Boehringer Ingelheim

HISTORY AND SUMMARY

Albert Boehringer founded Boehringer Ingelheim in Ingelheim am Rhein, Germany in 1885. It is currently one of the world’s largest pharmaceutical companies. They focus on the creation, manufacture, and marketing of new and novel drug products. Their main focus of drug research involves the areas of respiratory disease, oncology, and disorders of the central nervous system. They also conduct research for animal health and animal pharmaceuticals.

The company first began by producing lactic acid. It was the first company to ever produce lactic acid commercially and experienced tremendous success early on. After their success, chemist Heinrich Wieland established the company’s research and development department. The currently participate in collaborative research projects with both industry and academic research partners that seek to develop new and influential drugs.

CONTROVERSY

WHISTLEBLOWER CASE

In 2005, Robert Heiden, an employee at Boehringer Ingelhim, filed a lawsuit against the company. He alleged that the company had been marketing “off-label” drugs that had not been approved by the FDA to treat the conditions that Boehringer Ingelheim had been claiming they would. Heiden believed that these drugs posed serious health risks and that they were not a valid means of treating people.

He acted as a whistleblower and helped the government to build a case against Boehringer Ingelheim. He wore a wire and recorded conversations that took place within the company. He also was able to analyze millions of documents and pharmaceutical notes that had been created following pharmaceutical reps visits to doctors’ offices and hospitals. He facilitated a process that allowed for an FBI agent to attend a sales presentation put on by members of Boehringer Ingelheim. In the presentation, members of the company pushed the use of a drug known as Micardis. This drug was not yet approved to treat the conditions the members of the company claimed it would, and they had no research at the time to support the claims.

Boehringer Ingelheim paid out $95 million in 2012 to settle the case. It was found that the company had been marketing these off label drugs without the approval of the FDA.

PRADAXA

Boehringer Ingelheim agreed to pay out $650 million to around 4,000 people who had filed lawsuits against the company after taking Pradaxa. Pradaxa is a blood thinner that is used to prevent blood clots from forming. It is often prescribed to people suffering from a condition known as atrial fibrillation. This condition occurs when a person’s heart does not beat properly. When this happens, blood can clot in the chambers of the heart. These clots can become dangerous and lead to both heart attack and stroke. Pradaxa prevents a certain protein in the blood from working which then prevents blood clots from forming.

Those who have sued Pradaxa believe they were not adequately warned of the dangers of the drug. There are serious risks that can develop when taking the drug. Because Pradaxa prevents blood clots from forming, it can often be difficult to stop the bleeding once it has started. There is not an antidote currently available that can stop the bleeding once it starts.  Hundreds of deaths have been attributed to an uncontrollable amount of bleeding.

Many people believe that Boehringer Ingelheim marketed the drug as a type of “one-stop” solution that would solve all of patient’s symptoms without presenting any risks. This was not the case as Pradaxa comes with a number of dangerous side effects that can sometimes lead to death. Both doctors and patients feel as though they were not adequately warned of these serious side effects.