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 the devices and drugs your doctor prescribes to you to be safe to use. You deserve justice whether a device or drug fails because of quality control or manufacturer recklessness.

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 
  • Lack of adequate warnings or instructions

Defective Design

When flaws in the product cause harm to the consumer, the courts will review two standards to determine liability: 

  • 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 outweigh the burden of taking precautions against the injury’s occurrence.

Manufacturing Defect

The court first must understand whether it was the product’s design or the manufacturing process that caused the product’s flaw. In the event that it was the manufacturing process, the courts will utilize strict liability to determine the manufacturers’ fault.

This means that there doesn’t need to be an actual intent to cause injury for a valid claim. This also means that the manufacturer does not 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 where they say “possible side effects include…” Then it proceeds to present a list of illnesses and injuries the consumer may or may not sustain. This is how the manufacturer typically provides adequate warning to consumers. If they do not provide adequate warning, a claim can hold them responsible for injuries their product causes.

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.

The statute of limitations extends if the reason for the injury is unknown for a period of time. In this case, it doesn’t begin until an entity, such as a victim, discovers the defect. An example of this would be if the doctor hides a device’s failure or the cause of injury after a botched surgery.


If a defective device or a dangerous drug has injured you or a loved one, you may be entitled to damages. Pennsylvania uses the modified comparative fault standard, which protects you in these cases. This fault standard means that the injured party cannot be more than 50% responsible for the injury.

The court can award you 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 its own risks. 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, Scranton’s 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 and personal injury.

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