Articles Posted in Medical Device Liability

The U.S. Court of Appeals for the 7th Circuit in Chicago addressed the issue of the need for expert testimony on causation when the issue is beyond the understanding of laypersons.

The product liability claim here involved the allegation of a defective intrauterine device (IUD) that broke when it was removed from the plaintiff’s uterus, leaving a fragment of it behind.

Cheryl Dalton sued Teva North America, the manufacturer and distributor of the ParaGard, the IUD.

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The plaintiff, Jo Huskey, and her husband filed a product liability lawsuit against Ethicon Inc. and Johnson & Johnson. After a nine-day trial, the jury returned a general verdict in the amount of $3.27 million for the Huskeys on their design defect, failure to warn and loss of consortium claims. Ethicon appealed after the trial judge denied its post-trial renewed motion for judgment as a matter of law or in the alternative for a new trial.

The court of appeals found that the Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error.

In 2008, Jo Huskey began suffering symptoms of Stress Urinary Incontinence (SUI).  In January 2011, after her condition worsened, she discussed treatment options with her physician. By this time, Mrs. Huskey was regularly leaking urine while coughing, laughing and sneezing. She also experienced pain during intercourse. At the suggestion of her physician, Mrs. Huskey agreed to have the doctor surgically implant a medical device called the Tension-Free Vaginal Tape-Obturator (TVT-O).

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In August 2010, the Federal Drug Administration (FDA) posted a letter it sent to a medical device manufacturer regarding the safety of its metal hip implants. The letter informed the medical device manufacturer that the FDA had become aware that it had not obtained marketing approval before releasing its metal-on-metal hip implant device for sale and that the company should stop marketing this device immediately.

The medical device manufacturer, DePuy Orthopaedics, Inc., had not received FDA approval for its TruMatch™ Personalized Solutions System prior to releasing it for sale. Therefore, the FDA was warning the medical device manufacturer that it needed to cease production of this product while it went through the proper channels of obtaining the FDA’s approval.

In addition, while DePuy had been cleared by the FDA to market its Corail® Hip System, which was intended to be used for a total hip arthroplasty. However, DePuy had made several changes to its Corail Hip System that were not approved or tested by the FDA and therefore could not legally be marketed or used.

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Medtronic, the maker of Sprint Fidelis, a heart defibrillator cable, has taken its product off the market. But the problem with it still being used by some 150,000 people around Illinois and the country has resulted in several deaths in removing the defective cable.

Medtronic estimates that the cable has failed in a little more than 5% of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.

Already 4 patients have died during extractions. It is feared that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of these operations.

“I think we are seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at who specializes in cable extractions. For many patients around Illinois, the big issue is who is skilled enough to remove these defective heart implants. It is thought that some surgeons removing the cables do not have the required skill level.

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In 2007 Medtronic recalled their heart device, the Sprint Fidelis Cardiac Leads, which has caused the deaths of at least 13 people. Essentially the product, the Sprint Fidelis cardiac leads, connects the patient’s heart to a defibrillator. Along with deaths, the Federal Drug Administration (FDA) has received about 2,200 reports of serious injuries related to the leads.

The Sprint Fidelis lead is at the center of Riegel v. Medtronic, Inc., a medical device liability lawsuit that is receiving a lot of attention from the legal community because of the involvement of preemption issues.

Yet despite the FDA recall and the highly publicized Riegel lawsuit, around 150,000 people still have the leads from this device in their body and it is still in widespread use amongst Illinois residents. Typically doctors decide to leave a fractured heart device lead in place when implanting a new one. Doctors are faced with a difficult choice when confronted with the large number of people who rely on this product because of the high degree of injury associated with it.

Last week the FDA issued an advisory to physicians regarding patients that would benefit from having the failed leads extracted, which urged the physicians to ensure that the procedure is performed by a physician skilled in removing these type of failed leads.

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A February 2008 decision by the Supreme Court stands as a barrier to patients who desire to sue for medical device liability. The Supreme Court ruling in Riegel v. Medtronic, Inc. holds that patients or their surviving heirs would be barred from suing makers of complex medical devices like the Medtronic’s heart device product, if the Food and Drug Administration (FDA) approved its sale.

Since that ruling, judges nationwide have applied the Supreme Court decision to a wide range of cases where manufacturers was being sued. The most recent dismissal was just last week by the Wisconsin Supreme Court.

But now members of Congress want to change the law. Lawmakers and patient advocate groups say that that February 2008 Supreme Court decision left patients legally powerless against the FDA’s oversight of products.

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U.S. District Court Judge Virginia M. Kendell denied a Chicago woman’s medical device liability claim that her left knee injuries were caused by her knee replacement device. The complaint was removed to the federal court from Chicago’s Cook County Circuit Court and contained claims of negligence, strict liability and breach of warranty based on Illinois law.

Judge Kendall granted summary judgment in favor of the the manufacturers, Zimmer Holdings, Inc., Zimmer U.S., Inc., and Zimmer, Inc., in a lawsuit brought by the plaintiff, Joyce Link.

After reviewing the case facts, Judge Kendell held that Ms. Link’s claim against Zimmer for their manufacturing of the Natural Knee II was preempted under the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. Per Judge Kendall’s ruling this act “imposed detailed federal oversight onto the introduction of new medical devices onto the introduction of new medical devices onto the market”. Judge Kendall credited her interpretation of Riegel v. Medtronic, 128 S.Ct. 999 (2008), as partial basis for her opinion.

In addition, Judge Kendall cited 21 U.S.C. § 360(c), which states that as part of the oversight states and their subdivisions are barred from implementing their own requirements concerning medical devices, such as the Natural Knee II. The federal act specifically preempts any state requirement regarding a medical device “which is different from, or in addition to” a requirement imposed by the MDA.

In Judge Kendall’s opinion, the state requirement is not preempted unless it also “relates to the safety or effectiveness of the device or to any other matter” covered by the MDA. Kendall held that Ms. Link’s claim was just the kind that Congress intended to preempt under the MDA.

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Since early 2006, drug and medical device companies have been on an unprecedented roll as pre-emption clauses become more and more prevalent. Despite recent controversies over prescription drugs like Vioxx and Celebrex, drug companies continue to successfully utilize Federal Drug Administration (FDA) policies to shield drug companies from civil lawsuits in the form of pre-emption clauses. This has far-reaching effects on pharmaceutical liability lawsuits in Illinois and the rest of the country.

And not just the FDA are upholding and propagating these preemption clauses- the U.S. Supreme Court has also supported pre-emption laws that prevent claimants from filing civil law suits against deep-pocketed drug and medical device companies in state courts.

The beginning of the preemption era can be traced back to January 2006, when the FDA issued a statement of its new labeling policy under the “Laws, Acts, and Rules > New Requirements for Prescribing Information.pdf.” This policy not only set out labeling requirements, but also deemed that if the FDA approved the labeling then this alone “pre-empts conflicting or contrary state law”.

The federal pre-emption clauses have little or no bearing on FDA drug recalls, which can be initiated by the FDA, by FDA statutory authority, or by the drug company itself. The FDA maintains a list of recent drug recalls.

Yet the seemingly simple pre-emption declaration had far-reaching effects within the legal community and reversed decades of policies enforcing state’s rights to civil enforcement of liability law. This was done without a public notice or hearing- instead it was quietly tacked on to the labeling policy.

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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.

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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.

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