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EpiPen Deaths Illustrate Dangers of Medical Device Manufacturing Defects

Medical devices have revolutionized healthcare in many areas, allowing people who would have been incapacitated or even died in an earlier era to live long, relatively healthy lives. However, as new devices move rapidly through research and development and out to the public, the potential for error is significant. That risk is greatly increased if the device manufacturer fails to act promptly to address possible manufacturing defects.

Earlier this month, the Food & Drug Administration (FDA) sent a warning letter to Meridian Medical Technologies/Pfizer, Inc., manufacturer of the EpiPen.

FDA Warning Regarding EpiPen Production

The EpiPen is a “combination product,” in that it is a single unit that includes both a drug and a device for delivery. The device is a self-injector that allows a person suffering a severe allergic reaction to quickly administer a shot of epinephrine, which can be life-saving for a person entering anaphylaxis. Of course, the life-saving attribute depends on the device functioning properly.

The FDA’s warning letter cited hundreds of complaints about the devices failing in life-threatening emergencies, including some in which the patient died. In addition to these reports, Meridian itself reported the discovery of a faulty injector unit in a shipment of component parts. The company did reject the lot and another associated lot, but did not further sample for additional defective parts and continued to manufacture the devices using other lots of the same component, purchased from the same source.

Unfortunately, this is just one example of a medical device manufacturer or pharmaceutical company failing to take adequate precautions in the face of significant risk to those depending on its products. While the EpiPen issue is just beginning to unfold, similar decisions in the industry have led to significant injury and death, and several have resulted in class action settlements or verdicts.

Negligence Claims and Product Liability Claims in Medical Device Cases

When a medical device or other product harms a consumer, there are generally two types of claims available. The first is a standard negligence claim, similar to the claim a person injured in a car accident or after slipping on the wet floor of a local business might file.

To establish a negligence claim, the injured party must prove that the defendant had a duty to him, that the defendant failed in that duty, and that the defendant’s failure in that duty caused his injuries.

Although the elements of negligence are present in many product liability cases, including defective medical device cases, it is typically not necessary to prove negligence.

Strict Liability in Texas Product Liability Cases

There are three general types of product liability claims in Texas:

Design defects: When a product liability case is based on a design defect, the plaintiff must show that the product itself was unreasonably dangerous, even when manufactured precisely according to specifications. A design defect will typically affect the safety of every unit of the product.

Manufacturing defects: A product liability claim based on a manufacturing defect will allege that a flaw in the manufacturing process, faulty materials, or faulty components rendered certain units unsafe. If in fact some of the EpiPen injection components used in manufacture of the devices were defective, that could form the basis for a manufacturing defect-type product liability claim.

Marketing defects: A marketing defect case depends on demonstrating that the defendant failed to provide adequate warnings or instructions for safe use of the product, creating a likelihood of use by people or in a manner that was likely to cause harm.

If a product is defective in one of these three ways at the time it leaves the manufacturer’s hands, the manufacturer is responsible for harm caused by the product as a result of the defect. This is true even if the manufacturer exercised all reasonable care in designing, manufacturing and labeling the product.

Defective Medical Device Litigation and Other Product Liability Claims are Complex

When you’ve been injured by a defective product, particularly a medical device, proving your claim can be complicated and require very technical evidence. If you believe that you have a claim against a medical device manufacturer or other product manufacturer, it is in your best interest to talk with an attorney who is experienced with complex claims. You will also want to ensure that the law firm has the resources necessary to conduct a thorough investigation, retain experts, and otherwise fully prepare and litigate your claim. Contact Simmons and Fletcher, P.C. or visit our website here for more information on product liability.