The U.S. Supreme Court is Mensing with Your Legal Rights

By Bob Schwartz

The U.S. Supreme Court correctly held in its 2010 decision in Wyeth v Levine that state tort laws do not conflict with federal law, and can be used to hold the pharmaceutical manufacturers accountable for the serious injuries and damages caused by their dangerous drugs.  The legalese for the legal issue that made the basis of that decision is “preemption.”  Are claims brought on state tort laws inconsistent with and, therefore, preempted by federal law.  The Court recognized that the Food and Drug Administration (FDA) could not possibly shoulder all of the responsibility for determining the safety of a prescription drug during the drug approval process.  It further recognized that tort laws were not inconsistent with the federal laws and regulations that the FDA operates under, and that those laws play a very important role in determining the safety and effectiveness of dangerous drugs that the FDA approves. After all, the only information the FDA has to make those decisions comes from the drug’s manufacturer.  No comfort level there.

In June, 2011, the same U.S. Supreme Court in Pliva Inc. v. Mensing held just the opposite for the manufacturers of the generic forms of these dangerous drugs.  The Court found that state tort claims are inconsistent with and preempted by federal law, and are not permitted.

This ruling is significant for a number of reasons.  The company that develops and obtains FDA approval to market a drug (called the “innovator”) maintains that exclusive right for a 10-year period.  That 10-year period can be extended under certain circumstances.  After that 10-year period and/or any extended periods run, the exclusivity is lost.  Other drug companies can then manufacturer and market the innovator’s exact same drug under their own name.  These identical drugs are called “generics.”  The generic manufacturers do not have the same duties to test generics for safety and effectiveness, and for full, complete and accurate disclosure of all known risks of serious side effects associated with that drug that the innovator has during the drug approval process. These are the sole responsibilities of the innovator.  If the innovator’s label for the drug is inadequate and incomplete, the generic’s label will be inadequate and incomplete.  If your physician prescribes a generic form of a drug or, worse yet, if your insurance company will only approve and pay for a prescription filled with the generic form, and you suffer a serious injury and damages from that drug, you will now not be able to file suit to seek compensation against the generic drug manufacturer.

Since the innovator obtained FDA approval and is responsible for the drug label’s full, complete and accurate disclosure of all known risks, it appears that the patient may be able to bring suit against the innovator even though the patient ingested the generic and not the original form of the dangerous drug.  The pharmacy, pharmacist, insurance company and physicians are also left exposed by this ruling for their part in the patient’s injuries and damages.  Prior to the Mensing decision, Bailey & Galyen did not include pharmacies, pharmacists, insurance companies and physicians in cases filed against the drug companies for serious injuries and damages.  The Supreme Court’s decision now forces us to include these others in such lawsuits.

While the ruling is consistent with Levine, its disservice is that it leaves the generic manufacturers untouched and unaccountable for serious injuries caused by their dangerous drugs.  It puts the consumer between the proverbial rock and a hard place, with the fox guarding the hen house.

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