On March 4, 2009, there was a tangible shift in the playing field between consumers and big business. Consumers have always faced a steep uphill climb when fighting corporate America and defective products. This month, the Supreme Court of the United States thankfully offered a rope to make that climb a little easier when it allowed injured persons to sue for injuries caused by defective drugs.

Wyeth v. Levin

The tale of Diane Levin is truly disturbing and highlights the massive loopholes created by the FDA regulations that the drug companies have driven countless profits through. In 2007, Levin, a professional musician, went to the hospital to treat a migraine headache. After being injected with a drug manufactured by Wyeth, she left with injuries that led quickly and irreversibly to the loss of her right arm. Specifically, Levin’s arm was amputated because Wyeth’s drug Phenergan, prescribed to alleviate nausea associated with a migraine headache reached her arteries. Phenergan was given to Levin using a method of administration that was permissible under Wyeth’s labeling instructions, even though Wyeth knew this method increased the risk of contact with arteries and serious injuries.

The drug was administered intravenously through a technique known as an “IV push.” In this method, a syringe pushes medication directly into the patient’s veins. Wyeth had known for decades that if Phenergan is administered by the “IV push” method, even by experienced clinicians, inadvertent arterial contact can result. This is in contrast to administration through a free flow IV bag, which reduces the risk of inadvertent arterial injection because the nurse or physician can be more certain that the needle has been placed in the vein.

Wyeth had known that when Phenergan comes into contact with an artery, the artery dies, necrosis, gangrene and amputation will result. Four experts testified at the state court level that if Phenergan is used intravenously it should be done only through a hanging IV bag and the labels should have warned against the use of IV push. However, Phenergan’s label did not contain any such warning regarding using of the IV push method. The Vermont Supreme Court held that the FDA never made any determination as to whether the label should have warned against the IV push method.

Because the IV push method was used to administer Phenergan to Levin, the drug penetrated her artery. For seven weeks after the injection, she suffered unimaginable physical and emotional pain as she watched her right hand turn black and die. In short as a result of being subjected to an unsafe and unnecessary method of administration of a drug to curb nausea, Levin endured two amputations. First, she lost her right hand and then her right arm up to the elbow harming her profession and life-long passion to be musician and play the guitar.

Background of FDA Labeling

The FDA’s labeling rules require a prescription drug or medical device manufacturer to make any changes to its label and to add or strengthen a warning about a possible adverse reaction as soon as it has reasonable evidence that the drug or device causes an adverse reaction. The importance of this rule was underscored in congressional debate regarding the passage of the Food and Drug Administration’s Amendments Act of 2007, which gave the agency additional authority to better regulate prescription drug approvals. When Congress passed this law, it understood the FDA’s rules to impose a duty on drug manufacturers to update their labels when they became aware of potential hazards.

Consumers who have been hurt by drugs and other dangerous products will now have more latitude since the Supreme Court has ruled that Federal Regulations do not always preempt state law. It is clear and the Supreme Court reaffirmed that Congress never intended to give the FDA full and total authority over drug labeling. Rather, state courts have had the right to hear cases in which people have been injured by drugs. And further, drug companies have the responsibility to fix their labels and keep them current with the latest warning information. Drug companies, the Court said, must also inform the doctors of dangers of drugs through their ubiquitous sales forces or by sending out letters to physicians. In this technology driven market economy this is certainly a simple endeavor. Wyeth, backed by the Bush administration, argued that once drug warning labels get FDA approval, the label does not need to be changed unless the FDA expressly asks for it. Part of Wyeth’s argument was that it was more efficient for Federal Regulations to take precedence because state laws vary so much. Anyone who has had any experience with these regulatory agencies knows that they move at a glacial pace. Science and technology are quickly evolving and it makes sense for drug companies to disseminate new information as soon as its available.

The Court also rejected Wyeth’s claim that allowing juries to entertain such claims would hamper the broader objectives of the Federal Statute. Indeed, the Court noted that the FDA had always welcomed state common law actions right up until it recently changed its position in 2006. Throughout its opinion, the Court stressed that the manufacturer bears responsibility for the contents of its label at all times. In our civil justice system, the Court noted, innocent people generally have recourse in state courts to hold companies accountable when they shirk their legal responsibilities. Drug companies are no different.

In his dissent, Justice Alito, who was joined by Chief Justice Roberts and Justice Scalia, started by writing “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the FDA is ultimately responsible for regulating warning labels for prescription drugs.” To the contrary, the state tort system picks up when federal regulators fall down on the job. Can anyone really say with a straight face that they have complete and total confidence in the job the federal regulators are doing? If so, countless defective drugs and consumer products would never make it to market. We all know that is not the case.

In fact, serious data has found that side effects regarding prescription drugs are at a near epidemic rate. Consumer Reports recently reported that one in six Americans who have ever taken a prescription drug experiences side effects serious enough to send them to a doctor or hospital, but the majority of consumers don’t know that they can report these side effects to the FDA which are responsible for tracking drug safety problems.

Legislation on the Horizon

Recently, Democrats in Congress just introduced a measure to allow consumers harmed by medical devices approved by the FDA to sue the device manufacturer in state court. This is in response to the Supreme Court in Reigal v. Medronic. In Medronic, the Supreme Court allowed the dismissal of a lawsuit involving a ruptured catheter. In that case, the Supreme Court ruled that the FDA approval preempts state courts from hearing liability suits against the makers because such suits could minimize devices FDA determined benefits and risks. Medronic and the Bush administration asserted that “allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state court requirement” different from the FDA requirements because such complaints are based on state laws. There is now legislation being funneled through Congress, that tries to further even the playing field with regard to making sure defective medical devices are also subject to state tort laws. Congress should act quickly to close up these loopholes as well.

It has often been said that the role of government is to fill the void when citizens acting individually cannot bridge the gap. This is the reason we have regulatory agencies that try to ensure that our roads are safe, the environment is protected and the food we eat is safe to name just a few. However, our government is under a tremendous amount of pressure and cannot meet the demands to ensure that the public is safe from defective products. That is why the avenue to the Court’s must remain open so injured citizens can seek redress against companies that manufacture, market, sell and , of course, profit from defective and unsafe products. If this important constitutional right is abrogated, the onslaught of dangerous and defective products hitting the market will have no limitation.