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.