Thank you, Carmen. I would like to join you and the Associate Attorney General in recognizing the prosecutors – both federal and state – analysts, and investigators who worked tirelessly over the past two years in support of this investigation into the tragic events of 2012. Their collaboration and devotion to the American people has resulted in these significant charges we announce today, and we thank them for their outstanding work.
Back pain is one of the most common ailments in this country. Millions of Americans suffer from it, many of them so severely that their only relief, short of surgery, is to get a shot from their doctor or health care provider. It is a routine procedure.
And yet, 64 people are dead. Killed by an outbreak that initially confounded public health officials – because no one had ever been injected in the spine with a fungus before.
Every day we take for granted the many ways in which our lives depend on the responsible actions of people we have never met. As consumers, we are in no position to fully ensure that the drugs we take are safe and effective or that the food we eat is not tainted – and yet, when we take an item off the shelf at the drug store or the grocery store, or visit the doctor for treatment, we do not think about whether we are putting our health at risk. And we shouldn’t have to. Getting a shot for back pain, eating a peanut butter sandwich – these are everyday activities, not Russian Roulette.
For these reasons, those who produce and sell the drugs that we take and the food that we eat have a special responsibility – one that has been enshrined in laws such as the Federal Food, Drug and Cosmetic Act. They have a responsibility to make sure their products are produced under suitable conditions, and with appropriate and truthful labeling. And they have a responsibility above all to make sure that what leaves their factories and warehouses and clinics is safe.
Those of us who enforce these laws have a special responsibility too. It is a responsibility that the Department of Justice views as among its most vital. And its most basic. After all, the highest priority of the Department is to protect the American people – and that means doing everything in our power to ensure that the food and drugs we put in our bodies – and in our children’s bodies – are safe.
For this reason, this Administration has made health care fraud – including wrongful acts that jeopardize the safety of our food and drug supply – a top priority from the beginning. The partnership between the Departments of Justice and Health and Human Services – which was elevated to a new level in May 2009 with the creation of the Health Care Fraud Prevention and Enforcement Action Team, or “HEAT” – has returned billions to the taxpayers and sent a clear, loud message across the health care industry that unlawful practices will not be tolerated. And in 2011, the Department transformed the Office of Consumer Litigation in the Civil Division into the Consumer Protection Branch, a team of dedicated lawyers, investigators and staff whose single-minded focus, every day, is to protect the health, safety, and economic security of all Americans.
Working with U.S. Attorneys’ Offices across the country, we have worked to enforce the law against every kind of health care scheme imaginable: from those who sell counterfeit drugs or unapproved medical devices, to those responsible for tainting our food and drugs or misleading our doctors. We are steadfast in our commitment to use every criminal and civil tool at our disposal to hold accountable those who are willing to put our lives at risk in the reckless pursuit of their profits.
Today’s indictment of those at NECC responsible for the meningitis outbreak is an important step towards justice for the victims, and for a safer America for the rest of us.
But, the indictment is only a step. It is the next step in a process that began two years ago, when dedicated public health officials across the country identified and then stopped a deadly outbreak unlike any anyone had ever seen. Those heroes saved countless lives.
Now, it is our turn. Our turn to enforce the law, to hold accountable those charged with recklessly causing the loss of life, as well as those whose conduct put others at risk, and to do our part to make sure this never happens again.
I’d now like to introduce our partner in this effort, the Deputy Commissioner of the FDA, Howard Sklamberg.