Pharmaceutical Litigation

By Bob Schwartz

Pharmaceutical litigation refers to lawsuits filed against the manufacturers of prescription or over-the-counter drugs.  The litigation is made up of individual lawsuits that seek compensation for very specific injuries caused by these drugs, injuries that patients were either not warned about or insufficiently warned about.  These lawsuits enforce the states’ civil laws protecting consumers against defective and dangerous products.  Allegations of violations of additional civil laws are also included in these lawsuits.  The legal theories most commonly used in such lawsuits are:

  • Products Liability:  The pharmaceutical companies’ drugs were defective and unreasonably dangerous when they entered into the stream of commerce and when received and taken by the patient in the following respects:
    • The drugs were defectively designed;
    • The drugs were defectively manufactured; and/or
    • The drugs were defectively marketed.
  • Strict Products Liability:  The pharmaceutical companies are responsible for the damages their actions or products cause regardless of any “fault” on their part, because their activity is inherently hazardous and no amount of care would have prevented the injuries.
  • Negligence:  The pharmaceutical companies owe a duty to their consumers to avoid causing harm.
  • Gross Negligence: The pharmaceutical companies’ disregard for the safety and welfare of others caused damage.
  • Fraud:  The pharmaceutical companies made representations of material fact that were justifiably relied upon by the consumer.
  • Breach of express and implied warranties.

To be able to file a pharmaceutical lawsuit, we must be able to prove, from the potential new client’s pharmacy and medical records, that the potential new client:

  • took the dangerous drug that the litigation is based on,
  • for the minimum amount of time required for the particular dangerous drug to cause the specific serious injuries that the case is based on,
  • suffered the specific serious injuries that the case is based on, and
  • suffered economic and noneconomic damages from those injuries.

The investigation of every potential new client’s case continues even after the Power of Attorney is signed and we are hired to represent the client.  It continues after the lawsuit is filed.  Sometimes it does happen that this continued investigation shows one or more problems with the lawsuit that may require its dismissal.  We work hard to avoid that circumstance by carefully evaluating the lawsuit at every step of this process.  However, new medical records and scientific studies can shed light on any one or more of the important elements in these cases.

Pharmaceutical litigation is based on the inadequacy of the label’s “warnings.”  These warnings are included in the “package insert” or “label” that describe the FDA-approved uses, benefits and risks of the drug.  This label is usually provided by the pharmacist or with the prescription drug.  It is usually a foot long, three inches wide and has print the size of ants.  This is what the pharmaceutical companies use to warn you about their drugs.

It will have the warnings in order of severity, starting with the strongest warning:

  • Black Box Warning: The strongest possible warning to be required on a prescription drug.
  • Description: A description of the drug that will lay out its strengths or doses.
  • Clinical Pharmacology: Information regarding the study of the actions and metabolism of the drugs in living animals.
  • Pharmacokinetics: How the drug is distributed, metabolized and absorbed, and excreted through the body.
  • Drug Interactions: How the drug interacts with other drugs in the patient’s system.
  • Clinical Studies: Scientific studies conducted to explore the risks and benefits of a prescription drug.
  • Indications and Usage, Contraindications: Warnings about who should not use the drug.
  • Warnings, Precautions and Adverse Reactions
  • Overdosage, Dosage and Administration

It is impossible to understand these warnings without the help of your doctor.  Patients must read labels carefully and ask questions.  Ask your doctor to discuss the risks and benefits of the drugs with you, and do not take a drug prescribed for you until all of your questions have been answered and you understand the risks and that the drug’s benefits outweigh these risks.  Ask your doctor if the serious risks justify taking this particular drug, and if not, if there is an alternative with fewer or no serious risks.

If you or a loved one was injured by a prescription drug, contact us to discuss your legal rights.

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