Articles Posted in Product Liability

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A “medical food” called Limbrel, which doctors prescribe to treat osteoarthritis of the knee, has been linked to several cases of liver disease in a small study. The effects seem to be rare and easily reversible, but patients should be aware of the potential for harm.

The “medical food” is marketed as Limbrel, also known as flavocoxid. Doctors and patients should be aware of the potential for liver problems, said study lead author Dr. Naga Chalasani, director of the division of gastroenterology and hepatology at Indiana University School of Medicine, in Indianapolis. Primus Pharmaceuticals Inc., maker of Limbrel, said the main ingredients of the pills are plant elements known as bioflavonoids, specifically baicalin and catechins. The company says Limbrel helps improve mobility and relieve joint discomfort and stiffness related to arthritis.

In the United States, medical foods are not subjected to the clinical trials required of prescription drugs.
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A problem has developed with the St. Jude implanted heart device: A wire or lead that connects a defibrillator to a patient’s heart has been failing, often with fatal results. The lead, a model called Riata, has been used by more than 128,000 patients worldwide.
The electrical wires within the Riata lead have been known to break through the insulation, causing shocks in some patients and other more serious injuries. More important, the Riata wire failure does not react to the need for a lifesaving jolt to keep a failing heart beating.
St. Jude stopped selling the Riata product in late 2010. In December 2011, The U.S. Food and Drug Administration (FDA) announced the voluntary physician recall of the Riata and Riata Silicone Defibrillation Leads as a Class I Recall. This means that the FDA believed there was potential risk of serious injury or patient death caused by the devices’ malfunction.
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This case concerned the first of over 500 cases regarding the Wright Medical Conserve “metal-on-metal” hip replacement device designed and manufactured by the defendant. The plaintiff filed a products liability suit alleging, among other things, that the defendant was liable for design defects based on strict liability and negligence.

On appeal, the defendant challenged the entry of a $2,100,000 judgment. The court rejected the defendant’s argument that the district court erred in ordering the jury to continue deliberations after the jury had already begun to deliver its verdict.

In this case, upon recognizing the inconsistency in the jury verdict, the district court immediately halted publication of the verdict and instructed the jury that an error had been made; the district court acted in a neutral and non-biased manner in acknowledging and addressing the inconsistent verdict; and the district court also recharged the jury.
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In this case, a manufacturer, Intuitive Surgical Inc., sold a surgical device, the robotic surgical system, to a hospital, Harrison Medical Center, which credentialed some of its physicians to perform surgery with the device. The surgical device is a robotic surgery tool called the “da Vinci System.”

At the trial, an expert urologist for Josette Taylor, the wife of Fred E. Taylor who died four years after undergoing a failed prostatectomy surgery by the robotic device, opined that the surgeons must be credentialed in order to use the da Vinci System. The doctor testified that the da Vinci robotic surgical system is one of the most complex devices used in surgical procedures.

The manufacturer’s warnings regarding that device were at the heart of this case: whether the manufacturer owed a duty to warn the hospital that purchased the device. The manufacturer argued that since it warned the physician who performed the surgery, it had no duty to warn any other party.
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In a recent Journal of the American Medical Association Surgery (JAMA Surgery) article, the safety concerns of the use of the transvaginal mesh in pelvic organ prolapse (POP) repair has been noted by the U.S. Food and Drug Administration (FDA).The recent article by two physicians was published in the Journal of the American Medical Association Surgery edition published online on Nov. 30, 2016.

The article highlights studies that reveal the incidences and timing of complications related to the use of the transvaginal mesh organ prolapse repair, the amount of vaginal mesh used with mesh erosions and repeated surgery after pelvic organ prolapse repair and urinary incontinence surgery. The study is discussed expertly in the JAMA article by the authors, physicians Bhumy A. Davé, M.D., a female pelvic medicine & reconstructive surgeon associated with Northwestern Medicine, and Anne-Marie Boller, M.A., M.D., FACRS, a colon and rectal surgeon also with the Northwestern Medical Group in Chicago.

The article points out that the recent transvaginal mesh study focused on the clinically important mesh complications (those that require an intervention as opposed to asymptomatic erosions) and it references a statewide database, which minimizes under reporting that occurs when patients change doctors secondary to complications.
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In Illinois it is well-settled law that prohibits defendants and their lawyers from communicating with treating physicians without the consent of the patient. In this case, plaintiffs sued five pharmaceutical companies in federal court where it was claimed they were injured by testosterone-replacement products.

In this multidistrict litigation case, one of the defendants, AbbVie Inc. requested that the federal court trial judge bar attorneys on both sides from having pre-deposition contacts with treating physicians of plaintiffs.

In the opinion written by U.S. District Judge Mathew F. Kennelly, the court, following Illinois law, stated that either side’s counsel may interview a witness and prepare him or her for the deposition by previewing the questions that may be asked, reviewing relevant documents and so on. There is nothing at all improper about this.  Indeed, adequate witness preparation is a key of good trial (and deposition) preparation.  In short there is no prohibition of pre-deposition of pre-testimony contact between a lawyer and the ordinary fact witness.

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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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There are more than 2,000 cases filed in the Actos Multidistrict Litigation (MDL) pending before a United States District Court judge in the Western District of Louisiana. The Actos MDL bellwether cases involve identifying two of the best plaintiff cases and a third case selected by the defendant Takeda Pharmaceuticals. Takeda is the manufacturer of Actos, which has been associated with bladder cancer. Actos is in a class of insulin-sensitizing drugs known as Thiazolidinediones, which was approved to treat Type II diabetes.

The Western District of Louisiana bellwether trials are scheduled to start Jan. 27, 2014;  a second will begin in April 2014.

There are about 3,000 cases pending in the Circuit Court of Cook County, Ill.  The bellwether process here is under way.  The cases in Chicago’s Circuit Court are being handled by Judge Deborah Dooling. 

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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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A new study shows that energy drinks may increase blood pressure and lead to a dangerously high heartbeat.

The study is an analysis of seven previous studies. It showed that these drinks appeared to disturb the heart’s natural rhythm. Over time, the drinks may lead to an irregular heartbeat or death and raise blood pressure, according to the study. The study results were presented by the American Heart Association on March 21 during a convention in New Orleans.

Two commonly sold energy drinks are Monster Energy Assault and Rockstar.

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