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Takeda Pharmaceuticals

Takeda Pharmaceuticals, the United States' subsidiary of Japan’s Takeda Pharmaceuticals Company Limited, was founded in 1998. Thanks to its diabetes drug, it is one of the top drug manufacturers in America. Over three centuries ago, the parent company began as a single medical shop in Osaka, Japan. Over the years, it grew into a successful publicly traded company. It was the first manufacturer of penicillin and vitamin B supplements.

In 1995, Takeda entered the medical scene in America with Lupron, its cancer-fighting drug. With the introduction of Prevacid, a treatment for stomach ulcers, Takeda took American and European markets by storm. Today, Takeda sells to approximately 79 countries and earns international sales approaching $1 billion.

Drugs or Medical Devices Recalled Against Takedo

Throughout the years, Takeda has experienced a few drug recalls. Back in 2011, Takeda’s Japanese parent company announced it would voluntarily recall Dasen, a drug used to combat inflammation, and serrapeptase, its generic counterpart. This recall was based on studies that showed the drug brought no significant positive effects to patients. It was decided that additional research was necessary to prove the drug’s efficacy.

Another major recall for Takeda involved its anemia drug, Omontys. These injections brought reports of hypersensitivity reactions among kidney dialysis patients. Some of these reactions were fatal. Kazumi Kobayaski, spokesman for Takeda, explained the company was working with the FDA and agreed to this voluntary recall as an ongoing effort to make patient safety a top priority.

Actos, a drug manufactured to treat type 2 diabetes, has yet to be recalled, but it is generating great concern from the public. Many users believe Actos causes bladder cancer, heart failure, and eye problems. The FDA is closely following ongoing studies that deal with this medication and has released a safety announcement that highlights its possible dangers. Other countries have pulled the drug from public consumption.

To issue a recall in this country, the FDA must conclude that there is a “reasonable possibility” that a drug causes “serious adverse health consequences or death.” The federal organization is constantly reviewing data and has issued advisories to physicians who are prescribing it.

In 1999, studies showed Actos caused bladder tumors in animals but was still approved by the FDA. Today, this health organization has updated the Actos drug label with information about an increased risk of bladder cancer and advises people with a history of this type of cancer to avoid the medication. Even though this drug has not been officially recalled, a user still has the right to seek legal counsel for help recovering compensation for injuries resulting from the consumption of this diabetes drug.

Lawsuits Filed Against Takedo

Takeda is facing multidistrict litigation concerning Actos. This means various federal lawsuits are grouped into one proceeding. Also, the drug manufacturer is being hit by various Actos lawsuits in state courts as well. Patients taking Actos claim Takeda did not warn the public of the deadly risks associated with the drug. Former employee, Dr. Helen Ge, filed a separate lawsuit that accused the company of failing to disclose adverse side effects to the FDA. She accused executives at Takeda of coercing her to ignore or under-report noted adverse reactions, which were experienced by users. She noted complaints of delirium, bladder cancer, congestive heart failure, and suicidal tendencies.

Verdicts Against Takedo

The first federal case involving the development of bladder cancer as a side effect of taking Actos resulted in a landmark $9 billion punitive damages verdict. This trial was the first trendsetting case in federal court, where approximately 3,000 other complaints of similar allegations are pending. This large award was ordered to be split by Takeda Pharmaceuticals and Eli Lilly, a major United States drug distributor. District Judge Rebecca Doherty found Takeda acted “in bad faith” regarding pretrial discovery and destroyed evidence that was relevant to the case. During the trial, the judge expressed concerns that approximately 46 files from Takeda management went missing. Despite the lost documents, the trial included internal communications and scientific studies Takeda tried to hide from the public. Plaintiffs argued the drug giant knew of increased risks of developing bladder cancer in humans from the early 2000s.

Questionable behavior also occurred inside the courtroom. District Judge Kerry Early held defense lawyers for Takeda Pharmaceuticals violated evidentiary procedures nine times during pending litigation. Plaintiffs accused the defense of acting in a “disrespectful” manner as well.

Besides this verdict, Takeda Pharmaceuticals recently announced an offer of $2.2 billion to settle over 8,000 federal and state lawsuits against Actos. When finalized, it will be a historic class action settlement, which amounts to $275,000 per case. This offer is only valid for patients who have already sued or hired an attorney to file a lawsuit against Takeda. Since the deal is not formally finished, it is not too late to make a claim against the drug company. However, the time to file may be running out. If you have taken Actos and suffered injuries, it is essential to seek legal assistance immediately.

Sanctions Against Takedo

Although Takeda currently faces no sanctions from the FDA, the manufacturer’s research is being closely eyes by the federal agency. In other countries, Takeda received sanctions imposed by the Japan Pharmaceutical Manufacturers Association for promotional activities regarding Candesartan Antihypertensive Survival Evaluation. A third-party investigation was launched into the matter, and the manufacturer fully cooperated. The company’s activities as vice president of the organization were suspended for six months.

In the Actos court case, defense lawyers were sanctioned for courtroom misconduct. This was a separate issue from Takeda’s liability of releasing a drug known to increase the risk of developing bladder cancer. This punishment comes weeks after a Federal District Court sanctioned the drug company for destroying documents, which may have provided proof of the drug giant’s negligence. This act is believed to be the key factor that contributed to the $9 billion dollar award. Although Takeda vows to appeal this verdict, its sales of Actos are expected to drop drastically.

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