GlaxoSmithKline (GSK)
GlaxoSmithKline (GSK) can trace its roots back to a small apothecary in 18th Century London. Through multiple corporate mergers, GSK found its current form in 2001. It manufactures prescription medicines, vaccines and consumer health products.
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GlaxoSmithKline is a Big Pharma corporation. It sits at No. 282 on Forbes’ Global 500 rankings. GSK is ranked number 6 among the top 20 pharma companies by revenue in 2019, according to FiercePharma.
The British pharmaceutical company is well-known for products like Advair, Ventolin, Theraflu, Advil and Centrum.
Like many pharmaceutical companies, GSK has stepped up to develop treatments for COVID-19. In March 2021, the company announced an interim review of its experimental antibody VIR-7831, also known as GSK4182136, showed an 85 percent reduction in hospitalization or death, according to a company press release.
“We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.”
But GSK has faced allegations of unethical and unsafe business practices. Some of its former employees were criminally prosecuted on two different continents.
Some of GSK’s popular pharmaceuticals have led to product liability lawsuits. These include Avandia, Zantac, Paxil, Prevacid 24HR, Nexium 24HR and Zofran.
About GlaxoSmithKline
GlaxoSmithKline is a global health care company with headquarters in Brentford, London. Emma Walmsley is GSK’s CEO. She is the first woman to be chief executive of a major pharmaceutical corporation.
Total revenues for GSK reached $34 billion pounds in 2020. This equates to $47.3 billion in U.S. currency.
In 2020, GSK employed about 94,000 people in over 150 countries. Its U.S. headquarters are in Philadelphia. GSK has a separate research facility in North Carolina.
GlaxoSmithKline History
GlaxoSmithKline started in 1715 as Plough Court pharmacy, a small apothecary shop in London. GSK evolved through a series of mergers over two centuries.
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1830
Smith & Gilbert drug house opened in Philadelphia. (Mahlon Kline later joined the entity.)
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1842
Thomas Beecham started Beecham’s Pills in England.
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1856
Plough Court pharmacy took on the name Allen & Hanburys.
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1880
American pharmacists Henry Wellcome and Silas Burroughs started Burroughs Wellcome & Company in London.
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1958
Glaxo Laboratories acquired Allen & Hanburys.
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1989
SmithKline Beckman and the Beecham Group merged to form SmithKline Beecham.
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1995
Glaxo and Wellcome merged.
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2001
SmithKline Beecham and Glaxo Wellcome merged in a $75.7 billion stock deal. This gave GlaxoSmithKline its official start.
GlaxoSmithKline Products
GSK focuses on vaccines, pharmaceutical drugs and consumer health care products. The company’s vaccine business distributes about 2 million vaccines a day to around 160 countries.
GSK is the maker of the industry’s broadest range of inhaled respiratory products. These include Advair, Ventolin and Breo Ellipta. The company has also partnered with Pfizer and Shionogi to form a global HIV business, ViiV Healthcare.
GSK’s respiratory and HIV pharmaceutical businesses are its top moneymakers. Overall, its pharmaceuticals business raked in about $24 billion (17 million pounds) in 2020.
- Prevacid 24HR and Nexium 24HR
- Proton pump inhibitor heartburn and stomach acid reducers
- Advair/Seretide
- Inhaled asthma/COPD medication (combination steroid and bronchodilator)
- Paxil
- SSRI antidepressant
- Wellbutrin
- Antidepressant
- Avandia
- Type 2 diabetes medicine
- Flonase/Flovent
- Inhaled corticosteroids
- Zantac
- Antihistamine that blocks stomach acid
- Zofran
- Anti-nausea medication
- Theraflu
- Cold and flu medicine
- Nicorette
- Gum and lozenges to aid in smoking cessation
- Excedrin
- Pain reliever for headaches and migraines
- Abreva
- Skin cream to treat cold sores or fever blisters
- Fluarix/FluLava
- Seasonal flu vaccines
- Rotarix
- Rotavirus vaccine
- Ambirix
- Hepatitis A and B vaccine
- Bexsero
- Meningitis B vaccine
- Boostrix
- Tetanus, diphtheria and pertussis vaccine
- Menveo
- Meningitis ACWY vaccine
- Menjugate
- Meningitis C vaccine
- Priorix
- Measles, mumps and rubella vaccine
GlaxoSmithKline Lawsuits and Settlements
GlaxoSmithKline has faced a number of product liability lawsuits. Patients filing lawsuits accuse the company of manufacturing dangerous or defective products.
Personal Injury Lawsuits Against GSK
Zantac
Injuries
Cancer from NDMA contamination
Lawsuit Status
GSK reported that it had been named in about 1,200 Zantac lawsuits on its 2020 annual report. In December 2020, the court granted GSK’s motion to dismiss claims on innovator liability. As of March 2021, there have been no verdicts or settlements.
Zofran
Injuries
Birth defects
Lawsuit Status
GSK faced 476 federal Zofran lawsuits in February 2021. The first bellwether trial has been set for Oct. 18, 2021.
PPIs
Injuries
Acute kidney injury, chronic kidney disease and end-stage renal failure
Lawsuits Status
More than 13,700 PPI lawsuits are pending in federal court in New Jersey. GSK is named in thousands of claims for Prevacid 24HR and Nexium 24HR, the company said in its 2020 annual report. The first PPI bellwether is set for November 2021.
Paxil
Injuries
Suicidal thoughts and birth defects
Notable Verdicts
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2009
Philadelphia jurors awarded $2.5 million in a Paxil lawsuit filed by the family of a 3-year-old born with severe heart malformations.
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2017
Chicago jurors ordered GSK to pay $3 million to the widow of a corporate attorney who killed himself after taking a generic version of Paxil not made by GSK.
Notable Settlements
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2006
GSK settled thousands of addiction claims for a total of $160 million.
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2010
GSK settled Paxil and pregnancy claims for $1.14 billion.
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2016
GSK paid $6.2 million to settle a Canada class action lawsuit involving 50 mothers and their children.
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2010
GSK settled over 10,000 Avandia lawsuits for more than $500 million.
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2011
GSK agreed to pay $250 million to settle 5,500 death and injury claims.
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2011
GSK set aside $6.4 billion for future lawsuits and settlements.
Fraud, Misbranding & Failure to Report Safety Data
In 2012, GlaxoSmithKline pleaded guilty to federal criminal offenses. The company’s crimes included misbranding of its antidepressants Paxil and Wellbutrin. GSK also failed to report safety data to the FDA about its diabetes drug Avandia.
GSK admitted to illegally promoting Paxil for treatment of depression in children.
The company reached a civil settlement with the U.S. federal government in which it agreed to pay a fine of $3 billion.
The plea represented the largest health care fraud settlement in U.S. history. It resolved allegations of pricing fraud.
GSK reached a related civil settlement with the U.S. Justice Department. It resolved allegations of improper marketing of Advair and Zofran.
In March 2020, the Department of Justice (DOJ) sent GSK a notice of a civil investigation it had opened into allegations of False Claims Act violations by the company because of Zantac. DOJ requested documents on June 18, 2020. On the same day, the New Mexico Attorney General filed a lawsuit against GSK for violations of false advertising statutes and state consumer protection, among other claims.
GlaxoSmithKline Drug Recalls
GlaxoSmithKline recalled some of its products for defects, possible tampering and reduced effectiveness. Products affected include consumer weight loss products, vaccines and albuterol inhalers.
| Date | Drug/Device/Vaccine | Units | Reason |
|---|---|---|---|
| 2020 | Children's Robitussin Honey Cough and Chest Congestion DM and Children's Dimetapp Cold and Cough | Lots: 02177 (Exp. Jan. 2022), 02178 (Exp. Jan. 2022) and CL8292 (Exp. Sep. 2021) | Inclusion of incorrect dosing cups that could lead to accidental overdose |
| 2018 | Ventolin and Seretide | 200,000 | Possible damaged foil strip containing medication inside the device resulting in reduced number of doses delivered by the inhaler |
| 2017 | Ventolin | 600,000 | Leak in the propellant that delivers the medicine resulting in a smaller dose of medication than indicated |
| 2017 | Menveo Meningococcal vaccine | Lot M16095 only (5 doses – 10 vials – per package) | Precautionary; the batch was subject to mechanical intervention during sanitary filling operations not supported by validation data |
| 2015 | Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes (PFS) flu vaccine | All remaining 2014-2015 doses | Potential for reduced effectiveness due to a decrease in vaccine strength prior to its expiration date found through routine testing |
| 2015 | Ventolin HFA | More than 128,000 | Defective delivery system resulting in less than 200 doses |
| 2014 | Alli weight loss products | From all U.S. and Puerto Rico retailers | Some of the packages were tampered with and may contain product that is not alli |
GlaxoSmithKline Scandal
A Chinese court ordered GlaxoSmithKline to pay $492 million in 2014. The fine resolved charges of bribing doctors in China to use GSK products. It was the biggest penalty ever imposed by a Chinese court.
The court sentenced Briton Mark Reilly to four years in prison. He was the company’s British executive for China. Four other Chinese employees received the same punishment.
But the employees may never serve prison time. The court postponed the sentences. Reilly was deported.
In February 2018, GSK was still answering to fraud investigators in its home country.
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