Medical product liability applies when a person is injured by a defective medical product or drug after they did not receive appropriate warnings about the product’s potential side effects or known defects.

Patients have the right to “informed consent” choices about their medical treatment. If a company lies, misleads, or neglects to adequately inform doctors and patients of risks, they may be held liable (meaning financially responsible) for the harm the product causes. That responsibility extends to cases of wrongful death as well.

There is no one number that accurately describes an “average” payout for defective medical device cases, as each case is unique. Some cases involve multiple plaintiffs injured by the same defective devices suing collectively in a class action or mass tort case. For individuals, the amounts are directly related to the severity of their injuries and the cost of their losses like medical bills, lost wages, and pain and suffering.

Here are case results The Lyon Firm has secured for clients injured by defective medical devices:

• Multi-plaintiff results:
  • $5,500,000
  • $2,075,000
  • $1,520,000
  • $725,000
• Single plaintiff results:
  • $1,200,000
  • $560,000

Multi-million dollar outcomes are a real possibility in cases that involve such invasive injuries. These amounts reflect the cost of reparative surgeries, the loss of a person’s prime earning years and career advancement, and the damage that long-lasting or chronic pain does to a person’s quality of life.

Yes, you can sue a medical device manufacturer for faulty medical equipment.

Because many of the medical devices on the market may be inadequately tested and rushed to the consumer market to make a profit, patients and their attorneys have filed many claims against the manufacturing companies. When manufacturers are negligent and injure patients with defective medical devices, litigation is often necessary to restore the financial and human loss that is endured.

Here is the evidence your attorney may prepare to prove a medical device company is liable for damages:

• The defective product: It is important to preserve the product in order for experts and medical professionals to make certain arguments. It is critical to preserve all physical evidence and medical records.
• Regulatory documents: Documents obtained from the U.S. Food and Drug Administration (FDA) can prove insightful in understanding how the device was approved, any past adverse events reported by physicians and consumers, any warning letters issued to the company, and any testing that was or was not performed prior to marketing.
• Corporate documents and depositions: Attorneys coordinate to compile and review company documents for pertinent materials. Paperwork may reveal internal admissions of negligence, and depositions (official sworn statements or interviews) may provide crucial clarity. Relevant topics may range from regulatory affairs, science and research, marketing and sales, to post-market surveillance.
• Expert witnesses: These are professionals who can speak to medical, ethical, or economic concerns. Also treating physicians or implanting surgeons may need to testify that a different warning or instruction would have changed the manner in which the device was used, thereby preventing injury.
• Demonstrative evidence: Computer graphics and other visuals are critical in assisting the jury to understand the medical science, the device, the risks, and the injury suffered.

Defective medical device litigation provides answers when medical device companies are unwilling to be honest with consumers and their physicians about the risks and dangers of their products.

Many companies have been involved in medical device litigation for defective product designs and failure to adequately warn claims. The litigation often precedes a voluntary recall. Many critics have argued that an overly-lenient FDA approval process is partly to blame for the increase in medical device defects and injuries reported.

Here is a general summary of the two types of processes a manufacturer can utilize to gain FDA approval to access the U.S market to sell medical devices:

1. Pre-market Approval Process (PMA): The pre-market approval process requires a medical device company to submit safety and efficacy data on the proposed device. PMA is a longer and more expensive process, and typically these products include innovative, cutting-edge technology.
2. A 510K Process: The 510K approval process, however, allows medical devices to obtain FDA approval without submitting safety and efficacy testing data. A company may introduce a new medical device if the device is a “substantial equivalent” to another device that previously went through the more rigorous pre-market approval process discussed above.

Many device models are put to market under the more lenient 510K pre-approval process and are not properly tested. This puts American consumers and recipients at risk of serious injury.