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Can I Sue the Manufacturer of an FDA-Approved Drug? Wyeth v. Levine and Its Implications for Consumers

Written by Berkowitz

Illustration Of Fda Food

The US Food and Drug Administration (FDA) is responsible for testing and approving all drugs sold on the US market (substances defined as “dietary supplements”, such as vitamins, are subject to a more lenient set of regulations). Although the FDA is a federal agency, there is no federal law authorizing civil compensation for individual consumers harmed by dangerous drugs. Instead, people injured by dangerous drugs rely on state products liability law.

Connecticut Products Liability Law in a Nutshell

Connecticut products liability law allows you to file a lawsuit against the manufacturer, wholesaler, or retailer for a drug that injured you due to its defective and unreasonably dangerous condition. You must allege and prove one of three types of defects:

  • A design defect;
  • A manufacturing defect; or
  • A failure to adequately warn of the product’s dangers or possible misuses.

Once you have identified a particular type of defect, proven that the drug is defective and unreasonably dangerous, and proven that the drug harmed you in some way, you don’t have to prove that anyone is at fault to win your claim – that much will be assumed.

The Issue

What happens when state law authorizes one of its citizens to sue a drug manufacturer for harm caused by a drug that has already been approved by the FDA? The question is uncontroversial, of course, if the consumer is alleging a manufacturing defect. After all, since the FDA approved the drug based on its design, a lawsuit based on a manufacturing irregularity that resulted in a drug that did not conform to its FDA-approved design, should be uncontroversial.

The issue gets murkier, however, when a consumer seeks to sue a drug manufacturer under state law based on the design itself or when a lawsuit is based on a failure by the manufacturer to provide certain warnings (“This pharmaceutical should not be used by pregnant women,” for example) that even the FDA did not see fit to require the manufacturer to provide.

Federal Preemption

When state and federal laws appear to be inconsistent with each other, it is tempting to answer this question in terms of a legal principle known as federal preemption. Under the federal preemption doctrine, state law claims cannot be asserted to the extent that they conflict with contrary federal law – in other words, when state law and federal law duke it out, federal law wins – and you lose. It’s not always that simple, however.

When it comes to federal preemption of state products liability law, the US Supreme Court has ruled in favor of a consumer who sued a drug manufacturer over deficient product warnings after the drug had already been approved by the FDA. This landmark ruling is widely considered to be the greatest legal victory for consumer protection in quite some time.

The Case

In the 2009 case Wyeth v. Levine, Diana Levine sued Wyeth, a US pharmaceutical company, in Vermont state court under a products liability theory. Levine originally complained of migraine headaches and nausea. When the health clinic’s initial treatment failed to resolve these problems, she returned and was given Demerol and Phenergan intravenously.

The physician’s assistant inadvertently injected this medication into her artery instead of her vein, resulting in gangrene, the loss of her right hand, and, eventually, the loss of her entire forearm. This loss was devastating for someone who made her living as a children’s musician.  Levine sued Wyeth, the manufacturer of Phenergan, alleging that the product’s warnings failed to sufficiently emphasize the dangers of injecting the drug into an artery.

Levine won in Vermont state court, but Wyeth appealed, eventually going all the way to the US Supreme Court, based on its claim that, since Phenergan’s warnings had already been approved by the FDA, a state court was barred by the federal preemption principle from second-guessing the FDA’s approval of the drug’s warnings.

Wyeth v. Levine Reaches the US Supreme Court

The Supreme Court disagreed, holding, in essence, that FDA approval establishes a minimum standard for product warnings, not a maximum standard. And that individual states are free to hold drug companies to a higher standard than the federal minimum established by the FDA.

The court’s ruling, however, is not as absolute as it might seem, because it was not based on a constitutional issue. Its reasoning was based on the assumption that Congress did not intend FDA approval to preempt state law claims. If Congress were to specifically authorize the FDA to preempt state law by approving a drug, state law claims might be barred.

The Implications

Wyeth v Levine is considered a ground-breaking legal precedent because it opened the door to state law claims by injured consumers of FDA-approved pharmaceuticals. Proponents of the decision (including the majority of the Supreme Court itself) point out that, since the FDA has limited resources to oversee all of the various pharmaceuticals on the US market, consumers benefit when states are allowed to conduct their oversight.

Critics of the ruling assert that:

  • Lay juries should not be entrusted with the task of determining whether drug warnings are adequate when the FDA employs numerous experts to make this determination;
  • Opening the floodgates to litigation in this matter will encourage drug manufacturers to over-warn out of an abundance of caution, thereby rendering doctors reluctant to prescribe patients medications that might save their lives; and
  • Increased litigation may also increase the price of pharmaceuticals when drug manufacturers pass on the cost of lawsuits to consumers, thereby rendering these drugs unavailable to many people who simply cannot afford them.

Why Precedent Matters and How It Can Be Challenged

The US legal system, based largely on common law, works differently than the legal systems of most of the world’s nations. Under common law, judges can effectively make new laws by deciding cases one way or the other. A decision is valid only in the jurisdiction of the court that issued it. Precedent issued by the Connecticut Supreme Court, for example, applies only in Connecticut, while US Supreme Court precedent applies throughout the US.

What Is “Precedent”?

When a court makes a decision, various members of the legal profession will examine the ruling to see whether it could apply to similar cases. Does the ruling in Wyeth v. Levine, for example, apply to products liability lawsuits based on design defects (instead of inadequate warnings, as in Wyeth v. Levine)? Legal reasoning will be employed to determine whether it applies in various situations. Sometimes opinions differ, and sometimes a consensus develops.

When a consensus develops, a legal precedent is established. Courts are typically reluctant to overturn a legal precedent, especially if it was issued by a higher court. One of the reasons for this reluctance is that courts do not like to abandon precedent only to see their ruling overturned by a higher court. Sometimes they will do so, however, and sometimes a court will overrule its precedent because the newest members of the court see things differently.

How Precedent Is Challenged

The lawyer for a party to a lawsuit is free to devise persuasive arguments to convince the court that the precedent should be overturned (a relatively rare occurrence) or that the precedent shouldn’t apply to his client’s particular case (a much more common occurrence):

“Your Honor, my client’s case is different from Wyeth v. Levine because my client is complaining of a design defect, not inadequate product warnings. The precedent established in Wyeth v. Levine should not apply to this case because [insert lawyer’s carefully constructed argument here].”

Since every case is different, the court may agree with the lawyer’s argument. If this happens, the drug company will likely appeal – after all, the law typically allows a losing party to demand at least one appeal. After the appeals court issues a decision, however, the next higher court will probably have the discretion to dismiss the appeal by refusing to hear the case. If that happens, the lower court’s decision will stand and the case will finally be over.

What Happens If the Case Gets to the Supreme Court

If one party attempts to appeal to the Connecticut or the US Supreme Court, the Court could react in the following ways:

  • Refuse to hear the case at all, thereby allowing the lower court’s decision to stand (the most likely reaction);
  • Hear the case and overturn its precedent in Wyeth v. Levine, thereby ruling in favor of the drug manufacturer;
  • Hear the case and decide that, since its specific facts are different from Wyeth v. Levine, the new case shouldn’t be governed by Wyeth v. Levine (the drug manufacturer could win or lose this way); or
  • Hear the case, uphold Wyeth v. Levine, and rule against the drug manufacturer.

Why Your Lawyer Matters

In Wyeth v. Levine, Diana Levine faced a situation in which federal preemption appeared to bar her claim due to the federal preemption doctrine, even though she lost her entire forearm due to inadequate product warnings applied to drugs prescribed by her doctor. Had her lawyer been less skilled in challenging what was then considered to be a difficult if not insurmountable legal obstacle, she could have been denied compensation from Wyeth.

A skilled lawyer can utilize legal knowledge and insightful argumentation to persuade a court that a precedent does not apply or that it is time for it to be overturned. Even if the case is resolved through a private settlement (as most cases are), a skilled lawyer can win concessions from a drug manufacturer who fears (i) losing in court or (ii) spending so much money litigating and appealing that it would be cheaper to simply raise its settlement offer to a reasonable level.

Contact Berkowitz Hanna Today

If you believe that you may have been harmed by a defective drug or by a drug with inadequate product warnings, call Berkowitz Hanna immediately or contact us online 24/7 for a free initial consultation. We will fight relentlessly for your interests – and our track record speaks for itself. We serve clients from throughout Connecticut from our offices in Stamford, Bridgeport, Danbury, New Haven, and Shelton.