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THE US SUPREME COURT IS “MENSING” WITH YOUR LEGAL RIGHTS


The US 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 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 FDA could not possibly shoulder all of the responsibility for determining the safety of a prescription drug during the new drug approval process. It further recognized that tort laws were not inconsistent with the federal laws and regulations that the FDA operates under, and 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 that decision comes from the drug’s manufacturer. No comfort level, there.

In June, 2011, the same US 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 are preempted by federal law and are not permitted. This ruling is significant for a number of reasons. First, the company that develops and obtains FDA approval to market a drug (called the innovator) maintains that exclusive right for a ten year period. That ten year period can be extended under certain circumstances. After that ten year period and/or any extended periods run, the exclusivity is lost. Other drug companies can manufacturer and market the innovator’s exact same drug under its own name. These identical drugs are called generics. Second, the generic manufacturers do not have the same duties that the innovator has in the new drug approval process to test generics for safety and effectiveness and for full, complete and accurate disclosure of all know risks of serious side effects associated with that drug; this is the sole responsibility of the innovator. Third, if the innovator’s label for the drug is inadequate and incomplete, the generics label will be inadequate and incomplete. Fourth, 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 injuries and damages from that drug, you will not be able to file suit to seek compensation against the generic manufacturer.

Since the innovator obtained FDA approval and is responsible for the drug label’s full, complete and accurate disclosure of all know risks of serious side effects, 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 included 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 them in the lawsuit.

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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I Can Understand Buying a Car Without A/C, But Not Without Turn Signals


This article may appear to be about the annoying people who change lanes and make turns without the courtesy and safety of using their turn signals. It’s not. It is about safety devices, designs and equipment that are found on consumer products.

Turn signals, seat belts, fire retardant children’s pajamas, safety locks on guns and rifles, and shields and other protective covers are just a few of the safety devices, designs and equipment that consumers enjoy because of decades of litigation by trial lawyers on behalf of innocent victims. These safety devices, designs and equipment actually work when they are not tampered with, removed, circumvented or altered. So, if you buy a car with law-mandated safety equipment such as seat belts, why would you not use them? If you bought a table saw with a law mandated safety guard over the sharp, spinning blades, why would you remove? If you bought a gun with a safety lock, why would you not use it until ready to fire the gun? It is hard to understand, but many people do ignore safety devices, designs and equipment. Worse yet, these safety devices, designs and equipment are often tampered with, removed, circumvented or altered on a regular basis. Not only are all consumer protections lost at that point, but the ability to bring a lawsuit to recover for injuries and damages is severely impaired if not completely destroyed by such conduct. The consumer must respect not ignore – the warnings and safety devices, designs and equipment that are there for their protection.

Prescription drugs have safety devices, designs and equipment, too. Prescription drugs are dangerous and do have side effects, and need these safety devices, designs and equipment, called warnings. Warnings are contained in the package insert that comes with the prescription either from the company or the pharmacists. Warnings work only when they are accurate, complete and adequate. Further, accurate, complete and adequate warnings work only when strictly followed: The drug must be taken as prescribed by the physician, and a prescription drug prescribed for one person must not be taken by someone else.

The drug companies must accurately and completely disclose all of a prescription drug’s dangerous side effects so the warnings accurately, completely and adequately warn the patient. Drug companies must also constantly update the warnings as new information is obtained. More times than not, however, the drug companies are not inclined to give accurate, complete and adequate warnings because more numerous and severe the warnings, the fewer prescriptions will be written for that drug. The prescribing physician will find a better, safer alternative drug that is equally effective without the same risks.

Litigation against the drug companies is based on inaccurate, incomplete and inadequate warnings, as well as manufacturing and design defects. The prescribing physician has the responsibility to discuss a prescription drug’s side effects with the patient, as well as the risk of those side effects and the benefits of the drug. It is only when the warnings that the physician has access to do not include all known dangerous side effects that a case exists against the drug companies. After all, we know all drugs have side effects. We as the patient have the absolute right to know what those side effects are so we can have that risk/benefit discussion with the physician and make the decision whether to take the drug. As a patient, we have the right to know what the drug company knows about their prescription drugs before we take it. After we take the dangerous drug and are injured by it, the questions becomes what did they know and when did they know it.

You can t claim ignorance of the drug’s warnings any more than you can claim you bought the car without turn signals or that the seat belt is too uncomfortable to wear. All are safety devices that are there for your safety.