Articles Posted in Pharmaceutical Errors

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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.

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GlaxoSmithKline has settled with 38 state attorney generals for $90 million in connection with its unfair and deceptive promotion of a diabetes drug, Avandia. Illinois Attorney General Lisa Madigan and Oregon Attorney General Ellen Rosenblum led the way in the allegations that GlaxoSmithKline marketed its brand-name medication, Avandia, to treat Type 2 diabetes.

The attorney generals alleged that GlaxoSmithKline misrepresented the drug’s safety or left out facts about its effects on cholesterol and cardiovascular health.

“Our investigation demonstrated that GlaxoSmithKline had little regard for the facts or for the health and safety of the patients it targeted with its misleading marketing,” Illinois Attorney General Madigan stated.

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The New York Times has reported that long-time use of prescription antacid drugs can result in certain illnesses, including severe anemia, bone fracture and infections. The medications can be especially dangerous for older patients, who are urged to used them as briefly as possible.

The Times cited the example of a medical student, Jolene Rudell, who fainted; she assumed that the stress of being in medical school had caused her to pass out. Two weeks later, she lost consciousness again.

Blood tests showed Rudell’s red blood cell count and iron level were dangerously low, even though she is a hearty eater (and a carnivore). Her physician pointed to another possible culprit: a popular drug used by millions of Americans to prevent gastroesophageal acid reflux, or severe heartburn.

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The United States Preventive Services Task Force has issued a draft statement recommending that healthy women should not take low doses of calcium or vitamin D supplements to prevent bone fractures.

The group is an independent panel of experts in prevention and primary care and was appointed by the federal Department of Health and Human Services. In a report, the task force said there was insufficient evidence to recommend taking vitamin D with or without calcium to prevent fractures in postmenopausal women and men.
Scientists who took part in the study said a normal healthy diet provides enough vitamin D and calcium.

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It was not long ago that Yaz and Yasmin ranked as one of the leading birth control pills on the market. They were able to corner a large share of the market in large part due to a successful ad campaign marketed towards women under 35 and promises to decrease acne and premenstrual depression. However, nowadays when Yaz and Yasmin are in the news it is related to the large number of lawsuits filed against the drugs’ manufacturer.

Bayer Pharmaceuticals Co. began manufacturing Yasmin in 2001 and Yaz in 2006. These new forms of birth control differed from older versions of oral contraceptives in that Yasmin and Yaz contained less estrogen and added a new synthetic form of progestin, called drospirenone. Supposedly, this new combination would lower the risk of blood clots typically caused by high levels of estrogen in birth control pills.

However, recent studies have shown that in fact Yaz and Yasmin users actually have a greater risk of developing blood clots than women using older forms of birth control. In addition, new information has suggested that Yaz and Yasmin also can cause heart failure, strokes, and other organ failures. As a result, over 11,300 product liability lawsuits were filed against Bayer.

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Doctors are relying more and more on narcotic medications to treat patients’ increased complaints of chronic pain. However, while this might mean that more patients’ pain is being treated in the short-term, it has some potentially harmful long-term consequences. The longer patients remain on opiate medications, the less effective they are at treating pain, which sometimes results in the dosage increasing to potentially dangerous levels.

A recent medical malpractice lawsuit, Estate of Mary Shannon v. Dr. Timothy Sanders, et al. involved claims that the defendant physician’s negligence in prescribing a pain patch caused a patient’s death. The Grundy County lawsuit alleged that Dr. Timothy Sanders, an anesthesiologist, contributed to the decedent’s death by extending the use of her Fentanyl patch. The anesthesiologist had used the Fentanyl patch to treat the patient’s pain following a short, one-hour surgery to treat her broken hip. However, within nine hours of the surgery the patient died.

While the patient’s death was ultimately attributed to her Chronic Obstructive Pulmonary Disease (COPD), an autopsy report revealed that Fentanyl intoxication significantly contributed to her death. The 71 year-old decedent had been on a Fentanyl Duragic Patch for several years prior to her death as a means of treating chronic pain caused by compression fractures in her back. Fentanyl is an opiate drug and is often not prescribed for patients with COPD because of its potential to cause respiratory problems.

The decedent’s family brought a lawsuit against the defendant anesthesiologist in which it was alleged that he should not have continued the order of the Fentanyl patch for as long as he did. Instead, the family contended it should have been removed following the surgery, arguing that its continued use was contraindicated. Furthermore, the decedent’s family was critical of the anesthesiologist prescribing the Fentanyl patch in conjunction with her warming blanket on the basis that the patch should not have been exposed to a heat source.

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In TV and movie trial dramas, we are always shown a jury hotly debating over the case facts, with one or two jurors holding out against the rest of the jury. However, in Illinois, in order for a jury verdict to stand it needs to be unanimous. This means that if even one of the jurors cannot agree with the rest of the jury, then the judge finds the jury to be deadlocked and declares a mistrial.

This occurred in the Illinois wrongful death lawsuit of Estate of Steven Prehn, deceased v. Dr. Sandeep Amin, University Anesthesiologists S.C., 07 L 1115. After the jury debated for over ten hours over the course of two days it was still unable to reach an unanimous decision. While nine jurors were in favor of the plaintiff, the remaining three jurors were in favor of the defendant doctor.

Prehn involved the death of a 46 year-old father of three from a pain medication overdose. Steven Prehn had visited Dr. Amin, a pain management specialists, at his Rush Pain Center facility with complaints of chronic pain. Dr. Amin prescribed Methadone, an opiate or narcotic medication typically prescribed to treat moderate to severe pain. Twenty-six hours after the office visit, Prehn was found dead at his home from a Methadone overdose.

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A Cook County wrongful death lawsuit involving the death of a 45 year-old woman was settled by the decedent’s estate for $1.35 million. The Illinois lawsuit dealt with claims of medical negligence on behalf of the defendant surgeon and the hospital where he as employed. Jerry Markbreit for the Estate of Betsy Markbreit v. Jose Velasco, M.D., et al., 07 L 8703.

The Illinois surgical malpractice began in 2004, when Ms. Markbreit was admitted to Rush North Shore Medical Center to have a benign growth on her thyroid gland. Prior testing had indicated that the benign growth was limited to the right side of Ms. Markbriet’s thyroid gland, a finding that was confirmed on the surgical report. Yet the surgeon, Dr. Jose Velasco, elected to perform a total thyroidectomy on the decedent.

The Cook County medical malpractice claim was critical of the surgeon’s decision to perform a total thyroidectomy. Ms. Markbreit had only been scheduled for a partial thyroidectomy and given the fact that her benign growth was isolated to one side of her thyroid gland there was no medical reason to perform a total thyroidectomy. This lack of medical necessity was significant because the plaintiff’s wrongful death lawsuit traced all of Ms. Markbreit’s subsequent medical problems and eventual death back to the unnecessary total thyroidectomy.

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Johnson & Johnson has announced that it will be dropping one of its medical devices from production – by the end of 2011, the company will cease manufacturing its drug-coated heart stents. The company explains its decision was due its decreasing market share in the heart stent category; Johnson & Johnson is looking to funnel the newly freed funds into developing other medical products.

Johnson & Johnson’s drug-coated heart stents were manufactured in conjunction with Cordis, its subsidiary. Cordis’s Cypher stent was the first drug-coated heart stent approved by the FDA. However, by the end of this year, it will no longer be manufactured. Likewise, Cordis will halt its research and development of a new stent, the Nevo stent.

The sale of drug-coated heart stents represents a $4 billion market, which previously had been divided between Johnson & Johnson/Cordis, Boston Scientific, Medtronic, and Abbott Laboratories. However, Cordis’s portion of that market has been decreasing. In 2006, Cordis made $2.6 billion globally from the sale of drug-coated stents, whereas last year it only made $627 million.

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France’s Agence Francaise De Securite Sanitaire Des Produits De Sante (AFSSAPS) banned the use of Actors, a drug prescribed to control diabetes, due to concerns that it increases the risk of bladder cancer amongst patients taking the drug. Actors manufactured by Japan’s Takeda Pharmaceutical and is one of the pharmaceutical company’s top-selling drugs. The French medical board’s decision has caused Germany to follow suit in banning the diabetes drug, with reports that the UK might soon follow.

The French drug suspension not only affects Actos, but also applies to Competact, a similar prescription drug that combines Actos with metformin. Both drugs were suspended because they contained the active ingredient Pioglitazone, which has been linked to the increase risk of bladder cancer. This risk was documented in a study of antidiabetic patients taking antidiabetic medicines that was conducted by the Caisse National d’Assurance Maladie between 2006 and 2009.

The sale of Actos was approved in Europe in 2000, with Competact being approved in 2006. Since that time, an estimated 230,000 patients use Actos in France alone. In 2010, Europe accounted for Y29.5 billion, or about 7.5%, of Actos Y387.9 billion in global sales. The banning of Actos in Europe could drastically affect the fate of the Japan-based pharmaceutical company and exposes it to potential pharmaceutical liability lawsuits.

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