B as in Billion   (April 8, 2014)

Takeda Pharmaceuticals U.S.A., manufacturer of the diabetes drug Actos (pioglitazone), just issued a press release today, indicating that a jury has awarded $6 billion in punitive damages from Takeda and $3 billion from co-defendant, Eli Lilly. That's "B" as in "billion." The jury also awarded $1.475 million in compensatory damages to Terrence Allen, who has bladder cancer, as well as the massive punitive damages amount. Legal bloggers seem to think the amount of the punitive damages award will come down on further review -- and it's no surprise that Takeda plans to appeal. (For those of you attorneys who are reading this blog, the case is "Actos Products Liability Litigation Case No. 6:11-md-2299".)

Seems that Takeda screwed up on records retention. In the world of pharmaceutical manufacturing, if there's litigation pending, the corporate attorneys will issue a company-wide edict that all documentation relating to the legal matter must be retained. In the companies that I worked for, and presumably throughout the industry, there are Standard Operating Procedures about the process, and lists of what products are subject to these legal holds. And occasionally the company lawyers send out reminder letters discussing the legal holds.

Takeda has learned the hard way that the courts take this matter very seriously. The judge's "Memorandum Opinion and Ruling" in the Takeda case is on-line. In this document, she points out that records from 46 key employees, including company executives, had been deleted after leaving Takeda. Takeda has admitted 38 of the 46 custodial files at issue were either lost, destroyed, or otherwise rendered inaccessible, after Takeda had issued a broadly worded Litigation Hold about Actos in 2002.

The plaintiffs’ attorneys showed that the litigation hold was in place for Actos-related records which clearly instructed custodians to not “destroy, delete, throw away or otherwise discard any such documents or electronic data.” The legal hold was also refreshed several times over the years. Takeda tried to argue that the litigation hold did not apply to the specific issue of bladder cancer, which didn't arise until around 2010, and they argued that they therefore did not have a duty to preserve information for this case until then.

The judge didn't agree. She said "This Court has determined Takeda had a duty to preserve 'any and all documents and electronic data which discuss, mention, or relate to Actos' beginning in July 2002, at the time Takeda implemented the 2002 Litigation Hold in both the United States and Japan, and in 2006 in Europe."

Were the missing records important? Definitely. In the judge's report, she notes:

* An August 2005 email from Mick Raebel, Takeda Vice President of Regulatory Affairs, to (among others) Kiyoshi Kitazawa and Phillip Collett (Vice President ofRegulatory Affairs at Takeda Global Research and Development Centre (Europe) Ltd.). In this email, Mr. Raebel outlines the "Best Case Scenario," "Worst Case Scenario," and "Most Likely Scenario" concerning data connecting Actos to bladder cancer and the drug's labeling. The foregoing email was not located in Mr. Kitazawa's file [which is lost] but, rather, was found in the file of another Takeda employee.

* Perhaps the most compelling evidence of potential beneficial relevance and prejudice to Plaintiffs, she states, is the correspondence of Tai Matsuzawa and Kiyoshi Kitazawa. Mr. Matsuzawa was a Vice-President of the Pharmaceutical Group of Takeda Chemical Industries, Inc. in Japan, while Mr. Kitazawa was a Managing Director, Board Member, and General Manager of Takeda's Strategic Product Planning Department. (All of Mr. Kitazawa's e-mails were deleted after the Litigation Hold was in place.) Some of the correspondence between them and their company's partner at the time, the Upjohn Company, who was planning to withdraw from the partnership, was obtained from Upjohn. The correspondence shed light on the efforts by these Takeda top brass to attempt to persuade Upjohn to downplay the safety issues Upjohn proposed to mention in their letter of withdrawal from the partnership, and Takeda's attempt to persuade Upjohn to change the reason for their withdrawal to concerns with the efficacy of Actos as a reducer of blood glucose.

As the judge points out, "The potential relevance of the foregoing information is obvious, as that which was located relates to Takeda's knowledge about the potential health concerns of Actos as those concerns might relate to bladder cancer and the sufficiency of the company's warnings on its labeling."

A bit of background about Actos (pioglitazone) and the risk of bladder cancer seems in order at this point. I have written about this issue previously: France and Germany Withdraw Use of Actos Because of Risk of Bladder Cancer and Generic Actos and Bladder Cancer, and the FDA has issued myriad reports on the issue, available at the FDA website.

Basically, there's an increased risk of bladder cancer with Actos; this is especially true if the patient uses Actos for more than one year. It is recommended that the drug not be used if the patient already has active bladder cancer, and be used with caution in patients with a history of bladder cancer. Patients should also be advised to "contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer."

For what it's worth, the FDA doesn't think the drug should come off the market, but France and Germany Health Authorities did suspend the use of Actos because of the "small increased risk of bladder cancer."

What should patients taking Actos or the generic version (pioglitazone) do at this time? The FDA has advised that patients do the following:

• You should not take pioglitazone if you are receiving treatment for bladder cancer.
• Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
• Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
• Talk to your healthcare professional if you have concerns about Actos or its generic form, pioglitazone.