Recent Developments

Between 1938 and 1971, obstetricians in the United States prescribed DES to pregnant women to help prevent miscarriage and premature birth. DES, or Diethylstilbestrol, was a toxic, carcinogenic synthetic hormone given to pregnant women to regulate their estrogen levels and help bring their pregnancies to term. Patients prescribed DES were assured the drug was safe for their unborn fetuses.

In 1971, the FDA advised doctors to stop prescribing DES after a medical study showed an increased risk of a rare type of vaginal cancer in the female offspring of women given DES during pregnancy.  Since that time, other studies have linked DES with a multitude of medical problems including increased risk of vaginal, cervical and breast cancers as well as reproductive problems and high-risk pregnancies.  

A 2011 study in the New England Journal of Medicine found 12 different medical conditions related to in utero DES exposure. This study also found that the risk of breast cancer in DES offspring doubles after age 40.

The Centers for Disease Control (CDC) estimates that over 6 million women were given DES between 1938 and 1971; therefore, millions of people were exposed to DES prenatally and are now at increased risk for cancers and reproductive problems. Unfortunately no test exists to determine if you were exposed. The horrible irony of this disaster is that studies now show that DES was not effective in preventing miscarriage. 

DES daughters are now pursuing negligence claims against manufacturers of DES, primarily Eli Lilly & Co., for the medical and reproductive problems from which they suffer due to their prenatal DES exposure. And men are not immune from the effects of DES.  DES Sons have shown testicular abnormalities and increased risk of testicular cancer.

DES claimants contend that DES drug manufacturers breached their duty to the public in two ways:  first, by failing to adequately test the drug before allowing doctors to prescribe it to patients and secondly, by failing to adequately warn of the potential risks of taking the drug.  No animal testing was done nor were any medical studies conducted to determine the drug's short and long-term effects on either the mother or her unborn fetus.  Additionally, mothers were not given adequate warnings about the potential risks to themselves and unborn babies from taking DES thereby precluding them from making an informed decision about taking the drug.

Despite numerous medical studies to the contrary, drug manufacturers claim there is no direct scientific evidence causally linking use of DES during pregnancy and the occurrence of and increased risk of breast and other cancers and reproductive problems in the children of DES pregnancies.  

Jury selection in one of these DES cases started last Friday in Boston. The case of the Melnick sisters involves four sisters whose mother took DES during her four pregnancies.  All four sisters have suffered reproductive problems and all were diagnosed with breast cancer in their 40's.  Significantly, their mother did not take DES when she was pregnant with their oldest sister and that sister is the only one of the five sisters who has not suffered reproductive problems nor been diagnosed with breast cancer. Bubalo Goode Sales & Bliss PLC is assisting in the trial in Boston.

UPDATE: The case settled after two days of trial.

According to an article filed yesterday by Denise Lavoie of the Associated Press, "... four sisters are now suing a former maker of DES, or diethylstilbestrol, in a case set to unfold in federal court on Friday, when it will become one of the first of scores of such claims around the U.S. to go to trial. The Melnick women are seeking unspecified damages." For more information, click here.

Studies dating back to 2005 have shown that pregnant women who take Selective Serotonin Reuptake Inhibitors (SSRI) antidepressants like Zoloft, Celexa, Lexapro, Paxil and Prozac, while pregnant are at a substantially increased risk of giving birth to a child with a serious heart or other birth defect. The studies show an increase risk in the first and third trimesters. For example, the FDA issued a Public Health Advisory on December 8, 2005 based on U.S. and Swedish studies showing that exposure to certain antidepressants in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed.

On July 19, 2006, the FDA issued a Public Health Advisory for SSRIs, based on a study that suggests there may be additional risks of SSRI medications during pregnancy. In this study, PPHN (Persistent pulmonary hypertension of the newborn) was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. Another study showed that mothers who took antidepressants during pregnancy gave birth to babies who experienced withdrawal symptoms such as seizures, tremors, gastrointestinal problems and sleep disturbances.

Most recently, a study published in the July 2011 issue of the Archives of General Psychiatry suggests a link between the use of SSRIs in the year prior to delivery and an increased risk of having a baby with autism spectrum disorder. Researchers found that when SSRIs were used in the 12 months prior to delivery, the risk of having a baby with autism spectrum disorder doubled. When the SSRIs were used during the first trimester, however, that risk quadrupled. Researchers note that more studies should be conducted to replicate the findings.

There is controversy over the safety of these drugs since the long term effects on the baby are still unknown. If you took any SSRI antidepressant medication during pregnancy and your baby suffered any type of birth defect, you may qualify for damages or remedies that may be awarded in a possible lawsuit.

More than fifteen years after this lawsuit made headlines, it is still the topic of jokes. Everyone knows the McDonald's coffee case. It has become the example of how citizens take advantage of America's legal system. But the truth is nothing like the news stories. Hot Coffee reveals what really happened to Stella Liebeck, the Albuquerque woman who spilled coffee on herself and sued McDonald's. The documentary also explores how and why the case garnered so much media attention, who funded the effort and to what end. After seeing this film, you will decide who really profited from spilling hot coffee.

"Hot Coffee" is premiering on the HBO Documentary channel on June 27.

http://hotcoffeethemovie.com/

Thursday, March 11, 2010
Contact: Karen Aldana
Tel: 202-366-9550

Traffic Fatalities for 2009 Reach Record Low
Calendar Year 2009 Traffic Fatalities Continue Record Downward Trend
The U.S. Department of Transportation today announced that the number of overall traffic fatalities reported at the end of 2009 reached the lowest level since 1954, declining for the 15th consecutive quarter. According to early projections, the fatality rate, which takes into account the number of miles traveled, reached the lowest level ever recorded.

"This is exciting news, but there are still far too many people dying in traffic accidents," said U.S. Transportation Secretary Ray LaHood. "Drivers need to keep their hands on the steering wheel and their focus on the road in order to stay safe."

The projected fatality data for 2009 places the highway death count at 33,963, a drop of 8.9 percent as compared to the 37,261 deaths reported in 2008. The fatality rate for 2009 declined to the lowest on record, to 1.16 fatalities per 100 million Vehicle Miles Traveled (VMT) down from 1.25 fatalities per 100 million VMT in 2008.

"This continuing decline in highway deaths is encouraging, but our work is far from over," said National Highway Traffic Safety Administrator David Strickland. "We want to see those numbers drop further. We will not stop as long as there are still lives lost on our nation's highways. We must continue our efforts to ensure seat belts are always used and stay focused on reducing distracted and impaired driving."

The National Highway Traffic Safety Administration attributes the decline in 2009 to a combination of factors that include, high visibility campaigns like Click It or Ticket to increase seat belt use, and Drunk Driving. Over the Limit. Under Arrest which helps with the enforcement of state laws to prevent drunk driving and distracted driving. In addition, the decline is also the result of safer roads, safer vehicles and motorists driving less.

NHTSA annually collects crash statistics from the 50 states, the District of Columbia and Puerto Rico to produce annual reports on traffic fatality trends. The agency intends to update 2009 estimates regularly as more data becomes available. The final counts for 2009 will be made available in the summer of 2010. To view the preliminary fatality statistics visit: http://www-nrd.nhtsa.dot.gov/Pubs/811291.PDF

Date Published: Tuesday, March 2nd, 2010

Merck & Co. has made a final $4.1 billion payment to its Vioxx settlement fund. According to an Associated Press report, final payouts to former Vioxx users or their survivors should be made by the end of June.

Vioxx was approved for use in 1999, and quickly became a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The withdrawal prompted thousands of product liability lawsuits that claimed Merck didn't properly warn doctors and patients of the drug's risks.

Date Published: Wednesday, August 11th, 2010

A new study has found that normal weight women on hormone replacement therapy (HRT) and those who take combination estrogen/progestin therapy (EPT) over a longer time may face a higher risk of breast cancer, according to a report posted on WebMD. EPT drugs include Prempro and Premphase. According to the journal Cancer Epidemiology, Biomarkers & Prevention, the study results-" HRT and Breast Cancer Risk: Study Details"-indicated that while it is widely known that EPT does increase breast cancer risks, what remains unknown are the response of different combinations, which women are high risk, and if risk changes based on tumor sub-type. The team looked at HRT and breast cancer risks using the California Teachers Study cohort, said Cancer Epidemiology, Biomarkers & Prevention and, after a 9.8-year mean follow-up, "2,857 invasive breast cancers were diagnosed."

The group compared women who never took HRT to women who said they were on estrogen therapy (ET) for no less than 15 years and found that those women on long-term ET experienced a 19-percent increased risk of breast cancer, said Cancer Epidemiology, Biomarkers & Prevention. When the timing increased (15 years or more), the risk increased (83 percent), with the greatest risk seen in women using continuous combined EPT therapies. The team concluded that the findings call for more "personalized risk-benefit discussions with women contemplating HT (hormone therapy) use."

In addition to considering HRT by type-estrogen alone or an estrogen/progestin combination-and length of regimen, the team looked at the women's body mass index, or BMI, said WebMD. Progestin is key because it tells breast tissue to split, which can increase cancer risks, noted WebMD.

While women with a high BMI-30 or higher, considered obese-did not experience an increased breast cancer risk, women with BMIs of 29.9 or lower did, despite that obesity on its own is a breast cancer risk, wrote WebMD. Increased risks for breast cancer with HRT was linked to tumors positive for estrogen and progesterone and HER2-positive, explained WebMD.

The American Congress of Obstetricians and Gynecologists said that women should take the smallest dose of HRT for the shortest time frame, WebMD noted.

The report also noted that one study co-author-Christina A. Clarke-served as an expert plaintiff witness in a lawsuit over Prempro hormone therapy.

NewsInferno.com disclaimer: This article was posted on Wednesday, August 11th, 2010 at 6:11 am at NewsInferno.com and is filed under Pharmaceuticals

Worries Mount

Date Published: Tuesday, April 20th, 2010

Controversy continues to swirl around Yaz and Yasmin, Bayer Healthcare's popular birth control pills. While Bayer touts two studies it commissioned as proof that the drugs are safe, other studies have found that contraceptives like Yaz and Yasmin increase the risk of blood clots more than other types of birth control pills.

Yasmin, first marketed in 2001, and Yaz, introduced in 2006, are made with a synthetic progestin called drospirenone. It was once thought that this ingredient was safer than other forms of progestin. But according to a report in The Los Angeles Times, two 2009 studies published in The British Medical Journal have called this theory into question.

One study, which looked at blood clot risks in healthy Danish women ages 15 to 49, found that of 4,213 cases of various kinds of blood clots reported between 1995 and 2005, more than 2,000 occurred in women who used oral contraceptives. Contraceptive pills made with the synthetic progestins desogestrel, gestodone and drospirenone all had a higher risk of blood clots compared to those made with an older form of progestin called levonorgestrel.

The second study, which involved 3,200 women in the Netherland, found those taking pills with levonorgestrel had a four times higher risk of getting blood clots than women taking no birth control. However, the other types of pills carried a higher risk. Those made with drospirenone were 6.3 times more likely to be associated with blood clots. Only pills made with desogestrel had a higher risk - 7.3 times greater.

Dr. Sidney Wolfe, founder and director of Public Citizen's Health Research Group, told The Los Angeles Times that the studies' conclusions are reason for concern. He said the second study "clearly concludes that the safest thing to do is take the older [birth control pills], not the third generation or Yaz." Wolfe also added that his group has already put Yasmin on its "Do Not Use" list because it can raise blood potassium levels.

Bayer, of course, insists that Yaz and Yasmin are safe. According to the Los Angeles Times, the company cites two studies that concluded that there was no greater risk of mortality, cancer or cardiovascular problems from pills with drospirenone than other oral contraceptives. But both of those studies were paid for by the drug maker.

The controversy surrounding Yaz and Yasmin has attracted scrutiny. According to The Times, the U.S. Food & Drug Administration (FDA) is conducting an ongoing study of pills like Yaz and Yasmin to evaluate their safety. As of November, the agency had received reports of 993 cases of pulmonary embolism (blood clots in the lungs), 487 of deep vein thrombosis (clots in the deep veins) and 229 of other blood clots for the two medications combined, The Times said.

In the U.S., Yaz and Yasmin have been named in about 1,100 lawsuit, many of which are consolidated in a multidistrict litigation in federal court in the Southern District in Illinois. Bayer also faces three putative consumer class actions claiming economic loss, one of them also claiming personal injuries, as well as two class actions in Canada. The lawsuits claim Yaz and Yasmin caused plaintiffs to suffer blood clots, heart attacks, stroke, gallbladder disease and other health problems.

NewsInferno.com disclaimer: This article was posted on Tuesday, April 20th, 2010 at 9:13 am at NewsInferno.com and is filed under Pharmaceuticals, YAZ Birth Control.

Linked to Reglan Tardive Dyskinesia

Date Published: Tuesday, February 2nd, 2010

Reglan, a drug used to treat digestive disorders, has been associated with a movement disorder called tardive dyskinesia. Tardive dyskinesia causes involuntary and repetitive movements of the body. Score of people from around the country have filed tardive dyskinesia lawsuits against Wyeth Pharmaceuticals, the maker of Reglan, as well as the manufacturers of its generic equivalents.

In February 2009, the U.S. Food & Drug Administration (FDA) mandated that the makers of Reglan add a black box warning to its label regarding the risk of tardive dyskinesia associated with chronic, long-term use. The FDA's mandate followed the publication of analyses that suggested that Reglan is the most common cause of drug-induced movement disorders. A black box is the FDA's strictest safety warning.

Tardive dyskinesia is characterized by:

• Involuntary/ repetitive movements of the extremities
• Facial tics
• Lip smacking, pursing and puckering
• Face Grimacing
• Tongue protrusion
• Rapid eye movements or blinking
• Impaired movement of the fingers.
• Restless Leg Syndrome (RLS)

There is no treatment or cure for tardive dyskinesia. While stopping Reglan may relieve some symptoms in some patients, in other patients the symptoms of tardive dyskinesia actually worsen when Reglan is discontinued.

To prevent tardive dyskinesia, Reglan should not be taken for more than 12 months, and it has not been approved for longer user. However, it has become apparent that doctors have been prescribing Reglan for much longer periods. Reglan tardive dyskinesia lawsuits allege that Wyeth Pharmaceuticals knew of a widespread tendency among physicians to mis-prescribe Reglan, and promoted the drug for longer use despite the lack of safety data to support such uses.

A number of tardive dyskinesia lawsuits also name the manufacturers of generic forms of Reglan as defendants. Earlier this month, the U.S. Court of Appeals for the Firth Circuit rejected the argument by a generic drug maker that federal law preempts a state-law failure-to-warn claim filed by a user of generic Reglan who developed tardive dyskinesia.

NewsInferno.com disclaimer: This article was posted on Tuesday, February 2nd, 2010 at 6:47 am at NewsInferno.com and is filed under Legal News.

McIntosh decision clarifies landowner responsibility

Thanks to our client, Irene McIntosh, and her attorney, Christopher Goode , the Kentucky Supreme Court has finally clarified the duties a business or premises owner owes to people on their property. In Kentucky River Medical Center v. McIntosh , the Supreme Court held that the defense of "open and obvious" is no longer grounds for dismissal of the case.

Irene McIntosh was working as a paramedic at the time of her fall. As she guided a critically ill patient on a stretcher into the ER at Kentucky River Medical Center, she tripped over a curb next to a ramp. She landed hard and fractured her wrist and hip. A Breathitt County jury found for McIntosh and awarded her $155,409 for her medical bills and lost wages. The hospital unsuccessfully argued that it was up to McIntosh to see and avoid the curb which would constitute a complete defense and absolve the hospital of responsibility for this dangerous condition. The Court of Appeals affirmed the jury verdict.

In an opinion authored by Justice Mary Noble, the Kentucky Supreme Court affirmed the verdict and adopted the modern trend of most states: "In such cases the fact that the danger is known, or is obvious . . . is not . . . conclusive in determining the duty of the land owner, or whether he has acted reasonably under the circumstances." Chief Justice Minton and Justices Abramson, Cunningham and Venters joined Noble in her opinion.

Justice Noble further explained this approach was consistent with Kentucky's pure comparative fault system. Even if the injured person was at fault for failing to appreciate an open and obvious hazard, the business or land owner too should be held responsible for its negligence. Noble also pointed out that this represents good public policy by discouraging dangerous conditions rather than encouraging them.

The result of this important decision will hopefully be to allow victims of dangerous conditions to have their day in court. If you or someone close to you has suffered injuries as a result of a fall, it is vital that you contact an experienced law firm quickly so the dangerous condition can be examined and investigated.