What are the elements of a pharmaceutical products liability case in PA?

People making pharmaceutical products liability claims must prove the product has a defect and meets specific criteria to be considered dangerous.

Defective pharmaceutical products can expose people in Williamsport to serious injuries, permanent disablement and even life-threatening complications. When these defects arise due to oversights or negligent decisions on the part of drug makers, victims may have legal recourse. However, victims must meet various criteria to secure compensation. Besides proving that they suffered physical injuries from the product in question, victims must complete all of the following tasks.

Documenting product defects

People who file pharmaceutical products liability claims must first show that the product suffered from a dangerous defect. The three recognized categories of defects are as follows:

• Design defects. These pharmaceutical products are inherently dangerous, even when they are produced exactly according to manufacturer specifications.
• Failure to warn. These products are dangerous because manufacturers have not provided appropriate warnings or instructions about a drug’s intended uses, side effects or contraindications.
• Manufacturing defects. These products are harmful due to unintentional flaws in the production process. Consequently, these defects only affect random products in a line, rather than the entire line.

The Pennsylvania Supreme Court has held that Food and Drug Administration approval of a pharmaceutical product does not protect a company from claims that involve the first two defects. Even if the FDA reviewed a drug and the warnings that accompany it, people who suffer injuries due to the drug’s defects may still make claims.

Proving defects meet legal criteria

Unfortunately, not all dangerous or defective products provide grounds for products liability claims. In 2013, the Pennsylvania Supreme Court held that a product must meet one of two criteria in order to be considered dangerously defective. The product must pose a danger beyond what a reasonable person would anticipate. Alternately, the risk associated with using a product must significantly outweigh the difficulty or expense involved in mitigating that risk.

Satisfying claim deadlines

In Pennsylvania, people who have suffered harm due to defective pharmaceutical products have a limited amount of time to make claims. State law requires victims, including those seeking assistance from a traumatic brain injury lawyer, to file claims for any injury resulting from another party’s negligence within two years. This statute of limitations begins running at the date of injury.

Unfortunately, satisfying all of these legal criteria and proving that a pharmaceutical product was dangerously defective may be challenging. Consequently, people who have suffered injuries from these products may want to consider discussing their options with a products liability attorney. An attorney might be able to evaluate the strength of a person’s claim and provide advice on options for seeking recourse.

Attorney Cliff Rieders

Cliff Rieders is a Nationally Board Certified Trial Lawyer practicing personal injury law. A large part of his practice involves multi-district litigation, including cases related to pharmaceuticals, vitamin supplements and medical devices. He is admitted in several state and federal courts, as well as the Supreme Court of the United States. Rieders is the past regional president of the Federal Bar Association and is a life member of the distinguished American Law Institute, which promulgates proposed rules adopted by many state courts. He is a past president of the Pennsylvania Association for Justice, formerly Pennsylvania Trial Lawyers Association. As a founder of the Pennsylvania Patient Safety Authority, he served on the Board for 15 years.

Not only has Rieders held many highly esteemed, leadership positions, he authored legislation related to the Patient Safety Authority and the Mcare Act, which governs medical and hospital liability actions in Pennsylvania. He authored texts upon which both practitioners and judges rely, including Pennsylvania Malpractice Laws and Forms, and Financial Responsibility Law Issues in Pennsylvania, the latter governing auto and truck collisions in Pennsylvania. In addition, he wrote several books on the practice of law in Pennsylvania regarding wrongful death and survivor actions, insurance bad faith, legal malpractice claims and worker rights, among others. Rieders also serves as a resource to practitioners as a regular speaker for Celesq, an arm of the world’s largest legal publisher, Thomson Reuters West Publishing.

As recognition of his wide range of contribution to his profession and of his dedication to protecting the rights of his clients, he received numerous awards, among them the George F. Douglas Amicus Curiae Award, the Milton D. Rosenberg Award, the B’nai B’rith Justice Award, and awards of recognition from the Pennsylvania Trial Lawyers. [ Attorney Bio ]