As of December 2015, the manufacturer of the IVC Filter–Inferior Vena Cava Filter–was responsible for 30 deaths as a result of a product defect, that even when replaced with a "modified" device, still behaved in the same way, and caused the same life-threatening issues. An IVC Filter, when working correctly, according to Johns Hopkins was created to "[...]stop blood clots from going up into the lungs. The inferior vena cava is a large vein in the middle of your body. The device is put in during a short surgery."
For those with high risk of blood clot after stroke, heart attack, or pulmonary embolism, this routine procedure was created to prolong patients' lives and reduce the risk of pulmonary and cardiovascular events in the future. When surgically placed correctly–and if the device is manufactured properly–there should be little to no complications post-op after the patient is back on their feet. In fact, this device was created with the idea that by preventing blood clots, patients would need less medical treatment. Unfortunately, this was not the case, as a cash grab and rushed attempts to modify the original defective device resulted in life-threatening complications and more than 30 fatalities as of 2018.
Investigative reporting for the people
As proof of "foreseeability" in this instance, internal documents have surfaced proving the medical device manufacturer C.R. Bard was negligent due to their continuous attempts to ignore what they knew from the get-go: their devices had a high probability of malfunctioning and needed to undergo further modifications before they would be fit (if ever) for the human body.
According to an article published NBC News, investigating the claims made against Bard and Class Action lawsuit(s) filed against the medical device manufacturer:
"Confidential company records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company’s Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration."
Patient stories have impact
Claims date back to 2011 and even earlier than that, when patients like Mrs. Susan Karnstedt shared her IVC Filter nightmare with Stanford Hospital, who was able to save Mrs. Karnstedt's life before the complications resulted in another fatality. "At the time they put in [...] it was cutting-edge technology. [...] we first thought it was food-related but after some time the pain got worse to the point where I couldn't really sleep through the night," Mrs. Karnstedt shares in her video testimonial where she offered her ordeal to Stanford.
"Three of the prongs were perforating my small intestine–and the filter was continuing to expand–which really made this a life or death surgery for me," adds Karnstedt.
Her surgeon, Dr. William Kuo further explains on screen: "Susie came to us at the perfect time, because prior to 2010, patients with these severe filter problems had very few options for treatment."
Manufacturing standards failed
Strict Product Liability applies to products (in this case medical devices) purchased with the expectation that it will act as expected. This especially applies to medical devices such as wheelchairs, walkers, neck and back braces, and in this instance IVC Filters placed inside the body of a patient because they can be life-sustaining to the patient. To apply the rule of Strict Product Liability in a court of law, several factors must be met. In this case, we'll use defective IVC Filters placed in patients as an example of such:
- The product or medical device has to be considered “unreasonably dangerous” in regard to its defect; this can be either within the design, during the manufacturing process, or during shipment to the seller. So in the case of an IVC Filter, C.R. Bard knew of the inappropriate expansion of the device into the soft tissues of the body (in Mrs. Karnstedt's case, her abdomen and small intestine were perforated as a result of the device not acting as promised; resulting in life-threatening and near fatal consequences).
- The defective device caused the victim injury while it was being used in the way that’s considered reasonable (intended to be used). In the case of an IVC Filter implanted by a qualified surgeon who is trained in these devices, the expectation that the patient will fully recover from the surgical procedure is highly reasonable. When the IVC Filter caused pain and furthermore harm to the patient, this is considered a defect not caused by the patient or the surgeon–but the manufacturer is at fault. In this case, that would be C.R. Bard.
- The product hasn’t been modified from the condition in which it was originally purchased. The word “substantially” applies in this instance. For example: having to remove the device from its protective packaging before inserting it into the body of the patient would be considered "reasonable" and not "substantial". No harm came to the device between the time it was removed by a qualified surgeon and the time it was placed properly into the patient. The device itself had issues from the time it was manufactured, and C.R. Bard ignored them.
Lives at stake
While IVC Filter Class Action lawsuits go far, far beyond simple Strict Product Liability in multiple ways, a judge would take into consideration that on top of any wrongful death, bodily injury, or medical malpractice that may have occurred as a result of the patient having this device inserted into their body in an effort to save their life–Strict Product Liability damages may also be appropriate when deciding how much compensation each member of a Class receives.
Remember: it's of utmost importance to retain an attorney with experience in Class Action lawsuits, so as not to prolong the already lengthy legal process. Class Action lawsuits make take years to settle, but a board certified civil trial attorney has their client's best interest and will be able to tackle the complexities that go beyond the unilateral Personal Injury claim.
Learn more about life-threatening IVC Filter defects by visiting our Class Action website at classactionlawsuit.legal