Product Liability Attorney Blog

Anna Blyth's case against GlaxoSmithKline, the makers of the popular antidepressant drug Paxil, has been dismissed by a Philadelphia judge.

In the case, Blyth alleged that taking Paxil during her pregnancy caused her now 14-year-old daughter Anna to be born with specific cardiac birth defects. Part of Glaxo's defense strategy was to state that while unfortunate, 3-5 percent of all live births today are to children with birth defects. They also stated that this happens with and without the mother having taken medications during the pregnancy.

Glaxo officials have stated before that they don't think they did anything wrong in how they researched and studied Paxil. This includes how they shared the information that these studies produced with various regulators like the FDA. Glaxo claims that after Paxil had been granted approval from the FDA for use, the company acted correctly when marketing the prescription medication. This included how Glaxo monitored its safety, and how it updated the information on how it is used during pregnancy.

All of the information on Paxil's label was said by Glaxo to be new information that was available at the time. The company said that it put everything on the labels as soon as new information was made available. Glaxo officials also say they submitted all new data to regulators, the public and the medical community. For these reasons, the company believes it should not be held liable for Anna's birth defects.

The judge in this case apparently agreed with Glaxo and granted the dismissal. This case is cause for Glaxo to celebrate big time since it has lost or settled many of its recent lawsuits and has been forced to pay more than $1 billion in settlements and fees. But the jury remains out on whether this case will set the precedence for future birth defects cases against Glaxo since the Blyth case is the first of its kind to come to trial.

A unit of Pfizer Inc., Wyeth has beaten a challenge from generic drug makers against a patent on the extended release version of Effexor. This occurred in Australia.

On November 7, federal courts judge Jayne Jagot dismissed the challenge filed by Sigma Pharmaceuticals, Generic Health Ltd. and Alphapharm Ltd. She dismissed the challenge because she ruled that Wyeth's patent was valid. Jagot said that she wouldn't revoke the patent because the applicants didn't establish proper grounds for her to do it.

Sigma lost about AU$218.5 million (US$221 million) in the six months that ended July 31, and the other makers of generic drugs are not allowed to sell any copies of Effexor. This is in accordance to the ruling. Effexor was Wyeth's most popular and profitable antidepressant drug. In 2008 alone, the drug sold AU$3.9 billion dollars worth. That is, of course, until generic versions of the drug started being released and sold. After this, Effexor sales dropped to AU$175 million during their third quarter.

Jagot also decided to put an order against Sigma and the other generic drug makers to force them to destroy any copies that they might still have of Effexor. The order was suspended for a period of 14 days or at least until her ruling starts going through the appeals process. Sigma was selling their generic version of Effexor under the name Evelexa in May 2009 in Australia. Within a month, Wyeth was granted an order that blocked the sale of the generic version until the trial.

Generic versions of popular antidepressant drugs like Effexor are getting to be more and more popular with consumers. Most people would prefer to get these drugs on a discounted price rather than pay full amounts for medications that are taken over a long period of time; still, profits for the generic drug manufacturers like Sigma will continue to fall drastically if these blocks continue.

The maker of Paxil, GlaxoSmithKline, has been linked to many different lawsuits lately. Glaxo again is accused of ignoring the suicide risk that is involved with patients that take Paxil. This time, however, Glaxo and Paxil are being linked to the Catholic Church’s efforts to cover-up a child abuse case and the death of a Paxil-prescribed priest whose sister was involved.

It is said that Father Rick Tucker committed suicide because he was feeling distraught about how his parish decided to ignore a child abuse claim. He was taking Paxil at the time, and many believe that the drug may be directly responsible for him taking his own life. Judge David Hamilton, a federal judge in Indiana, ruled that Tucker's sister Debra had just cause to sue Glaxo over the death of her brother. He decided that the drug’s side effects may have made the priest kill himself — not the stress of the cover up as some others believed. Tucker shot himself to death in September 2002.

The abuse case began in 1966. Debra was young and was allegedly raped by a choir instructor in St. Lawrence 3-4 times per month. It is also said that she also had an abortion at some point because the abuser told her to. The abuse stopped when she moved after the death of her parents. Once the incidents were mentioned to the church, officials apparently didn't do anything about it and that they tried to hide it from the rest of the congregation and the public. Debra sued them for breach of contract in 2000. The tried to make a deal with the church that would keep her abuser away from any and all children in the church. In return she would not sue the church.

Tucker was so anxious about his sister's plight (the rapes and the lawsuit) that he began taking Paxil August 28, 2002, to calm himself down. The drug immediately sent him into a depressive tailspin that eventually led to his suicide, his sister claims.

Debra's specific claims against Glaxo and Paxil note that the company knew of the suicidal effects of Paxil since 1990 and that it didn't warn the public properly. When Glaxo asked that the case be dismissed, the judge decided that the case needed to be heard.

The FDA has decided to approve Levaquin in the form of injections and tablets (levofloxacin in 5 percent dextrose) for the treatment of community-acquired pneumonia (CAP). The injection will be in a 750 mg dosage to be administered daily for a period of five days.

"In an effort to address bacterial resistance, the World Health Organization (WHO) Antimicrobial Resistance Guidelines have called for aggressive, short courses of therapy,” says Thomas File Jr., a medical doctor from Northwestern Ohio Universities. “Levaquin 750 mg meets these guidelines because it is highly efficacious, well-tolerated and treats CAP in half the time of the standard 500 mg regimen."

This new five-day treatment is going to mean that patients will have to take less Levaquin overall, so their exposure to the drug will be less likely to cause some of the side effects that the drug possesses. Each year there are up to 2 million diagnosed cases of CAP. In fact, it is the leading cause of death from infection diseases in the United States.

A lot has been said recently about Levaquin and the tendon rupture risks it poses to patients. It is an antibiotic that is used to treat many infections like urinary tract infections, as well as bacterial infections such as bronchitis and sinusitis.

When being used to treat pneumonia, doctors believe that since Levaquin would be used in concentrated doses it is less likely that patients treating their pneumonia with the drug will develop an antibiotic tolerance toward it. This will make the treatment much more effective since it is short term. Antibiotic resistance is develop0ed in patience that are overexposed to antibiotic medications that generally becomes ineffective when they are used for a lengthened time. This quick five-day Levaquin treatment should be a good solution to that problem.

Lawyers for the Blyth family currently are arguing in court that Glaxo didn't properly warn consumers of the horrible potential birth defects Paxil can have on the newborns of women who took the drug while pregnant.

They also claim that results of Glaxo-conducted research in the 1980s clearly showed that Paxil caused death in the babies of animal test subjects and simply didn't tell the public about it. Kimberly Baden, the Blyth's lawyer, claims that Paxil taken during pregnancy caused a narrowing of the aorta that leads from Anna Blyth's heart. The girl is currently 14 and has undergone more than one surgery to correct this already.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden stated. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

This current court case is the first case to go to trial since Glaxo settled a case for $2.9 million in 2009. The case went in favor of a teenage boy that also suffered from birth defects caused by his mother taking Paxil during pregnancy. Right now, Glaxo is denying that Paxil has anything to do with Anna's heart defects. Company officials also deny any connection between these birth defects and the results of the animal research.

Glaxo's lawyers continue to say that Glaxo did include references to deaths of animal subjects on the drug’s label in 1995, which could make the point mute during the course of the trial. Since Anna's mother saw and read the label in 1995 when she was pregnant, her claims could all come to nothing regardless of whether or not Glaxo originally hid the animal testing research from the public. The fact that the information was available in 1995 could make all the difference in this case.

GlaxoSmithKline, the manufacturer of the popular antidepressant drug Paxil, recently lost another case when the State of Washington was awarded $6 million for its case that claimed that Glaxo sold drugs that didn't meet federal standards.

Last month, court proceedings revealed that GSK made a mistake during the manufacturing of four drugs — one of which was Paxil CR. The others were Avandamet, Kytril and Bactroban.

The federal government and many other states have filed drug adulteration claims in court after a whistleblower made statements that said that the company made a lot of important mistakes in the production of the drugs that were manufactured at its plant in Cidra, Puerto Rico. The same person also said that because of these errors, some patients that received Paxil got either a version with no active ingredient while others got a version of Paxil that had only the active ingredient in them, making them more dangerous. Still more versions of the drug had no controlled release ingredient.

Washington state plans to use the money to fund its Medicaid program and repay the federal government for its share of the prescription costs of Medicaid, with the rest going to the state’s general fund. This is a relatively large victory for the state of Washington in that the decision has made Glaxo liable for their mistakes made in Puerto Rico. More suits likely will follow, as patients that have taken these drugs are expected to have something to say about it. With all of the complications surrounding Paxil, patients should be aware if they have been given doses of these drugs and contact their doctors right away.

It is fairly well known that Paxil poses a risk of suicides in teens and young children. Regardless of this, however, GlaxoSmithKline is testing the drug on children as young as 7.

Glaxo, the manufacturers of the drug, has been testing Paxil on these small kids as a part of a research study. But here’s the catch: The company is conducting the tests in Japan. The popular antidepressant has been under fire recently due to the risks of suicides that the drug poses, but it appears as if the company wants to prove that there is less suicide risk in a small population of users. It seems as if Glaxo is hoping to cast enough doubt on the current claims that Paxil is directly responsible for the suicides on the population as a whole.

While Paxil already carries a back box warning on the label, this study just shows how drug manufacturers try to design their research studies in a way that will make their products look as good as possible. The main goal of the current study is not for Glaxo to understand why it makes some kids commit suicide. Instead, it’s actually being billed as an efficacy study (meant to show you how the drug works). This is unnecessary because this information already has been documented; we already know how the drug works and what benefits it provides.

For the study, Paxil is being tested against a placebo which shows just how biased the research is. Just about any kind of drug will work better for your conditions than a sugar pill. Right now Glaxo is just trying to use this study to downplay the suicide risks that have already been associated with Paxil. If the results are bad, more than likely Glaxo will never publish the results.

According to federal regulators, SB Pharmaco, a unit of the major drug manufacturer GlaxoSmithKline, just pleaded guilty to the charges that it sold adulterated drugs.

The U.S. Department of Justice states that as part of this plead, Glaxo now will have to pay a criminal fine of $150 million as well as paying civil penalties that are expected to add up to approximately $600 million. These penalties will be paid to federal and state authorities.

SB Pharmaco admitted to knowingly making and distributing drugs that did not adhere to the current "good manufacturing" laws. One of the drugs included in this group is the popular antidepressant Paxil. Under federal law, drug makers have to meet a specific set of standards in making their drugs to help ensure that the drugs are safe and pure when sold in the United States. Adulterating prescription drugs works the same way it does when a narcotics drug dealer cuts the drug they are selling with something else so that they can produce more product for sales in the street.

The prosecutors in the case also stated that Glaxo knowingly lied in July to federal health care programs like Medicaid when they reported a $750 million charge during the financial statement for the second quarter. This came after the company reached an agreement to settle the charges with the federal regulators.

P.D. Villarreal, the current head of global litigation at Glaxo, said that the fines help to solve an issue that has been going on for a long time. He also stated that the company regrets not reaching the U.S. safety standards.

"GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes,” he adds.

Cheryle Eckard, the claimant in the civil case against Glaxo, will be given somewhere around $96 million out of the money that Glaxo has to pay in fines to the federal government.

GlaxoSmithKline, the makers of the popular antidepressant Paxil, recently lost a civil lawsuit in Philadelphia. The jury in the case awarded $2.5 million to Michelle David, who had filed the lawsuit on behalf of her son, Lyam Kilker, who had just turned four.

Michelle filed the suit and sought $1.2 million to aid in covering future medical costs and other damages caused by Paxil. Her son has heart defects that Michelle claimed were the direct result of Glaxo's refusal to properly warn the public about the proper risks in taking Paxil. The jury seemed to agree with a 10-2 vote. This is a direct match to an award that was handed down five years ago when Glaxo agreed to pay the state of New York $2.5 million as a means of taking care of any claims against them that GSK hid test data showing Paxil may increase the chances of young people committing suicide.

Michelle's lawyer was ecstatic with the verdict, calling it the first suit to get a jury to say the drug caused the injury. But business analysts on the side of Glaxo didn't share the same opinion; Navid Malik, an analyst at Matrix Corporate Capital in London, said, “I don’t think the link is proven, so there will likely be collective settlements which will keep costs low. If this was a threat to GSK, the first verdict might have been 100 times greater.”

While the family cannot seek any punitive damages as the jury did not find Glaxo's behavior outrageous, Glaxo disagrees with the verdict and will be appealing it. Considering just how much information has come out about Glaxo in the last year, it may be wise for the company to pay the settlement and walk away. Recent FDA restrictions placed on Avandia along with all of the other evidence mounting up against Glaxo and its practices might just be too overwhelming for a fast company recovery.

The recent suit against GlaxoSmithKline, the makers of Paxil CR, that orders the company to pay $750 million in penalties to the federal government for selling adulterated drugs may not be over yet. The government plans to follow up on the poor manufacturing practices present at GSK’s Puerto Rico plant.

For months, the idea that federal regulators want to begin holding company officials just as accountable as the corporate bodies they represent for false claims that they file for government health programs has been a hot topic. The federal False Claims Act did manage to get back billions of dollars for health care fraud; however, it is the companies that have been paying for it and not the executives, who are getting away with making plea deals.

This most recent case began with a complaint that was filed six years ago by a quality control manager. Her case concluded with the whistle blower being awarded a $96 million settlement. When Carmen M. Ortiz, The United States attorney for Massachusetts, was approached Tuesday and asked if there could still be any individual accountability in the case, she answered. “I really shouldn’t comment specifically in relation to this case because the investigation is ongoing.” She also stated that the corporate aspect of the case settled.

While it is not clear if the case is going to continue, it is clear that at least one former Glaxo official was singled out in the indictment for the Puerto Rico case that centered on drugs like Paxil being adulterated during the manufacturing process. So far, that person is not being named; however, it is known that the person was hired in April 2003 as the site director of the facility. It also is known that this person was accused of interfering with quality control complaints. The person effectively was removed from the position in October 2004. As to how or if the case might continue with further investigations leaning toward individuals is anyone's guess.

Glaxo is feeling the pinch in its third quarter profits after the FDA placed severe restrictions on the availability of its extremely popular drug Avandia, which is used to treat type 2 diabetes.

When data from the company's third quarter returns came in, Glaxo officials found that they had experienced a 3.5 percent loss in earnings. Much of this loss was the result of generic competition in the market. But the fact that Avandia has been banned from the shelves in Europe coupled with the recent FDA restrictions placed against Avandia in the U.S. certainly had a major impact.

Glaxo is expecting low sales on Avandia because of the high number of lawsuit rulings against the company in regards to Avandia and Paxil, as well as from generic competition from popular herpes medications like Valtrex, which actually drove the company’s sales down by 8 percent in the U.S. and 9 percent in Europe.

CEO Andrew Witty has stated publicly that that third-quarter revenue did go down by at least 2 percent because of the FDA restrictions in the U.S. alone. Of course, the government cuts in Europe adds to the decline. Glaxo is definitely feeling the loss. At one point, Avandia was the only new product the company had to offer; hence, a lot of hopes were hinged on its success. The many legal problems of the company along with a drop in sales certainly have Glaxo on their toes. If the lawsuits and investigations don't stop soon, Glaxo is going to continue to feel the pressure on them as more quarterly reports come back with little to show.

The Associated Press has reported that Mylan Inc., the sellers of the generic version of popular antidepressant Paxil CR, has not been granted the injunction it requested in hopes of blocking other companies like Apotex from selling generic versions of Paxil.

The appeals decision is a response to the decision that came down in a case that was first reported in September. As part of that case, the court granted a temporary block against Apotex from selling its generic version of the antidepressant manufactured by GlaxoSmithKline. However, the temporary block against Apotex didn't last, as the U.S. District Court has chosen to deny that the block stay permanent. It is Mylan's choice now whether to appeal that decision.

In the suit, Mylan claims that it has had an exclusive agreement with Glaxo that allows only Mylan to sell the generic version of Paxil since 2008. The claims, which since have been denied, were that Glaxo violated that agreement when they agreed to let Apotex sell the same generic versions as Mylan. Apotex of Canada is one of Mylan's major competitors, so Glaxo's decision presents a conflict of interest for Mylan.

Mylan likely was expecting that the temporary order against Apotex selling generic Paxil would stand, so the decision handed down took them by surprise. The final decision in the case came down on Oct. 18 and Mylan will likely lose profits because of it. Right now Mylan Inc. is the largest U.S.-based generic drug company and generic Paxil was likely one of Mylan's big sellers. Since May 2008, the company's generic version of Paxil has generated hundreds of millions of dollars in sales in America alone, so this has to be a blow.

To add injury to insult, sales of Paxil have dropped in the third quarter due to the recent controversies surrounding Glaxo’s other popular drug Avandia.

A new study published in the Journal of the American Medical Association has revealed that most of the antidepressant drugs in the same class as Paxil that contain paroxetine and imipramine actually do nothing more than a placebo does when it comes to assisting patients with mild, moderate and even severe depression.

According to Robert DeRubeis, a psychologist at the University of Pennsylvania who was part of the team that performed the meta-analysis, patients taking Paxil would have done just as well if they were taking placebos instead of the antidepressants. The meta-analysis was taken from data that was comprised of six studies with more than 800 participants.

The patients that had an initial depression score of 23 or lower dropped an average of 8 points when they were given antidepressants like Paxil in comparison to a 7-point drop in people that were given a placebo. According to DeRubeis, this information should help doctors and patients take a moment to see what else they can do to combat their depression besides taking drugs like Paxil. He suggested using tools like exercise and psychotherapy.

Paxil, made by GlaxoSmithKline, currently is one of the most popular SSRI drugs on the market, even with the current controversy surrounding its safety risks. This study is just another piece of bad news to sideswipe Paxil recently. Since Paxil first hit the market in 1993, many claims have been made against the risks in taking the drug. There have been numerous complaints that Paxil increases suicide risk, heart attacks, strokes and even causes death.

The makers of Paxil also have gone under the microscope for shady dealings in the making and marketing of other drugs, as well. With so many claims against Glaxo's drugs, this study may present a serious backlash. However, it must be noted that for the time being Paxil in its brand names and generic forms remains one of the more popular antidepressants on the market.