It is estimated that between 2018 and the early months of 2019, some 595.98 million medical device units were recalled in the United States. As a patient, you expect that the devices and drugs prescribed to you for care will not only be effective, but safe. However, be it failed quality control, or recklessness by the hands of the manufacturer causing harm to people, justice must be sought.

If you or a loved one was injured by a defective device or a dangerous drug, you have the right to file a claim against the manufacturer. Kalinoski Law Offices can help.

Product Liability in Defective Medical Devices, Drug Recalls

In Pennsylvania, there are three forms of product liability a claim may fall under: defective design, manufacturing defect, or lack of adequate warnings or instructions.

Defective Design

When flaws in the product or device design cause harm to the consumer, the courts will review two standards to determine liability; The Consumer Expectations Standard and the Risk Utility Stands.

  • The Consumer Expectations Standard questions if the product is more dangerous than the reasonable consumer would expect.
  • The Risk-Utility Standard questions if the injury sustained was serious enough or likely enough to have outweighed the burden of taking precautions against the injury’s occurrence.

Manufacturing Defect

In cases where a product design does not lead to injury but rather, a flaw in the manufacturing process does, the courts will utilize strict liability to determine the manufacturers’ fault.

This means that there need not be actual intent to cause injury, nor does the manufacturer need to be aware of the manufacturing flaw. In manufacturing defect cases, the court will simply review if the flaw in manufacturing caused your injury.

Lack of Warnings/Instructions

We’ve all seen the commercials for new drugs on the market saying “possible side effects include” followed by a list of illnesses and injuries the consumer may or may not sustain. However, in cases where the manufacturer of a drug or medical device fails to provide adequate warning of potential dangers or makes it difficult to see or understand, the manufacturer can be held responsible for the injury.

Statute of Limitations

In cases of product liability, consumers have two years to make a claim for personal injury or wrongful death from the date the injury or death occurred.

However, in cases of fraudulent concealment, where the defect is not discovered at the time of injury, the statute of limitations does not begin until the time in which a reasonable person would have discovered the defect.

An example of this would be if a patient undergoes a medical procedure and the doctor hides the device’s failure or the cause of injury.


If you or a loved one was injured by a defective device or a dangerous drug, you may be entitled to damages. In Pennsylvania, the modified comparative fault standard is used, which means that the injured party cannot be more than 50% responsible for the injury.

You may be awarded damages for:

  • Medical costs
  • Lost wages
  • Emotional distress, and pain and suffering
  • Disability

Common Medical Device, Drug Claims

There are hundreds of thousands of medical devices and drugs on the market today, each with their own risks with use. However, the most common medical device and drug claims include those against:

  • Pacemakers and Defibrillators
  • Hearing Aids
  • Breast Implants
  • Contraceptives
  • Hip and Knee Replacements
  • Insulin Pumps
  • Surgical Mesh

While some injuries may not be serious, others can be fatal. Common injuries are:

  • Organ damage and loss
  • Infection
  • Heart attack
  • Stroke
  • Tissue/bone damage
  • Chronic pain
  • Permanent disability

Kalinoski Law Offices: Defective Medical Device/Drug Recall

If you’ve sustained an injury or lost a loved one due to a defective medical device, know that Scranton personal injury attorney Craig Kalinoski is here for you. We will review your case with the care and compassion needed to ensure you and your family receive the compensation you deserve while holding those responsible for your injuries.

If you have a defective medical device or drug recall claim, contact Kalinoski Law Offices today.

We fight for the rights of our clients in a wide spectrum of practice areas, ranging from criminal defense to family law to civil rights and personal injury.

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