Second IVC Filter MDL Created

An inferior vena cava filter, or IVC filter, is a tiny device implanted by doctors to “catch” migrating blood clots that have broken away from an arterial wall. The device is often put in as a prophylactic measure. In so doing, the IVC filter prevents a blood clot from forming, preventing stroke and other life-threatening events.

The IVC filter is a wire device that is often described as resembling a spider. Unfortunately, any one of the metal extremities or shards on the device can break off and be carried away by the blood stream, finding its way to the heart or lungs. The likelihood of splintering increases the longer the device remains in the body. The devices seem to work for their intended purpose, but should not be left in the body permanently, and should be removed once the danger of a serious blood clot has passed.

The main manufacturers named as defendants in various lawsuits are C.R. Bard and Cook Group, Inc., or Cook Medical.

It is alleged that as early as 2003, Bard’s own research and studies showed that the IVC filters posed an unreasonable danger to patients from splintering. The company did not tell the FDA about their findings, or warn patients or doctors, and continued to sell and market the Recovery IVC filter until it could create a suitable replacement. Bard only removed the Recovery IVC from the market when it had a new filter, the G2, in 2005. Since 2005, the FDA has received 921 device adverse event reports involving IVC filters.

In May of last year, the FDA issued a safety bulletin advocating that the ideal window for device retrieval is from 29 to 54 days after implantation. That said, the FDA was on record, as early as 2010, indicating that an IVC filter should be removed as soon as the danger of a pulmonary embolism had passed.

In October 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated 27 lawsuits against Cook Medical from 11 districts into Multidistrict Litigation No. 2570 in the Southern District of Indiana before Judge Richard L. Young. This MDL is comprised mostly of lawsuits over the Günther Tulip and Celect filters.

The first lawsuits filed against C.R. Bard were filed in California and Pennsylvania state courts in 2012. On August 18, 2015, the JPML centralized 22 lawsuits involving C.R. Bard IVC filters into Multi-District Litigation No. 2641 in Arizona under U.S. District Judge David G. Campbell. Those lawsuits involve the Bard Recovery, G2, and G2 Express retrievable filters.

The use of an IVC filter may cause the following problems:

IVC Filter migration

IVC Filter fracture

IVC Filter perforation

Tilting of the IVC Filter

The inability to retrieve the IVC Filter

Pulmonary embolism

Compromised respiration

Stroke

Death

Pittman, Dutton & Hellums, P.C. is currently investigating IVC filter cases. If you or someone you know received an IVC filter and has been injured, please contact Booth Samuels at (866) 515-8880 or by email at booths@pittmandutton.com

Zimmer Recalls Persona Knee Replacement Components

On March 12, 2015, Zimmer issued a voluntary recall of the Persona Trabecular Metal Tibial Plate following an increase in complaints of loosening and radiolucent lines (x-ray evidence of separation of the metal plate from the bone). The loosening of the device can result in severe pain and the need for revision surgery.

According to the FDA, this recall affects 11,658 of these knee components worldwide. Zimmer distributed the recalled Persona Trabecular Metal Tibial plates in at least 25 states and at 13 major Veterans' Administration medical centers throughout the U.S. from Nov. 29, 2012 until Jan. 23, 2015. This recall does not involve the femoral component or cemented tibial plates.

Zimmer marketed the Persona Knee as the “most clinically successful knee replacement more personalized than ever.” Yet, patients who were implanted with the Persona Knee have experienced serious problems or needed revision surgery.

Complications can include:

•       Loosening of the implant

•       Pain

•       Limited mobility

•       Numbness or stiffness in the leg

•       Appearance of radiolucent lines on x-ray

•       Early implant failure of the knee implant

•       Need for revision surgery

If you or someone you know received the Zimmer Persona Trabecular Metal Tibial Plate and have experienced complications, please call Booth Samuels at (866) 515-8880 or by email at booths@pittmandutton.com

Medical Identity Theft

We all have read about the massive data breaches in the news over the last few years. The Target breach, the Mapco breach, and the Anthem breach are but a few. The thought of some far-away computer hacker in a basement in Russia, or the far-East, is nothing foreign to us these days. Cyber-security systems, no matter how seemingly airtight, are vulnerable. We are all at risk. It seems every week, there is a story of another large company that was hacked and our personal information was stolen.

But how is your personal information used? A lot of times, your information is sold on the internet in bulk around the world (see my previous blog post). The purchasers of stolen information use credit card numbers to buy goods or pay for services. Sometimes they file false tax returns using your information to steal your rebate or claim one of your dependents on their return.

However, an alarming new trend is occurring in the world of identity theft and it is medical identity theft. Thieves use your personal information to receive treatment at hospitals and clinics, get prescriptions, or buy medical equipment. Usually, the health care provider is nowhere in your vicinity or provides treatment for a condition you do not have.

Victims sometimes only find out when they get a bill or a call from a debt collector. They can wind up with the thief’s health data and history in their own medical charts. A patient’s record may show she has diabetes when she does not, say, or list a different blood type—errors that can lead to dangerous diagnoses or treatments.

Adding insult to injury, a victim often is not allowed to fully examine his own records because medical-privacy laws such as HIPPA protect the thief’s health data. All the while, hospitals sometimes continue to hound victims for payments they did not incur.

To make the situation more alarming, medical identity theft is growing. According to a recently published survey, medical identity theft affected 2.3 million adult patients in 2014 versus 1.4 million in 2009. Another report published in February estimated that computer-data breaches of personal health information affected more than 40 million patients from 2009 through 2014.

Such identity theft has led about 40 companies, including Blue Cross Blue Shield Association and Aetna Inc., to form the Medical Identity Fraud Alliance. Some hospitals have turned to biometric screening to confirm patient identities. Also, unlike in financial identity theft, health identity-theft victims have a much more difficult time clearing the illegal bills because there is no health-care equivalent of the Fair Credit Reporting Act or the Fair Debt Collection Practices Act, which limits consumers’ monetary losses if someone uses their credit information.