Thousands of people rely on Copaxone to treat multiple sclerosis, an autoimmune disease in which the immune system attacks the myelin sheath that coats the nerves in the body, causing messages to and from the brain to be delayed or fail altogether.

Teva Pharmaceuticals, the company that manufactures Copaxone, has faced a number of lawsuits claiming that the company engaged in aggressive marketing practices and paid kickbacks to boost the sales of Copaxone, violating the False Claims Act that protects US government programs like Medicare from fraud.

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What Is Copaxone?

Copaxone is a brand-name prescription medication containing glatiramer acetate. It is used to treat multiple sclerosis (MS) and prevent further relapses of the condition. The medication is made up of combined amino acids which may help to prevent the immune system from attacking the nervous system in people with MS. Although Copaxone is not effective in completely curing multiple sclerosis, it may minimize the incidences of relapses.

Who Manufactures Copaxone?

Copaxone is manufactured by Teva Pharmaceuticals, an pharmaceutical company headquartered in Tel Aviv, Israel. Though Teva has proprietary, brand name medications, the company is also the largest producer of generic drugs.

Who Is Teva Pharmaceuticals?

Teva Pharmaceuticals was founded as a wholesale drug company in Jerusalem in 1901. At that period in history, Jerusalem was a part of the Ottoman Empire rather than withing the independent country of Israel. By the 1930s and 1940s, the founders grew the company with loans from immigrants to the area. In the 1950s, the company went public before later merging with two other companies, Assia and Zori, acquiring its current name, Teva Pharmaceuticals, Ltd.

Is Copaxone FDA-Approved?

Copaxone is currently approved by the FDA for adult patients who are diagnosed with MS. It is used mainly to reduce the occurrence of progression or relapses of MS. It is approved for patients with clinically isolated MS whose condition has been confirmed through magnetic resonance imaging (MRI), those with secondary active progressive MS, and those with relapsing-remitting MS.

What Is Multiple Sclerosis?

Multiple sclerosis (MS) is a brain and nervous system disease in which the body’s immune system attacks the myelin sheath that coats the nerve fibers. This results in communication problems between the body and the brain. MS can, over time, cause the nerve fibers to deteriorate and can cause permanent damage to the body’s nervous system.

Is There a Cure for Multiple Sclerosis?

There is no cure for MS. However, medications like Copaxone can help to manage symptoms, aid in recovery after an attack, and modify the disease’s course.

What Are the Symptoms of Multiple Sclerosis?

The symptoms of MS can include:

  • Lack of coordination
  • An unsteady gait
  • Inability to walk
  • Vertigo
  • Numbness in one or more limbs on one side of the body
  • Weakness in one or more limbs on one side of the body
  • A tingling feeling
  • Certain neck movements cause electric shock sensations
  • Double vision (prolonged)
  • Partial loss of vision in one eye at a time
  • Complete loss of vision in one eye at a time
  • Pain during eye movement
  • Blurred vision
  • Slurred speech
  • Fatigue
  • Cognitive problems
  • Mood problems
  • Sexual function problems
  • Bladder function problems
  • Bowel function problems

Symptoms may vary from person to person. One person’s experience of multiple sclerosis can be very different from someone else’s. The symptoms may also change over the course of the disease depending on which nerves in the body are impacted.

What Are the Types of MS?

Multiple sclerosis may progress as a continually worsening disease or as a cycle of remission and relapse. Each relapse can result in different symptoms that may develop over a period of days or weeks. Relapses may be followed by periods of remission in which symptoms either partially improve or go away completely. Remission periods may last for months or even up to years before symptoms start to return. In some people, MS occurs as a cycle of relapses and remissions while in others, the symptoms gradually get worse.

What Is Clinically Isolated Syndrome (CIS)?

Clincally Isolated Syndrome (CIS) is the development of some of the symptoms of multiple sclerosis for a period of a minimum of 24 hours. In some cases, CIS can eventually develop fully into MS.

What Is Relapsing-Remitting Multiple Sclerosis (RRMS)?

RRMS is the type of multiple sclerosis of cycles of relapses and remissions. There are periods in which the MS symptoms flare up and then other periods in which the symptoms either improve or go away altogether.

What Is Secondary Progressive Multiple Sclerosis (SPMS)?

SPMS is a type of multiple sclerosis in which symptoms steadily get worse over time. There still may be cycles of relapse and remission with SPMS, but here, the relapse periods involve symptoms that are worse than usual and symptoms persist through remission periods but just aren’t as severe during those times.

What Causes Multiple Sclerosis?

MS is caused by immune systems attacks on the myelin sheath that coats the endings of nerves in the spinal cord and the brain. The myelin sheath functions similarly to the plastic insulation on the exterior of an electrical wire. If that exterior coating is damaged, it can interfere with the proper functioning of the wires. Similarly, if the myelin sheath on nerves is damaged, the messages those nerves transmit can be slowed or even blocked.

What causes the immune system to start attacking the myelin sheaths in the body’s nervous system is still unknown, however. It’s thought that a combination of genetic and environmental factors may be at play.

What Are the Risk Factors of Multiple Sclerosis?

The following are risk factors that may increase chances of developing multiple sclerosis:

  • Genetics
  • Family history
  • Smoking
  • Climate (cooler climates)
  • Low vitamin D levels
  • Gender/sex (women)
  • Age (20-40)
  • Race (white)
  • Obesity
  • Certain autoimmune disorders
  • Certain infections

What Complications Can Occur from Multiple Sclerosis?

Multiple sclerosis may result in the following symptoms:

  • Muscle spasms
  • Muscle stiffness
  • Severe weakness, especially in the legs
  • Paralysis, especially in the legs
  • Bladder problems
  • Bowel problems
  • Sexual dysfunction
  • Forgetfulness
  • Cognitive difficulties
  • Depression
  • Anxiety
  • Mood swings
  • Rare seizures

How Does Copaxone Work?

Copaxone or glatiramer is a synthetic protein used for treating MS and works by simulating myelin’s basic proteins to insulate the spinal cord and nerve fibers in the brain. Although the mechanism is action not entirely understood, the drug may also work to block T-cells that damage myelin.

Copaxone is delivered as an injection under the skin. Some individuals may have a localized skin reaction. Some may have a more serious reaction than others. Make sure you inform your doctor about whether or not you are allergic to mannitol or glatiramer prior to taking Copaxone. You should also inform your doctor if you plan to become pregnant or are currently pregnant.

What Are the Side Effects of Copaxone?

The side effects of taking Copaxone may range from common to severe. Other medications may also interact with Copaxone including vitamins, over-the-counter medicines, herbal products, and prescription drugs, and may increase the risk of side effects. You should always talk to your doctor about other medications and supplements you are taking.

What Are the Common Side-Effects of Copaxone?

More common, mild to moderate side effects of Copaxone may include:

  • Flushing
  • Skin rash
  • Weakness
  • Nausea
  • Vomiting
  • Anxiety
  • Depression
  • Mood changes
  • Heart palpitations
  • Infections
  • Common cold
  • Flu
  • Weight gain
  • Weight loss
  • Sweating
  • Back pain
  • Allergic reaction at the site of the injection

What Are the Symptoms of an Allergic Reaction to Copaxone?

If you’re allergic to Copaxone, you may experience some of the following symptoms:

  • Swelling of the face
  • Difficulty breathing
  • Hives
  • Swelling of the tongue
  • Swelling of the throat

Symptoms of allergic reaction should be treated as a medical emergency.

What Are the Serious Side Effects of Copaxone?

Some side effects may also occur at the time you inject the medicine.

  • Fluttering in your chest or a pounding heartbeat
  • Flushing
  • Chest pain
  • Skin changes where the injection was given

These symptoms should be reported to a health professional right away.

Why Is Teva Pharmaceuticals Facing Copaxone Lawsuits?

Teva Pharmaceuticals is facing Copaxone lawsuits from both the United States government and insurance companies over accusations of the company receiving kickbacks and using questionable marketing practices in order to sell more Copaxone.

What Copaxone Lawsuits Are There?

In 2013, former sales representatives for Teva sued the company as whistleblowers. These whistleblowers claimed that the company was paying doctors kickbacks to prescribe Copaxone and another medication, Azilect at “educational” events that were falsely created to facilitate sales of the drugs.

In 2020, the United States government filed a complaint against Teva Pharmaceuticals USA, citing the False Claims Act. This complaint alleged that Teva had paid kickbacks to boost its Copaxone sales through charitable organizations, resulting in submission of false claims to Medicare.

In 2022, Blue Cross and Blue Shield of Vermont and the Vermont Health Plan filed a lawsuit against Teva Pharmaceuticals alleging that the company used overly aggressive marketing tactics in order to sell more Copaxone. The plaintiffs claimed that Teva issued coupons to consumers that would encourage them to use Copaxone instead of a cheaper generic alternative. During this period, from 2002 to 2019, Teva made more than $30 billion from sales of Copaxone. The insurance companies filed lawsuits because even though individuals may have benefited from the discounted price of Copaxone, insurance companies ended up paying the difference between the generic version of the drug and the price Teva was charging for the brand name Copaxone.

Teva Pharmaceuticals faces a 2022 lawsuit in Israel, which claims that the company has failed to pay $100 million in royalties. Teva owned the rights to market Copaxone, but the drug itself was developed by scientists at the Weizmann Institute of Science who were owed royalties from Teva’s sales of the drug.

What Is the False Claims Act?

The False Claims Act is a federal law that holds any person or organization that defrauds a US government program liable for that fraud. This act, also called the Lincoln Act, is the government’s main legal method for combating fraud perpetrated against it. Teva was accused of violating the False Claims Act by encouraging false Medicare claims.

What Is a Kickback?

A kickback is a type of fraud in which a person or an organization illegally receives payment for a service that has been rendered in an improper way, such as unnecessary treatments. Teva has been accused of paying kickbacks through charities in order to bribe a boost in sales for Copaxone.

What Copaxone Lawsuit Settlements Are There?

In 2020, Teva Pharmaceuticals paid a $54 million settlement in a lawsuit claiming that the company had paid kickbacks in order to boost Copaxone sales. Other cases are still ongoing regarding Teva’s alleged kickbacks, aggressive marketing, and violations of the False Claims Act.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.