Depakote increases birth defects risk

Depakote increases birth defects risk

Children born to women who took the epilepsy drug valproic acid (Depakote or Depakene) during their pregnancy’s first trimester are more than 2.5 times more likely to have serious births defects. These injuries can affect the brain, heart and limbs, according to a study published in the New England Journal of Medicine.

Serious Depakote birth defects include:
◆   Cleft palate
◆   Hypoplastic right heart (underdeveloped right side)
◆   Undescended testes
◆   Hand malformations
◆   Dysplastic (abnormally developed) ribs
◆    Hypospadia (male baby’s  urethra opening occurs in wrong place)
◆   *Spina Bifida (spinal column fails to enclose spinal cord)
◆    Fetal death

*Among the most severe side effects, spina bifida is a birth defect in which the spinal cord and backbone fail to develop or close properly. The risk of spina bifida in the offspring of mothers taking valproic acid during pregnancy is 1 – 2 percent, while a recent study found babies subjected to their mothers’ use of valproic acid during the first trimester were 12.7 times more likely to have spina bifida compared to babies whose mothers did not take the drug.

Lolkje T.W. de Jong-van den Berg and colleagues at the Netherlands’ University of Groningen found babies subjected to their mothers’ use of valproic acid during the first trimester were 12.7 times more likely to have spina bifida than babies whose mothers never took the drug.
Babies whose mothers took valproic acid were also 2.5 times more likely to have an atrial septal defect (heart), about five times as likely to have a cleft palate (upper lip and roof of the mouth) or hypospadias (abnormal penis), more than twice as likely to be born with an extra hand digit (polydactyly), nearly seven times more likely to have craniosynostosis (premature skull fusion restricting skull, brain growth).

While valproic acid was associated with a higher relative risk of the six birth defects, researches noted the absolute risk of having a baby with any of the defects remains small. For example, the risk of a baby’s having spina bifida was 0.6 percent – or six in 1,000 – among women who took the drug, compared to five in 1,000 of babies born to mothers who didn’t.

But given mounting evidence of the risks of valproic acid to fetuses, researchers urged women of childbearing age to try other drugs to control their seizures.

“These findings provide further evidence to avoid valproic acid, if possible, in pregnant women and (for doctors) to discuss with girls and women of childbearing potential the risk of the drug for the unborn child,” van den Berg said.

Dr. Kimford Meador – a professor of neurology at Emory University in Atlanta – echoed that warning: “This drug should not be used as a first-line drug for epilepsy in women of childbearing age. (There) are multiple types of malformations that can be associated with valproic acid.”

The review was published in the June 10, 2010 issue of the New England Journal of Medicine (NEJM).

Researchers first looked at eight studies that included nearly 1,600 births and identified some 14 birth defects that seemed to be much more common among the children of women who took valproic acid early in pregnancy.

Armed with that information, researchers analyzed data from a large European study that included nearly 4 million births and 98,000 birth defects. They found women who took valproic acid in early pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who took no epilepsy drugs. The findings were similar when birth defect rates among those taking valproic acid were compared to the rates for women who took other epilepsy drugs, leading researchers to conclude it was the valproic acid, not some other epilepsy drug, that was to blame.

Among those who took valproic acid during early pregnancy, the chances of having a baby with any of the defects was less than 1 percent — cleft palate (0.3 percent), hypospadias (0.7 percent), polydactyly (0.2 percent), craniosynostosis (0.1 percent).

Previous research has also linked valproic acid to spina bifida, other birth defects, cognitive problems in children, Meador noted. In April 2009, Meador was lead author of a study that appeared in NEJM linking exposure to valproic acid in the womb to lower IQ scores in children.

The American Academy of Neurology recommends pregnant women avoid valproic acid, according to background information in the publication. Yet because roughly half of pregnancies are unplanned, according to the study, researchers said all women of childbearing age should be warned about the dangers.

Despite such concerns, Meador said valproic acid is often still prescribed. In 2006, valproic acid was the second most commonly prescribed epilepsy drug. Meador added that Valproic acid is also prescribed to prevent migraines and to treat bipolar disorder.

Meador also said that despite the risks, valproic acid can be a very effective drug and may be the best choice for some patients whose seizures are not well-controlled by other medications.

Reuters was the source for much of this story.

Zoloft Lawsuits in Philly MDL

Zoloft Lawsuits in Philly MDL

Roughly 330 Zoloft birth defect lawsuits have been filed against Pfizer in the MDL (federal multidistrict litigation) established in U.S.District Court, Eastern District of Pennsylvania. The first Zoloft trials are scheduled to begin in 2014. These cases involve birth defects resulting from the use of Zoloft.

Twenty five lawsuits will be chosen among the total pending, 12 from a list chosen by plaintiffs’ lawyers and 13 by defense attorneys. After discovery and pre-trial proceedings are completed, the first bellwether trial regarding birth defects linked to Zoloft will begin in mid September 2014. Bellwether trials are considered cases which test the waters to give indications about how the litigation will proceed in the long run.

Virtually all of the Zoloft lawsuits claim that the drug taken during pregnancy can increase the risk of delivering a baby with severe birth defects, and Pfizer knew about the link between Zoloft and birth defects.

The birth defects include heart defects, clubbed foot, oral clefts, cleft lip and palate, delayed development, Autism, Persistent Pulmonary Hypertensin of the Newborn (PPHN), Gastrochisis, atrial and ventrical septal heart defects, pulmonary atresia and stenosis, Hypoplatic Left Heart Syndrome (HLHS), Transposition of Great Arteries, Coarctation of the Aorta (coA), Tetralogy of Fallog (TOF), cranial defects, neural tube defects, Spina Bifida.

If you have been injured by Zoloft schedule your free initial consultation online or call us at 508-499-3366.

Supreme Court rules against drug victims

Supreme Court rules against drug victims

The Supreme Court ruled in a 5-4 vote today that people hurt by generic drugs cannot collect compensation from the companies that made those drugs. The case was Mutual Pharmaceutical Co., Inc. v. Bartlett.

The same five justices who voted against compensating Gladys Mensing (Pliva v. Mensing) and thousands of others hurt by generic drugs also voted against Karen Bartlett and the many thousands of others who will continue to be affected by generic drugs that have harmed them: Antonin Scalia, John Roberts, Clarence Thomas, Anthony Kennedy, Samuel Alito.

See the full Supreme Court ruling

Z-pack FDA Warnings

Z-pack FDA Warnings

Z-pack – azithromycin – could lead to deadly heart rhythms

The popular antibiotic Azithromycin could trigger a potentially deadly irregular heart rhythm for some patients, the FDA warned in March 2013.

Sold as Zithromax, Zmax,  a “Z-Pack” is prescribed to treat bacterial infections such as bronchitis, pneumonia, ear infections and more.

The FDA has warned that the pills can cause abnormal changes in the heart’s electrical activity that could lead to a fatal heart rhythm. Patients at greatest risk are those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or those who use  certain drugs to treat abnormal heart rhythms.

In a March 12, 2013 update, the FDA stated: “Health care professionals should consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events.”

A May 2012 study triggered the new guidance, along with, another study by Pfizer, the antibiotic’s maker, which assessed risks to electrical activity of the heart in those taking azithromycin.

A New England Journal of Medicine study last May – which was paid for by the National Heart, Lung and Blood Institute – found there would be 47 extra heart-related deaths per one million course of treatment with five days of Zithromax, as compared to 10 days of amoxicillin and other antibiotics. The FDA said risks of cardiovascular death associated with levofloxacin (Levaquin) treatment were similar to those associated with azithromycin treatment.

• Zithromax antibiotics tied to rare heart risks

Dr. Harlan Krumholze, a Yale University health outcomes specialist who was not involved  in the study, downplayed its findings. He told the AP last May: “People need to recognize that the overall risk is low.” He also posited that more research was needed, but said that patients with heart disease, “[s]hould probably be steered away” from Zithromax.

The FDA also issued a post-study statement in May 2012 that the agency was aware of the findings, and it would review the results and communicate any new information.

The AP also reported that Zithromax sales totaled $464 million in 2011, according to health care information company IMS Health.

Anatomy of a Lawsuit

Anatomy of a Lawsuit

Many of our clients understandably ask about the process of filing their drug case. We hear many questions repeatedly: How does my drug case work? How long does it take to file my drug case? How long before I see some money or some results?

The basic procedure works this way. Once companies receive copies of our petition informing them that we have filed a lawsuit, they have approximately 20 days to answer.  Their response is typically in a form that basically says, “We didn’t do it.  Prove it, if you can.”

The next step in the process is called discovery.  This is the time given us by the court to investigate and develop the case.  Discovery can  last from six to twelve months or longer, depending on the scope of the litigation.

One of the first steps in discovery requires  a plaintiff to answer many written questions (interrogatories) and provide several documents relevant to the lawsuit, through a formal request for production. Once we receive the interrogatories and request(s) for production of documents, we contact the plaintiff to help answer the questions and locate the relevant documents.  We  then type everything and submit the final document  to  defense.

As part of the discovery process, the plaintiff and many other key witnesses and experts will also be interviewed in person and under oath by lawyers for the defendants.  This interview under oath is called a deposition.  During the deposition, a plaintiff will be asked many of the same questions previously answered in writing, and also some new questions.

Once discovery is complete, if the Court has not yet assigned a trial date, we request one.  Prior to trial, the court may require we participate in a dispute resolution process called mediation.  If a case is not settled during mediation, we move forward to trial preparation. Though we typically handle  many of cases at one time, we work every case with the assumption that it will go to trial. The litigation process  in a drug case typically takes between two and five years, depending on many factors; but it can take longer, as with the Accutane litigation which still continues after more than seven years.

Anyone with questions is urged to contact us at 508-499-3366.

Judge overturns $6.5 Million Verdict

Judge overturns $6.5 Million Verdict

It’s a wonder we even bother to hold trials anymore. In the latest miscarriage of justice, a California judge overturned the verdict of a six-week jury trial by accepting defense arguments that an expert whom the jury had seen interrogated in court was not qualified to determine that Actos had caused plaintiff Jack  Cooper’s bladder cancer.

On May 1, Judge Kenneth Freeman overturned $6.5 million dollar jury verdict (entered on April 26) for plaintiff Jack Cooper in Cooper vs. Takeda  (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles). Freeman granted two key Takeda’s motions which lead to his reversal.

Freeman granted Takeda’s motion to exclude the opinions of Dr. Norm Smith, the plaintiff’s causation expert who had hypothesized that Actos was a substantial causal factor in Mr. Cooper’s bladder cancer.  Granting that motion meant that no opinion supported the cancer causation finding; so the judge then granted Takeda’s motion for non suit, which threw out the verdict.

Judge Freeman dismissed Dr. Smith’s work thusly:

“[I]t is evident to the Court that the matter in which Dr. Smith conducted his differential diagnosis is based on speculation, is not reliable, not done with intellectual rigor expected of an expert, and is therefore inadmissible under prevailing California law.”

Absent Dr. Smith’s opinion that Actos specifically caused Mr. Cooper’s bladder cancer, there was no other evidence, according to Judge Freeman, to support the jury’s verdict against Takeda; therefore Freeman granted a non suit.

Mr. Cooper’s lawyers will appeal Freeman’s decision to an appellate court. One can only wonder how Judge Freeman could dismiss the jury verdict on an apparent technicality.  The jury had six weeks to look at all the evidence, to hear the qualifications and the testimony of Dr. Norm Smith, and to hear him cross examined for hours by Takeda defense lawyers. The jury also heard all the testimony of all the experts hired by Takeda. The jury then decided, and then Judge Freeman decided the jury couldn’t be entrusted to do the job they were chosen to do. What’s the point of having a jury trial at all if the jury’s decision can be so easily dismissed by a judge?

What is this whole decision if not complete contempt for the entire jury system? If you want to ask what’s wrong in this country, you might start by asking why it’s ok for a judge to categorically dismiss the work of an impaneled jury who have heard six weeks of testimony from both sides.

Actos Verdict: $6.5 Million

Actos Verdict: $6.5 Million

First Actos Trial

A Los Angeles jury on April 26, 2013 found Takeda liable for injuries that included bladder cancer suffered by a former Pacific Bell telephone cable splicer, Jack Cooper. The jury returned a verdict of $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles).

Jury deliberations lasted eight days following testimony before Judge Kenneth Freeman in Los Angeles Superior Court. The jury found defendants’ failed to provide adequate warnings about Actos’  dangers, and that Takeda’s Actos was a substantial factor in Mr. Cooper’s injuries.  The jury also awarded $1.5 million for loss of consortium.  Cooper was diagnosed with bladder cancer in November 2011 after taking Actos for diabetes for more than two years.

Evidence in the nearly two-month trial revealed in-house emails in which Takeda executives urged colleagues to persuade the U.S. FDA not to demand increased bladder cancer warnings on Actos’ label.

In one email, Takeda executive Kiyoshi Kitzaawa wrote: “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally.”

Actos’ sales peaked in 2011 at 4.5 billion, which was then about 27% of Takeda’s revenue, according to data gathered by Bloomberg news. Takeda today faces more than 3,000 suits alleging Actos causes bladder cancer or other ailments. Other cases wait in state court in Illinois. More than 1,200 suits have been consolidated before a federal judge in Louisiana. According to court filings, the first federal case is set for trial in January.

See the full Bloomberg article: Takeda Denies Actos Bladder-Cancer Link at First Trial

In August 2011, a report by eHealthMe based on FDA reports and the user community stated that 50 (0.22%) of 22,512 people reporting Actos side effects,  had bladder cancer.  A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients. It found that one-fifth of patients reporting bladder cancer were taking Actos.

Dose-Related Dangers

In September 2010, the FDA ordered a safety review of Actos.  The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos.  A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year.  Taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer compared with never taking Actos.

A French Medicines Agency study found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.