Riegel v. Medtronic

On Wednesday, the U.S. Supreme Court held that Food and Drug Administration approval of medical devices preempts personal injury claims filed under state laws. The decision, which was split 8-1, holds that the preemption applies to certain medical devices that meet FDA specifications, and were approved by the administration before being marketed to the public.

You can read more about the decision, here.

I know there are a lot of philosophical differences about the benefits of a free market, but in my opinion, if there is going to be minimal governmental regulations on the front end, then injured persons need to be able to hold negligent manufacturers responsible. If there's no oversight, there should at least be accountability. That's what the civil justice system is supposed to provide.

Drug Companies And False Advertising Pt. 2

Will they ever learn?

The New York Times is reporting that drug manufacturer Eli Lilly may be fined as much as $1 billion for misleading customers about the uses of antipsychotic drug Zyprexa.

The U.S. Food and Drug Administration approved Zyprexa only to treat schizophrenia and bipolar disorder. Eli Lilly salespeople, however, marketed the drug to doctors and health care providers for "off label" uses such as mild depression, anxiety, and age-related dementia. The drug was not approved for such uses, and in addition to having adverse consequences for users, resulted in hundreds of thousands of dollars in Medicaid and Medicare expenses--which in turn cost taxpayers and senior citizens money.

Additionally, the fine prompted a lawsuit by Eli Lilly's shareholders, who allege that the company's off label marketing was in "reckless disregard" of the risks of illegal advertising, thereby costing millions of dollars in litigation expenses, devaluing the stock, and damaging the shareholders' interests.

Drug Companies And False Advertising

A new study showed that Merck & Co, Inc., a national pharmaceutical manufacturing company, knew that its anti-cholesterol drug, Vytorin, was no more effective than generic counterparts--which cost much less.

Unfortunately, Merck falsely represented to its customers that Vytorin was more effective than the less expensive drugs.

Health care costs are already too high for most average Americans. This study reveals that consumers needlessly overpaid for name-brand drugs when the generic, less expensive alternatives would have been just as effective.

In related news, Merck reported $24.31 million in revenue for 2007.

Hernia Patch Defect Causes Injuries

A hernia is a protrusion of an organ or other tissue through the membrane that normally holds it in place. Most hernias develop in the abdomen, and are accompanied by pain or discomfort. Laparascopic hernia repair operations are among the most common surgeries performed today.

During such procedures, the doctor uses sophisticated instruments to put the organ or tissue back in its place. The doctor will then repair the hole or weakness where the tissue came through. One of the ways doctors do this is by reinforcing the membrane with a mesh prosthesis, or "patch." These patches are constructed of special fibers imbedded with a memory recoil ring that holds the material in place.

Some kinds of patches, including the Bard Composix Kugel Hernia Repair Patch manufactured by Davol, Inc., a division of C.R. Bard, can be dangerous. Specifically, the patch's memory recoil ring has been known to break open. As a result of this defect, the mesh can come loose, or worse, the sharp edges of the broken ring can perforate organs, including the intestines. Harmful bacteria can then leak into the body, causing infections and other serious complications.

Because of these defects, beginning in 2005, the FDA issued a recall on several kinds of Bard Composix Kugel Hernia Repair patches. To date, there have been six separate recalls issued for defective patches.

If you have undergone surgical hernia repair and experienced post-operative complications, such as unexplained pain, nausea, infection, or other symptoms, you may have been injured by a defective Bard Composix Kugel patch. The company, and not you or your private insurance carrier, should be responsible for your pain and suffering, as well as the medical bills you will incur. You have a right to recover, even if your model has not been recalled. The Utah medical malpractice attorneys at G. Eric Nielson & Associates can help. Call for a free, no-obligation consultation today.

Killer Pain Killers: The Danger of Opioid Analgesics

Analgesic drugs are commonly used to relieve pain. Some analgesics, such as aspirin and acetaminophen, are relatively mild and are available over the counter.

Other analgesics, however, are powerful narcotics, and are available only with a prescription. Some common prescription analgesics include morphine and codeine, which are naturally occurring opiates; hydrocodone (Vicodin and Lortab) and oxycodone (OxyContin and Percocet), which are semi-synthetic opioids; and fully synthetic opioids, such as Fentanyl and Methadone. Under the close supervision of health care providers, these drugs can play an important part of a patient's pain management regimen.

Unfortunately, these drugs can also cause serious side effects, from nausea and constipation to respiratory arrest and even death. Additionally, due to their narcotic nature, there is a high propensity for addiction and abuse. Over-prescribing these drugs, or improperly supervising a patient's pain management regimen, can cause serious personal injuries and give rise to medical malpractice claims.

Sometimes, careless physicians can transition patients from one narcotic painkiller to another, with disastrous consequences. For instance, Methadone is metabolized very slowly, and has a half-life of 15-60 hours. Additionally, it is fat soluble, and can remain in your system longer than other drugs. Likewise, OxyContin, a popular brand of oxycodone, is formulated to be released over time (the name is an abbreviation of Oxycodone Continuous release). When a patient is taken off of a "slow" drug and transitioned to a fast acting, instant release version, overdose can easily occur. The results of overdose can include respiratory arrest, anoxic brain injuries, or even wrongful death.

The Utah Medical Malpractice Lawyers at G. Eric Nielson & Associates are experienced in handling products liability and medical malpractice cases involving narcotics and pharmaceuticals. We work closely with a team of pharmacologists, toxicologists, and medical doctors to determine whether patients have been injured by dangerous drugs, medical negligence, or pharmacist error. If you or someone you know has been injured because of addiction, overdose, or death, contact the attorneys at G. Eric Nielson & Associates for a free consultation today.