FDA Calls for Label Changes on Blood Pressure Medication Benicar®

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The U.S. Food and Drug Administration (FDA) has completed a safety review of Benicar® and other olmesartan drugs and has requested that drug manufacturers update the labels on these drugs.

According to the FDA, the labels should include information about some of these studies and reviews. The safety review by the FDA was prompted by results of a ROADMAP (Randomized Olmesartan and Diabetes Micro albuminuria Prevention) trial that examined the effects or using olmesartan in patients with type 2 diabetes.

Although the FDA believes there was no clear evidence of medical complications, the ROADMAP trial has found that there was an increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo. The FDA believes that the benefits of olmesartan drugs outweigh the potential risks, however, patients are advised to speak with their healthcare professionals about any concerns they have taking the drug.

A different study, the Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial, also suggested that a high-dose of olmesartan could result in cardiovascular risks among diabetic patients.

This data raises concerns of possible cardiovascular disease risks among diabetic patients who use Benicar, Benicar HCT and other olmesartans. If you begin to experience cardiovascular disease symptoms such as chest pain, shortness of breath or heart arrhythmias, speak to your doctor right away.

This is the second time the FDA has approved labels for Benicar in less than two years. In 2013, the FDA called on drug manufacturers to include information on the link between Benicar and gastrointestinal problems. Many consumers who have taken Benicar and Benicar HTC have suffered spru-like enteropathy symptoms, which can be similar to symptoms of Celiac disease.

If you or someone you know has suffered serious side effects prior to these label changes, the victim may be entitled to file a Benicar lawsuit. The attorneys at Phillips Law Group can help you determine what your legal rights are.

Call us at 1-800-706-3000 or fill out the Free Case Review form on this page to schedule a free legal consultation.

8 Common Workplace Violations

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Employment Law in Arizona

Employment laws can vary from state to state, but knowing what your legal rights are in the workplace can help you determine if your employer is violating the Fair Labor Standards Act.

From overtime to vacation pay to bonuses, employers are known for violating certain employment laws. Here are eight of the most common workplace violations.

Unpaid Vacation Time
The Fair Labor Standards Act (FLSA) states that if an employer does provide vacation time, the time accrued should be part of the compensation you receive. If you were fired or quit, you’re entitled to the vacation time you accrued, per company policy.

"Use it or Lose" it Vacation Time
Use it or lose it vacation policies are illegal in some states, including California. In 2013, a California court declared one company’s policy illegal and claimed that the policy violated the California Labor Code.

Failing to Pay Commission or Bonuses
Although commission and bonuses are not regulated by the FLSA, if you and your employer came to an agreement about such compensation, you are entitled to receive the commission or bonus promised – depending on your state’s laws.

Unpaid or Improperly Calculated Overtime
Under the FLSA, overtime pay rules are based on a standard 40-hour work week. Employees who work over 40 hours must be paid at a rate of one and one-half times their regular hourly rate. Make sure you are keeping track of the hours you have worked and that your employer is following the federal overtime guidelines.

False Reporting
When non-exempt employees work overtime, some employers will look the other way or will not allow the hours to be reported. If an employer does not allow you to report overtime or fails to pay you for these hours, their actions do not comply with the FLSA.

Violating Federal Minimum Wage Standards
As of July 2009, the federal minimum wage is $7.25 per hour. Some exceptions, however, include student workers and disabled workers who may be paid at a lower rate. Young workers may also be paid less during their first 90 days of employment. Additionally, workers who receive tips on the job may be paid a minimum rate of $2.13 per hour.

Offering Comp Time Instead of Overtime Pay
In some cases, an employer may opt to provide an employee with comp time instead of overtime pay. Comp time is basically paid time off; however, employers are the ones benefiting from this because if they paid you overtime then they would be required to pay you time and a half.

If you suspect that your employer is violating the Fair Labor Standards Act, the employment law attorneys at Phillips Law Group can help you. Contact us today by filling out the Free Case Review form on this page.

General Motors Recalls Additional 3.16 Million Vehicles

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Yesterday, General Motors announced a recall of 3.16 million additional vehicles, which brings the total number of vehicles recalled this year in North American to approximately 20 million.

The new recall will bring in vehicle models from the years 2000 through 2014 in order to replace the ignition keys. The current keys and ignition switch may cause the key to turn when the vehicle is jostled by railroad tracks, potholes, or other obstacles.

Though this recall sounds similar to past recalls which are the subject of multiple lawsuits, GM says that this switch problem is different than the faulty ignition switch problems with the Chevy Cobalt.

The makes and models of the newly recalled vehicles are:

  • Buick Lacrosse, 2005-2009
  • Chevrolet Impala, 2006-2014
  • Cadillac Deville, 2000–2005
  • Cadillac DTS, 2004–2011
  • Buick Lucerne, 2006–2011
  • Buick Regal LS & GS, 2004–2005
  • Chevy Monte Carlo, 2006–2008

Vehicles affected by the recall should be taken to a General Motors dealership for repairs. For more information on the GM recalls, visit Phillips Law Group’s GM Timeline page.

If you believe that a faulty vehicle part caused your accident, contact Phillips Law Group today at (800) 706-3000. 

Pradaxa Blood Thinner Lawsuits Settled for $650 Million

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The German pharmaceutical company which developed and marketed Pradaxa has agreed to settle almost 4,000 lawsuits over the blood thinner for a total of $650 million dollars. 

Pradaxa is accused of causing over 500 deaths and more than 3,000 bleeding-related complications. The $650 million settlement should give each claimant an average of $162,500. 

The plaintiffs in the Pradaxa lawsuits allege that the drugmaker was aware of problems with bleeding-related complications before the drug was submitted for FDA approval in 2010. After it passed the FDA process, patients and doctors reported 3,781 bleeding side effects and 542 deaths associated with the drug in 2011. 

The FDA approved Pradaxa as a drug similar to Coumadin, or warfarin, meant for preventing strokes caused by blood clots. Because of the mechanism of these types of drugs, some risks of bleeding complications are inevitable. However, the plaintiffs alleged that Pradaxa could cause a patient to bleed to death with no way to control or stop the medication. In fact, a Pradaxa “antidote” was developed shortly after the drug was approved, and has earned Boehringer an additional billion dollars in sales. 

The news of the settlement came shortly after evidence emerged revealing that Boehringer had concealed 22 serious bleeding complications during the FDA approval process. Additionally, the judge presiding over 2,500 of the Pradexa complaints handed down almost a million dollars’ worth of sanctions against the pharmaceutical company after it failed to preserve “countless” important records on the development and manufacturing of the drug. 

These sanctions may have influenced the drug company’s decision to settle. Legal observers also note that Boehringer may be attempting to avoid even greater sanctions, like those handed down to other pharmaceutical companies for destroying records.  The company maintains that it has committed no wrongdoing, and is simply settling the case to avoid prolonged litigation expenses. 

To read more about this story, go to: http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html

President Obama Vows to Investigate Phoenix VA Hospital

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The President briefed the country Wednesday about the growing controversy centered around the Phoenix VA Hospital.

For the past month, allegations have been swirling accusing the Phoenix VA of widespread impropriety and maintaining secret waiting lists which kept veterans waiting months for treatment. At least 40 veterans are believed to have died while languishing on a hidden waiting list.

President Obama addressed reporters on Wednesday, saying “When I heard allegations of misconduct — any misconduct, whether it's allegations of VA staff covering up long wait times or cooking the books — I will not stand for it, not as commander in chief, but also not as an American,"

Controversy Grows

At least 26 VA facilities nationwide are being investigated for their patient practices.  The Phoenix VA Hospital, where the controversy first erupted, faces some of the most egregious accusations.

To hide a large backlog in patients waiting to be seen, the Phoenix VA developed a secret waiting list for patients which was different than the reports the VA provided to Washington.

According to several whistleblowers, when a veteran would come to the Phoenix VA Hospital seeking treatment, VA employees would make him or her an appointment on their computer system, but would not save it. Instead, a copy of the appointment computer screen was printed out, and the electronic information was deleted. The information from the hard copy paper printout was then used to place the veteran on the secret list, where he or she might say for several months or even years until an appointment could be made. Once an appointment was made for the veteran, his or her information was re-entered into the computer shortly before the date of the appointment and saved—making it appear that the veteran had only waited a few days from the time he or she sought an appointment to the time that he or she actually saw a physician. Whistleblowers estimate that at least 1,400 to 1,600 veterans are currently on this secret list.

Email communications obtained by CNN show that the hospital’s top management, including Phoenix VA Hospital Director Sharon Helman, were well-aware of the practice and even defended its use to VA employees.

Washington Investigates

A top white house aide is heading to Phoenix to analyze the situation. All records, secret or not, have been ordered to be preserved for the official review, though VA Secretary Eric Shinseki has acknowledged that some notes and records were already destroyed.

In addition, the House of Representatives has passed the VA Management Accountability Act, meant to curb some of these abuses. It is not yet known if the Senate will also pass this Act.

As for Phoenix VA Director Sharon Helman, she was placed on leave after these allegations surfaced. She was also ordered to repay the nearly $10,000 she received in bonus pay from the federal government.

It remains to be seen how these accusations will affect veterans’ health care in the near future or in the long term. One thing is for certain, however: Our veterans deserve better.  

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