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.

Supreme Court rejects BP appeal of oil spill settlement

Supreme Court rejects BP appeal of oil spill settlement

CBS/AP / December 8 2014, 2:53 PM

NEW ORLEANS – The Supreme Court is leaving in place BP’s multibillion-dollar settlement with lawyers for businesses and residents over the 2010 oil spill in the Gulf of Mexico.

The justices did not comment Monday in rejecting the London-based oil giant’s arguments that lower courts misinterpreted settlement terms and put BP on the hook to pay inflated and bogus claims by businesses.

The court’s decision makes the economic and property damage settlement final, starting a six-month deadline for filing claims, said plaintiffs’ attorney Joe Rice of Mount Pleasant, South Carolina.

BP PLC wanted the court to consider whether people and businesses seeking payments under the settlement included some who haven’t actually suffered any injury related to the spill.

A district court and an appeals court ruled that, under the settlement BP agreed to, businesses do not have to prove they were directly harmed by the spill to collect money – only that they made less money in the three to eight months after the spill than in a comparable pre-spill period.

BP’s Macondo well blew up on April 20, 2010, killing 11 men. An estimated 103 million to 176 million gallons of oil spewed into the Gulf of Mexico before the mile-deep well was capped July 15, 2010. Lawyers for BP and the government agree that 34 million gallons was captured before it could pollute coastal marshes and fishing grounds.

“Today’s ruling is a huge victory for the Gulf, and should finally put to rest BP’s two-year attack on its own settlement,” lead plaintiffs’ attorneys Stephen J. Herman and James P. Roy said in an emailed statement.

The settlement doesn’t have a cap, but BP initially estimated that it would pay roughly $7.8 billion to resolve the claims. The company said it can no longer give a reliable estimate for total cost. The company, which made separate settlements for medical claims and seafood-related business claims, has paid more than $13 billion in claims by individuals, businesses and government entities and another $14 billion-plus on response and cleanup, according to its oil spill website.

BP remains concerned “that the program has made awards to claimants that suffered no injury from the spill – and that the lawyers for these claimants have unjustly profited as a result,” BP spokesman Goeff Morrell said in an emailed statement.

He added, “We will therefore continue to advocate for the investigation of suspicious or implausible claims and to fight fraud where it is uncovered.”

In an interview with “60 Minutes,” Ken Feinberg, the lawyer hired by BP to sort out who was hurt by the spill and who was not, said: One fellow down in Alabama said to me, when I asked him for proof, he said, ‘Mr. Feinberg we do things with a handshake down here.’ I said, ‘That’s fine, but a handshake won’t get you compensation.'”

Feinberg added that it was important to prevent fraud in this case because there will be future catastrophes.

“What happens the next time, in terms of a company’s willingness to do something similar?” Feinberg asked.

BP Senior Vice President Geoff Morell gave “60 Minutes” examples of what they believed where fraudulent claimants: “We’re talking about a wireless phone company store that burned to the ground and shut down before the spill. An RV park owner that was foreclosed upon before the spill. And I love this one. A Pontiac dealer who could no longer sell Pontiacs because GM had discontinued the line before the spill.”

James Roy, one of the victims’ lawyers, told “60 Minutes” he does not feel sorry for the oil giant.

“BP got a good settlement,” Roy said. “And BP was represented by very, very good lawyers who were worthy adversaries who fought tooth and nail for their client. And it was a hard-fought settlement. Their own lawyer said it was a very generous settlement.”

The 5th U.S. Circuit Court of Appeals did get the method for calculating losses changed after BP argued that claims administrator Patrick Juneau wasn’t correctly matching business’s revenues and expenses. The company has been trying to oust Juneau. U.S. District Judge Carl Barbier rejected its claims but BP went to the 5th U.S. Circuit Court of Appeals.

A third-party audit of the settlement program, made public in November, found that it correctly processed 99.5 percent of claims. Chicago-based McGladrey LLP described the program as “well-designed and appropriate.”

 

 

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.

 

Quote of the Day 8-25-2014

“There is one way in this country in which all men are created equal -there is one human institution that makes a pauper the equal of a Rockefeller, the stupid man the equal of an Einstein, and the ignorant man the equal of any college president. That institution, gentlemen, is the court.”

-Atticus Finch – To Kill a Mockingbird

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.