About Merck & Co.
Merck & Co. is an American pharmaceutical company which produces some of the most well-known drugs in the pharmaceutical business, as well as consumer health products. Outside of the U.S., the company is known as Merck Sharp & Dohme (MSD) but is unrelated to the German company, Merck Group KGaA.
Merck & Co. is America’s second-largest pharmaceutical company and in 2021 made approximately $48.7 billion in revenue. The company is based in New Jersey and employs about 68,000 people.
Merck has had multiple blockbuster medications which have been highly successful, however several Merck products have resulted in thousands of lawsuits due to severe injury or death including medications like Vioxx, Fosamax and Januvia.
The History of Merck & Co.
Merck & Co. first got its start in Germany in 1668 when its founder, Friedrich Jacob Merck, bought an apothecary in Darmstadt, Germany to start his business as Engel-Apotheke. Nearly one-hundred and fifty years later, in 1827, Heinrich Emmanuel Merck converted the pharmacy into a drug manufacturing facility as E. Merck.
The first products that were sold by the facility were morphine, codeine, and cocaine. A U.S. division was opened in 1891 as Merck of Darmstadt., with a manufacturing facility founded in 1902 in New Jersey.
In 1917, the U.S. division of Merck was Nationalized by the U.S. government and set up as a separate company in post WWI reconstruction. The German company of Merck is known as Merck KGaA but has no financial stake or affiliation with Merck & Co. due to separations imposed by WWI and WWII.
In 1953, Merck acquired a Philadelphia drug company, Sharp & Dohme, to become the largest U.S. drug manufacturer at the time and is still known as Merck, Sharp & Dohme (MSD) outside of the U.S. Merck & Co. worked with other major pharmaceutical companies through the 1980s and 1990s, such as Astra AB, Johnson & Johnson, Schering-Plough and Zeneca.
Merck & Co. merged with Schering-Plough in 2009, giving them access to brand name consumer products like Coppertone and Dr. Scholl’s and has since acquired a large number of smaller companies to remain as the second-largest pharmaceutical company in the U.S.
Since the Schering-Plough merger, Merck has continued to expand through acquisitions and partnerships including:
- Idenix Pharmaceuticals
- Cubist Pharmaceuticals
- Quarted Medicine (partnership)
- Complix (partnership)
- IOmet Pharma
- Afferent Pharmaceuticals
- Vallée S.A.
- Immune Design
- Antelliq Group
- Peloton Therapeutics
- Tilos Therapeutics
- Themis Bioscienc
- Quantified Ag
- Seattle Genetics
- PrognostiX Poultry
- Pandion Therapeutics
- Acceleron Pharma
In 2021, Merck began work on treatment for COVID-19, seeking Emergency Use Authorization for Lagevrio (molnupiravir), an oral antiviral used to treat SARS-CoV-2. Though the medication is available for use in the U.S. and other countries around the world, concerns about its safety and long-term efficacy have been raised and clinical testing is still ongoing.
Merck & Co. has played a notable role in current affairs throughout its history. In 1889, Merck & Co. first published what is known as the Merck Index. The Merck Index is an encyclopedia of chemicals, drugs, and biological information for use by health care professionals and scientists. It has also published other references including The Merck Manual (1899) and The Merck Veterinary Manual and other textbooks still in use today.
In 2009, during the Vioxx scandal, Merck was exposed for fraudulent publishing. It was discovered that the Australian division of the company had paid Elsevier, a medical publishing platform an undisclosed amount to produce eight issues of a fraudulent medical journal. The publication was called “Australasian Journal of Bone and Joint Medicine” which appeared to be a legitimate, peer-reviewed journal.
The journal was found to have reprinted Merck-friendly articles but never disclosed that it was a sponsored publication. The CEO of Elsevier later apologized, admitting that the practices were false and should never have been allowed.
Merck & Co. Products
Merck & Co. produces medications in multiple therapeutic areas, as well as other medical and health products. They have manufactured over-the-counter medications like asthma and allergy medication as well as vaccines, antibiotics, cancer treatments, veterinary products and medications for other diseases and disorders. Some notable products include sunscreen, hair-growth medication Propecia, antihistamine Claritin, HPV vaccine Gardasil, and antidiabetics like Januvia.
Merck & Co. first manufactured legacy medications like morphine and codeine but became an early producer of vaccines and infectious disease treatment. The company produced the first commercial smallpox vaccine in the U.S and provided 4.18 billion units of penicillin, the first successful antibiotic during WWII.
After a number of years working on the discovery of vitamins, MSD scientists invented a method to synthesize Vitamin B12 in 1936. The company isolated and produced a number of other vitamins as well, becoming very profitable in therapeutics and animal feed.
Merck was first with many childhood vaccines including Mumps, Rubella, Trivalent MMR, Hep B, and Varicella (chicken pox) and important in other “firsts” as well including:
- First diuretic for hypertension
- First HIV medication
- First Statin cholesterol-lowering medication
- First cervical cancer vaccine
In a philanthropic effort, Merck & Co. was one of the first pharmaceutical companies to offer Patient Assistance Programs for patients who cannot afford their name brand products.
Notable Merck products include:
- Januvia / Janumet
- Propecia / Proscar
- Intron A
- Recombivax HB
- Erbevo (Ebola Vaccine)
Merck & Co. Controversies and Lawsuits
Because of Merck’s long history in the U.S. and the vast number of products produced, the company has faced thousands of lawsuits. Some of the drugs that have led to litigation against Merck & Co. include:
In the last decade or so, Merck & Co. has paid out over $4.85 billion in judgements and settlements for lawsuits regarding Vioxx, including one $950 million settlement and millions of dollars for lawsuits, settlements and penalties related to other drugs. Some lawsuits have been dismissed but many may still remain in open courts.
The most well-known corporate scandal involving Merck & Co. is the Vioxx scandal. Vioxx was once a leading pharmaceutical pain treatment used for diseases like osteoarthritis. Like other Cox-2 inhibitors, Vioxx was linked to heart attack and death in some users and the company was accused of concealing risks of the medication.
Merck faced thousands of Vioxx lawsuits and has paid over $4.85 billion in settlements, fines and other payments for drug injury and criminal liabilities due to Vioxx. The medication was recalled in 2004 and most cases were settled as part of a group settlement offer in 2008. The company also paid $58 million in settlements and fines to 30 states for deceptive practices but some non-injury agreements have yet to be met regarding securities and stockholder misconduct.
Osteoporosis medication, Fosamax (alendronate) was known to cause gastrointestinal problems and worsen certain other health conditions. Patients have reported experiencing problems of the esophagus such as trouble swallowing (dysphagia), and gastritis (digestive irritation) and may develop esophageal erosion due to gastric reflux.
Although Fosamax is intended to prevent bone loss, the medication may cause a loss of bone density. Patients reported bone fractures, and some developed a condition known as osteonecrosis of the jaw (ONJ) which caused in a loss of jawbone tissue.
Hundreds of lawsuits were filed, claiming that Merck knew about the dangers of Fosamax and though many of the lawsuits were dismissed, court battles are still ongoing including a Supreme Court judgment which directed the lower courts reconsider a ruling that allowed lawsuits to go to trial. After losing two bellwether trials, Merck settled about 1,200 cases for $27.7 million but thousands of cases may still remain.
Attempts to add warnings to the Fosamax label have been largely rejected by the FDA and the drug remains available in both brand name and generic form.
Januvia and Janumet Lawsuits
Januvia (sitagliptin) is a newer medication for treating type 2 diabetes. It gained FDA approval in 2006 but like similar medications Byetta and Victoza, has caused many different health problems for patients. A related medication, Janumet, is a combination of sitagliptin and metformin and may also be responsible for a number of injuries.
By 2011, over 200 patients had reported cases of pancreatitis as a result of Januvia. About 10 to 30 percent of these cases were fatal. Since then, hundreds of patients have reported pancreatic cancer and pancreatic disorder and patients, and their families have filed suit for compensation of these cases.
Januvia/Janumet lawsuits were combined with similar sglt2 medications, Byetta and Victoza lawsuits into a multidistrict litigation against Merck & Co. to help move through the cases more efficiently. A number of the lawsuits were dismissed in 2021, and no settlements have been announced for any of the medications. In 2022, new concerns were raised when Januvia was found to be contaminated with nitrosamine but no large lawsuits have been announced regarding the contamination.
Zostavax and Gardasil Lawsuits
Vaccine compensation for injuries falls under federal jurisdiction and compensated by federal funding, however a number of claims of drug injury and others of ineffectiveness are still under consideration for Merck vaccines Zostavax and Gardasil.
One family may have met the “burden of proof” for HPV vaccine, Gardasil injury or death and appears to be advancing in the court system while others have been compensated by the U.S. government as part of the National Vaccine Injury Compensation Program.
Lawsuits against Zostavax claim that instead of protecting patients against the Varicella Zoster virus, the vaccine caused them to develop a more severe infection resulting in painful blisters, scarring and nerve damage. Several cases have been dismissed and though n settlements have yet been decided, the number of lawsuits still appears to be growing and may reach into the hundreds.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.