Chicago Personal Injury Lawyer Blog

The U.S. Food and Drug Association is responsible for ensuring that new medical devices are safe enough to be put on the market. As a federal agency, the FDA controls regulation nationwide and within Illinois and Chicago. But what most consumers don't know is that the process for approving these medical devices doesn't always ensure that they are effective alternatives to already established medical treatments.

The majority of newly approved medical devices undergo a 501(k) review. Under this review process the manufacturer needs to prove that their device is substantially similar to another device that has already been approved for the market. Once they have done that, the manufacturer just needs to show that the device does what it claims. Yet in the field of medicine, just performing a function is different than guaranteeing the supposed outcome.

For example, let's suppose that Elaine, an Illinois woman, was trying to decide between which type of radiation she should get to treat her breast cancer. Her options range from conventional radiation, which would irradiate her whole breast five times per week for a total of five weeks, to a newly-FDA approved radiation therapy method called MammoSite brachytherapy. This new method only requires radiation for five days and uses radioactive 'seeds' to treat the cancer.

All things being equal, the MammoSite option is much more appealing because it gets the job done in a fraction of the time and is Elaine's first choice. Her doctor recommends it and she decides to go with the newer treatment option. However, what Elaine doesn't know is that even though MammoSite is FDA-approved, the long-term effectiveness of the treatment is not yet proven. While early studies have come back with promising results, it will be years before there is enough data to determine whether it is as effective as conventional radiation. Yet many of the women undergoing this form of treatment are unaware that it is still in an experimental state and are trusting the FDA-approval and their doctors' recommendation.

Continue reading "Are All FDA Approved Devices Safe?" »

A California Appellate Court supported a trial court's ruling that the Medical Device Amendments (MDA), Title 21 USC §360k(a), preempts any state law imposing safety requirements on manufacturers of a medical device. So even though the medical device did not pass all of the state's safety requirements, in Blanco v. Baxter Healthcare Corp. the plaintiff's claim was denied because the medical device in question met all the FDA requirements. As we see again and again, the MDA's preemption claim is making it increasingly difficult to seek legal recourse for a faulty medical device. Of course, this would hold true for our cases in Chicago and around Illinois.

Claudia Blanco was diagnosed with mitral valve stenosis and needed to have her natural valve replaced with an artificial one. During surgery a bileaflet mitral heart valve manufactured by Baxter-Travenol Laboratories was inserted. A year after Blanco received the valve Baxter suspended marketing of its product due to reports of possible valve failures. However, Blanco didn't receive any notice of the valve problems for another five years. And while the notice advised her of the potential problems it did not advise her to have the valve removed or replaced. Less than ten years later Blanco's artificial valve failed and she was rushed to the hospital for an emergency valve replacement, but died. After her death a representative from Baxter evaluated her valve and determined that the failure was in fact caused by a faulty valve.

But despite the evidence that the product was faulty Blanco's claim was denied by both the trial and appellate courts. Because the medical device had passed a "rigorous" approval by the FDA it was protected from litigation for product liability. Also, because the device's warnings were also approved by the FDA a claim cannot be brought for failure to warn.

Continue reading "Blanco v. Baxter Healthcare Corp.: Court Upholds Medical Device Preemption Clause" »

Chicago's 7th U.S. Court of Appeals reversed a federal district judge's ruling that barred the Illinois product liability claim of Lenore Aebischer. In 1997 at age 44, Lenore underwent a hip replacement. But the prosthetic hip manufactured by defendant Stryker Corp. allegedly failed due to structural defects, and Lenore required a second replacement surgery.

Stryker Corp. moved to dismiss the complaint filed by Lenore because the 2-year statute of limitations had run when the case was filed in Chicago in 2005. In Illinois, typically the statute of limitations begins running from the date that the claimant should have known that there was a problem with the defective medical device. The Chicago district court found that in 2002 Lenore was aware that her hip problems were caused by a manufacturer's defect.

In 2001, Lenore saw her orthopedic surgeon for left hip pain and was told that her hip replacement might last 15-20 years. In 2002, the same doctor determined that her pain was caused by osteolysis and from particles of plastic that had broken loose from the prosthetic hip. In 2003, the surgeon performed a second hip replacement surgery to replace the failed original prosthesis. After the surgery, the surgeon told Lenore that the osteolysis was worse than he had originally thought and that the original hip device had "advanced or catastrophic failure".

Because of her surgeon's discoveries during her procedure in January, 2002, the Illinois federal district court said that the plaintiff was on "inquiry notice" that her injury might have been wrongfully caused based on the surgeon's explanation of the osteolysis and that particles of plastic from the prosthesis had gotten between that device and her hip bone.

Continue reading "Illinois Hip Replacement Product Defect Suit Survives After Statute of Limitations Runs: Re-Evaluation of When Discovered Injury" »

The American Association for Justice (AAJ) is lobbying for the rights of consumers injured by defective medical devices. In Riegel v. Medtronic, Inc. the U.S. Supreme Court ruled that manufacturers of medical products weren't liable for damages if their device received premarket FDA approval (see 03/01/08 post for more details). It is up to Congress to restore the rights of the consumer.

The Medical Device Safety Act of 2008 is set to mimic the 1976 Medical Device Act (MDA), which is what the U.S. Supreme Court relied on for its decision in Riegel v. Medtronic, Inc. The new act seeks to add the following language to the section titled "No Effect on Liability Under State Law":

Nothing in this section shall be construed to modify or otherwise effect any action for damages or the liability of any person under the law of any State.

By adding this language the new Act ensures that civil suits can be filed under state law even if the device was approved by the FDA.

In order to ensure that the new act protects the rights of consumers the AAJ is actively lobbying, uniting attorneys from across the country in their common goal. If you, too, feel strongly about this bill it is vital that you contact your member of Congress and voice your support for the bill.

Continue reading "Attorneys Lobby for Consumer Rights Stripped Away in Riegel v. Medtronic, Inc." »

In the case Riegel v. Medtronic, Inc. the U.S. Supreme Court ruled that the manufacturer of the medical device could not be sued under state law when the device causes an injury. What this means for patients is that it is now harder to file a lawsuit against a maker of medical device that is FDA approved.

FDA recall video of the leads used in Medtronics pacemakers.

In its decision the Supreme Court relied on the Medical Device Amendments of 1976 (MDA) which holds that a state cannot establish regulations that are different than established by the FDA, or that are in addition to the federal requirements. Nor can state regulations supersede those laid out by the FDA regarding safety and effectiveness.

In Riegel v. Medtronic, the Riegels sued the manufacturer after a Medtronic catheter burst in Charles Riegel's coronary artery during heart surgery. The relevant catheter had premarket FDA approval. In their claim against Medtronic the Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. However, because their claim was based on violations of New York law and not federal law, the court dismissed the Riegels' claim.

So despite the fact that the medical device had caused severe and permanent injuries to Riegel there is no legal recourse for them. As long as the device in question adequately meets all federal regulations and has federal approval then your legal options are limited.

Continue reading "US Supreme Court Holds Medical Devices Exempt from Liability in Riegel v. Medtronic " »