With a new claim filed, Rex Medical LP joins the ranks of inferior vena cava filter manufacturers being sued in Pennsylvania state court over complications allegedly associated with their implantable blood filters.

Plaintiff Rebecca C. claims she was implanted with a Rex Medical-made Option Retrievable inferior vena cava filter in February 2013.

She says she suffered significant injuries when an attempt to surgically remove the filter in March 2014 ended in failure.

Rebecca now says the Option filter has a tendency to fail and that manufacturer Rex Medical should have done more to address the issue. She says the Option filter has high rates of fracture, migration, tilting out of place and perforation of the inferior vena cava.

Rex Medical either knew or should have known that the Option filter was “defective and unreasonably dangerous,” she says.

Rebecca challenges the testing Rex Medical performed on the Option filter, claiming that Rex failed to establish and maintain adequate testing according to FDA requirements. She argues that more adequate testing was warranted to properly evaluate whether the device would work safely following implantation.

Had Rex Medical complied with the FDA requirements, Rebecca says, her filter would have been manufactured better and would not have caused her injury.

Rebecca’s inferior vena cava filter lawsuit is pending under case no. 160300207 in the Court of Common Pleas for Philadelphia County, Pa.

Manufacturer C.R. Bard has also faced similar claims. In one of the first such claims to go to trial, the plaintiff claimed that a Bard filter broke apart, injuring the patient and necessitating further medical treatment including surgery.

A group of similar claims against Bard has been consolidated into a single multidistrict litigation, transferred in August 2015 to the U.S. District Court for the District of Arizona.

What Is An Inferior Vena Cava Filter?

The device at the center of Rebecca’s claim and many others like it is an implant used to prevent pulmonary embolism in patients who can’t take anticoagulant medications.

The function of the inferior vena cava is to return blood from the lower body to the heart and lungs. If a blood clot forms in the legs or pelvis, it can travel up the inferior vena cava to the lungs and cause a pulmonary embolism.

A filter placed inside that vein can trap the clot before it reaches the lungs.

Generally, anticoagulant medications are used to prevent pulmonary embolism. But since these medications are not a suitable option for some patients, an inferior vena cava filter is an alternative treatment.

Like many other medical devices, an inferior vena cava filter comes with a risk of complications.

The FDA publicized the issue in a 2010 safety alert based on 921 reports of adverse events received from 2005 to 2010. These reports detailed cases in which filters fractured, migrated out of place, perforated the vein wall or released detached parts into the bloodstream.

The FDA notes that these filters serve no useful function once the risk of pulmonary embolism has subsided. Therefore the agency recommends removable of retrievable filters that are no longer needed as a way of preventing future complications.