Solomon Neuhardt applauds the FDA and helps raise awareness

The FDA announced a new and serious warning about possible liver damage from Multaq, a heart medication released in July of 2010. The drug is used to treat abnormal atrial rhythms – atrial fibrillation (Afib). It is marketed as an advance in treatment because it demonstrated a lower incidence of hospitalization than traditional drugs used for the condition. However, the FDA only approved it with under their Risk Evaluation and Mitigation Strategy (REMS), a program that monitors patients closely for adverse reactions. This system is used when the FDA feels there is enough data to release a drug for use, but not a large enough database to assure complete safety.

With two incidents of liver damage that required transplants, the FDA is now warning doctors to consider the serious risks that might come with prescribing the drug. The medication is not being removed from the market. The recommendation is that physicians monitor liver enzymes and other indicators closely. In these two cases, there was severe cell damage in the liver directly l inked to the drug.

Although a final ruling from the U.S. Supreme Court isn’t expected until this summer, things aren’t looking good for generic drug manufacturers. At issue is whether their labeling has to reflect important medical warnings – even when those warnings aren’t required by the FDA.

This is especially important for drugs that are sold without a prescription but which may be taken on the recommendation of a physician. Drugs like Motrin (ibuprofen), aspirin and Tylenol (acetaminophen) would fall under this category. A physician may tell someone to take an over-the-counter preparation as part of his or her therapy. The patient then has to rely on the package information available at the point of purchase – without the input or oversight of a pharmacist.

The latest case involves a minor child who was prescribed Motrin following surgery to remove two moles. The pain reliever was purchased by his parents as a generic in the over-the-counter version. Subsequently, the child developed a high fever and liver failure. This was determined to be due to an interaction between the ibuprofen and the anesthetic used in the mole surgery.

Rulings bring attention to an important consitutional question

Solomon Neuhardt, an injury attorney in Billings, Montana, is watching the development of new cell phone law carefully. “It may have a significant impact on how fault is decided in automobile accident cases,” says Mr. Neuhardt. At issue is whether or not the police need a warrant to search a cell phone after an accident.

“The law is being decided in cases across the nation, with judges in California allowing warrantless searches and those in Ohio denying them.”

The matter remains untested in Montana courts, but would impact what investigation tools the police have available after an accident. If the police can simply look at a driver’s cell phone and see that they were texting at the time of the accident it would establish grounds for a ticket (texting while driving is against current Montana law) and might indicate responsibility for the accident.

Arecent uptick in auto and casualty insurance company television ads caught my eye. One company in particular advertises that they are the nation’s largest. I checked Allstate’s website, and they are. A Fortune 100 company, Allstate reports $133 billion in assets. In the U.S., they are the big dogs when it comes to “personal line” insurance. Personal line refers to insurance for personal property, liability and for medical care after an accident.

Checking further, I found that profits are up. Remember the financial crash of ’08? That hit insurance companies hard because many were heavily invested in stock market instruments that fell. But, according to the Insurance Journal, by November of ’09, “Allstate Corp., the largest publicly traded U.S. home and auto insurer, reported a third quarter profit Wednesday, the improvement from a year ago loss made possible by lower catastrophe and investment losses.”

That last bit is important – “lower catastrophe and investment losses.”