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As of this month, over two hundred families have filed suit against GlaxoSmithKline (GSK) alleging that blockbuster anti-nausea drug Zofran caused their children to be born with defects. These birth defects range from cleft palate to malformed limbs to congenital heart defects. Until now, families who have been affected by Zofran have largely remained silent, but recently a couple in Alabama decided to tell their story.

John and Clara Rickman, parents from Birmingham, Alabama, welcomed a new son into their family last year. The child, Nicholas, was born with a congenital heart defect and required three heart surgeries: the first at just five days old. Clara took Zofran to help alleviate her morning sickness symptoms during the pregnancy, and the Rickmans fear that the use of this drug may have contributed to Nicolas’ heart problems.

Zofran entered the market in 1991. The FDA approved the drug for the treatment of chemo-therapy related nausea in cancer patients. The drug has never been approved for use in pregnant women. Despite this, many doctors prescribe this drug for use in treating morning sickness. This type of prescription is called “off-label.”

Prescribing drugs off-label is a common practice among physicians in the United States. It is estimated that about 20% of all prescriptions are written for off-label uses. While doctors have the ability to use their professional judgment and decide if an off-label use is the best option for their patients, drug companies are not allowed to promote the use of their drugs for any purpose other than FDA approved uses. Plaintiffs, including the Rickmans, allege that GSK violated FDA rules and encouraged doctors to use the drug for the treatment of morning sickness.

In the last few years, several studies have linked the use of Zofran in pregnant women with an increase in the rate of birth defects. One study also noted that prescriptions for Zofran, and its generic form, have reached an historic high with over 100,000 prescriptions per month to pregnant women.

In January, a federal judge ruled that lawsuits against Zofran manufacturer GlaxoSmithKline (GSK) could proceed. These suits allege that that GSK promoted Zofran, an anti-nausea drug, for off-label use during pregnancy. This type of promotion is illegal, and it may have lead to serious birth defects in children whose mothers used Zofran to treat morning sickness.

Off-label use occurs when a doctor prescribes a drug for a purpose that is not approved by the FDA. This practice is not illegal and is in fact quite common. An estimated 20% of all prescription are written for off-label uses. Off-label use can be dangerous, however. In the case of Zofran, plaintiffs allege that when used in pregnant women, the drug can cause serious birth defects. Plaintiffs also allege that GSK promoted Zofran for use in pregnant women despite the fact that off-label promotion is prohibited by federal law.

GSK filed a motion with the court to dismiss all pending Zofran claims. They argued that the claims were constitutionally barred because they were preempted by a Food and Drug Administration decision not to reclassify the drug at GSK’s request. Federal Judge F. Dennis Saylor IV of the District of Massachusetts recognized that this type of decision differed from a citizen’s petition for reclassification. Judge Saylor denied GSK’s motion and, in doing so, allowed the Zofran claims to continue.

This decision is a victory for all families injured by Zofran. The drug has been linked to serious birth defects including congenital heart defects, kidney malformation, cleft palate, and gastrointestinal defects. These types of birth defects can take a serious toll on families and result in thousands of dollars in healthcare costs.

If you or a loved one has been harmed by Zofran, let us know. We would love to help your family get the compensation and closure that you deserve. When Injuries strike / We strike back.

1-877-542-4646

According to an NBC News report, C.R. Bard, a manufacturer of IVC Filters, knew of problems with its products, but continued selling them anyway. IVC Filters work to catch blood clots and prevent pulmonary embolism. Unfortunately, many of these filters are faulty and can cause serious injury and death. This happens when pieces of the filter break off and embolize causing damage to the heart and brain.

In 2002, C.R. Bard released its Bard Recovery Filter. The filter was supposed to save lives, but reports of injury and death caused by the filter quickly began to mount. Bard commissioned a confidential study which found that its filters caused problems at a higher rate than competing products. Despite this, Bard did not issue a recall. Instead, in 2005 it released its G2 series of filters. According to internal memos, Bard was aware by December of 2005 that the G2 series of filters had many of the same problems as the Recovery Filter. Still, Bard executives decided to leave the G2 filters on the market until 2010 by which time they were responsible for more than a dozen deaths and hundreds of injuries.

Nearly 100 lawsuits have already been filed against Bard over its defective IVC filters. These suits seek to hold the company accountable for the harm that it has done to patients both through the defective design of its products and through its willful decision to put profits before safety.

If you or a loved one has been injured by any brand of IVC Filter, now is the time to act. The attorneys at McSweeny / Langevin focus their practice on complex litigation against large drug companies and medical device manufacturers. We can help you get the compensation you deserve. Give us a call for a free case evaluation. 1-877-542-4646

A new study published in JAMA Pediatrics links antidepressant use during pregnancy with increased rates of autism in children. More specifically, the study focused on expecting mothers who were taking selective reuptake inhibitors (SSRIs) like Prozac, Zoloft, and Lexapro. This study used six years of data from the Canadian registry of newborn children to make its findings.

Of the 145,456 newborns studied 1,054 (a rate of .7%) were eventually diagnosed with autism. Of the 2,532 babies whose mothers used SSRIs during the second or third trimesters of pregnancy, 31 (1.2%) were found to be autistic. Among mothers who took SSRIs in the first trimester, 1% of their children were eventually diagnosed with autism. Researchers had previously suspected that there was a link between autism and depression in expecting mothers, but this study seems to point to the idea that maybe it was the use of SSRIs that made them suspicious.

Doctors have cautioned that pregnant women should not stop taking SSRIs simply because of this study. Although it appears that the drugs increase the risk of autism, the overall risk is still low. The dangers of having untreated depression, including alcohol and drug use, can be much more harmful to a developing child than antidepressants. Expecting mothers should ask their doctors about the risks associated with SSRIs and make the decision that is best for them and their families.

If you or a loved one took an antidepressant during pregnancy and subsequently had a child diagnosed with autism, you may be entitled to damages from the manufacturer of the drug. We can help. The experienced attorneys at McSweeney/Langevin focus their practice on helping families who have been harmed by dangerous drugs and defective medical devices. Their experience means that they can help your family get the aid that you deserve. Give us a call.

1-877-542-4646

People who experience great physical trauma are often at a greater risk for blood clots. Traditionally, IVC filters have been used as a means of lowering blood clot risk in trauma patients, but a new study shows that IVC filters do not improve these patients’ chances of survival.

The removable IVC filter was introduced in 2005 to prevent pulmonary embolism (blood clots that can block the lungs) in patients who cannot be treated using traditional anticoagulation therapies such as warfarin or Xarelto. Unfortunately, over the last decade the FDA has received nearly 1,000 reports of adverse patient outcomes caused by defective IVC filters. These include reports of pieces of filters breaking off and creating embolisms in the brain, heart, and lungs.

In October of this year, researchers from the University of Michigan published a study which found that the placement of IVC Filters does not result in a survival benefit for trauma patients. The study, which took place over four years, looked at nearly 40,000 trauma patients to analyze the difference in outcomes between those who received an IVC filter and those who did not. The findings were remarkable. Researchers found no noticeable difference in the survival rates of people who had IVC filters implanted and those that did not. In fact, the patients who had IVC filters experienced an increase in rates of deep venous thrombosis.

This sort of ineffectiveness is particularly troubling in light of the failure rate of these devices. A study performed at York Hospital in Pennsylvania looked at the safety of implanted IVC filters. This study found that 16% of devices had fractured, and that in three-quarters of these instances, the pieces had travelled to the heart.

If you or a loved one has an IVC filter, now is the time to reach out to an attorney who can evaluate your case and see if you are eligible for compensation. The attorneys at McSweeney / Langevin focus on this type of litigation, and they are ready to help you. Give us a call today. When Injuries Strike / We Strike Back.

1-877-542-4646

On October 18^th, the Judicial Panel on Multidistrict Litigation ordered that all pending Zofran cases be consolidated in the U.S. District Court for the District of Massachusetts. This is a victory for all parents whose children have been harmed by Zofran.

Zofran is an anti-nausea drug that was introduced by GlaxoSmithKline in 1991. Although the drug is not FDA approved for use in pregnant women, approximately one million women are prescribed Zofran each year to help them cope with morning sickness. This type of use, known as “off-label,” is not illegal, but it can mean that the drug presents risks that are not fully understood.

Zofran may be linked to birth defects

Unfortunately, it appears that Zofran use during pregnancy may lead to serious brith defects. Since the drug was released in 1991, the FDA has received hundreds of reports of birth defects in children born to women who took Zofran while pregnant. Data about whether Zofran causes birth defects is still inconclusive, but several studies have shown a correlation between use of the drug and an increased risk for birth defects.

In response to the possible link between Zofran and birth defects, many families across the country have filed suit against GlaxoSmithKline in order to seek answers and receive compensation for the harm that they have suffered. Because so many people have sued GlaxoSmithKline for the same issue, the Judicial Panel on Multidistrict Litigation ordered that all Zofran cases be placed into a single MDL. An MDL gathers up all of the cases from around the country on a single issue and places them in front of one judge. This saves plaintiffs time and money by speeding up the process and eliminating redundant and wasteful discovery.

If you or a loved one has been injured by Zofran, now is the time to act. The attorneys at McSweeney / Langevin are experienced lawyers who focus their practice on dangerous drug and defective device cases. Give us a call. We can help. 1-877-542-4646

In August, the Judicial Panel on Multidistrict Litigation ordered the centralization of all Bard IVC Filter cases in the District of Arizona. This order was an acknowledgement by the court that many people are having problems with their Bard IVC Filters. When cases are centralized into a multidistrict litigation (MDL), it allows all plaintiffs to share the cost of pre-trial work and prevents duplicative discovery. For those who have been injured, this means that litigation is less expensive and takes less time.

Bard IVC Filter patients are experiencing serious side effects

The cases in the Arizona MDL all allege shocking injuries that resulted from the implantation of Bard IVC Filters. One of the most common and serious types of alleged injury occurs when pieces of the filter break off into metal fragments that can travel through the blood stream. These fragments eventually catch and embed themselves in various parts of the body. Sometimes these fragments cause more minor injuries such as bleeding or discomfort, but when fragments end up in the heart or brain, they can cause truly life-altering injuries and even death.

If you or a loved one has an IVC filter, it can be difficult to figure out whether you should be worried or if you have a possible case against the manufacturer. Many people do not even know what brand of filter they have inside of them. We can help you through this scary and confusing time. Medical Device manufacturers have teams of attorneys hired to protect their interests. You deserve to have someone on your team who can make sure that your rights are adequately protected.

We can help. McSweeney / Langevin practices primarily in the area of mass tort litigation. This means that our attorneys routinely take on large corporations to protect the rights of our clients. We are not afraid to do what is necessary to make sure that our clients get the compensation they deserve. If you or a loved one has an IVC Filter, give us a call. We can help you to know your rights and get the peace of mind you need. 1-877-542-4646

In August, all pending Interior Vena Cava (IVC) filter litigation was centralized in Texas and Nevada as part of a Multidistrict Litigation (MDL). MDLs gather up all pending cases against a common defendant arising out of a similar issue, and place them together in front of one judge for all pretrial motions and discovery.

MDLs are great for plaintiffs because, by centralizing cases, time and money can be saved. This means that those who have been injured by defective medical devices can receive more compensation quicker.

MDLs differ from class action lawsuits because in an MDL, each plaintiff files their own case that is a reflection of the specific harm that has come to them. That means that every plaintiff can receive the compensation that makes sense for them rather than simply being a member of a class.

After all of the cases  have been centralized, the first step in an MDL is the Initial Status Conference. This conference allows the parties to inform the court of their issues, and allows everyone to create a plan that will guide the cases going forward. In the IVC Filter MDL, the initial status conference will be held on October 29th.

If you would like to know more about how IVC filters are can be harmful, follow this link.

Now is the time to act if you or a loved one has had an IVC filter implanted. Many of these products are defective, and the only way to know if you are entitled to compensation is to speak with an IVC filter attorney. We can help. Give us a call at 1-877-542-4646, to get a free confidential case evaluation today.