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Big Tobacco Ads Are Back, But This Time They Include The Facts

New Tobacco Ads are coming intent on exposing the truth about the lies told by Big Tobacco, keep reading to find out more.  You may have noticed the recent reappearance of cigarette advertisements from the major cigarette manufacturers, Altria, R.J. Reynolds Tobacco, Lorillard, and Phillip Morris USA popping up in print and broadcast. These ads mark another victory against the deceptive practices…

After OSHA Investigation and Fines for inappropriate handling of Asbestos, Davidson County Commissioners vote to take a Proactive Approach to Asbestos — by Funding an Asbestos Survey that will Include 38 County Facilities that are 35+ years old

On October 10, 2017, the Davidson County Board of Commissioners unanimously approved a proposal from TrinityEnvironmental to conduct comprehensive asbestos surveys on 38 facilities around Davidson County. The survey, costing the county $42,000, will evaluate the facilities, locate, and describe the condition of any materials that could potentially contain asbestos. The company will then advise the county and provide training…

A Nationwide Voluntary Recall was issued for EpiPen and EpiPen, Jr. on March 31, 2017.

A Nationwide Voluntary Recall was issued for EpiPen and EpiPen, Jr. on March 31, 2017.

EpipenOn March 31, 2017, the U.S. Food and Drug Administration (FDA) announced a Nationwide Voluntary Recall had been issued for EpiPen and EpiPen, Jr.

The Nationwide Voluntary Recall was issued by the drugs manufacturer MYLAN, due to a potential defect that could cause the device to be infective, leading to a failure that would prevent the appropriate delivery of the lifesaving medication to a patient that is having a severe allergic reaction.

The failure of an EpiPen or EpiPen, Jr. as described in the recall could result in serious injury or death for a patient having a severe allergic reaction.

This current recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of the device failing to activate due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Both reports are related to the single lot that was previously recalled.

The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

EpiPen or EpiPen, Jr., are devices that deliver a dose of the lifesaving medication, epinephrine to patients experiencing a severe allergic reaction. In September 2017, the FDA sent a letter to the manufacturing facility that Mylan utilizes to produce the EpiPen or EpiPen, Jr., expressing a number of concerns, with the most alarming being that after receiving “hundreds of complaints” the company failed to investigate the potential for a deadly defect in the product.

Furthermore, the letter questions why, after defective devices were linked to patient deaths the company took no actions to investigate or correct issues related to the potential for failure of the devices until the FDA began investigations.

In addition to this Nationwide Voluntary Recall, Mylan issued another recall of EpiPens earlier this year. That recall impacted more than 20 lots of EpiPens. Mylan has also come under fire for increasing the price of the EpiPen. The price for the EpiPen has increased more than 400% in recent years. The company has also been investigated by the U.S. Justice Department for overcharging the government that ended with Mylan entering into a $465 million settlement with the agency.

For many, this has caused great concerns related to the safety and effectiveness of the products. If you are one of the thousands of people that have been prescribed or that stock EpiPen or EpiPen, Jr. in your emergency medical kit, please check the recalled lot information listed below.

If you or your family member has had an issue when using an EpiPen or EpiPen, Jr., that may have caused further health complications, it is important to report those issues to the FDA.

If you or a family member used an EpiPen or EpiPen, Jr., and experienced a failure of the device to function properly, resulting in additional health complications or death, those claims should be investigated. The attorneys at Wallace & Graham, P.A. are here to assist you, and investigate your claim.
For help investigating potential claims related to defective with an EpiPen or EpiPen, Jr., please contact our office at 1-800-849-5291.

FDA Information on the EpiPen or EpiPen, Jr. Nationwide Voluntary Recall

According to information posted on the FDA website, as of March 31, 2017, the recall effects 13 lots. The 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers, who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
Product/Dosage                                                  NDC Number         Lot Number                       Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg                49502-501-02                  5GN767                             April 2017
EpiPen Jr Auto-Injector, 0.15 mg                49502-501-02                  5GN773                             April 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  5GM631                            April 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  5GM640                            May 2017
EpiPen Jr Auto-Injector, 0.15 mg                49502-501-02                  6GN215                             September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM082                            September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM072                            September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM081                            September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM088                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM199                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM091                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM198                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM087                            October 2017

To review FDA RECALL INFORMATION, click here.

SOURCES
EpiPen® Voluntary Recall Website    https://www.epipen.com/recall-information

FDA News Release FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm550170.htm

FDA Company Announcement, March 31, 2017; Mylan Provides Update on Meridian Medical Technologies’, a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector https://www.fda.gov/safety/recalls/ucm550173.htm

FDA News Release, March 31, 2017; FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm550170.htm

FDA Letter, Dated: September 5, 2017 to Meridian Medical Technologies, Inc. a Pfizer Company https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm

Withdrawals, & Safety Alerts Website: https://www.fda.gov/safety/recalls/

How Consumers Can Report an Adverse Event or Serious Problem to FDA https://www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm

EpiPen cost soars, but it’s not the only drug to http://www.cnn.com/2016/08/23/health/epipen-price-mylan-prescription-drugs-increase/index.html
Mylan Wraps Up $465 Million U.S. Accord Over EpiPen Rebates https://www.bloomberg.com/news/articles/2017-08-17/mylan-agrees-to-465-million-settlement-of-u-s-epipen-claims

Photo credit CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=1193843

After 3-Alarm Fire at Dow Chemical Plant in Northeast Charlotte, questions are being asked about the safety of the workers and those living near the location.

After 3-Alarm Fire at Dow Chemical Plant in Northeast Charlotte, questions are being asked about the safety of the workers and those living near the location. The Dow Chemical Co. plant located on the 6100 block of Orr Road in east Charlotte was the site of a three-alarm fire on Wednesday morning (Sept. 27th). A spokesperson from Dow Chemical Co.,…

News Update: Declaratory Judgment Action Brought against Duke Energy

News Update: Declaratory Judgment Action Brought against Duke Energy       In 2012, Duke Energy became the largest electric utility in the country.[1] With great power comes great responsibility. Duke Energy has a responsibility to deal with the issues that have come to light with coal ash. The 2014 Dan River spill turned a sharp spotlight on those issues. There…

PRESS RELEASE: PETITION TO INTERVENE FILED BY DUKE’s RATE PAYORS WHO LIVE NEAR DUKE ENERGY’S COAL ASH IMPOUNDMENTS

PRESS RELEASE PETITION TO INTERVENE FILED BY DUKE’s RATE PAYORS WHO LIVE NEAR DUKE ENERGY’S COAL ASH IMPOUNDMENTS August 23, 2017 – Amy Brown of Belmont and Deborah Graham of Salisbury, along with others in their neighborhoods near Duke power plants, filed a petition to intervene in the rate hike application that Duke Energy Carolinas LLC has given notice that…

PRESS RELEASE CLASS ACTION AGAINST DUKE ENERGY BROUGHT BY NORTH CAROLINA PLANT NEIGHBORS

PRESS RELEASE CLASS ACTION AGAINST DUKE ENERGY BROUGHT BY NORTH CAROLINA PLANT NEIGHBORS August 23, 2017 – Amy Brown of Belmont and Deborah Graham of Salisbury, along with representatives of other neighborhoods near Duke power plants, filed a class action lawsuit today in Raleigh. The lawsuit seeks injunctive relief and damages against Duke Energy Carolinas, LLC and Duke Energy Progress,…

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The Great American Eclipse is now less than 7 days away!1024px-Diamond_ring_eclipse art

On Monday, August 21, 2017, a total solar eclipse will occur and for the first time in over 99 years, the event will be visible to almost every state in the United States. Many people have been planning for this event for years. Others have only recently developed an interest in the awe-inspiring event.

As people across the country prepare for what has been dubbed the Great American Eclipse one of the most discussed issues is how to view the event, and the need to have special solar eclipse glasses to protect your eyes from the damage that can be caused by looking directly at the sun.

Experts, including NASA and the American Astronomical Society (AAS), have been warning consumers that many of the solar eclipse glasses that are available on the market are unsafe. They want to make sure that everyone that plans to view the Solar Eclipse protects their eyes.

To ensure that consumers deal with reputable retailers and vendors when buying solar eclipse glasses, NASA and the American Astrological Society (AAS) have put together a list of Reputable Vendors of Solar Filters & Viewers. This list was created by the members of the AAS and is based on members past experiences with each vendor.

The AAS’ reputable vendors of solar filters and viewers list:

Glasses-Angled solar glasses

• American Paper Optics (Eclipse) / EclipseGlasses.com / 3dglassesonline.com
• APM Telescopes (Sunfilter Glasses)
• Baader Planetarium (AstroSolar Silver/Gold Film)
• Celestron (EclipSmart Glasses & Viewers)
• DayStar (Solar Glasses)
• Welding filters with shade 12 or higher
• Explore Scientific (Solar Eclipse Sun Catcher Glasses)
• Lunt Solar Systems (SUNsafe SUNglasses)
• Meade Instruments (EclipseView Glasses & Viewers)
• Rainbow Symphony (Eclipse Shades)
• Seymour Solar (Helios Glasses)
• Thousand Oaks Optical (Silver-Black Polymer & SolarLite)
• TSE 17 (Solar Filter Foil)

To visit the AAS website click here, https://eclipse.aas.org/resources/solar-filters

Over the weekend web retailer, Amazon.com issued a warning to customers and began offering refunds to consumers that purchased Solar Eclipse Glasses sold via Amazon by some third-party vendors that have the potential of being unsafe. Amazon has been reaching out to customers that may have purchased the potentially unsafe glasses.

In a statement, Amazon said, “Safety is among our highest priorities. Out of an abundance of caution, we have proactively reached out to customers and provided refunds for eclipse glasses that may not comply with industry standards.” The statement also explained that Amazon was making the recall and refund announcement because they “want customers to buy with confidence anytime they make a purchase on Amazon.com and eclipse glasses sold on Amazon.com are required to comply with the relevant ISO standard.”

So if you bought your solar eclipse glasses via Amazon.com check the retailer’s website for more information. If you purchased your solar eclipse glasses from another retailer, make sure that they meet the ISO standard.

For other information about the Great American Eclipse, including information about safe viewing, the science of an eclipse, and a map showing the phases and path of the eclipse, visit the website: www.greatamericaneclipse.com

For more information about the Solar Eclipse Glasses recalled by Amazon, click here.

For more information about the Eclipse and how you can view it safely, NASA has created a website full of Eclipse Watching Information and Safety Tips to visit the NASA Eclipse 2017 website, click here.

For resources about the Great American Eclipse from the American Astrological Society, click here

Coverage of the Amazon Recall, Fake Solar Eclipse Glasses Are Being Sold Online. Here’s How to Avoid Scams, from Melisssa Chan, can be viewed online from TIME.COM 

Everyone at Wallace & Graham, want you to enjoy the Great American Eclipse and make sure that you protect your eyes!