Eli Lilly & Co.

Eli Lilly & Co. Overview

Eli Lilly & Co. is a U.S. pharmaceutical company founded and based in Indianapolis, Indiana. Lilly employs over 37,000 people around the globe, with nearly 9,000 of those engaged in research and development of new drugs. The company reported revenue of $28.3 billion in 2021 and markets products in 120 countries. Eli Lilly’s current focus is in treatment of diabetes, cancer, neurological disorders, immunologic disorders, cancer, and other illnesses.

Lilly also joined the fight against COVID-19 with use of Olumiant (baricitinib) after approval of an Emergency Use Authorization by the U.S. Food and Drug Administration. Olumiant is also used to treat rheumatoid arthritis and alopecia areata. The company has also received EUA for bebtelovimab, an investigational monoclonal antibody for the treatment of mild-to-moderate COVIC-19 in adults and children over 12 years of age.

Though the company has been highly successful with multiple blockbuster drugs, some of Eli Lilly’s medications have resulted in drug injury lawsuits including Zyprexa, Cymbalta, Byetta, Jardiance, Prozac, and others.

Eli Lilly History

Eli Lilly and Company is one of the oldest pharmaceutical companies in the world. It was founded in 1876 by a pharmacist, who was also a veteran of the Civil War. Colonel Eli Lilly was frustrated by the lack of appropriate and effective medications during that time. The first innovations developed by Eli Lilly and Company included gelatin coatings for pills and capsules, sugar coating for pills and flavorings for liquid medications making them easier to take. The company primarily manufactured the dosage forms for their own medications but also became suppliers for other companies who wanted to use the new technology.

The first employees of Eli Lilly & Co. were primarily members of the Lilly family – including Col. Lilly’s son Josiah who later became President of the company. Lilly’s son and grandsons each served as successive presidents of the company, keeping the management of Lilly within the family for over 100 years. The company mission was to develop pharmaceuticals of the highest quality and to promote management from within. Eli Lilly and Company went public in 1952 and expanded to locations in South America, Europe, Africa, and Asia. The first non-Lilly CEO was hired in 1993 after the company’s first quarterly loss.

Eli Lilly was originally known for its quality medications and hired its entire promotional staff from a pool of pharmacists to ensure that the sales representatives were well versed in pharmacology and chemistry of the medications they were detailing.

Eli Lilly is credited with the development of insulin to treat diabetes, became a major producer of antibiotics and anti-infectives, and expanded into animal health with the development of a veterinary division, Elanco. Lilly has since expanded into central nervous system, oncology, immunology, and other medications, while maintaining a large presence in the diabetes market.

Lily has been involved in a number of acquisitions and mergers as well as co-marketing agreements. Some of Lilly’s products have been highly successful including well-known medications such as the insulin line, Byetta, Jardiance, Jentaduo, and other medications for diabetes, penicillin and cephalosporin antibiotics such as Keflex and Ceclor, anti-depressants such as Prozac and Cymbalta and recently, medications for erectile dysfunction (ED) such as Cialis, a testosterone product Axiron and an antipsychotic medication Zyprexa.

Though many of Lilly’s products have been highly successful, some of the medications have been shown to cause serious injury, leaving Eli Lilly facing a number of lawsuits involving those medications. In 2021, Eli Lilly and Company reported over $28 billion in global revenue.

Eli Lilly Current Products

Eli Lilly currently produces, markets, or distributes over 39 drugs in the US, with several drugs in the top 100. The top selling drug, Trulicity, a medication used for the treatment of Type 2 diabetes had estimated sales of just over $4.1 billion in 2019. Lilly’s other diabetes medications including insulin products Humalog and Humulin, along with other antidiabetics such as Jardiance, Tradjenta and Trulicity make up a substantial portion of annual revenue.

Currently marketed products include:

• Humalog (insulin lispro)
• Humulin (human insulin)
• Basaglar (insulin glargine)
• Baqsimi (glucagon nasal powder)
• Glucagon (glucagon injection)
• Jardiance (empagliflozin)
• Synjardy (empagliflozin/metformin)
• Tradjenta (linagliptin)
• Jentadueto (linagliptin/metformin)
• Trulicity (dulaglutide)
• Mounjaro (tirzepatide)
• Amybid (florbetapir F18)
• Tauvid (flortaucipir F18)
• Zyprexa Relprevv (olanzapine)
• Emgality (galcanezumab-gnlm)
• Reyvow (Lasmiditan)
• Alimta (pemetrexed)
• Forteo (teriparatide)
• Cyramza (ramucirumab)
• Cialis / Adcirca (tadalafil)
• Erbitux (cetuximab)
• Retevmo (selpercatinib)
• Verzenio (abemaciclib)
• Humatrope (somatropin)
• Taltz (ixekizumab)
• Olumiant (baricitinib)
• Investigational (EUA) bebtelovimab

A number of medications historically produced by Lilly have caused serious injury and could be the subject of medical injury lawsuits.

Eli Lilly Lawsuits

Eli Lilly has faced a number of lawsuits for multiple products, some of which have resulted in settlements of thousands of dollars for the victims. Notable Eli Lilly lawsuits include:

Actos – produced by the Japanese pharmaceutical company, Takeda. Actos (pioglitazone), used for diabetes, was co-marketed by Eli Lilly from 1999 to 2009 in the US. Both companies faced thousands of lawsuits for injuries such as congestive heart failure and bladder cancer. In 2015, Takeda agreed to settle thousands of Actos lawsuits for $2.3 billion)

Byetta – originally produced in conjunction with Amylin Pharmaceuticals and used for diabetes. Exenatide, the active ingredient may have caused pancreatitis and pancreatic cancer. Lilly is no longer in partnership with Amylin but both companies, along with AstraZeneca faced multiple lawsuits stemming to pre-2011 use and similar lawsuits have been filed for a next generation product, Bydureon. Many of the Byetta lawsuits have been dismissed but others may still remain in courts.

Zyprexa – Lilly was the subject of the largest criminal fine in pharmaceutical history for its illegal marketing of olanzapine for dementia and pediatric use when it was approved for bipolar disorder and schizophrenia in adults. Lilly paid $1.42 billion in criminal penalties and civil lawsuits. Another $62 million has been paid to litigants in 32 states and more lawsuits are pending. The company also agreed in 2007, to pay $1.2 billion to settle 30,000 lawsuits for people who claimed they had developed diabetes due to Zyprexa use.

Prozac – one of the most famous drugs of all-time. Prozac was attributed with a high risk of suicide and Eli Lilly paid over $50 million by the year 2000 for multiple lawsuits regarding Prozac use. In addition, Prozac use is suspected of causing birth defects in pregnant women, though the company has not admitted to liability in lawsuits that claim Prozac birth defects.

Symbyax – a combination of the active ingredients in Prozac (fluoxetine) and Zyprexa (olanzapine). Lilly faced a number of unsuccessful lawsuits for claims of birth defects such as cleft lip and palate, anencephaly, spina bifida and club foot.

Axiron – testosterone replacement therapy has been linked to a higher risk of heart attack, stroke, blood clot development, and death. Axiron is the second best-selling testosterone product on the market and many manufacturers of testosterone replacement products are facing hundreds of lawsuits regarding injury and death. About 400 Axiron lawsuits against Eli Lilly were settled in December of 2017.

Cymbalta – used to treat depression. Cymbalta has been shown to cause severe withdrawal effects in some patients. Lilly has been accused of misleading consumers and the medical community about the likelihood and severity of possible withdrawal effects. Lilly faced a number of lawsuits regarding Cymbalta withdrawal and class action lawsuits filed by people who claimed the company misrepresented the drug. Though settlements may have been reached in a few lawsuits, the class action lawsuit was dismissed in October 2017.

Jardiance – an SGLT2 inhibitor medication used to treat Type 2 diabetes. Jardiance and similar medications have been linked to an increased risk of ketoacidosis, kidney disease, cardiac problems and other injuries to the extremities or genitalia. Though most SGLT2 lawsuits have been filed against other manufacturers, Eli Lilly may be facing hundreds of Jardiance lawsuits, many of which have been consolidated in federal court but have yet to be settled.

Though notable lawsuits have not been filed for other Lilly drugs such as Effient, Strattera, Cialis, Jenadueto, Syngardy, and Tradjenta, these drugs belong to classes of medications that have caused serious injury and resulted in lawsuits.

Insulin Pricing Controversy

Eli Lilly has come under fire by political leaders in the White House and U.S. Congress over pricing of its insulin products. In January 2019, U.S. representatives demanded explanations for dramatic and rapid increases in insulin process. Lawmakers claimed that annual costs of insulin rose from $2900 in 2016, to $5700 in 2020. Others have also been quick to compare U.S. insulin pricing to prices outside of the U.S. which is claimed to be a fraction of what U.S. patients pay. Current and past presidential administrations have attempted to reduce the cost of insulin for U.S. patients, with the most recent attempt guaranteeing that Medicare recipients would not pay more than $35 per month for insulin products. The measure has yet to take effect and does not provide relief for people who are not on Medicare.