Pharmaceutical Litigation


Pharmaceutical Litigation

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What Types of Legal Claims May Patients Bring Against IVC Filter Makers for Their Injuries?

IVC Filter Claim

Consumer products are purchased by Americans every day.

Most of us assume products, from aspirin to automobiles, have passed through some oversight for safety and efficacy. In fact, it is tough to imagine any manufacturer putting a faulty product on the market, just like it is tough to imagine that our watchdogs in government, whose job it is to protect our health, may not be doing their job.

Unfortunately, both things do happen in the real world.

Consumer products, drugs, medical devices can all hurt you or a loved one causing death and injury.

The high cost of medical bills, medical procedures that keep you from earning an income, the time an injury has cost you, pain and suffering, all deserve compensation, especially if we learn, as we often do, that the company had forecast that some of these injuries might occur, and went ahead and put their product on the market anyway.

You and I do not do our job with such reckless abandon and lacking concern for the safety of others. A corporation should not be allowed to get away with such behavior either.

Our U.S. Food and Drug Administration (FDA) started seeing the red flags flying over inferior vena cava filters years ago. These are implantable metal devices that are put in the largest artery in the body to prevent a blood clot from moving to the lungs or heart.

IVC Injury Claims

The agency began receiving hundreds of reports about problems with the IVC filters. Problems included perforated organs and blood vessels, filter erosion and migrating to different parts of the body. Patients experienced filters embedded in internal organs causing them to lose consciousness and requiring emergency surgery. Some patients died.

The FDA never issued a recall of any IVC filters.

The reports largely concerned IVC filters made by two companies, C.R. Bard and Cook. Bard makes the Recovery, the G2, and the G2 Express, the Bard Eclipse, the Meridian and Denali. Cook makes the Gunther Tulip and the Cook Celect filters.

The complaints led to lawsuits against both companies. These are defective product or product liability lawsuits.

Product Liability Lawsuits

Plaintiffs are the individuals allegedly injured by these devices and they allege the companies were negligent in putting a faulty product on the market; had defective marketing practices and design of the devices; and failed to warn physicians about the dangers so they could pass that information onto patients considering an IVC filter. The lawsuits also say the companies breached their implied warranty about the safety of the devices. The companies withheld vital data while negligently misrepresenting the benefits versus the risks of their IVC filters.

We know that Bard withheld valuable information patients who have liked to know before their implant. A report was prepared by consultant Dr. John Lehmann by December 2004. The Lehmann report found Bard’s Recovery filter had far higher complication rates than its competitors. Still Bard did not make that report public and certainly did not tell patients. Instead it worked on a new version of its IVC filter. The G2 and G2 Express also displayed similar side effects.

Bard IVC products are connected to 27 deaths among the injuries. Even the new replacement filter, intended to be an improvement, is linked to at least 12 deaths. The problems are compounded the longer the device is left in the body making it more difficult to retrieve in some instances.

We have also learned that Bard wanted all copies of the Lehmann report destroyed. A Nevada state court denied that request.

Complainants, also known as plaintiffs, have suffered a variety of injuries.

Kevin Phillips had to undergo open heart surgery when a piece of the Bard Recovery IVC filter broke apart and perforated his heart. Kelly Vlasvich says a Bard G2 filter migrated in her body to damage her heart and lungs. She now claims she is disabled, disfigured and is unable to resume a normal life. Larry Johnson says a Cook IVC filter fractured and moved to his heart two years ago. He lost consciousness and had to undergo three surgeries. He too experienced pain and suffering, a shock to his wellbeing and a financial loss.

The Food and Drug Administration began receiving reports of these side effects a dozen years ago. In 2010 the agency said there were more than 900 reports of adverse events, as complications are called by the FDA. The IVC filters were associated with embolisms, filter fractures, device migration and filter perforation.

Multidistrict Litigation

Right now there is litigation forming against Bard in the form of multidistrict litigation or an MDL. That is the consolidation of cases with a similar complaint by plaintiffs.

Cook is facing product liability lawsuits consolidated in the federal court in the Southern District of Indiana. There are more than 250 lawsuits filed against Cook in Indiana that are being prepared for trial. Bellwether cases will be selected to test how juries may respond to testimony they hear from both sides. Often it is the bellwether cases that indicate to a defendant company that it is wise to settle.

Cook keeps asking for delays in sitting down to a settlement conference to seek some resolution to the litigation. Meanwhile the case count continues to rise.

Meanwhile, MDL cases are consolidated naming Bard in the U.S. District Court in Arizona. There too the number of complaints filed continues to rise.

Additionally there are product liability cases filed in various states, Florida, Pennsylvania and California among them. Canadians have filed lawsuits that seek damages for Canadians hurt by IVC filters. Individual lawsuits are being filed across the U.S.

It is not uncommon for a defendant company to stall and wait before offering to settle product liability cases. This only serves to drag out the pain and suffering of those patients who once trusted their doctor and the company that made their medical device.

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Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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