Articles Posted in Pharmaceutical Errors

The patient-physician relationship is built on trust — the patient trusts that his or her doctor is acting within the standard of care and the physician trusts that the patient is following orders. In this Illinois medical malpractice case, both parties argued that the other violated this mutual trust. The plaintiff argued that the defendant doctor acted negligently, while the doctor argued that the plaintiff failed to follow his medical advice.

The case arose after the 19-year-old plaintiff developed lithium toxicity. The defendant psychiatrist, Dr. John Huh, had prescribed the plaintiff lithium for her bipolar disorder.This in itself was not unusual. Lithium is often prescribed to treat patients with bipolar disorder due to its ability to reduce the frequency and severity of bipolar depression.

However, lithium carries with it some fairly serious side effects, including muscle weakness, sudden hair loss, poor concentration, drowsiness, vomiting, and diarrhea. In order to prevent these serious side effects, physicians regularly monitor the levels of lithium in a patient’s blood stream, adjusting the dosage as necessary. However, in this case, Dr. Huh failed to obtain regular blood draws, thereby missing the warning signs that the plaintiff was developing lithium toxicity.
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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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The plaintiff, Stephan Urbaniak,was prescribed and took a drug called Reglan for six years. He developed severe movement disorders. The prescribing physician, Dr. John Ross, admits that he was unaware of the risk of developing these movement disorders from long-term use of this prescription drug.

By operation of the “learned intermediary doctrine,” the pharmacy cannot be held liable for choosing not to verbally warn the plaintiff or his physician about the medical risks associated with long-term use of Reglan.

There is no specific reason that the pharmacy could have known about that, which would have made plaintiff specifically someone who could not be treated with Reglan longer than 12 weeks.
Accordingly, the Illinois Appellate Court affirmed the dismissal of the lawsuit against the pharmacy and physician.
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Stephanie Hollingsworth, 26, suffered from lupus and bilateral arm and leg pain. She was admitted to a hospital’s cardiac care unit where she was diagnosed as having acute vasculitis secondary to Sjogren’s syndrome, an immune system disorder.

The rheumatologist assigned to her care was Dr. Yvonne Sherrer, who ordered a STAT dermatology consultation and a skin biopsy, which showed necrotizing vasculitis. Hollingsworth, who was taking broad-spectrum antibiotics, developed a foot drop. Neurological assessments showed abnormalities of her lower extremities.

Dr. Sherrer transferred her to another facility three days later. Staff at this hospital administered Cytoxan for her necrotizing vasculitis on or around the third day of that admission.
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A Colorado jury has signed its verdict for $14.9 million to a couple in Colorado. This medical negligence lawsuit alleged that an outpatient surgery center was negligent in administering a steroid that caused Robbin Smith’s paralysis from the waist down.

The jury determined that The Surgery Center at Lone Tree LLC, the defendant in the case, was negligent in treating Smith in 2013 by injecting a steroid called Kenalog in her spine despite the drug company’s warning. Two years before the injection was done, the drug maker of the steroid drug, Kenalog announced that Kenalog should not be used for epidural procedures as Smith was given.

The Colorado jury found that the surgery center’s negligence and its choosing not to obtain Smith’s informed consent to the steroid injection was a cause of her paralysis. This record-setting verdict was entered on March 23, 2017.
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More than 25 lawsuits have been filed against Johnson & Johnson subsidiaries, Janssen Pharmaceuticals and Bayer Corporation, in consolidated cases in the Louisiana federal district court regarding the serious side effects of the blood-thinning drug, Xarelto.

Xarelto has been associated with serious side effects, including internal bleeding, gastrointestinal bleeding, brain bleeds and death.

It has been reported that thousands of individuals — patients who have been prescribed Xarelto as a blood-thinner  — have been affected. The presiding federal judge is Judge Eldon E. Fallon.

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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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The U.S. Supreme Court is scheduled to hear arguments soon on whether a generic drug maker can be held responsible for a patient’s injuries. The case is considered very important for pharmaceutical companies, federal regulators and patients who take generic drugs. Some experts estimate that generics make up 80 percent of all drugs taken by people in the United States.

The case before the high court will involve Mutual Pharmaceutical Co., which sold a drug called sulindac, an anti-inflammatory. This medication was given by a pharmacist to a patient named Karen Bartlett, who was suffering mild shoulder pain in 2004. Bartlett, who lives in New Hampshire, claims she began taking the drug and, only a few weeks later, suffered an intense reaction to it. Her skin began to peel off, she was forced to live in a burn unit in a nearby hospital and later was in a medically induced coma. She lost her vision and is now legally blind. Also, she alleges that the medication permanently damaged her lungs and esophagus.

Bartlett sued Mutual, saying the company should be liable for her injuries. She took her case to federal district court, where a jury awarded her $21 million. An appeals court upheld that verdict in 2010; now the case is headed for the high court.

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A class-action lawsuit brought by a named plaintiff, City of Livonia Employees’ Retirement System, has resulted in a $67.5 million settlement of the class-action lawsuit brought by former shareholders of Wyeth, Inc. The lawsuit alleged that shareholders were misled about the risks associated with the antidepressant, Pristiq.

The settlement was made public on Nov. 9, 2012, one month after Pfizer agreed to pay $164 million to settle a separate lawsuit accusing it of misleading investors about clinical trial results for the arthritis drug, Celebrex.

When the U.S. Food and Drug Administration refused to approve Pristiq to treat “hot flashes” in post-menopausal women until it learned more about the potential for heart and liver side effects, Wyeth share value lost more than $7.6 billion.

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More Yasmin birth control lawsuits have made their way through the court system against the manufacturer Bayer. According to a recent report, Bayer has settled many cases and paid a reported $402 million setting aside another $600 million for future settlements. Approximately 11,000 lawsuits have been filed in the federal multidistrict litigation consolidated in the Southern District of Illinois.

Some of the lawsuits brought by injured plaintiffs are for blood clots while others claimed gall bladder problems.

Bellwether trials, those cases found to be most meritorious, were scheduled to go to trial early in 2012. But the parties instead wanted to mediate cases resulting in settlements in at least some of them. Other settlements have been reached in blood clot lawsuits, but there have been no settlements of gall bladder claims.