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Surgical Equipment & Products News South Africa

Defective medical devices and implants can cause harm: How to claim compensation

Artificial hips, insulin pumps, contraceptives, breast implants and pacemakers are among many devices that have caused injuries and sometimes resulted in patients having to undergo follow-up medical care or worse - in some cases - losing their lives.
Source: Supplied.
Source: Supplied.

In the past decade the US Food and Drug Administration (FDA) has collected 5.4 million ‘adverse event’ reports which included 1.7 million injuries and almost 83,000 deaths and nearly half a million who had surgery to remove a device.

If you’ve been injured or had a medical condition made worse by a defective medical device or implant, you may be able to claim compensation. Lawsuits of this kind hinge on the legal concept of ‘product liability’.

This is according to Kirstie Haslam, partner at DSC Attorneys, who says that in legal terms, a medical device refers to any device, monitor, instrument or machine used by medical practitioners to treat a disease, illness, injury or disability.

Haslam cites common examples of medical devices which include: defibrillators, Cpap machines, ventilators, glucose-monitoring systems and surgical equipment, tools and instruments.

She explains that medical implants are devices or prostheses designed to remain in the body permanently and include: stents, breast implants, pacemakers, knee/hip replacements, medical mesh products (including hernia and transvaginal) and inferior vena cava filters.

Famous cases of defective medical devices

Defective medical devices and implants can cause serious health hazards, even death. Haslam cites some famous cases.

  • West Pharmaceutical’s Vial2Bag fluid transfer systems: Based on the number of units, the largest recall in the world took place in 2019 when 38.8 million Vial2Bag fluid transfer systems were recalled. The fluid transfer system had functioning issues that risked an overdose or underdose of medication to patients.

    Complaints were made to the US Food and Drug Administration (FDA) after 16 pregnant women suffered serious health issues when the device administered oxytocin during delivery.

  • Allergan Natrelle Biocell textured breast implants: In July 2019, US medical device and pharma giant Allergan recalled 246,381 of its textured breast implants after FDA analysis showed it led to an increased risk of anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. A possible link was first reported in 2011.
  • Medtronic MiniMed insulin pumps: In August 2018, a cyber security risk to the remote control of insulin pumps used by diabetics to self-administer insulin forced Medtronic to recall more than 1,000 devices. The defect allowed hackers to gain control of the remote control and potentially instruct the pump to over or under deliver insulin, potentially leading to death.
  • Types of lawsuits involving faulty medical devices

    If you’ve experienced personal injury as a result of a dangerous or defective medical device or implant, Haslam says that three types of claims can be made:

    • defectively manufactured medical devices
    • medical devices with a defective design (even though properly manufactured)
    • defectively marketed medical devices.

    Haslam highlights some of the most common claims:

    • Cochlear implants: Faulty cochlear implants can cause painful sounds and the need for surgery to replace the implants.
    • Defibrillators: Defective defibrillators can cause unnecessary shocks or fail to provide a lifesaving shock to a patient.
    • Knee replacements: Surgery to replace a knee can cause further injury and discomfort. This may be due to a defective product or the way it was fitted.
    • Surgical equipment: Malfunctioning or defective surgical tools and equipment can cause severe injury during an operation.

    • Hospital devices: Any defective hospital device, such as a scanner, temperature-control device, ventilator or monitor, could lead to a misdiagnosis or diagnosis delay that could cause a patient to become very sick or die.
    • Breast implants:Thousands of women have suffered injuries, various autoimmune diseases and cancer as a result of defective or harmful breast implants. Thirty-three deaths have been reported in women who suffered BIA-ALCL after having dangerous Allergan breast implants.

  • Who is liable for injuries due to a defective medical device or implant?
  • Often, it is solely the manufacturer of a defective medical device or implant that is responsible for a claimant’s injuries. “If a manufacturer sold a defective medical device or failed to warn patients and doctors of potential risks, the manufacturer is liable,” says Haslam.

    “A medical practitioner who knew about a defect or risk in a medical device or implant and failed to disclose this to a patient could also be held liable.”

    She says that courts apply strict liability in product-liability cases, which means a plaintiff doesn’t have to prove negligence. However, Haslam says that a legal team must prove that a medical device or implant was defective and that it was directly responsible for the injuries or illness. “This is complex and requires expert testimony and detailed knowledge of product liability law,” she adds.

    Compensation claims for defective medical devices and implants are complex legal cases that require the expertise of a product liability attorney, she explains.

    “The legal process for a defective medical device claim is complex, challenging and expensive – and can take many years,” she says.

    “As a result, many personal injury lawyers who specialise in product-liability cases offer their expert services on a no-win, no-fee (or contingency fee) basis. The attorney represents you for as long as your case takes and will carry the costs of engaging experts and specialists without charging an initial fee.”

    If the case is won, your attorney will receive a fee (either a fixed sum or percentage of your settlement) in accordance with the agreement that was signed. Haslam says that this must be in compliance with the terms of the Contingency Fees Act.




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