Articles Posted in Medical Device Liability

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Kreisman Law Offices is reviewing and handling lawsuits on behalf of patients who have suffered infections following knee, hip or other joint replacement surgeries. The lawsuits currently in place allege that 3M’s Bair Hugger warming blanket, which is widely used in hospitals across the country, are the cause of devastating injuries related to infection. Surgical patients exposed to the use of the Bair Hugger blanket have been known to be contaminated by the air in operating rooms that many times causes infections leading to sepsis and MRSA.

Many of the pending lawsuits have named Arizant Healthcare and 3M Company, charging the companies that the Bair Hugger warming blankets have manufactured, designed and distributed are defective and cause severe and debilitating infections. It has been alleged in the lawsuits that the manufacturers and distributors have known about the infection risks for more than 6 years and have chosen not to warn hospitals, doctors and patients about the dangers.

The 3M Bair Hugger is a warming blanket that uses forced air designed to keep the patient’s body temperature at a normal range. It is used principally during hip and knee replacement surgeries. The Bair Hugger device forces warm air through a hose into a special blanket that is draped over the patient in the surgical suite.

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Barbara Watt underwent a hiatal hernia repair surgery. The procedure was carried out by general surgeon Dr. Cimenga Tshibaka, and it was unsuccessful. Dr. Tshibaka performed a second surgery, this time using a synthetic surgical mesh. The second surgery was about 2 weeks after the first.

The following month, Watt was diagnosed as having an esophageal leak, which required nine additional surgeries to, among other things, remove the synthetic mesh that had eroded into her esophagus.

As a result of these many surgeries, Watt must now eat slowly and in limited amounts. She must also wear special undergarments due to scarring and is unable to bend over to lift more than 5 pounds. She also missed time from her job as a financial operations specialist where she was earning $21 per hour.

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It has been reported that the medical devices that pose the greatest safety risk to patients, including the metal-on-metal hip implants, are allowed into the marketplace without sufficient evaluation for safety and effectiveness.

According to a recent New England Journal of Medicine article, it was found that previously cleared medical devices, including  the metal-on-metal hip implant, were cleared without being fully assessed for safety and effectiveness.

The medical device amendments of 1976 created three classes of devices:  Class I included low-risk devices like a toothbrush; Class II devices were of moderate-risk like an infusion pump; and a Class III medical device would be one that would put a patient at high risk, such as the metal-on-metal hip implants.

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In a 9th Circuit decision handed down in January 2013, the court of appeals found that the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetics Act were not a wedge to prevent a plaintiff from making a state negligence claim against Medtronic. In a series of previous cases dating back to 2008, defendants, manufacturers and distributors of medical devices were armed with preemption defenses as a result of the cases of Riegel v. Medtronic, Inc. and bolstered by Bell Atlantic Corp. v. Twombly and Ashcroft v. Iqbal.  Because of the conflicts in the different U.S. Circuit Courts, there is a good possibility that the U.S. Supreme Court will take up these cases to clarify this litigation and rectify the conflict in the districts.

In the Stengel v. Medtronic case, the 9th Circuit held that the plaintiff’s claim of state law negligence for the defendant’s choosing not to report known risks of its product to the FDA, was not expressly nor impliedly preempted by the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.

In the Stengel case, Stengel had a Medtronic pump implanted in his abdomen to control pain he had in his back. Unfortunately, an inflammatory mass formed at the tip of the pump’s catheter that caused permanent paraplegia. 

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On July 8, 2013, the U.S. District Court in Charleston, W.Va., started the first bellwether jury trial in the C.R. Bard, Inc. Multidistrict Litigation (MDL). Bard manufactures transvaginal mesh products. Not long after the beginning of the trial, the trial judge declared a mistrial. After opening statements and the testimony of at least one witness, a physician then testified inadvertently that the manufacturer (Bard) was no longer selling this type of mesh product, which was at issue in the case.

The court declared the mistrial because the testimony violated a pretrial order that prohibited evidence of a subsequent remedial measure. The case was restarted again in mid-August, but this time the jury returned a $2 million verdict for the injuries suffered by Donna Cisson, a public-health nurse from Georgia. She received the Bard Avaulta Plus implant in 2009. Jurors deliberated for 12 hours over two days before reaching their verdict. The vaginal mesh implant is made by Bard. Bard’s attorneys have said on the record that the company intends to appeal the verdict ($250,000 in compensatory damages and $1.75 million in punitive damages), which they say was wrong because Cisson’s injuries were not caused by Bard’s product.    

The transvaginal mesh products are used in surgical procedures to repair conditions in women that have pelvic organ prolapse and stress urinary incontinence. Bard has removed its Avaulta Plus implant product off the market in 2012 after the FDA ordered that all makers of these implant products review reports of organ damage, infection and pain during sex.

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Neal Nuss, age 73, was transported to St. James Hospital in Blue Island, Ill., on Sept. 5, 2006 following an auto accident. Nuss was admitted to the hospital and diagnosed with subdural hematoma; he was evaluated by a neurosurgeon. 

Over the next three days, doctors determined that the subdural hematoma was not big enough to operate on. Nuss was discharged from the hospital on Sept. 8, 2006. The doctors planned to monitor his condition as an outpatient. The monitoring was overseen by the defendant Dr. Cheryl Woodson, the patient’s primary care physician.Dr. Woodson instructed Nuss to return as an outpatient to undergo a CT scan at St. James Hospital for comparison. Nuss followed up as directed and saw Dr. Woodson on September 12 and underwent the CT scan on September 13. The scans were interpreted by radiologist, Dr. Green.

The doctors concluded that Nuss’s condition was stable and his next follow-up visit was planned with the neurosurgeon five days ahead.

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The Illinois Appellate Court affirmed a trial judge’s decision in a medical negligence claim brought by Kathleen Smeilis. She developed a progressive neurological condition called cauda equina syndrome, which requires prompt surgical treatment to prevent permanent nerve damage.

In this case, Ms. Smeilis was admitted to Glenbrook Hospital in August 1999 and then transferred to a nursing home operated by Dr. Lipkis, the defendant. Lipkis personally examined Ms. Smeilis for the first time on Aug. 14, 1999. No unusual neurological activity was found until she was transferred back to Glenbrook Hospital four days later. Ms. Smeilis was then transferred to Evanston Hospital for immediate surgery. She suffered permanent nerve damage because she was not immediately diagnosed with cauda equina syndrome.

In 2001, the plaintiff and her husband brought a negligent lawsuit against Glenbrook Hospital, Dr. Lipkis and several others. They relied on the expert testimony of a neurosurgeon, Gary Skaletsky, M.D., who testified that Ms. Smeilis should have had surgery by Aug. 10, 1999, to avoid the neurological damage. In September 2007, after the discovery was completed, all defendants, except Dr. Lipkis, settled with Ms.

Smeilis and her husband for $3.2 million, and the case against those defendants was voluntarily dismissed. In October 2007, Ms. Smeilis and her husband filed a new complaint against Dr. Lipkis and his corporation alleging that he was the proximate cause of Ms. Smeilis’s injury.

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As surgical techniques become more advanced, more Americans are undergoing minor surgical procedures. And while many times these surgical procedures result in seemingly miraculous results, with the prior symptoms disappearing completely, some may also result in unanticipated side effects. A recent Cook County lawsuit serves as an example of some of the negative potential outcomes that can result from surgical negligence.
The Cook County lawsuit was filed against Gottlieb Memorial Hospital following a 2007 vaginal prolapse reconstruction surgery performed at its hospital. The surgeon, Dr. Robert Lai of Midwest Urology Associates, Ltd., was also named in the medical malpractice lawsuit. The lawsuit alleged that the negligent post-operative care the plaintiff received resulted in permanent nerve damage.

The 50-some year-old plaintiff had presented to Dr. Lai for a reconstruction surgery that was meant to correct her incontinence, constipation, and vaginal prolapse. The surgery was performed and seemed to have been a success. However, as the plaintiff prepared for her discharge from the hospital the day after the surgery, she began to experience weakness, pain, and tingling in her leg and buttock.

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In Illinois, the statute of limitations governing civil cases, e.g. medical malpractice, product liability, and personal injury cases, is typically two years. However, the Illinois Appellate Court recently revisited exactly when that two-year statute begins in its analysis of the “discovery rule” as it relates to Mitsias v. I-Flow, 2011 Ill.App. (1st) 101126 (Sept. 23, 2011).

The discovery rule refers to the general rule that the statute begins when a plaintiff knew or should have know about the cause for his injury. The injury in question in Mitsias deals with both a medical malpractice claim and a later product liability lawsuit involving the plaintiff’s shoulder surgery. In 2001, Mitsias underwent a shoulder surgery during which a “pain pump” was implanted. However, Mitsias later developed glenohumeral chondrolysis, or destruction of cartilage in her shoulder and joint.

In 2003, Mitsias filed a medical malpractice lawsuit against the surgeon who implanted the pain pump. However, during the course of the medical malpractice proceedings, Mitsias discovered that the source of her shoulder injury might not be a simple case of medical malpractice, but also have a product liability component. Consequently, Mitsias filed a second complaint against the manufacturers of the pain pump alleging that its defects caused her shoulder injury.

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A recent report by the National Joint Registry for England and Wales brings more bad news for patients who have received DePuy metal-on-metal hip replacements. According to the report, the DePuy metal-on-metal device has failed in over one-third of the British patients who’d received it. While the study does not reflect the failure rates for U.S. patients, it does report on data that we do not collect in the U.S. and therefore can be a useful indicator of potential failure rates in the U.S.

Metal-on-metal artificial hips were designed to last longer than their plastic counterparts, yet the medical advances in this case might have done more harm than good. The British report clearly shows that these all metal hip devices are failing at a much faster rate than artificial hips composed of alternate materials, including a combination of metal and plastic. And while the British report is not the first of its kind, its findings collaborates earlier studies which demonstrated that all metal hips are not as durable as the other options.

The main theory on why the metal-on-metal hip devices fail at a faster rate centers on the fact that every component is made of metal. While it would seem that metal would be more durable than plastic, in reality the all metal construction has led to other unexpected problems. As the metal hip socket rubs against the metal hip joint, the movement seems to release tiny particles of the various metals. This debris is released into the surrounding hip cavity and not only causes crippling injuries to the person, but also diminishes the effectiveness of the metal artificial hip. Therefore, it is the design defect of the all metal construction that is leading to the increased failure rate of metal-on-metal hip devices.

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