Who should be held responsible?

Should a drug or device manufacturer be liable when a provider harms the patient? What about if they are aware of possible risks when the drug is administered incorrectly? This woman settled with the clinic where the mistake was made, but has continued to pursue a lawsuit against Wyeth, the manufacturer of the product. Briefly, she argues that Wyeth should present the risks of a certain form of administration of the drug and Wyeth argues that it cannot because of state regulations. It’s a mess of an issue and is bringing up all kinds of problems that have not really been brought into the public light before.

Who gets the final say over safety standards? Wyeth? The FDA? Vermont? It all seems to be a bureaucracy that leads to blaming and scapegoating by all parties. This reminds me of ERISA, a federal law that was created to protect beneficiary’s health, life and pension benefits, but has created a loophole that also protects insurance providers from law suits. Both cases deal with the issue of pre-emption of state laws by federal regulations.

Here’s the deal. Although some might think that Wyeth should not be held liable, and therefore should not be sued, if the mistake made by this provider can be made by others, isn’t it a good thing to a) get the information dispersed to as many people as possible to try to prevent the mistake being made again and b) call into question the bureaucracy of control of safety standards and the issue of federal pre-emption that is preventing this from happening? Say what you want about medical malpractice and industry law suits, but they are often the only means people have of avoiding medical and personal bankruptcy (this woman not only racked up medical bills but also lost her livelihood), and for calling into light an issue that needs to be addressed (whether within an institution or within an industry). These are the ways in which changes are made to our health care system in this country. Go Erin Brockovich, go!