A lawsuit filed on June 23 alleges that an Iowa woman needed heart surgery after a defective Bard PowerPort implant malfunctioned.
The Bard PowerPort is an implant which allows for quicker, easier, painless injections of medications and drawing of blood. It is commonly used to give cancer patients chemotherapy.
The lawsuit alleges that the plaintiff’s PowerPort wasn’t functioning and wouldn’t flush, and that her doctors deemed removal of the device a necessity. Doctors eventually found the PowerPort had fractured, according to the lawsuit, found a fractured piece of the device in the plaintiff’s heart and had to surgically remove that piece from the plaintiff’s heart.
The lawsuit, which was filed in the United States District Court, Southern District of Iowa, seeks to recover financial compensation for the plaintiff for damages including past and future medical bills, emotional distress, and anxiety and fear about the possibility of future injuries such as cardiac tamponade.
Lawsuit Alleges Bard Knew Its PowerPort Device Is Defective
The Bard PowerPort device is a port/catheter system intended to provide regular access to one’s vascular system so medication, blood products, nutrition solutions and intravenous fluids can be delivered. The device is intended to make delivering medications into one’s bloodstream easier. The device is implanted under the skin and is then left there.
The PowerPort consists of a polyurethane catheter and an injection port.
A needle is inserted into the injection port, and medication is then carried from that port into one’s blood via a catheter, which is a small tube that is flexible, which is inserted into a vessel of blood.
The catheter is made from a mix of barium sulfate and polyurethane.
Bard’s marketing materials claim that the catheter “has less propensity for surface biodegradation, making it more resistant to environmental stress cracking.”
However, the lawsuit claims that it is known that barium sulfate can reduce polyurethane’s mechanical integrity as barium sulfate particles leave the catheter’s surface over time, leaving microfractures and degrading the catheter’s mechanical properties.
The lawsuit alleges that the process of manufacturing the catheter uses too much barium sulfate, leading to the raw polyurethane having too much viscosity before it polymerizes and causing barium sulfate to be improperly mixed into the polymer.
The lawsuit claims that because the barium sulfate was not mixed properly into the polymer, it created pockets of air and barium sulfate in the catheter’s body and on the catheter’s outer and inner surfaces.
The lawsuit alleges that this defect created a catheter surface with cracks, pits and fissures, increasing the risk that the catheter would fracture, with breaking points being caused by irregularities and notches on the catheter’s surface.
The lawsuit claims that the risk of the catheter fracturing also increases over time due to barium sulfate being lost from the surface of the catheter. The lawsuit claims this risk was not communicated to the plaintiff or her doctors.
According to the lawsuits, Bard misrepresented the safety of its PowerPort device, representing it as safe and effective despite knowing that the device was not safe because of its tendency to fracture and migrate.
Soon after Bard introduced the PowerPort to the market, according to the lawsuit, this being years before the plaintiff received her implant, Bard started receiving many adverse event reports from providers of healthcare which reported that the device was fracturing after implantation and that pieces of the device were migrating through bodies, including to the lungs and heart. Bard also allegedly received many adverse event reports regarding the PowerPort perforating internal vasculature.
The lawsuit claims that Bard received reports of injuries from the device including:
- Pericardial/cardiac tamponade
- Persistent and severe pain
- Cardiac arrhythmia
- Perforations of organs, vessels and tissue
The lawsuit claims that Bard managed to conceal “thousands” of records of device failures regarding their implantable ports, including the PowerPort, by reporting these failures through the controversial FDA Alternative Summary Reporting program, which was halted after an investigative piece prompted outcry from patient advocacy groups and medical professionals.
The lawsuit claims Bard concealed multiple episodes of fractured catheters from patients and physicians by reporting them through the Alternative Summary Reporting program.
The lawsuit claims that Bard claimed that the device can only fracture if placed the device improperly.
Lawsuit Seeks Damages Under Seven Counts
The lawsuit seeks to recover damage under seven counts:
Negligence is not exercising reasonable care in order to prevent harm.
The lawsuit alleges that Bard failed to exercise reasonable care by:
- Not thoroughly and properly testing the PowerPort device before selling it
- Not implementing safety improvements which were feasible
- Not thoroughly and properly analyzing data regarding pre-market PowerPort testing
- Not conducting enough post-market surveillance and testing of the device
- Selling the PowerPort without adequately warning about the PowerPort’s risks
- Promoting and advertising the PowerPort without exercising due care
- Continuing to manufacture and sell the PowerPort after knowing about its risks
Strict Products Liability: Failure To Warn
The lawsuit alleges that Bard is strictly liable for damages resulting from the PowerPort because they knew about its risks but failed to warn about these risks. Strict liability applies even when it is found that a defendant was not negligent, so Bard could be found not negligent and still end up being strictly liable for damages because they failed to warn about the dangers associated with the device.
The lawsuit claims that Bard claimed that its PowerPort device would only fracture when placed improperly by a physician, and that Bard, in reality, knew that this claim was wrong, but failed to warn that its device could fracture even when placed properly by a physician.
Strict Products Liability: Design Defect
The lawsuit alleges that the PowerPort is not reasonably safe for the use it is intended for, and that its design is defective. The lawsuit claims that a feasible, safer design alternative existed for Bard to use, yet Bard chose not to use said design.
Breach Of Implied Warranty
The lawsuit claims that Bard impliedly warranted that its PowerPort device was merchantable as well as fit for its intended purposes. The lawsuit alleges that the device is not merchantable or fit for its intended purposes because the use of too much barium sulfate in the catheter causes the catheter to fracture.
Breach Of Express Warranty
The lawsuit alleges that Bard expressly warranted that its PowerPort device was fit and safe for consumers to use, was merchantable in quality, would not cause side effects which are dangerous, and was fit and adequately tested for the use it was intended for. The lawsuit alleges the device, in reality, fails to conform to Bard’s express representations since its safety is not reasonable, it can cause multiple side effects which are serious, and it can cause permanent, severe injury.
The lawsuit claims that Bard fraudulently concealed information by:
- Representing that its PowerPort device was safe and fraudulently withholding and concealing information about the PowerPort’s risks
- Representing that its PowerPort device was safer than alternatives and fraudulently concealing information showing the device was not safer than said alternatives
- Concealing that it was aware the devices were migrating and fracturing due to reasons other than improper placement by physicians
- Not sharing that failure frequency and injury severity were much worse that were reported
The lawsuit alleges that these acts of fraudulent concealment were intentional and that Bard knew its representations about its device were false.
Violation Of The Iowa Private Right Of Action For Consumer Frauds Act
The lawsuit alleges that Bard’s acts and practices violate the Iowa Private Right of Action for Consumer Frauds Act because they constitute deception, unfair practices, fraud, false promises, false pretense, and the concealment, misrepresentation, omission and suppression of material facts.
Injured By A Bard PowerPort Device? We Can Help.
Call us today for a free consultation if you have been injured by a Bard PowerPort device. We can help you recover compensation for medical bills, lost wages, pain, suffering and more. We are contingency fee lawyers who won’t charge you any fee until and unless your case is over. We have been handling defective medical device claims since 1990 and have recovered over $350,000,000 for our clients. Call us today. Click here to read more.