Category Archives: Product Liability

New child safety seat regulations take effect in 2014 – are you ready?

New child safety seat regulations take effect in 2014 – are you ready?

In early 2014, a new amendment to a law stating that the LATCH (Lower Anchors and Tethers for Children) Restraint System should not be used when the combined weight of the child and car seat is more than 65 pounds will go into effect. LATCH systems have been required in cars since 2001, and have been effective in preventing injury to children, but the strength of the anchors cannot be guaranteed when the 65-pound limit has been exceeded by the joint weight of the car seat and child.

LATCH-equipped vehicles have at least two sets of small bars, called anchors, located in the back seat where the seat cushions meet. LATCH-equipped Child Restraint Systems (CRSs) have a lower set of attachments that fasten to these vehicle lower anchors. Most forward-facing CRSs also have a top strap (upper tether) that attaches to a top or upper anchor in the vehicle. Together, they make up the LATCH system. LATCH was designed to make child seats safer and easier to install.

But usually weighing between 15 to 33 pounds, some child seats are heavy enough on their own to prevent children as light as 32 pounds from using the LATCH system. The American Academy of Pediatrics has recommended that until the age of 8, children should remain in harness (including 5 point harness or booster with seatbelt), prompting car seat manufacturers to begin developing child seats with higher weight limits.

The current anchor requirements have been criticized by Joseph Colella, one of the five child-safety advocates who petitioned the National Highway Traffic Safety Administration (NHTSA) to complete the rule change. He and other advocates have found that the lower anchor weight requirements are based on older model child seats and the recommendations of how long children should be in child seats are outdated.

Another advocate of amending the law was the Alliance of Automobile Manufacturers, which sought the rule change after studies found that weight limits did not take into account how much the child seats weigh.

However, usage and awareness of the LATCH system is already low. A study performed by Safe Kids Worldwide, an organization that has become an authority on unintentional childhood injury prevention, discovered that most people are using the lower anchors only around 30 percent of the time. The top tether straps, designed to prevent head injuries among children, were also only used in about 30 percent of vehicles.

“Disconnecting tethers when their use is needed … could lead to a tragedy,” Stephanie Tombrello of advocacy group SafetyBeltSafe told USA Today.

To ensure you are meeting current guidelines with child seat regulations, first weigh your child, then weigh the child safety seat, then add the two weights together. If the weight of the child and child seat together exceeds 65 pounds, start using a seat belt restraint instead of the LATCH system until you find an updated child seat supporting the combined weight.

“While LATCH makes it easier to properly install car seats in vehicles, it’s important for parents and caregivers to know that securing a child seat with a seat belt is equally as safe — and that they have the flexibility to use either system,” says Transportation Department spokeswoman Lynda Tran.

The NHTSA reports child safety seats, or child restraint systems (CRS) are the most effective way to protect babies and young children in the event of an automobile accident. Statistics show that when child safety seats are properly installed and used, they reduce the chance of serious injury or death in a vehicle crash by as much as 71 percent. But these restraints cannot work if they are not installed properly. Sadly, three out of every four child restraints are not properly used.

Every year, thousands of children are tragically injured or killed in automobile crashes. For children ages 3-6, and 8-14, it is the leading cause of death. It is impossible to overstate the toll this takes on families. All 50 states and the District of Columbia and our territories have laws requiring the use of safety seats, booster seats and seat belts for children traveling in motor vehicles.

USA Today

Endo Health offers $54.5 million to settle some vaginal mesh cases

Endo Health offers $54.5 million to settle some vaginal mesh cases

(Reuters) – A unit of Endo Pharmaceuticals Inc said it has agreed to pay $54.5 million to settle some of the thousands of lawsuits in North America that it is facing over injury claims stemming from the use of transvaginal surgical mesh products.

Endo unit American Medical Systems Inc announced the settlement in a regulatory filing with the U.S. Securities and Exchange Commission on Thursday. The company did not disclose how many cases would be resolved by the agreement, in which the company did not admit any liability or fault.

AMS estimated its potential liability as of March 31 from all current and future vaginal mesh cases to be at least $160 million, according to another SEC filing. Settlement details were not disclosed.

AMS is one of several companies facing thousands of lawsuits over transvaginal mesh devices in U.S. state and federal courts, as well as Canada. The devices are designed to treat pelvic organ prolapse and stress urinary incontinence.

Market data submitted to the FDA showed that in 2010, approximately 300,000 women underwent surgery for pelvic organ prolapse, and roughly one in three of those used mesh. That same year, about 260,000 women underwent surgery for stress urinary incontinence, 80 percent of which involved transvaginal mesh.

Plaintiffs in the lawsuits have alleged a variety of injuries stemming from the devices, including chronic pain and incontinence.

In 2008, the U.S. Food and Drug Administration notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other transvaginal device makers to conduct post-market safety studies and monitor the rate at which adverse events were reported.

AMS said it has been hit with thousands of lawsuits since 2008 and expects the number to climb, according to a regulatory filing from May. As of April 26, there were approximately 7,700 mesh cases pending against AMS, Endo and certain subsidiaries,  an SEC filing said.

A spokesman for Endo did not immediately return a request for comment Friday.

Shares in Endo were down .32 percent or 12 cents to $37.38 in late afternoon trade.

Transvaginal Mesh Injuries

Transvaginal meshes have been shown to cause numerous injuries, including:
– Infections
– Internal bleeding
– Nerve damage
– Perforation of other organs and blood vessels
– Erosion of the vaginal mesh
– Problems/pain urinating
– Return of the condition treated (incontinence or pelvic recurrence)
– Pain during sexual intercourse

Thousands of women have already brought lawsuits against TVM companies for their vaginal mesh injuries. One woman recovered more than $11 million, including $7.76 million in punitive damages, after her transvaginal mesh eroded and caused her to undergo 18 surgeries to repair the damage.
If you have been injured by your transvaginal mesh, you can and should hold your TVM company accountable. Contact Rebecca at Langston & Langston PLLC.


GranuFlo and Naturalyte

GranuFlo and Naturalyte are dialysates, used to treat acute and chronic kidney failure during hemodialysis. On May 25, 2012, the FDA issued a safety communication, warning that there had been complaints about dosing errors during hemodialysis, which could cause increased bicarbonate levels. Increased bicarbonate levels can cause metabolic alkalosis, which is associated with cardiopulmonary arrest, low blood pressure and cardiac arrhythmia.

Both products have been recalled and it has been alleged that the risks involved with using these products were not adequately disclosed. If proper warnings had been issued, health care providers would not have used these products.

If you or someone you know has been harmed by these products, please contact us at 1-888-329-0827 or you can simply sill out our online contact form for a free assessment of your case.

Side effects and direct injuries that can be caused by Pradaxa

Side effects and direct injuries that can be caused by Pradaxa

Potential Injuries:
•Brain hemorrhage
•Joint pain
•Intestinal problems
•Joint Inflammation
•Kidney bleeding
•Internal bleeding

Symptoms of excessive internal bleeding:
•Bleeding that lasts a long time
•Coughing up blood
•Joint pain
•Red or black stools
•Uncontrollable, severe bleeding
•Urine that is pink or brown
•Vomit that looks like coffee grounds
•Vomiting blood

If you or a loved one has experienced one or more of the following after being treated with Pradaxa please contact us.

Pradaxa sales have exceeded $1 billion

Pradaxa has generated more than a billion dollars for Boehringer Ingelheim since first reaching the market in 2011. In 2013, projected sales are worth $603,000,000.

Pradaxa’s success has been largely attributed to an aggressive marketing campaign by Boehringer Ingelheim, conducted at a cost of $67,000,000 during the year leading up to its release. Pradaxa was promoted as a more effective alternative to the widely-used warfarin, which requires frequent blood monitoring and dosage adjustments.

According to the Pradaxa gastrointestinal bleed lawsuit filed in Texas, there were 272,119 prescriptions written between October 2012 and March 2011. During the same period, 932 “adverse event reports” were submitted to the FDA, including 120 Pradaxa related deaths and 500 cases of severe internal bleeding. A further 856 adverse event reports were filed in the subsequent three months, 117 of them pertaining to death.

If you or a loved one have taken Yaz you need to read this.

Yaz and Yasmin both use a new type of progestin hormone called drospirenone, which was designed to reduce many of the side effects of earlier birth control pills. However, researchers have now discovered that this chemical may contribute to more serious health risks.

In early FDA clinical trials, Yaz research identified risks with drospirenone, finding that the hormone could increase the level of potassium in the blood, leading to heart attacks and blood clots.

In August of 2009, The British Medical Journal published two independent studies conducted in Denmark and The Netherlands. Both found that women taking drugs like Yaz and Yasmin, with the hormone drospirenone, had higher risks for blood clots.

The British Medical Journal published further Yaz research in October of 2011 with a study from the University of Copenhagen finding that drugs like Yaz could increase the risk of venous blood clots.


FDA Blood Clots Risk Study

On October 27, 2011, the FDA released its own study of more than 800,000 women. Although it reached similar results, the FDA study quantified that drugs like Yaz containing drospirenone could actually increase the risk of blood clots by as much as 74%.

With such high occurrence rates and estimates that more than 80 million women have taken these birth control drugs, it came as little surprise when The Institute for Safe Medicine Practices reported that Yaz and Yasmin ranked second highest in 2011 for the number of complications reported to the FDA.

With Yaz research mounting and more than 10,000 lawsuits filed by women alleging serious side effects, Bayer announced in early 2012 that it would begin settling injury claims. The company has reserved more than $1 billion to settle these claims and continues to resolve cases for those affected.