Posted On: May 15, 2012

70 Yaz and Yasmin Birth Control Drug Cases Settled

349767_the_pill.jpgIt 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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Posted On: January 5, 2012

Illinois Appellate Court Clarifies Discovery Rule - Mitsias v. I-Flow

Legal_scale%202.jpgIn 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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Posted On: June 23, 2011

Johnson & Johnson to Stop Manufacturing Drug-Coated Heart Stents

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.

stents%201.jpgJohnson & 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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Posted On: June 14, 2011

Use of Actos Suspended Across Europe After Studies Link Its Use to Increased Risk for Bladder Cancer

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.

Pill%20Ban%201.jpgThe 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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Posted On: April 19, 2011

Topamax Found to Be Associated with Increased Risk of Congenital Birth Defects

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.

Prescription%20Drugs%202.jpgThis 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.

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Posted On: January 4, 2011

Evanston Hospital Over-Radiation Leads to Severe Brain Damage: The Hidden Dangers of Stereotactic Radiosurgery (SRS)

Radiation therapy is a common treatment for a large range of cancers and has been responsible for saving, or at least extending, many peoples' lives. However, the basic premise of radiation therapy involves targeting and killing cancerous cells in one's body. And while properly administered radiation therapy can save lives, when hospitals and doctors administer too much radiation it can result in negative effects for the treating patient.

Brain%20x-ray%201.jpgOverdoses of radiation is becoming more and more widespread amongst cancer patients. A recent report of Evanston's Northshore University HealthSystem, a Chicago-area hospital, provided one such example. A 50 year-old mother of three was administered dangerously high doses of radiation when the hospital staff made radiology errors involving the administration of her radiation doses. The young Illinois resident went from an active, vibrant person pre-radiation to a virtual invalid post-radiation and now resides in an Illinois nursing home.

This woman was just one of three oncology patients who received an overdose of radiation at Evanston Hospital. All three instances of the radiation errors were allegedly the result of faulty linear particle accelerators. These accelerators are used to focus the radiation on the cancerous cells and are commonly used for stereotactic radiosurgery (SRS).

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Posted On: December 28, 2010

Chicago Prosthetic Hip Replacement Case Not Preempted According to Court of Appeals - Bausch v. Stryker Corp.

Federal preemption of medical device liability lawsuits has been a volatile issue in recent years, with the courts typically preempting product liability lawsuits citing violations of individual state safety standards. However, in Bausch v. Stryker Corporation, et al., No. 09-3434, the issue was whether a product defect claim citing federal safety standard violations was also preempted by that product having federal approval. While a Chicago federal district court had dismissed Ms. Bausch's claim, that decision was recently overturned by the United States Court of Appeals for the Seventh Circuit. That Court of Appeals decision permitted Mr. Bausch to pursue his claim in federal court.

Knee%20xray%20%60.jpgThe case facts of the Bausch medical device lawsuit involve a hip replacement 56 year-old Margaret Bausch underwent, during which she received a Trident brand ceramic-on-ceramic hip replacement system manufactured by Stryker Corporation. The prosthetic hip device ended up failing and required an additional surgery to have it removed.

The specific type of prosthetic hip Ms. Bausch received was approved for sale in the U.S. by the Food and Drug Administration (FDA), but was later recalled due to a failure to comply with federal standards. In her Chicago medical device lawsuit, Bausch's attorneys cited Stryker's failure to comply with federal standards during the manufacturing process of its prosthetic hip devices.

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Posted On: July 20, 2010

Chicago's Rush University Medical Center Orthopedic Surgeons Sued Under Whistle-Blower Case

A whistle-blower lawsuit filed against Chicago's Rush University Medical Center was recently unsealed, allowing the Chicago public a glimpse of the case facts. Goldberg, M.D. v. Rush University Medical Center, et al. was brought by orthopedic surgeon Robert Goldberg, M.D. against his employer, Rush University Medical Center, and fellow surgeons alleging that the orthopedic department routinely overbooked its operating rooms and violated Medicare billing rules.

Scrubs%203.gifGoldberg alleges that Rush's orthopedic center operated as a business that emphasized quantity over quality, a claim that is supported by further allegations that the during 2004 and 2005 the orthopedic center regularly overbooked its operating rooms and relied heavily on its residents to perform surgeries. The assumption is that by overbooking these rooms the surgical center's patients were at a heightened risk for surgical errors and potential medical malpractice.

According to Medicare billing rules teaching surgeons, like the six surgeons named in this lawsuit, are required to be present in the operating room during key portions of the procedures. The case was filed as a whistle-blower lawsuit because Medicare is a federal institution, and as such falls under the federal government's umbrella. A whistle-blower claim is one in which the government has been victimized, such as by falsifying federal billing records.

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Posted On: May 24, 2010

Doctors Urge Warning Labeling for Food That Can Choke Children

Whether or not you have children, most people are familiar with warning labels on children's toys. These warning labels could include anything from lead content in painted toys, choking hazards from small parts, or potential injuries from sharp objects. Yet while there are ample warnings for children's toys, there are no warning labels itemizing the dangers to children from eating certain foods.

Warning%201.gifWe typically don't think of food as being dangerous to children, yet one horrific episode involves a 23 month-old child who died after a piece of popcorn she was eating became lodged in her lung and bronchial tubes. Her parents, like the majority of the general public, had no idea that popcorn was unsafe for their 2 year-old.

In an effort to increase awareness and prevent the recurrence of episodes like the one described, the American Academy of Pediatrics (AAP) is advocating for food warning labels. The AAP, based out of Elk Grove Village, Illinois, is one of the nation's leading pediatric groups. It is lobbying for the Food and Drug Administration (FDA) to require warning labels on foods that are known choking hazards.

According to a 2008 study, the ten foods that pose the highest choking hazards for young children are hot dogs, peanuts, carrots, boned chicken, candy, meat, popcorn, fish with bones, sunflower seeds and apples.

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