Products Liability and Prescription Drugs

In a world where prescription drugs are touted not only in the doctor’s office, but on TV and in magazine campaigns as well, consumers must be vigilant about their care. Technology is advancing at a rate that has increased the number of drugs presented to the Food and Drug Administration (FDA) at an unprecedented rate. The consumer must remember that these drugs are highly screened and need a prescription from a doctor for a reason, and use them as guided by their physician or pharmacist. However, even when taken as directed, prescriptions can carry risks, such as unknown side effects or drug interactions.

The FDA is responsible for approving the actual drug, as well as packaging and warning labels. Both the FDA and pharmaceutical companies hold a difficult role, they must evaluate the effectiveness and safety of a drug while bearing in mind the longer the drug is kept from the public, the fewer people it can help. Unfortunately, sometimes a product is released to the public without a full understanding of the risks associated with the product being published. There are even alleged incidents, such as with the drug Vioxx, where the pharmaceutical company marketing the drug may have known of certain risks that were not shared with the public. The prescribing power is given to doctors, who hold a responsibility to their client to fully understand the pros and cons of a drug, as well as possible effects that would do more harm to the patient than good in the long run.

These situations can lead to a claim for product liability and malpractice. While unknown side effects and interactions may be as little as bothersome to the consumer, they can have effects that lead to death. Currently, Thornhill Law Firm is representing a case where a patient was prescribed multiple medications, that when taken together, caused an overdose, leading to the death of a patient. Patients are not experts in medical care, this is why they seek the attention of a doctor when necessary. They place their trust in the ability of their physician and the drug companies to attend to their care to make them better, and when negligence occurs, it is only just that these sources be held accountable for their actions.

In recent times there has been a move towards preemption in these types of suits. Pre-emption allows for the federal standards to be as far as a Court can hold a company liable in a products liability matter. For example, Wyeth v. Levine is scheduled to be heard November 3, 2008 before the Supreme Court of the United States. In this case Levine was administered a drug that resulted in an amputation of her hand and forearm, because it was incorrectly labeled. Wyeth, the maker of the drug, is responsible for providing data to the Food and Drug Administration (FDA), so they can evaluate the efficacy of the drug and what type of warning label it ought to carry. Since the FDA imposes requirements, pre-emption would allow a lawsuit only up to the decided requirements, regardless of whether a tort action actually occurred. The argument for pre-emption centers around the cost of litigation, to the multi-billion dollar pharmaceutical industry, and the fear of over-warning so consumers are less likely to use their product, which can carry the risk of doing irreparable damage. An article in the New England Journal of Medicine noted:

Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety. Margaret Jane Porter, former chief counsel of the FDA, wrote, “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”Persons who are harmed have the right to seek legal redress. Preemption would erase that right. Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D., Why Doctors Should Worry About Premption, Vol. 359: 1 New Eng. J. Med. (2008).

It is important for these types of lawsuits to be heard in court, as everyone deserves their day in court when gross negligence occurs, regardless of whether or not a federal agency has established requirements.

Thornhill Law Firm is dedicated to seeking justice in product liability matters. To learn more about representation by Thornhill Law Firm with regards to product liability, please visit our website at or call us, toll-free, at 1-800-989-2707.