Articles Posted in Product Liability

by

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.

Continue reading

by

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.

Continue reading

by

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.

Continue reading

by

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.

Continue reading

by

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.

Continue reading

by

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.

Continue reading

by

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.

Continue reading

by

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.

Continue reading

by

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.

Continue reading

by

Topamax is an anticonvulsant medication that is prescribed to treat epilepsy and the associated seizures, or can also be prescribed to prevent migraine headaches. Recently, the Food and Drug Administration (FDA) released a new warning about some birth defects associated with Topamax. Specifically, the drug warning states that mothers taking Topamax showed higher incidences of cleft lips and cleft palates than mothers not taking Topamax.

This discovery was made by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, whose data showed that 1.4% of infants exposed to Topamax during the first trimester were likely to develop a cleft lip or cleft palate. The prevalence of cleft lips or palate in infants with no exposure to anticonvulsant medications was 0.07%.

In light of this new information, the FDA elevated the Topamax’s pregnancy category from C to D. Under Category D, “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in
pregnant women despite potential risks.” Physicians are advised not to prescribe Topamax to pregnant women unless the potential benefits of the drug outweigh the potential risks to the fetus.

Continue reading