Monday, December 16, 2013

A Second Order Cover Up? - Judge Finds Boehringer Ingelheim Allowed Destruction of Records Bearing on Allegations of Cover Up of Drug Adverse Effects

This case generated little coverage, a story in Bloomberg, and a post on PharmaLot, but perhaps should have received more attention.

Background - the Pradaxa Case

The background, per Bloomberg, is that

Boehringer [Ingelheim BmbH] is preparing to face the first federal court trial of claims that it hid Pradaxa’s bleeding risks. 
Pradaxa is dabigatran, a new anti-coagulant drug that can be used without frequent monitoring of blood tests, as is required when using the older drug warfarin.  However, unlike warfarin, the effects of dabigatran cannot be quickly reversed should a patient on the drug start to bleed.

The reason for the trial is that


Patients and their families alleged that Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, which can lead to so-called bleed-out deaths.

Pradaxa has generated more than $1 billion in sales worldwide for Boehringer, the world’s biggest family-owned drugmaker. Researchers have found it more effective at preventing strokes than older competitors, including Bristol-Myers Squibb Co.’s Coumadin.

Consumers’ lawyers contend that Boehringer officials marketed the drug as superior to existing blood thinners when they knew its performance was not better than similar medicines.

Pradaxa has been linked to more than 500 U.S. deaths over a two-year period, and Boehringer faces claims that it sold the drug knowing the medicine could cause bleed-outs among some patients, according to a federal panel that tracks consolidated cases. 

The Judge Found that by Letting Documents Vanish, the Company Committed "Egregious Wrongs"

The trial has not yet begun, and the allegations by the plaintiffs are unproven.  However, Boehringer Ingelheim already is the subject of a finding by the judge,

Boehringer Ingelheim GmbH  GmbH, the German family-owned drugmaker, withheld or failed to preserve 'countless' files sought by patients suing over the company’s blood thinner Pradaxa and must pay a fine of almost $1 million, a judge ruled. 

U.S. District Judge David Herndon in East St. Louis, Illinois, who’s overseeing more than 1,700 consolidated lawsuits over claims that Pradaxa caused excessive and sometimes fatal bleeding, concluded that Boehringer executives acted 'in bad faith' by failing to ensure that documents and files about the drug’s development and marketing were preserved.

'The wrongs here are egregious,' Herndon said in yesterday’s ruling. 'The gross inadequacy' of the company’s efforts to safeguard the documents justified a sanction of more than $931,000 against Boehringer, the judge said. 

The ruling apparently affirmed allegations made by the plaintiffs' lawyers,

The company can’t produce files of a high-level scientist involved in developing Prada’s or documents by consultants who worked on the marketing plan, patients’ lawyers alleged in court filings. The company also failed to order employees to save phone messages about their work on the medicine, they added. 

Of course, Boehringer Ingelheim contended otherwise,

 Boehringer said it has made 32 million pages of material about the drug available to the plaintiffs and has been bombarded with 'overly burdensome' document requests by patients’ lawyers, according to court filings. The company also argued that many of the documents sought by the plaintiffs’ attorneys are not relevant to the claims at issue. 

The judge vigorously disagreed,


In his 51-page ruling, Herndon said he was forced to deal with claims that Boehringer was improperly withholding documents from the inception of the case consolidation in 2012. Pradaxa suits filed in federal court across the country were gathered before Herndon for pretrial information exchanges.

Boehringer officials 'made misrepresentations' about their efforts to preserve documents and failed to take obvious steps to preserve files and other records, the judge said.

Boehringer executives 'failed to ensure the auto-delete feature of their employee cellphones, company owned and personal, was disengaged for the purpose of preserving text messages,'  Herndon said. This move 'allowed countless records to be destroyed.' 

Summary

We have now discussed numerous examples of what appears to be organized deception by health care organizations about their products or their conduct.  Recent examples included a settlement by Johnson and Johnson of a case alleging its subsidiary had hid evidence about problems with a device for sterilization of endoscopes (look here), and just before that a settlement in cases in which the same company was alleged to have hidden evidence about problems with a prosthetic hip device, and the drug Topamax (look here).

The current case is an example of a second order deception, covering up an alleged cover up of a drug's adverse effects. 

It appears that a culture of deception has taken hold in many of the world's most important health care organizations.  Deception and dishonesty may be seen as acceptable if it increases revenue, and hence the enrichment of top company insiders.  This seems to be the natural result of the belief that revenue is the only important goal, a product of the financialization of the world produced by the shareholder value ideology that dominates most Western business schools.  Pope Francis had a more incisive description of it, "the idolatry of money."

Without vigorous efforts to discover and counteract the countless deceptions that big health care organizations use to make more money and make their executives richer, we will continue to pay ever more for ever poorer results for patients' and the public's health.

Roy M. Poses MD for Health Care Renewal

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