The issues surrounding prescription drug liability are complex. As with any consumer product, there are federal safety standards that drug manufacturers must follow. The FDA determines whether and for what purpose a drug may be marketed, prescribed and sold, what information and warnings must be included on the label, and when it must be taken off the market. In general, many consumers (and some physicians, as well), may take FDA approval as adequate evidence of a drug’s safety. However, as we have seen in many cases where previously approved drugs have been taken off the market, FDA approval does not equal safety.

So how can this happen? How can a drug that is unsafe make it to market?

The concept of “safety” as concerns pharmaceuticals is somewhat relative. Pharmaceuticals are not expected to be 100% harmless. Because of the complexity of the chemical properties and variety of effects in different people, there is no drug that is completely safe for everyone. Think of it this way – even an innocuous food like peanuts can be deadly to someone who is allergic to them. Similarly, medications may be relatively harmless to most people, but cause serious harm to others.

The basis for NDA (New Drug Application) approval is based on efficacy and safety. Efficacy is the extent to which the drug is shown to improve the patient’s condition for which the drug is indicated. In other words, efficacy is the extent to which a drug does what its makers claim. The definition of safety, on the other hand, is a bit more ambiguous. For pharmaceuticals, safety is not defined in terms of absolute harmlessness, but rather whether the benefits outweigh the harm to the patient.

Unavoidably Unsafe

Restatement (Second) of Torts section 402A discusses “strict liability” for products. Strict liability means that sellers/producers of a product that causes harm are liable for the harm that product causes, regardless of whether or to what extent those sellers/producers are responsible. That means that you don’t have to prove the makers were negligent or malicious – just that they are liable. However, there is a clause called “comment K” that makes a sort of exception for pharmaceuticals according to the level at which a product is “unavoidably unsafe.” In other words, it is assumed that some properties of the drug are going to be harmful, but that that the benefit may outweigh the risk.

It appears that the FDA views pharmaceuticals in terms of a cost/benefit tradeoff rather than simply degree of harm. This difference is subtle, but important. A cost/benefit tradeoff assumes that some of the effects of the drug are harmful, but that this harm can be outweighed by the benefits of treating the indicated condition.

Who is Liable?

Another issue involved in pharmaceutical liability is determining who the liable parties are. The products can be determined unsafe by the FDA after subtle effects show consistent damage over many years and taken off the market, they can be tainted during manufacturing, such as the Tylenol poisonings in 1982, or they can be prescribed inappropriately or for off-label purposes. (An example of this is might be ADHD amphetamines prescribed for weight-loss.) In the case of generic drugs, there has been a recent Supreme Court ruling (Wyeth v. Levin) in which the drug’s brand name producer was held liable for faulty labeling in the generic version. The issue of state versus federal jurisdiction was brought by the defendant in an attempt to avoid the more stringent state rules, but since the rules were not in conflict, the defendants lost.

What Does All This Mean To Me?

Since some level of harm is allowed in drugs, the burden for proving liability becomes greater. You don’t just have to show harm – you have to show that the harm was not outweighed by the benefits for that drug. If the drug was taken for an indicated condition (or even for off-label use), it is often very difficult to prove that the drug in question was the cause of the problem. For new medications, especially when the symptoms are subtle, it may be years before problems are noticed.

When a drug is taken off the market, as Darvon and Darvocet were, the burden of proof for liability becomes much easier for a patient who has been harmed. Drugs are generally recalled only when there is much evidence of serious ill effects, so such cases tend to be much easier to pursue.

Overall, the formula for product liability in pharmaceuticals consists of: (1) showing harm was caused, (2) showing that the drug in question caused the harm, and (3) determining who is liable for the harm, (and under which set of laws). Simple, right?