Pradaxa Injuries and Deaths — Who is Responsible?

Boehringer Ingelheim is an international group of companies. It is the largest privately-owned drug manufacturer in the world, and is in the top-twenty of largest drug manufacturers globally.  It is reported that Boehringer Ingelheim, today, has 42,000 employees and 145 subsidiaries or affiliated companies. It operates 20 different manufacturing plants in 13 countries and focuses on drug products for both humans as well as animals.  Boehringer currently markets 33 drug products in the United States.

C.H. Boehringer Sohn AG & Ko.KG was founded by Albert Boehringer in 1885 in Germany.  The company began as a manufacturer of tartaric acid, which was mostly used for baking, carbonation of beverages, dyeing, and for pharmaceutical applications.   In 1893, Mr. Boehringer discovered that lactic acid could be mass produced, which led to a turning point for the company and it became the largest manufacturer of lactic acid for use in the food, leather, and textile industries.  The company began with 28 employees in 1885 and had grown to employ more than 1,500 workers by 1939 when the founder died. In 1939, the management of Boehringer Ingelheim was taken over by the founder’s two sons and his son-in-law. By 1939, the company was producing several brand name drug products.  During World War II, the company suspended production of tartaric acid and lactic acid and instead focused on manufacturing items needed for the war efforts.

From 1948 through the 1950s, Boehringer Ingelheim benefited from post-War expansion efforts and grew significantly, both in size as well as with regard to the scope of their products.  Boehringer’s first foreign subsidiary (Bender & Co. GmbH) was founded in Vienna in 1948. In 1955, Boehringer established a presence in Japan (Nippon C. H. Boehringer Sohn Co. Ltd) and founded a subsidiary in Florence, Italy (C.H. Boehringer Sohn SRL). Boehringer’s operations were also extended to Mexico, Venezuela, and Canada.

A number of drug products were introduced by Boehringer Ingelheim (BI) in 1950s through the 1980s for the treatment of respiratory, gastrointestinal, and cardiovascular conditions. The manufacturing capacity of BI was increased as it began to focus on a worldwide market for its products.  Some of the key products for the treatment of pulmonary conditions launched during this time period included Alupent, Bisolvon, Berotec, Atrovent, and Berodual. The company also produced several new cardiovascular drugs, Mexitil and Catapresan.  Boehringer’s web site contends that its launch of the drug Actilyse in 1987 was a significant milestone for the company in that it was the first thrombolytic treatment for patients who had suffered heart attacks; it was also the first drug produced at a new biopharmaceutical manufacturing company opened in 1986. Boehringer founded The Research Institute of Molecular Pathology in Vienna, Austria which conducts research relating to molecular and cellular biology, gene function, circuit neuroscience, and use of mathematics, computer science, physics, and engineering in conjunction with biological research.

Over the past couple of decades, Boehringer has ventured away from its roots as a family-owned business and has expanded its board of directors to include members who are not part of the founder’s extended family.  New marketing relationships have been forged with a number of pharmaceutical giants, including Pfizer, Eli Lilly, GlaxoSmithKline, Abbott Laboratories, and Genentech.  Boehringer has also extended its influence through the acquisition of STEAG (a micro-technology company) and some business segments of Fort Dodge (a veterinary medicine company formerly owned by Pfizer and Wyeth).   During the 1990s, several noteworthy drugs were introduced by Boehringer – Combivent, Flomax, Aggrenox, Spiriva, Viramune, and Micardis.

The launch of Pradaxa (dabigatran etexilate) in the United States was one of the most noteworthy happenings in the history of Boehringer Ingelheim.  It was the first new drug approved for the prevention of strokes in the European Union in 50 years.  While Boehringer cites this tidbit with pride, this will actually be a critical issue in the burgeoning Pradaxa litigation – did the world really need a new drug for the prevention of strokes?  And, if so, was Pradaxa the drug that should have been approved?

The following entities are part of this conglomerate and share some responsibility for injuries caused by Pradaxa:

• C.H. Boehringer Sohn AG & Ko.KG, parent company for the Boehringer entities, based in Ingelheim am Rhein, Germany;
• Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer US), domestic subsidiary and a Delaware corporation, with its principal place of business in Ridgefield, Connecticut;
• Boehringer Ingelheim Pharma GmbH & Co. KG (Boehringer Pharma), a foreign corporation, with its principal operations in Ingelheim am Rhein, Germany;
• Boehringer Ingelheim International GmbH (Boehringer International), also based in Germany;
• Bidachem SPA (Bidachem), a subsidiary of parent company Boehringer Ingelheim, based in Italy that manufactures chemicals and active ingredients for drug products.

All of these companies are likely to be included as defendants in lawsuits that are being increasingly filed in light of the global safety alarms over Pradaxa.  Within months since the drug was approved for sale in the United States and other countries, a startling number of adverse event reports have been reported to the FDA and other drug safety agencies. These reports document a startling number of drug-related deaths due to brain bleeds, gastrointestinal bleeds, and an inability to reverse bleeding associated with minor trauma in patients who have been taking Pradaxa.