to the FDA, the usual dosage range was between 5 and 40 milligrams per day. Additionally, most patients receiving Zocor are supposed to start at the lower end of that range, complimenting the drug’s impact with diet and exercise to reduce their lipid fats and cholesterol. Only patients who have a high risk for coronary heart disease – whether because they already have heart disease, have diabetes, peripheral vessel disease, or have a history of strokes or other cerebrovascular diseases – are intended to start at the higher end of that dosage range.

Even patients taking Zocor within that range of dosage levels could face serious side effects. However, patients who take Zocor in dosages above the FDA’s recommended use face a drastically higher chance of developing a severe muscle disease known as rhabdomyolysis.

General Side Effects of Zocor

People who take the FDA’s intended dosage of between 5 and 40 milligrams of Zocor per day face a host of side effects. During FDA clinical trials for Zocor, the most common side effects were:

• Upper respiratory infections (9%),
• Headaches (7.4%),
• Abdominal pain (7.3%),
• Constipation (6.6%), and
• Nausea (5.4%).

Additionally, many other, though less common, side effects have been found to occur in patients taking Zocor, including:

• Joint pain,
• Muscle pain,
• Gas,
• Indigestion,
• Heartburn,
• Bloating,
• Diarrhea,
• Insomnia,
• Skin rashes,
• Memory problems,
• Confusion, and
• Cold symptoms, including sneezing, a stuffed nose, or a sore throat.

In addition to these side effects, patients taking Zocor in doses above the FDA’s recommended range have been shown to exhibit significantly higher rates of serious muscle diseases that carry severe and potentially life-threatening complications.

Severe Side Effects for High Dosage Zocor Patients

Unfortunately, the FDA’s recommended dosage range of between 5 and 40 milligrams per day for Zocor, and the realization that patients receiving Zocor doses above that range have increased risks of serious complications came years after doctors had started prescribing Zocor in 80 milligrams per day doses to millions of people. Despite the drug being on the market since 1992, it was not until March 19, 2010, that the FDA released a warning about the potential for high doses of Zocor to lead to significant medical conditions, including myopathy and rhabdomyolysis. The increase in the chances of a patient developing these serious muscular diseases is not small: According to the FDA, patients who were taking 80-milligram doses of Zocor were 50 times more likely to develop rhabdomyolysis than patients who were taking the 20-milligram dose.

The FDA’s finding and subsequent warning came from a seven-year study that included patient reports of people taking Zocor. Out of the patients covered by the study, 53 developed myopathy during the period covered. 52 of those were taking the 80-milligram dosage, while only one was taking the 20-milligram dose. All 22 of the patients covered by the study who developed rhabdomyolysis were taking the higher dosage.

As a result, numerous people had already suffered these serious and potentially lethal side effects from taking high dosages of Zocor. Myopathy is a category of severe muscle tissue diseases. Rhabdomyolysis, on the other hand, is a serious and life-threatening medical condition that involves the death and breakdown of muscle fibers, which then enter the bloodstream. Once there, those muscle fibers can create further complications as other organs come into contact with them that are not conditioned to handle them. Most importantly, muscle fibers that enter the bloodstream from rhabdomyolysis wreak havoc on a patient’s kidneys, often causing renal failure that can be life-threatening.

There are numerous symptoms of rhabdomyolysis, all of them severe. They include muscle pain, weakness, stiffness, or tenderness, as well as aches and pains. These muscle issues become more and more severe as time goes on, until the muscle pain and debilitation are almost complete. These are only the direct implications of the rhabdomyolysis, however, as the muscle tissue weakens and dies. As the muscle tissue pulls away from the muscles, themselves, it enters the bloodstream where it can impact other organs. Muscle tissue that detaches from rhabdomyolysis poses a particular risk to the kidney, which tries to filter the tissues from the blood and gets damaged in the process. Kidney damage and failure is a common side effect of rhabdomyolysis, and can pose significant risks, and can even be fatal.

Despite the clear connection between high doses of Zocor and rhabdomyolysis and myopathy, doctors had been starting many of their patients, especially those who showed a high risk of coronary heart disease, at high dosage levels of Zocor. Many patients were never given doses of less than 80 milligrams per day, increasing their risk for serious muscle conditions considerably.

No Recall for Zocor

Even though Zocor has been strongly connected to myopathy and to muscle conditions like rhabdomyolysis, there has not been a strong push for its recall, considering the clear benefits of the drug at low doses. Instead, because the risk that Zocor carries for its patients only becomes significant at the 80-milligram dosage level, regulatory energy has only gone into urging doctors to only prescribe Zocor at a more acceptable and less dangerous dosage.

As a result, while the FDA has refused to make a recall of the drug, it has added warning labels to Zocor packages to notify doctors and consumers of the dangers present in prolonged use of a high dose. However, it is also clear from clinical trials and subsequent studies that Zocor does not pose as much of a danger to some patients as it does for others. Therefore, the FDA has placed an important limitation on its warnings: Doctors can still justifiably prescribe a higher dosage of the drug, even up to the potentially dangerous dosage of 80 milligrams per day, if a patient has been taking Zocor for over a year without showing side effects dealing with muscular disease or depreciation.

Current Litigation Dealing with Zocor

These warnings, however, do not help the countless people who took high dosages of Zocor because their doctor prescribed it without knowing the serious potential for muscular diseases like myopathy and rhabdomyolysis. For these unfortunate patients who have been hurt through no fault of their own, their only way to get the justice that they deserve is through the legal system.

Numerous lawsuits have been filed on behalf of injured patients who have suffered significant physical disabilities that come with long-term debilitations. Family members of those who have suffered from Zocor’s most serious side effects like rhabdomyolysis can also get compensation for their losses, as well.

Maryland Medical Malpractice Attorneys at Gilman & Bedigian

The personal injury attorneys at the Maryland law office of Gilman & Bedigian strive to help everyone who has been hurt at the hands of the pharmaceutical companies that produce defective or harmful drugs. By fighting for your rights and interests both inside and outside of the courtroom, we can make sure that all of your legal options are pursued and that you get the compensation that you deserve for your losses.

The injuries that over-prescribing Zocor has caused are severe and life-threatening. There is no reason why you and your family should not be fully compensated for your losses after such a devastating event. You should be able to count on your doctor and the drugs that they are relying on to make you better. Zocor has proven to be worthwhile for its ability to lower cholesterol, lipid levels, and reduce the risk of a heart attack. However, pushing pills in an attempt to correct the problem faster is not always a safe answer and now innocent victims have suffered.

If you or someone you love has been hurt from complications of taking Zocor, contact us online or call our law office at (800) 529-6162 for a free consultation.