About Bristol Myers Squibb
Bristol Myers Squibb (BMS) is a New York-based pharmaceutical company with research operations in 14 locations around the world. BMS is a self-described drug discovery and development company which invests $ billions into research to “discover, develop and deliver innovative medicines that help patients prevail over serious diseases”.
Bristol Myers Squibb has at least 32 marketed brand-name products with numerous medications in development in animal or human research trials. BMS also has co-marketing agreements with a number of other pharmaceutical companies both inside and outside of the U.S. The company had worldwide estimated revenue of $46.4 billion in 2021.
Bristol Myers Squibb has had a number of dealings with the Food and Drug Administration related to improper marketing and FDA violations, as well as involvement with the Securities and Exchange Commission and the Department of Justice over fraud in sales and pricing. The company has faced lawsuits regarding its blockbuster diabetes medications, Byetta, Bydureon, Farxiga, and Glucophage, antipsychotic Abilify, anticoagulant Plavix, and is now facing additional liability for its “next generation” anticoagulant, Eliquis.
History of Bristol Myers Squibb
Bristol Myers Squibb is the result of the merger of two large drug manufacturers, Bristol-Myers and E.R. Squibb, both with histories dating back into the 1800’s.
Edward Robinson Squibb, a young Navy doctor founded E. R. Squibb in 1858 after he became concerned with the quality of medications available during the Mexican War. E.R. Squibb company became the main source for medications during the Civil War, developing a kit containing the most common 50 medications needed on the battlefield, known as the Squibb pannier. The Squibb pannier included treatments including chloroform for anesthesia during amputations, quinine for malaria and herbal medications for dysentery.
The Squibb Institute for Medical Research was founded in 1938 which led the way in antibiotic development, becoming the largest penicillin plant in the world by 1943. The Squibb company dabbled in consumer health, introducing the first electric toothbrush in 1961 opened a medical adhesives company, ConvaTec, but focused most of its efforts on research into cancers and cardiovascular disorders, introducing the first ACE inhibitor for high blood pressure, Capoten in the mid-1970’s. Squibb went public in 1946 as Squibb International.
Bristol, Myers Company
Bristol-Myers was founded in 1887 when William McLaren Bristol and John Ripley Meyers purchased a failing drug manufacturing firm in New York, originally known as the Clinton Pharmaceutical Company. The name was changed to Bristol, Myers Company and was renamed Bristol-Myers in 1899. By 1924, the company had gross profits of over $1 million and went public in 1929. The company mainly concentrated on the consumer products market but in 1943, Bristol-Myers became a supplier of penicillin to the Allied armed forces.
During the late 40’s 50’s and 60’s, both Bristol-Myers and E. R. Squibb were heavy players in antibiotic development leading to discoveries of streptomycin, tetracycline, and other antibiotics. While Bristol-Myers continued its consumer expansion, purchasing Clairol and Mead Johnson & Company to manufacture cosmetics and infant formula, the company also introduced several early chemotherapeutic agents which are still in use today.
Bristol-Myers merged with Squibb in 1989 to form Bristol Myers Squibb (BMS), creating the second largest pharmaceutical and medical products company in the world. The company has continued to produce large-selling medications for cancer such as Taxol, cardiovascular disorders such as Pravachol and Monopril, antibiotics such as Cefzil, and antidiabetics such as Glucophage and a new type of anti-clotting medication, Plavix.
After the turn of the century, BMS focused its attention solely on pharmaceuticals, divesting a number of divisions including the cosmetics division Clairol, medical device companies Zimmer Holdings and ConvaTec, and the Mead-Johnson Nutritional division.
Over the past two decades, BMS has been honored for philanthropic work in AIDS/HIV and pediatric medicine, was given the National Medal of Technology by President Bill Clinton in 1998 and chosen as “America’s Most Admired Pharmaceutical Company” by FORTUNE Magazine in 2001. The company has continued expansion with a slew commercial agreements and acquisitions.
In August of 2012, BMS acquired Amylin Pharmaceuticals, giving BMS control of the blockbuster, novel anti-diabetes medications Byetta and Bydureon. Though these medications were revolutionary and big selling medications, they also brought big problems with a slew of personal injury lawsuits.
BMS’s next-generation anti-coagulant, Eliquis was approved in December of 2012, to join other manufacturer’s new type of anticoagulants and as a follow-up to the popular Plavix, which was co-marketed with French drugmaker, Sanofi-Aventis.
In February of 2014, BMS sold their global diabetes division to AstraZeneca, including the Byetta/Bydureon line and Farxiga along with other BMS products for approximately $2.7 billion.
Bristol Myers Squibb Manufacturing and Marketing Issues
Despite the BMS reputation of research and philanthropy, the company has had a number of legal interactions with federal agencies including the U.S. Securities and Exchange Commission (SEC), U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA).
In 2001, Bristol Myers Squibb was accused of requiring wholesalers to purchase more drugs than they needed. BMS sold approximately $2 billion “extra” drugs so that the company would meet its annual sales goals in an accounting trick known as “channel stuffing”.
After a dramatic revenue drop the following year, the BMS was subject to SEC and DOJ investigations, leading a securities fraud indictment for the former Chief Financial Officer, Frederick Schiff. Following the scandal, BMS paid $839 million in fines and restitution.
In 2007, Bristol Myers Squibb settled cases for off-label promotion of the atypical antipsychotic Abilify and multiple accusations of overcharging the government and inflated prices at the cost of $515 million
In 2010, BMS received a warning letter from the Food and Drug Administration regarding microbial contamination, poor environmental conditions, and substandard testing and sampling procedures at BMS facilities, some of which were repeated violations, previously noted in 2005 and 2009.
Bristol Myers Squibb Lawsuits
Bristol Myers has faced significant product liability issues over some of their products, including thousands of personal injury lawsuits. Though many of these drug injury lawsuits have already been settled, BMS may be subject to more in the future months.
Byetta / Bydureon
In the acquisition of Amylin Pharmaceuticals, BMS acquired the novel diabetes medications, Byetta and Bydureon. On assumption of the assets, BMS also assumed liability surrounding the products.
Byetta, (exenatide) is a twice daily injectable medication used for the treatment of type 2 diabetes. Bydureon is a once-weekly form of the same medication. Study results published in a 2011 edition of Gastroenterology showed that patients using Byetta had a risk of developing pancreatitis that was six times greater than those not taking the medication.
Pancreatitis is a medical condition caused by inflammation of the pancreas (responsible for insulin production) that can cause a need for hospitalization or may result in death. The study also found that Byetta may increase the risk of pancreatic cancer and thyroid cancer, at possibly up to three times the rate.
Multiple lawsuits have been filed due to Byetta and Bydureon use, and more lawsuits may still be expected. The diabetes line including Byetta/Bydureon products, Farxiga and other antidiabetics in development were sold to AstraZeneca in 2017, however BMS may still face liability in new or pending lawsuits.
Plavix (clopidogrel) was the first of a newer type of anticoagulants which did not require laboratory testing as other medications did. It was approved in 1997 and became the top-selling prescription product in the U.S. by 2011, providing over $7 billion in BMS revenue.
By 2010 however, the FDA had required a black-box warning to be added to the medication stating that some people may be unable to metabolize the drug and would be at increased risk for serious side effects. In addition, the agency warned that anti-ulcer medications like Prilosec (omeprazole), a proton-pump inhibitor could reduce the effectiveness of Plavix.
Patients who took Plavix and developed uncontrolled bleeding may have been at greater risk than more traditional anticoagulants as Plavix did not have an antidote. By 2017, BMS was facing over 5,000 Plavix lawsuits in federal, state, and local courts. A number of lawsuits filed in California state courts were dismissed, however those lawsuits may have been refiled in federal courts.
Though Plavix’ patent has expired, the drug remains a liability risk and the company may still face unsettled lawsuits.
In addition to drug injury lawsuits, in 2021, BMS and joint-marketer Sanofi, were ordered to pay $834 million to the State of Hawaii for failure to warn non-white patients properly of Plavix health risks. The company had been accused of unfair and deceptive business practices by failing to change the drug’s labeling to state that certain ethnic groups would be unable to metabolize the drug. The companies may also face a similar lawsuit filed by the State of New Mexico.
Eliquis (apixaban) is a next-generation anti-coagulant medication used to prevent clot formation in patients with atrial fibrillation or irregular heartbeat. Eliquis is a member of a newer group of medications which also includes anticoagulant Pradaxa.
They are known as direct factor Xa inhibitors that do not require blood testing as older medications did, but the newest Xa inhibitors also do not have an antidote.
This class of medications has caused serious adverse events resulting in uncontrollable bleeding which may result in death. In addition to thousands of lawsuits which were filed for BMS Plavix injuries, the company appears to be facing a large number of Eliquis lawsuits as well.
Celgene Shareholders Lawsuit
In 2021, Bristol Myers Squibb was accused of delaying the introduction of its lymphoma treatment Breyanzi, in order to avoid paying shareholders. The drug had been acquired in a 2019 purchase of oncology-treatment company, Celgene.
The acquisition agreement called for BMS to pay Celgene holders $9 per share if approval of Breyanzi (lisocabtagene maraleucel) and two other drug candidates were obtained by certain deadlines.
Though the other two medications were approved by the deadlines, BMS was accused of failing to make “diligent efforts” to obtain Breyanzi approval in a timely manner, in order to avoid paying the shareholder windfall. Breyanzi was approved in 2021, and the former shareholders of Celgene filed suit against BMS for their losses. Though BMS objected and attempted to get the case dismissed, the $6.5 Billion lawsuit filing was upheld in June 2022.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.