The function of retrievable inferior vena cava (IVC) filters is to prevent blood clots that have formed in a patient’s lower extremities or pelvis from going into the lungs or heart because if they do, the results could be serious and even fatal. When a blood clot travels to the lungs it is referred to as a pulmonary embolism. IVC filters are sometimes surgically implanted in patients that are at risk for developing blood clots that could be serious or life-threatening but are unable to take blood-thinning medication or have had recurring blood clotting issues despite taking this type of medication. These filters are typically surgically implanted in outpatient settings.
According to the U.S. Food & Drug Administration (FDA), the use of IVC filters has increased substantially since 2010. Indeed, just 10 years ago in 2007 nearly 170,000 IVC filters were implanted as compared to merely 2,000 in 1979. An IVC filter transports blood from the lower half of a patient’s body back into the heart.
FDA Voices Concern over IVC Filters
The FDA issued an official safety communication in 2014 to physicians implanting IVC filters in patients or those that followed a patient’s treatment who had an IVC filter surgically implanted.
The warning by the federal agency advised that once a patient was no longer at risk for pulmonary embolisms, physicians should consider having the IVC filter surgically removed. In fact, a scientific analysis conducted by the FDA noted that the benefit of removal compared to keeping an IVC filter in patients is between 29 and 54 days after implantation of the medical device.
The reasoning behind this conclusion stems from numerous adverse events reported to the FDA following IVC filter complications including: filter fracture, filter migration (or movement from original place), embolization (movement of filter fracture fragments or the entire filter to the heart or the lungs), difficulty removing the filter, and perforation of the filter. A 2013 report in the Journal of Vascular Surgery: Lymphatic Disorders published the FDA’s analysis on blood clot filter removals. According to the FDA, these adverse events may not have occurred if the IVC filters were removed from patients sooner. Consequently, the federal agency ordered manufacturers of IVC filters to collect additional medical research data regarding the use of the product in patients in order to get a clearer picture of the filter’s safety.
Blood Clot Filter Misbranding
The FDA has also investigated manufacturers wanting to produce retrievable IVC filters. Specifically, the FDA issued a warning letter to C.R. Bard, Inc. for misbranding one of its clot filter medical devices the Recovery Removal System, Model RC-15 for use with its G2 Filter and G2X Filter. The FDA has approved retrievable IVC filters to be implanted temporarily or permanently. The use of these medical devices for prevrenting recurring pulmonary embolisms has been approved by the FDA when blood thinning (anticoagulant) therapy has failed, blood thinning therapy is contraindicated (blood clots are still occurring) and/or as a required emergency intervention after a massive pulmonary embolism when conventional therapies are not expected to be helpful.
Medical Device Lawsuits
When a person is harmed by a medical device, an injured victim may file a lawsuit for monetary compensation under a product liability claim. All product liability cases resulting from injuries of a defective medical device generally allege one or more of three basic theories: defective manufacturing, defective design, and defective marketing.
- Defective manufacturing: a medical device is improperly manufactured or otherwise damaged when an error occurs at the manufacturing facility, during shipping, or at the hospital or doctor’s office. This defect can happen at any point between the manufacturing facility and the place where the patient received (or was implanted) the product;
- Defective design: a defectively designed medical device can be produced at the facility to the exact specifications of the product and arrive at the hospital or doctor’s office without issue but it is still unreasonably dangerous because of its inherent design. Sometimes the defect is not discovered until after the product is put out into the market and individuals start suffering harm;
- Defective marketing: this defect refers to an inadequate warning, a lack of warning, a recommendation, or instruction concerning the use of the medical device. This can include failure to provide adequate warning of the dangers of using the product, sophisticated sales pitches targeting the medical industry, or improper advice given by the manufacturer, physician, sales rep or other healthcare provider.
When it comes to a product liability lawsuit involving a medical device, it is important that an injured victim identify and include all potential defendants in his or her claim. This is because under this area of the law every person or entity that is part of the product’s “distribution chain” may be named. The distribution chain is the path the medical device took from the manufacturer all the way to the consumer. Possible defendants in a medical device claim include the:
- Manufacturer: typically, the manufacturer of a medical device is a large company because of the large market for these types of products and the technical specialty involved in developing the product.
- Retail supplier: while most medical devices are directly delivered to patients by way of a physician or hospital facility, if the product that harmed you was purchased through a pharmacy, drug store, or other retail supplier this entity is in the product’s distribution chain and can be named as a defendant.
- Testing laboratory or facility: any facility or laboratory that performed tests on the medical device prior to release on the market, particularly if they are separate and apart from the manufacturer.
- Sales representative: sales representatives often approach doctors and other members of the healthcare community, including hospitals and outpatient facilities, to promote the latest medical devices and make recommendations regarding the potential use of these products. If a representative recommended a device that injured you, he or she may be added as a defendant in the lawsuit.
- Physician: doctors that recommend a medical device may be held liable for failing to warn a patient of the potential dangers of using the product or providing improper instructions on how to use the product.
- Hospital or clinic: because these healthcare facilities are part of the chain of distribution in a defective medical device that caused harm, they may be named as defendants in the lawsuit.
Medical Device Injury Help
If you or someone you care about has suffered medical complications from the implantation of a IVC filter, contact the skilled medical device attorneys at the Roger Ghai Law Offices. This law firm has years of experience representing the injured and will fight for you and your loved ones to obtain the monetary compensation to which you are entitled.