FDA and Recalls: What to Know About Liability & Preemption

We seek medical treatment to correct illness, injuries, and chronic conditions. Part and parcel of this medical treatment are prescription drugs. From birth control to insulin to chemotherapy, millions of Americans take one or more pharmaceutical drugs daily. We do so in the hope that we can live fuller, longer, healthier lives. However, these drugs can pose dangers that the general public is not aware of until it is too late. 

FDA Approval of Pharmaceutical Drugs

The Food and Drug Administration (FDA) is a federal agency, which is responsible for controlling and supervising food, tobacco, dietary supplements, prescription and OTC drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal feed, and veterinary products. In its role of regulating prescription drugs, the FDA tests these substances, determines whether or not they can be approved for sale within the United States, and then, upon approval, monitors the safety of such substances and, if applicable, issues appropriate recalls if the substances are found to pose a threat to public health and safety. 

The Center for Drug Evaluation and Research (CDER) is an organization under the FDA that regulates over-the-counter and prescription drugs. It is responsible for reviewing applications for brand name, generic, and over the counter pharmaceuticals. In order for CDER to evaluate a medication, the pharmaceutical company must first conduct extensive evaluation and document the results. 

The first type of evaluation is known as Pre-Clinical Research. During this process, the pharmaceutical company is testing the substance for harm or toxicity. Pre-Clinical Research can be in vitro or in vivo. In vitro testing involves experimenting within a controlled environment outside of a living organism, while in vivo means the experiment occurs in a living organism.

If the substance passes muster at this stage, it will then proceed to Clinical Research. During this phase, researchers will document how the drug behaves in the human body, and therefore this phase includes the use of human test subjects. Clinical Research has four required phases (Phase 1 - Phase 4). Each of these phases requires that the total number of test subjects increase. If the drug successfully passes each phase of testing, it will go on for FDA review.

In the application to the FDA, the pharmaceutical company must disclose all relevant information about the clinical studies performed on the drug. The review team (which includes doctors, chemists, pharmacologists, and other scientists) will study all the findings, as well as potentially requesting further information. If the drug is approved, the FDA will work with the applicant pharmaceutical company to develop appropriate prescribing information.

There are certain drugs that obtain a different pathway to FDA approval. This generally happens when a drug has been created to meet a significant unmet medical need or could have the potential to treat a condition far better than anything currently on the market. In these cases, a drug may get some form of accelerated or fast-tracked FDA review.

Once a drug is approved and on the market, it moves into what is known as the Post-Market Safety Monitoring phase. This will continue for the life of the drug on the market. If the manufacturer wishes to make any changes to the drug's formation, it must apply to the FDA. Additionally, during this phase, the FDA will review the drug's advertising and its manufacturing facilities to ensure compliance with applicable regulations. The FDA will also receive and monitor all reports related to negative outcomes which might be related to the drug.

FDA Recall Process

The FDA will monitor all reports related to approved drugs and, if it is found to be warranted, issue a recall to protect the public from a drug that it has deemed to be a risk. There are three classifications of recalls. These include the following.

  • Class I: A dangerous or defective product that could cause serious health problems or death.
  • Class II: A product that might cause a temporary health problem, or pose a slight threat of a serious nature.
  • Class III: A product that is unlikely to cause any adverse health reaction but that violates FDA labeling or manufacturing laws.

 The FDA alerts the public to recalls via a weekly enforcement report. This report includes all recalls which have been classified under the criteria listed above as well as those which have yet to receive classification.

Once a recall has been made, the FDA will evaluate the effectiveness of the recall. It will examine the company's efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective, FDA will request the company take additional actions.

FDA Recalls and Liability

If a recalled drug causes serious injury or even death, what is the recourse for the victim and/or the victim's family? One major avenue is to file a lawsuit. Many times, large groups of victims will join together to file one lawsuit against the manufacturer of a pharmaceutical in what is called a class-action lawsuit. You've probably seen commercials or print advertisements that include some variation of "If you took the drug..." Such advertisement seeks to educate individuals who may be eligible to participate in a plaintiff group. The types of claims available for a defective drug can vary based on the circumstances. These can include:

Defectively manufactured pharmaceutical drugs

A pharmaceutical drug may have been properly designed, tested, and engineered to be safe, but encounter some problem during the manufacturing process. The drug may have been manufactured improperly, tainted by a substance encountered during production or packaging, or somehow adulterated. Additionally, the drug could have been mislabeled during the packaging process. In these types of cases, it is possible that the manufacturer could be liable for the damage caused as a result of these errors.

Defectively designed pharmaceutical drugs 

A pharmaceutical drug may be approved and hit the market, for the public only to later discover that it has seriously dangerous side effects. In these types of cases, it may be possible to hold the manufacturer of the drug responsible, based on the information it was privy to at the time of approval.

Inappropriately marketed pharmaceutical drugs

A pharmaceutical drug may have none of the defects mentioned above but may be inappropriate for the medical conditions for which it is being marketed and prescribed. A drug may be tested and work properly for treating one medical condition, but it may cause an unknown, severe side effect when used for a different one. If the drug was marketed for the use in which the side effect occurred, the manufacturer may be liable for such marketing. 

Preemption in Defective Drug Cases

Bringing a claim against a manufacturer for a defective drug could involve a clash between the federal legal system and the state court system, due to the fact that drugs are approved by the FDA. Under the doctrine of preemption, which is based on the Supremacy Clause, federal law preempts state law when the laws conflict.

Preemption can come into play in a defective drug case as defendant pharmaceutical companies have argued that they are shielded from liability for defective FDA approved drugs as they were in compliance with federal law, which should trump the tort law of the state in which the action has been brought. The United States Supreme Court has ruled on this issue on multiple occasions. In 2009, the opinion handed down in Wyeth v. Levine held that federal preemption does not shield brand name pharmaceutical companies from liability for defective FDA-approved drug labeling, even though pharmaceutical companies generally lack the authority to change drug labeling without FDA approval. An exception to this would be if a brand name pharmaceutical company can provide clear evidence that the FDA would have rejected any effective labeling changes that it might otherwise have proposed- in this case, preemption may be raised as a defense.

Two years later, the Supreme Court addressed the same issue, only focused on manufacturers of generic drugs. In Pliva v. Mensing, the court held that generic manufacturers were permitted to raise FDA preemption as a defense to a product liability claim based on defective FDA-approved warnings.

Defective Pharmaceutical Attorneys Gilman & Bedigian

Pursuing a claim for defective pharmaceutical drugs can be incredibly complex. If you think you might have a cause of action against any party due to injury caused by a defective drug, contact our legal team. We have extensive resources that allow us to fully investigate viable claims and, if necessary, take on major corporations to get justice for victims and their families. 

Let Us Help

If someone you are close to has been seriously injured or worse, you are naturally devastated not only by what has happened, but by the effect that the injury or loss has had on you and your family. At a time when you're vulnerable, traumatized and emotionally exhausted, you need a team that will support you through the often complex process that lies ahead.

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