Archive for August, 2009

On August 14, 2009, the British Medical Journal Online published two studies that contain significant findings for women who use the oral contraceptives Yaz or Yasmin. One of the studies was supervised by a leading authority on oral contraceptives, Dr. F. R. Rosendaal, of Leiden University in Leiden, Netherlands, and involved 1524 women. The other study involved all of the women in Denmark, 10.4 million women years.

Yazmin and Yaz Related Studies

The two studies include: The venous thombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, van Hylckama Vlieg, Helmerhorst, Vandenbroucke, Doggen & Rosendaal, BMJ 2009;339:b2921; and Hormonal contraception and risk of venous thromboembolism: national follow-up study, Lidegaard, Lokkegaard, Svendsen, & Agger (all of Copenhagen, Denmark), BMJ 2009;339:b2890.

Findings of the British Medical Journal Online Yasmin Studies

First, the studies concluded that women taking combination oral contraceptives (OC) containing drosperinone, such as Yaz and Yasmin, are six to seven times as likely to suffer a thromboembolism (such as Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)). This risk is equal to other third generation birth control pills.

Second, the studies found that Yaz / Yasmin did not provide any increased benefit for acne or weight loss, which are benefits Bayer previously touted for the drug. The study also found that there was no proof of improved effectiveness of treatment for premenstrual dysphoric disorder (PMDD) or similar premenstrual symptoms.

Third, the study also showed that women are at the highest risk of developing having a thrombotic event in the first three months of taking the OC.

A large number of women participated in the study, which was conducted by well-credentialed clinical investigators and, therefore, Bayer really must reexamine its warnings on Yaz and Yasmin to better educate and warn women about the risks of using these products, which includes the risk of DVT, PE and gull bladder injury, among other Yasmin side effects.

Contact a Yaz Lawyer or Yasmin Attorney Today

Bernstein Liebhard LLP is vigorously investigating and pursuing claims on behalf of injured women nationwide. Contact one of our Yasmin lawyers today for a free Yasmin lawsuit or Yaz lawsuit today.

In December 2008, the Ecri Institute released it second annual report on the top 10 technology hazards that should be on every hospital’s list of safety concerns for medical-device use.  The Ecri Institute conducts patient-safety research and investigates medical-device incidents.   Five of the hazards on the list are new. However, all of the five hazards dropped from the list are still seen as “significant concerns.”  The five new hazards just caused more problems in the past year, including retained devices and air embolism from contrast media injectors, causing them to placed on the list. 

The top 10 technology hazards are listed in order as follows:

1.  Alarm hazards
2. Injuries from needle sticks and other sharp objects
3. Air embolism from contrast media injectors
4. Retained devices and unretrieved fragments left in patients
5. Surgical fires
6. Anesthesia hazards due to inadequate pre-use inspection
7. Misleading displays
8. CT radiation dose
9. MR imaging burns
10. Fiberoptic light-source burns
     

While some problems involve a defective medical device, it tends to be inexperience and/or lack of knowledge on the user’s part that causes these devices to be hazardous.  Few people read the manual. If devices are used safely, fewer incidents would occur.  Every participant in the chain during the process has a responsibility to prevent a problem from arising. If you have been a victim of one of these technology hazards or any other technology, you may have a medical malpractice or hospital negligence lawsuit and may be entitled to a medical malpractice settlement.  You should contact a medical malpractice lawyer today for more information.

In news that is unfortunately starting to sound all too familiar, another lawsuit has been filed due to E. coli food poisoning. On July 16, 2009, attorneys filed a lawsuit in United States District Court in the Eastern District of Washington against JBS Swift & Company on behalf of a 16-month-old boy who was hospitalized after eating meat products manufactured and distributed by JBS Swift. After consuming the meat, the boy was rushed to the emergency room “writhing in pain” with severe gastrointestinal symptoms, including intense and bloody diarrhea and abdominal cramps. Stool samples revealed an E. coli infections and blood tests showed that he had developed hemolytic uremic syndrome, a complication of E. coli infection which caused his kidneys to fail. After being hospitalized for three weeks and undergoing dialysis and blood transfusions, the boy was released. However, he still suffers from long-lasting damage from his illness and his kidneys are only functioning at 30% of normal.

The lawsuit is related to an E. coli outbreak in Swift meat products across nine states that the Center for Disease Control (CDC) linked to making at least 23 people sick. As a result of that outbreak, Swift had issued a voluntary recall of 420,000 pounds of beef on June 24, 2009.

E. coli outbreaks, as well as many other food poisoning outbreaks, have become more commonplace in recent years, which is a troubling sign. Consumers must be wary of such foodborne illnesses, and be on the lookout for possible food poisoning symptoms, such as severe diarrhea, bloody diarrhea, vomiting, and severe abdominal cramping. For more information about E. coli lawsuits, contact an E. coli food poisoning lawyer today.

The University of California, Los Angeles (UCLA) is conducting an investigation into a top orthopedic surgeon and associate professor at its medical school for failing to disclose financial connections to several companies whose products he was researching. Dr. Jeffrey Wang lost his position as the co-executive director of the UCLA Comprehensive Spine Center for failing to report stock options, payments, and royalties he received from five medical device and drug companies between 2002 and 2008. While Wang is still on the school’s faculty, UCLA is investigating his work and considering further disciplinary action against him.

Dr. Wang failed to disclose ownership of stock options in Facet Solutions Inc. and Paradigm Spine LLC, and did not report royalties and consulting payments from Johnson & Johnson, FzioMed Inc., and Medtronic Inc., all of which manufacture products on which Dr. Wang was conducting research. Failing to report such financial relationships violates UCLA’s guidelines, and most medical schools have rules limiting how much money and gifts their doctors can receive from drug and device companies. The university is currently looking into whether the payments and stock interests impacted Wang’s research.

Medtronic has previously been scrutinized for allegedly having financial relationships with doctors conducting research on its products. The Department of Justice is currently investigating consulting payments made by the medical device company to Dr. Timothy Kuklo, a former Walter Reed Army Hospital surgeon who has been accused of falsifying the results of a study concerning Medtronic’s Infuse surgical grafts. As a result of incidents like those involving Wang and Kuklo, Senators Charles Grassley (R, Iowa) and Herb Kohl (D, Wisconsin) have proposed a federal law requiring companies to disclose all payments over $100 made to doctors. Information about abuses of University policy and illegal or improper kickbacks are often brought to light by whistleblowers. Read more about issues related to medical research, such as defective medical devices and medical malpractice.