The Centers for Disease Control and Prevention (CDC), the United States agency responsible for monitoring the nation’s health, along with the National Cancer Institute (NCI), the United States lead cancer research agency, have recently updated the federal statistics on cancer incidence and deaths in the US. According to that data, cancer is the second leading cause of death in the…
North Carolina Supreme Court Chief Justice Mark Martin opposes a bill in the Senate that would require justices and judges to run for reelection every two years.
North Carolina Supreme Court Chief Justice Mark Martin opposes a bill in the Senate that would require justices and judges to run for reelection every two years.
MEDICATIONS USED TO TREAT TYPE 2 DIABETES LINKED TO DIABETIC KETOACIDOSIS (DKA), ACUTE KIDNEY INJURIES, AND AN INCREASED RISK OF FOOT AND LEG AMPUTATION FDA HAS REVISED MEDICATION LABEL TO ADDRESS RISK
Medications used to treat type 2 diabetes Linked to diabetic ketoacidosis (DKA), acute kidney injuries, and an increased risk of foot and leg amputation
FDA HAS REVISED MEDICATION LABEL TO ADDRESS RISK
Attention: Have you or your loved ones been prescribed canagliflozin (Invokana, Invokamet) or dapagliflozin (Farxiga, Xigduo XR), a class of medications known as SGLT2 inhibitors prescription medications prescribed to control type 2 diabetes?
If so, please be advised that there have been numerous reports of patients with adverse reactions to these medications, including an increased risk for development of diabetic ketoacidosis (DKA), acute kidney injuries, and foot and leg amputation.
In response, the FDA has strengthened the existing warning about the risk related to these drugs, including revising the warnings on the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. The FDA advises patients that are currently taking CANAGLIFLOZIN (INVOKANA, INVOKAMET) AND DAPAGLIFLOZIN (FARXIGA, XIGDUO XR) to speak with their healthcare provider about any concerns.
To read the FDA Safety Announcement or Report any issues follow the link below:
FOR MORE INFORMATION, PLEASE VISIT THE FOLLOWING LINKS:
FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines CANAGLIFLOZIN (INVOKANA, INVOKAMET) AND DAPAGLIFLOZIN (FARXIGA, XIGDUO XR). https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm
FDA Drug Safety Communication: Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, https://www.fda.gov/Drugs/DrugSafety/ucm446852.htm
If you have concerns of injury as a result of taking one of these medications, including DKA, acute kidney injury, or foot and leg amputation, please call our office and ask to speak with Attorney Whitney Wallace Williams.
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…
Protect Our Environment — Tell your Senator to Vote No on Wheeler – to keep the environment safe! President Trump has nominated Andrew Wheeler, a coal industry lobbyist and a denier of climate change, to the second highest post at the Environmental Protection Agency (EPA). By nominating Wheeler to the EPA, the president is again placing more importance on big…
A Nationwide Voluntary Recall was issued for EpiPen and EpiPen, Jr. on March 31, 2017.
On 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
EpiPen® Voluntary Recall Website https://www.epipen.com/recall-information
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 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.,…
Tyson Foods Inc. Gets Called Out On Social Media with a Reminder that from 2010-2014, the Food Industry Giant that was the 2ND Biggest Polluter of US Waterways; polluting those waterways with about “18 million pounds of toxic chemicals annually.”
A proposed poultry operation in Kansas gets Tyson Foods Inc. is called out on Social Media with a reminder that the food industry giant was the 2nd biggest polluter of US Waterways between 2010 and 2014; dumping about “18 million pounds of toxic chemicals” into waterways annually.
Erin Brockovich took to social media to call out Tyson Foods Inc. as a major polluter of US Waterways in a show of support for Kansas community opposed to a proposed Tyson Foods poultry facility. Brockovich became well-known for her consumer and environmental advocacy work, following a movie from 2000 based on her experience working as a legal clerk, collecting evidence about water contamination that had sickened the residents of Hinkley, CA. In the last 20 years, she has repeatedly spoken out against known corporate polluters.
Because of the film, groups fighting to protect their communities from corporations that are known environmental polluter often contact Brockovich. Most recently, she has joined with residents of her home state of Kansas to oppose the opening of a Tyson Foods Poultry Facility.
Over the weekend, Brockovich spoke out on behalf of the residents in Tonganoxie, Kansas, a location not too far from her own hometown — Lawrence, Kansas — that are opposing the opening of a Tyson Foods poultry plant in the community.
On Sept. 7th, Brockovich took to social media to speak out against the proposed poultry facility. In the posting directed to Tyson Foods via her Facebook page, Brockovich acknowledges the many residents of Tonganoxie that had reached out to her for help, going on to call out Tyson Food Inc. for their history of polluting the nation’s waterways. In the post, she directly addresses Tyson Foods, saying to the company, “Clean up your act if you want respect. Get off the list of our nation’s biggest polluters and then come talk to us. Until then, you cannot continue to grow on the backs of the people.” (Link to Erin Brockovich FB post/Page)
Considering her stance on protecting the environment, and Tyson Foods Inc.’s history of pollution, it is no surprise that Erin Brockovich joined the community’s efforts by speaking out against a proposed Tyson Foods poultry operation.
As Brockovich pointed out in her post, Tyson Foods is responsible for dumping into the more than 18 million pounds of toxic chemicals into the nation’s waterway annually. This point is driven home further by the most current data that Tyson Foods submitted on its own behalf to the United States Environmental Protection Agency’s (US EPA’s) Toxic Release Inventory. According to that data, Tyson Foods Inc. was the 2nd biggest polluter of America’s waterways from 2010 to 2014, trailing behind AK Steel Holding Corp., who holds1st place as the biggest polluter of the country’s waterways. As pointed out by Brockovich, this means, “Tyson Foods and its subsidiaries’ processing plants dumped more than 104 million pounds of pollutants into waterways over those five years – more than Cargill Inc., Koch Industries Inc., and ExxonMobil Corporation combined.”
Supporters of the new facility, including a representative of Tyson Foods Inc., and local government officials have down played the company’s history as a major source of waterway pollution. Instead, supports are pointing to the benefits the new facility will bring to the community, which according to Kansas news KCTV, those that support the Tyson plant say it will bring 1,600 jobs to the area and help to improve the area’s economy to the tune of $150 million.
While the local citizens and government officials consider the fate of the Tyson operation it may be a good idea to take into account the cost to clean-up any sites that are contaminated by the operation. Considering that Tyson Foods Inc. has a history of waterway pollution, the cost of cleaning up (which seems inevitable) could far outweigh any potential benefits for the community as a whole.
My inbox is full of requests from the good people of Tonganoxie, Kansas asking for my help fighting a massive chicken processing plant in their community. Mothers have sent me photographs of their children at the local baseball field… just blocks from the location of the proposed slaughter house. Tyson Foods dumps more than 18 million pounds of toxic chemicals into America’s waterways each year ! ! !
I often struggle with how I can help in communities facing the hired guns from giant corporations… and the false promises of jobs… toting along paid off politicians. I was born and raised in Kansas… now living in California… where I too have been receiving pollution and environmental complaints about Tyson Foods for over a decade. I base my involvement on these matters based on a company’s current record… so here is a fun fact for Kansas Governor Brownback:
Tyson Foods Inc. was the second biggest polluter of America’s waterways from 2010 to 2014, according to the most current data the company submitted to the United States Environmental Protection Agency’s (USEPA’s) Toxic Release Inventory. Ranking only behind AK Steel Holding Corp, Tyson Foods and its subsidiaries’ processing plants dumped more than 104 million pounds of pollutants into waterways over those five years – more than Cargill Inc., Koch Industries Inc., and ExxonMobil Corporation combined.
Doug Ramsey, an official with Tyson Foods, lied about the company’s record of pollution and waste discharges… then demanded respect… sorry Mr. Ramsey, but I don’t respect a talking head from our nations biggest polluters that do in fact shit where they eat. Clean up you act if you want respect… get off the list of our nation’s biggest polluters… and then come talk to us… until then… you cannot continue to grow on the backs of the people.
Tyson Foods and Kansas Gov. Sam Brownback announced plans for a $320 million poultry complex near Tonganoxie. Protestors gathered to decry the plan. KANSASCITY.COM
FOR ADDITIONAL INFORMATION VISIT THE LINK BELOW
Class Action Lawsuit Settlement in favor of Military Families signals to Senate that they need to Support the CFPB Rule to protect consumers
Our firm is pleased to report a recent settlement in July 2017 between Bank of America and military families. The plaintiffs in the class actions consisted of a group of military families, on active duty service and deployments, who were overcharged and deceived by Bank of America. The 130,000 military families that took part in the class action against…
143 million Americans have data exposed by Equifax, and the company uses Arbitration Clause in Data Breach Help Website to prevent consumers from joining together if they seek any damages resulting from the breach
DATA BREACH AT THE CONSUMER CREDIT REPORTING AGENCY, EQUIFAX HAS EXPOSES THE DATA OF NEARLY 1/2 THE AMERICAN POPULATION. On Thursday, Equifax announced that the personal information of 143 million Americans — almost ½ the U.S. population — has been compromised after a data breach that exposed sensitive information including social security numbers, driver’s license numbers, and address information. The…