[Post updated May 2018] A recent article published by the Pharmaceutical Integrity Coalition highlighted the terrible tragedy that occurred several years ago when contaminated heparin was imported into the United States. Manufactured by Baxter International, a U.S. company, the adulterated drug was linked to over 100 deaths and hundreds of serious injuries. One woman was severely brain damaged.
Many times after the headlines fade, only the name of the whistleblower is remembered. Erin Brokovich became a household name after exposing contaminated groundwater linked to Pacific Gas & Electric. (Ironically, Erin Brokovich’s real name is Roberta Walker.) And many still remember Bradley Birkenfeld the whistleblower from UBS who turned a criminal conviction into a $104 million payment from the government.
Unfortunately, behind many successful whistleblower cases are innocent victims of fraud. Worse, many times the corporations and people responsible for these tragedies never apologize for their misconduct and crimes.
We thought HSBC and Bank of America were poor corporate citizens; now we think that big pharma may be worse. Lets look at the heparin tragedy and its aftermath.
In 2007, Baxter International was the major manufacturer of heparin, a lifesaving anticoagulant and blood thinner. The drug is often administered during heart surgeries and during dialysis treatment to prevent life threatening blood clots.
Baxter is now out of the heparin business but in 2007, it was obtaining the active ingredient for the drug from Scientific Protein Laboratories (SPL), another U.S. company. SPL was manufacturing the active ingredient in Changzhou, China. A subsequent investigation revealed that neither the FDA nor Chinese authorities had ever inspected the Changzhou factory.
Worse, that facility was purchasing the raw materials from a dozen “workshops” scattered throughout China. The FDA said SPL had no protocols in place to properly monitor what was coming from these workshops.
Ultimately, highly contaminated heparin was sold in the United States and made its way into the hospitals, pharmacies and clinics across the country. Baxter never took the proper steps to insure the products it was selling were safe or sought to insure the integrity of its supply chain.
In November 2007, the first reports of contaminated heparin came from Children’s Hospital in St. Louis. By the time the drug was recalled, patients across the United States had already died.
Baxter received high marks from Congress for its response to the tragedy but by then, the damage was done. Unfortunately, it will always be Baxter’s fault that the bad drugs even made it into the marketplace.
In April 2008, Robert Parkinson, the President and CEO of Baxter International, was hauled before Congress to answer questions about the tragedy. Speaking before a packed house, including victims and families of victims who had died, Parkinson said he was “terribly sorry” for their loss. He then went on to suggest that Baxter was a victim of the tragedy as well.
A company with $25.9 billion in assets claiming to be a victim?
No one suggests that Baxter introduced the contaminants into the drug’s active ingredient. The company did have the duty to ensure its products were safe and to know whom it was doing business with, however.
Criminals who are about to be sentenced tell the judge they are “sorry” and those apologies generally ring hollow. We give high marks to Parkinson for at least telling Congress that he took personal responsibility for the tragedy. The company’s statements outside Congress tell a different story.
The Coalition’s website examined Baxter’s website. Curious, I did too.
Baxter acknowledges that there was an “adverse reaction” to some of its heparin products. They say the reactions, however, were “temporary.” Tell that to the families of the 81 to 149 people whose deaths are linked to taking contaminated heparin.
The company also claims that its doctors were the ones who discovered the problems in early 2008 and immediately ordered a recall. Congress, however, found that the problems were discovered by Children’s Hospital in November of 2007.
In discussing the heparin tragedy, the company claims that patient safety is its “number one priority”. We find that the company’s actions – or inactions – tell a different story.
The company acknowledges in public filings and statements that it faced 740 lawsuits for injuries associated with the drug. Little is said about the dozens of people who died and those still living and still suffering. Instead, the company merely acknowledges that “in some cases” those cases involved a fatality.
Baxter only acknowledges one jury verdict of $625,000 and doesn’t discuss the millions of dollars paid to settle other claims.
We don’t think Baxter’s actions were intentional. No one at the company woke up one morning and decided to poison hundreds of patients already facing other serious medical problems. In our opinion, however, the company’s claims that it places patient safety first and that it was a victim of the tragedy are blatantly false.
Baxter didn’t properly test the ingredients going into their product, it didn’t properly test the products once manufacturing was complete, it didn’t effectively monitor their supply chain and it didn’t even seem to care that the facility producing the prime active heparin ingredient had never been inspected by the FDA or Chinese regulators.
Unfortunately, no whistleblowers came forward before the tragedy… no one from SPL’s Changzhou facility or U.S. testing facility, and no one from Baxter.
The deaths are certainly not the responsibility of the most of the hard working people in the pharmaceutical industry. It’s time, however, for the code of silence within the industry to be broken.
Congress passed the False Claims Act during the Civil War. That law empowers ordinary people anywhere in the world to file a suit on behalf of the United States. Last year the government paid whistleblowers over $635 million in award monies. The U.S. whistleblower laws also have important anti-retaliation provisions to protect workers that come forward, although the laws only reach whistleblowers in the United States or working for U.S. companies.
It’s time to put an end to profits over safety and an end to filthy pharma. If you are aware of unsafe drugs anywhere in the United States or unsafe manufacturing practices outside the U.S., give us a call. We have helped our whistleblower clients collect over $100,000,000.00 (US) in award monies.
Unfortunately, calling the FDA’s MedWatch hotline doesn’t get you an award. A sealed lawsuit has to be filed in federal court in order to become eligible for an award under the False Claims Act.
Update January 2017.
One would think that with the blood of dozens of heparin patients still on their hands, Baxter would clean up their act. They didn’t and apparently did clean much of anything. In January 2017, Baxter was fined $18 million to resolve charges that between 2011 and 2012, their clean room had moldy air filters. It cost millions of dollars to build a clean room yet Baxter didn’t bother properly maintaining their HEPA air filters.
The filters were so bad that many had visible black mold. Some of the filters were located directly above where sterile IV solutions were being made.
According to a maintenance worker, when he reported the mold to his supervisor, he was told to ignore it. He then talked to his boss’ boss and then his boss and finally HR and the plant manager. No one seemed to care. Despite mold in a sterile clean room being an FDA violation and dangerous, the worker was told, “Just wipe it off.” Later maintenance staff was told, “Whatever you do, don’t bring up the HEPA filters.”
Fortunately, that maintenance worker became a pharmaceutical whistleblower and filed both a False Claims Act complaint and called the FDA. [Complete details of this story can be read here.]
Do you have information about dirty drugs or cGMP violations? Visit our Pharma Whistleblower information page. Want to know if you have a case? Contact attorney Brian Mahany at or by telephone at (direct). All inquiries are protected by the attorney – client privilege and kept completely confidential.