Before a safe medication can be manufactured and prescribed, it must be designed. If there is an unknown or undisclosed safety issue with the design, then people may be hurt by the medication even if the manufacturer follows the design plan exactly.

When Is an Unknown Side Effect a Design Defect?

Prescription drugs are regulated because they have significant effects on the body. These drugs are approved by the Food and Drug Administration (FDA) because the potential benefitsDrug Design Defects: What You Need to Know of the medication outweigh the known risks of the medication for some patients. However, many FDA approved drugs have long lists of potential side effects. Those side effects may have been discovered during the drug’s design process and included on the medication’s safety label. A potential side effect—that is known and that patients are warned about—does not indicate that the drug has a design defect.

However, a drug may have a design defect if:

  • A pharmaceutical company fails to adequately test a new medication to determine whether it is safe and to identify risks that could be reasonably discovered.

  • A pharmaceutical company fails to truthfully communicate with the FDA during a medication’s approval process.

  • A pharmaceutical company fails to anticipate potential interactions with other medications or foods.

  • A pharmaceutical company fails to consider other, potentially safer, alternatives.

Generally, in order to prove that a medication had a design defect, you will have to prove that the design was not reasonably safe. Some factors that a court will consider when evaluating whether a drug’s design is reasonably safe include:

  • How serious the danger or side effect is that was not known or disclosed.

  • How likely it is that the danger or side effect will occur.

  • Whether it was possible for the pharmaceutical company to make a safer medication.

  • How much it would have cost the pharmaceutical company to make a safer medication.

All of these factors may be considered when deciding whether or not a drug is defective.

How to Get the Evidence You Need to Prove a Drug’s Design Defect Hurt You

In most cases, a design defect case comes down to a cost-benefit analysis. You may need to prove what the design defect cost you and what a safer alternative or a more careful design would have cost the pharmaceutical company. In order to prove these things you may need:

  • Your medical records that prove the extent of your injury and the connection between your injury and the medication.

  • Documentation of the drug’s design process, including testing.

  • Documentation provided to the FDA during the drug’s approval process.

It may be easy to get your own medical records, but it is considerably more difficult to get the documentation that you need from the pharmaceutical company. Our experienced lawyers can request this information in a legally compelling way so that you can find out exactly why you were hurt and so that you can make an informed decision about what to do next.

Protect Your Right to a Fair Recovery After a Prescription Drug Injury

Prescription drugs do not need to be risk-free when they are approved by the FDA or prescribed to patients. However, all reasonably foreseeable side effects should be known and appropriate warnings of those risks should be made so that each individual patient can make an informed decision about whether or not to take the drug.

A design defect takes away a patient’s right to make an informed decision about taking a medication after weighing the drug’s likely benefits and risks. If this has happened to you and you have been injured by a defective drug, then you may have the right to make a legal recovery from the pharmaceutical company that failed to design a safe medication.

You may not know right away what caused your serious adverse reaction to your medication, but a full investigation by our experienced prescription drug injury lawyers can help you get the information that you need so that you can make a fair recovery from the party that is responsible for your injury. Please contact our mass tort lawyers  today to schedule a free consultation and to learn more about protecting your rights.

Are You Looking for a Mass Tort Attorney in Boston, MA?

If you have been injured by dangerous drugs you need to speak with an experienced mass torts lawyer as soon as possible. Please contact us online or call our Natick Office directly at 888.904.6847 to schedule your free consultation.


John L. Keefe
Connect with me
Founding Attorney, Massachusetts Social Security Disability Lawyer