Category Archives: Product Liability

Invokana and similar SGLT2 Class drugs

Invokana and similar SGLT2 class drugs used to treat Type 2 diabetes are being investigated for causing serious side effects including:

  • Kidney Failure
  • Diabetic Ketoacidosis
  • Dehydration Requiring Hospitalization
  • Heart Attack
  • Stoke
  • Death

SGLT2 class drugs:

  • Invokana® (canaglifozin)
  • Invokamet® (canaglifozin and metformin)
  • Farxiga® (dapaglifozin)
  • Xigduo XR® (dapagliflozin and metformin extended-release)
  • Glyxambi® (empagliflozin and linagliptin)

To refer a case contact Shane or Rebecca Langston at Langston Lawyers, PLLC

 

Silent Recalls

Apr 15, 2015
by Jamie Schaefer-Wilson
The Safety Institute (TSI) has discovered that some manufacturers – including an ATV maker with models that catch fire – are bypassing the recall process of the U.S. Consumer Product Safety Commission (CPSC) by directly offering repairs or remedies to customers who complain about a defect.

These maneuvers are also known as silent recalls: a manufacturer tries to address a safety problem by offering a safety fix or new product without notifying the appropriate government agency and working with them on the mandated recall process. It’s not an accepted industry practice nor condoned industry-wide. Nonetheless, circumventing the recalls process is a significant potential consumer safety issue.

While researching consumer complaints in the Saferproducts.gov database we found seven manufacturers offering remedies directly to consumers in response to their complaints registered in the database. The products ranged from an ATV, a child’s backpack carrier, a crib/toddler bed, patio heater, portable heater, electric scooter and a treadmill. The repairs ranged from repair kits to advice on how to repair a potential defect.

And these recalls are not so silent – all of these incidents were found on CPSC’s website. Saferproducts.gov, monitored by the CPSC, is designed to capture consumer complaints and potential safety defects. It appears it has also been used to sidestep the recall process without somehow eliciting a red flag from agency staff. The CPSC did not respond to TSI’s questions about specific examples. Instead, Alex Filip, CPSC’s Deputy Director, Office of Information and Public Affairs, said:

“CPSC’s Office of Compliance has and continues to initiate a number of investigations as a result of manufacturer comments posted on SaferProducts.gov and other internet review sites.” 

Bypassing the Recall

One of the most egregious defects concerns an ATV, manufactured by Hisun Motors Corp, USA, with an unshielded exhaust system which could result in a vehicle fire. The issue was communicated to the CPSC staff by an ATV dealer who called the CPSC hotline to report the incident and the repair kit. The staffer registered the complaint and the repair into the saferproducts.gov database.

Here’s the consumer complaint from saferproducts.gov:

“The dealer stated that the driver came home and parked the ATV on his driveway. The driver turned off the engine and about 10 minutes later, he noticed smoke and flames coming from the rear of the ATV. The dealer stated that within 45 seconds, the ATV had engulfed in flames. The driver had driven the ATV on the day of the incident for 30 miles. The dealer and the driver believe that the incident occurred due to the unshielded exhaust. The dealer stated that the unshielded exhaust caused the rear floor panels to melt, lower down, and ignite.”

Here’s what the dealer told CPSC about the manufacturer’s response:

“The manf informed the dealer that they were aware of the problem and that all of the newer models were being sent out with a repair kit. The dealer was also sent a repair kit for another model he has in his shop. The dealer stated that the kit includes a whole new exhaust system that is shielded. The dealer stated that he has the leftover metal frame of the ATV that ignited. There are no recalls on this vehicle.”

The second serious example involves the Kelty Pathfinder backpack child carrier, manufactured by American Recreation Products. This product designed for children 16 to 40 pounds, apparently has straps that aren’t maintaining their integrity. Again, the manufacturer admits to the problem and offers a free replacement. There is no recall for this product and the replacement has not been tested by the CPSC.

Here’s the consumer complaint:

Kelty Pathfinder red straps disintegrated. All buckles attached with the red straps just pop off.

Here’s the response from American Recreation Products, Inc.:

This does appear to be a quality issue we are experiencing with this product. It also appears to be limited to Child Carriers with the red strapping, we’re thinking a “lot” issue. Anyone experiencing this product can contact Kelty Customer Service for a free replacement.

“Manufacturers are skirting the CPSC requirements in plain view. The Commission needs to take a firm stance on this issue to ensure that all consumers get the benefit of recall repair on known defects,” said Sean Kane, founder and president of the board of directors of The Safety Institute.

The Recall Process

When a product has a suspected defect that could lead to injury or death, the manufacturer must report the problem to the CPSC as soon as they learn of it. Often, they learn through testing or they discover it when consumers contact them with possible product defect issues.

No matter how the potential hazard is discovered, manufacturers have an obligation to report to the CPSC in a timely manner when there is reason to believe a substantial product hazard exists. According to the CPSC’s recall handbook, the reporting requirements are as follows:

“A. Section 15(b) of the Consumer Product Safety Act establishes reporting requirements for manufacturers, importers, distributors and retailers of consumer products, or other product or substances distributed in commerce over which the Commission has jurisdiction. Each must notify the Commission immediately if it obtains information which reasonably supports the conclusion that a product distributed in commerce (1) fails to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard upon which the Commission has relied under section 9, (2) fails to comply with any other rule, regulation, standard or ban under the CPSA or any other Act enforced by the Commission, (3) contains a defect which could create a substantial product hazard, or (4) creates an unreasonable risk of serious injury or death.

Section 15 requires firms to report “immediately.” This means that a firm should notify the Commission within 24 hours of obtaining information described in section A.1.”

If the product is a potential safety danger to consumers the CPSC will work with the manufacturer on a remedy. There are three possible remedies – recall, replace or repair. If there is a repair kit involved it is analyzed by CPSC engineers and they approve the kit/fix before it is offered to consumers. In other cases, the product is pulled completely and refunds or replacements are offered.

What’s Next

TSI informed the CPSC about the incidents above – along with others in which a manufacturer has acknowledged a defect and has offered a repair or remedy. TSI has no problem with manufacturers offering repairs for defective products. But it is not sufficient to simply reach out to consumers offering a remedy, repair or replacement. This needs to happen within the recall system. Repairs offered only after a product fails do not prevent the next injury or death, and prevention is at the heart of the recall system.

We urge the CPSC to examine these incidents and act.

Link to story: click here

 

 

Xarelto side effects

Have you or a loved suffered from taking Xarelto?

Patients were not properly warned of the side effects of Xarelto, i.e uncontrollable internal bleeding and that this bleeding could not be reversed as easily as with other anticoagulants.

Other serious and Life-threatening Side Effects:

  • Uncontrolled bleeding events
  • Gastrointestinal Hemorrhage
  • Hematoma
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Hemoglobin Decrease
  • Cerebrovascular Accidents
  • Peripheral Edema
  • Dyspnea

Symptoms of Xarelto bleeding side effects may include:

  • Lethargy
  • Unusual bruising or bleeding
  • Pink or brown urine
  • Red or black tarry stools
  • Coughing up blood
  • Vomiting that resembles blood or looks like coffee grounds
  • Headaches
  • Bleeding from the gums
  • Frequent nose bleeds
  • Weakness and swelling in the hands, arms, lower legs, ankles or feet
  • Joint pain or swelling
  • Dizziness
  • Death

Call Langston Lawyers PLLC at 877-LAW-0008 for more information.

Drug company funding drug study to obtain desired results

A recent survey of clinical trials revealed that when a drug company funds a study, there is a 90 percent chance that the drug will be perceived as effective whereas a non-drug company-funded study will show favorable results 50 percent of the time. Drug companies that basically “purchase” the scientific result they want often results in a defective and harmful pharmaceutical.

If this practice has brought harm to you or a loved one, call us, help stop this abuse.

 

Ovarian Cancer after using talcum powder?

Talcum powder and ovarian cancer:  As many as 10,000 cases of ovarian cancer diagnosed each year may have been caused by regular use of talcum powder. Talcum powder is used to absorb moisture and is widely available in various products including baby powder and adult products including body and facial powder. Talc products used regularly in the genital area could increase the risk of ovarian cancer if the powder were to travel through the vagina, uterus and fallopian tubes to the ovaries. A jury recently found consumer health care products manufacturer Johnson & Johnson knew of the cancer risks associated with its talc products but failed to warn consumers.

Call Langston and Langston 888-329-0827

Heart attack or stroke after Testosterone therapy

Testosterone Replacement Therapy products for men have been linked to an increased risk of death, heart attack and stroke. In one study, researchers found men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use. A second study found that men had a significant increase in risk of heart attack and stroke in just the first 90 days of testosterone therapy use. Testosterone therapy, such as the prescription topical treatments Androgel, Testim and Axiron, are used to help boost testosterone levels in men who have “Low T,” a deficiency of the male hormone.

Call Langston and Langston 888-329-0827

 

 

By: Irvin Jackson | Published: May 1st, 2014 (AboutLawsuits.com)

A new report warns that use of the atypical anti psychotic medication Risperdal to treat autism may help reduce tantrums and improve focus, but it carries potentially serious risks, including weight gain, sleepiness and other side effects.

Risperdal (risperidone) was originally introduced for adults with schizophrenia, but it has been widely used for children with bi-polar disorders, autism, irritability, aggression and behavior disorders. It was the first drug ever approved by the FDA for treatment of some autism symptoms, and is the most widely known. In addition, it has been widely used off-label to treat hyperactivity and to reduce repetitive behaviors.

A report by the Simons Foundation Autism Research Initiative released this week, highlights a number of concerns over the potential side effects of Risperdal for autism treatment.

While experts indicate that Risperdal definitely can reduce tantrums and help autistic children focus on other methods of treatment, they also warn that it carries a serious risk of weight gain and fatigue. In addition, not everyone who is given the drug experiences the benefits and the problems frequently return when its use is stopped, experts told the Initiative.

On average, children given Risperdal experience about six pounds of weight gain within eight weeks of beginning therapy. While that may not seem like much to a 140 pound adult, for a 60 pound boy that gain is significant.

Weight gain associated with Risperdal and other atypical anti psychotics has also been associated with an increased risk of childhood diabetes. An August 2013 study published in the medical journal JAMA Psychiatry found that side effects of Risperdal and other similar drugs may triple the risk of diabetes for children.

Use of Risperdal among young boys has also been linked to a rare disorder known as gynecomastia, which involves the abnormal growth of breasts among males. Due to the known weight gain associated with the drug, these Risperdal breast development problems are often not immediately diagnosed until the breast growth significantly outpaces the weight gain.

In recent years, Johnson & Johnson has been facing a growing number of Risperdal gynecomastia lawsuits brought on behalf of teens and young adults, which allege that the drug maker failed to adequately warn consumers or the medical community about the risks associated with the medication. In some cases, plaintiffs indicate that boys using Risperdal have developed breasts measuring as large as a 38D cup size, often resulting in the need for surgical removal of the breasts.

This latest report published by the Simons Foundation Autism Research Initiative concludes that Risperdal should be used with caution, and only for children with the most serious autism symptoms, and only after other treatment options have failed.

 

 

Do you have CSST Piping installed in your home?

If you have Corrugated Stainless Steel Tubing (CSST) installed in your home you may be at risk for fire damages caused from lighting. You may be eligible to file a claim against the manufacturer for related costs and further damages. Click this link: Langston CSST Piping Contact Form for a free case evaluation. Do not wait, the time to act may expire!

Fire Marshal, Family Blame Fatal Fire on CSST

A Lubbock fire marshal is joining a North Texas family in blaming corrugated stainless steel tubing for a fatal fire and explosion that claimed the life of their son.

Brennen Teel was visiting friends Ross and Meg Rushing in Aug., 2012, when a clap of thunder was heard over their Lubbock home. Moments later, the burglar alarm sounded and the Rushing’s couldn’t turn it off.

Brennen and Ross went to get a ladder from the garage to disable the security system.

“That’s when the explosion happened,” said Ross Rushing. “Honestly, I thought I was dead immediately.”

Meg grabbed the children and headed for the door. Ross climbed out from under the buckled garage door, but he couldn’t find Brennen in the thick black smoke.

Firefighters would later find Brennen’s body in the garage. They believe he opened the drop down attic staircase, not knowing the attic was on fire. Oxygen rushed in, causing a backdraft explosion.

“I would not wish this on anybody. Anybody. This has been a nightmare,” said Ken Teel, Brennen’s father.

Garett Nelson, the Lubbock Fire Marshal, determined the fire started with the yellow corrugated stainless steel tubing in the attic. CSST are flexible tubes used to pipe gas to furnaces and appliances in many newer homes.

At least six companies make yellow CSST in the United States and it’s approved by The National Fire Protection Association, which writes the building codes for gas piping.

Nelson doesn’t believe a fire such as this would have occurred if the home hadn’t been constructed with CSST.

“I think it would be very safe to say, no, not the same way,” Nelson said.

Nelson believes lightning hit the chimney cap, traveled into the attic, jumped or arced onto the CSST and punctured tiny holes in the thin walls of the tubes that released and ignited the gas, creating mini blow torches.

“Now we’ve got flame jets coming out of those pipes, so it very quickly involved the entire attic,” said Nelson.

Believing the CSST contributed to a death, the City of Lubbock issued a moratorium that bans contractors from installing the tubing.

“This needs to end with Brennen Teel. That needs to be the last fire death that is created because of a bad product,” said Nelson.

The company that made the CSST in the Rushing’s home said their product is not to blame.

Titeflex declined an on camera interview but in a statement William A. Brewer III, a lawyer representing the company said, “Naturally, we are deeply saddened by the accident. However, we believe the claims advanced against our client are without merit.” (Read the entire statement here.)

The company’s experts believe the fire and explosion were caused by lightning damage to electrical wiring which ignited foam insulation in the attic. Insulation they will argue was improperly installed. A claim the insulation company denies.

“They do that in every case. That’s their defense, their modus operandi is blame someone else, blame anybody, blame the plumber, blame the electrician,” said Ted Lyon, the Teel family attorney.

Experts Lyon consulted with have no doubt the fire started with the CSST, including expert Mark Goodson who is an engineer and a scientific adviser to the state fire marshal’s office.

Goodson has personally investigated more than 200 CSST cases and has testified against CSST manufacturers in other fires.

For more than a decade he’s looked at cases where fire departments across the country have reported holes in CSST after lightning storms.

In his lab he punched a hole in a piece of CSST similar in size to holes he’s seen in actual fires to show NBC 5 Investigates what the jet of flame from a hole in CSST can look like.

Goodson said the fire can continue to burn from the pipes, like a blow torch, until the gas is cut off. Meanwhile, the fire can grow faster due to the constant supply of flammable gas.

“That’s what distinguishes them from many other types of fires, is the blow torch effect, and how fast the fire develops,” said Goodson.

The CSST industry claims fires are unlikely to happen if the CSST is properly connected or “bonded” to the electrical grounding system in the house.

The National Fire Protection Association’s committee on the issue of CSST safety recently said bonding and grounding CSST provides “a reasonable level of safety,” but the agency has not made a final decision on use of the product in future versions of the building code. In 2010 NFPA warned manufacturers they might prohibit CSST in the future if manufacturers couldn’t show bonding and grounding reduces the risk.

A recent industry supported study by the Gas Technology Institute found bonding and grounding CSST will reduce the risk of damage during, “…nearby lightning strikes.”

But when it comes to lightning that hits the house directly, the study found bonding and grounding, “does have limits” and “ … a direct lightning strike may carry enough charge to cause damage …”
Bob Torbin, one of the men who pioneered CSST, recently spoke to firefighters in Dallas. The company he works for is not involved in the Lubbock case.

He declined to be interviewed on camera but argues CSST is no more of a risk than many other things that can spark a fire if a home takes a direct hit by lightning.

“There’s nothing in your house that’s lightning proof,” said Torbin.

Some fire investigators said the difference between CSST and other things in the home that can spark a fire is that CSST carries flammable gas that can continue to feed a fire.

“So they’re assuming if it’s a direct strike, all bets are off, they know that,” said Nelson. “There are direct strikes. It’s not like they don’t happen.”

Critics of CSST argue the walls of the tubing are simply too thin, much thinner than the old black iron pipe that was used to supply gas in homes for decades.

“I will state that in almost 30 years of looking at fires I have never seen black pipe fail from lightning,” said Goodson.

CSST manufacturers said their product is safer than black iron pipe — which has more joints that can leak causing explosions. Black pipe is not flexible and can crack in an earthquake or tornado or when a home foundation shifts.

Meanwhile, the Teels insist they’ll continue to speak out and won’t settle their lawsuit unless Titeflex agrees to changes.

“We have a voice now. Brennen’s story is not over just because he’s gone,” said Becky Teel, Brennen’s mother.

“The bottom line is we expect them to take the product off the market. That’s minimum,” said Ken Teel.

They’re frustrated that Titleflex now makes a new black-coated CSST called “flashshield” that’s advertised as more being more lightning resistant. But the company still sells the old yellow version as well.

“So they made something safer. But they continued to leave the other on the market,” Becky Teel said.

Titeflex insists yellow CSST is still safe. Brewer, the company’s attorney said, “We have complete faith in this product.”

Brewer believes the Lubbock Fire Marshal reviewed only studies commissioned by the Teel’s attorneys in determining to issue a moratorium on the use of CSST.

“Many may find that to be questionable, if not irresponsible. Many national regulatory bodies and fire safety agencies have found CSST, when properly installed, to be safe and effective,” Brewer said.

Fire Marshal Nelson responded, telling NBC 5 Investigates, “To say that all we considered was one side of the information is pretty disingenuous.”

Nelson said he has also read independent research trying to make the best decision for his community. He said he based his initial decision on the fact that a death occurred and that his department had seen other fires involving CSST. Nelson said he’s given the manufacturer opportunities to present him more information but has not received any so far.

More than a year after the fire in Lubbock, Brennen Teel’s parents want him to know their fight for answers isn’t over.

“After the explosion, we never found his cellphone. That number’s still alive. I text him often, fill him in on where we are,” said Ken Teel.

Source: http://www.nbcdfw.com