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Daiichi Sankyo

Daiichi Sankyo manufacturers pharmaceuticals and medical equipment for humans and animals. The company participates in global research and includes four units for development, supply, quality, and safety. In 2005, Sankyo and Daiichi Pharmaceuticals merged and established a holding company. Both manufacturers had a rich history in the pharmaceutical industry. For example, Sankyo manufactured the first antibiotics in Japan, and Daiichi introduced one of the first tuberculosis medications in the country. Together, they produced successful drugs to treat the flu, acid reflux, and Alzheimer’s disease. In 2008, Daiichi Sankyo bought a majority share of Ranbaxy Laboratories, one of the world’s biggest manufacturers of generic drugs. However, this transaction proved to be bad news for Daiichi Sankyo. Ranbaxy was responsible for a number of products deemed unsafe for public consumption, which led to numerous lawsuits.

Drugs or Medical Devices Recalled Against Daiichi Sankyo

Daiichi Sankyo developed Rezulin, the first glitazone troglitazone made to lower blood sugar levels and treat type 2 diabetes. It was marketed in the United States by Parke Davis. Within three years of public use, it was recalled. Throughout the time the drug was available, numerous complaints were documented. Despite the apparent health concerns, Daiichi Sankyo earned over $1.8 billion in sales. In June 2002, newspapers reported internal documents surfaced indicating the manufacturer masked proof this medication had toxic effects on the liver. Besides liver damage, the drug was suspected of causing severe heart problems as well. Studies showed it was possible for Rezulin to cause abnormal thickening of the heart’s left ventricle, which raised the likelihood of cardiac failure.

In 2013, Ranbaxy suffered a number of manufacturing issues. Quality concerns were raised by the FDA, so Daiichi Sankyo was forced to recall over 64,000 bottles of its generic cholesterol drug. It appeared there was confusion with dosages in bottles. High dose pills were uncovered in sealed bottles of lower dose Lipitor generics. This is just one issue that had the FDA concerned over its manufacturing processes. One year before, Ranbaxy recalled the same drug after it was discovered many vials contained tiny glass particles.

Another drug causing problems for Daiichi Sankyo is Benicar, its popular blood pressure medicine. Benicar is in the family of angiotensin receptors. These types of drugs usually generate over $7 billion each year for manufacturers. Although multiple forms of these medications are on the market, only Benicar has been linked to the development of sprue-like enteropathy, an intestinal disorder that disrupts the correct absorption of nutrients. A patient who is not properly treated will starve to death.

Lawsuits Facing Daiichi Sankyo

Over the years, Diiachi Sankyo experienced numerous lawsuits. After the Rezulin recall, the manufacturer was flooded with complaints over serious problems and death that resulted from its side effects. After taking this drug, patients suffering from liver failure and other infections took legal action to recoup loses for pain and suffering. Families of victims filed wrongful death suits as well. Many claimants alleged the manufacturer under reported side effects that led to the problems.

Another large number of lawsuits have been filed against the drug company over Benicar. Many patients claim the medicine causes severe diarrhea and dehydration. Certain studies have linked Benicar to gastrointestinal conditions, including celiac disease. In October 2014, the first wrongful death lawsuit was filed over Benicar usage. Similar suits claim Daiichi Sankyo aggressively advertised the drug and paid over $1 billion to push the medicine to the public and tout its superior efficacy. However, the FDA determined the drug company’s claims could not be substantiated and led to many injuries. If a person suspects problems from taking Benicar, it is essential to seek legal advice quickly. Each state has a time frame when an injury claim can be filed.

Verdicts Against Daiichi Sankyo

Some of the largest verdicts against Daiichi Sankyo involved Rezulin. Since March 2000, this drug was the basis for over 35,000 lawsuits across the country. In December 2001, a Houston jury awarded $43 million to a woman who claimed she experienced extreme liver damage after taking the drug. Evidence proved negligent behavior on behalf of the manufacturer for not reporting dangerous side effects to the public. This verdict was meant to send a message that patient safety is important. In the end, the estimated cost to settle all lawsuits approached $975 million.

Benicar lawsuits are still being fought in courtrooms across the country. Although no disclosed verdict amounts have been discussed, Daiichi Sankyo has agreed to pay $39 million to the United States government and state Medicaid programs to settle allegations it gave kickbacks to doctors who prescribed the drug. This case originated from a lawsuit filed by a former sales rep under whistleblower provisions of the False Claims Act.

FDA Sanctions Against Daiichi Sankyo

The FDA has issued many sanctions against Daiichi Sankyo and its subsidiaries. For instance, there are a number of actions facing Ranbaxy. The federal agency issued import alerts and bans after questions were raised about its manufacturing processes overseas. Also, drug applications were frozen after the company was found to have falsified data and testing results. As punishment, Ranbaxy was forced to pay $500 million in criminal and civil fines.

In regards to Daiichi Sankyo’s problems with Benicar, the FDA reported clear evidence that the drug causes extreme gastrointestinal problems. The manufacturer was forced to make label changes to make patients aware there are heightened risks of developing such issues.

To overcome its problems, Daiichi Sankyo has plans to reorganize its Japanese supply subsidiaries. As of April 2014, the drug giant was no longer a majority shareholder of Ranbaxy, which relieves many headaches. Ranbaxy was purchased by Sun Pharmaceuticals for $3.2 billion. However, further turmoil faces the company as many of its lucrative drug patents are set to expire in 2016. In the days ahead, this manufacturer must overcome doubts about its quality and safety measures, or it will fail to maintain its foothold in the world of pharmaceuticals, and more lawsuits will follow.

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