WHY PREVENT MEDICAL ERROR CHOSE TO ACT ON ADULTERATED RANBAXY GENERIC DRUGS
A groundbreaking judgment against a major generic drug manufacturer
Following a lengthy investigation that uncovered numerous data and FDA application problems, in May of 2013, Ranbaxy pleaded guilty to USFDA drug safety manufacturing and generic drug application violations at two of its plants in India. Their parent company at the time, Daiichi Sankyopaid out over $500 million dollars in fines and penalty fees to resolve a whistleblower lawsuit filed by a former Ranbaxy employee.
Prevent Medical Error’s role in uncovering Ranbaxy problems
Prevent Medical Error (PME) continues to publicly acknowledge and thank everyone who has helped investigate Ranbaxy activities – from the WHO officials who first identified application problems in 2004 to United States authorities to the Ranbaxy insider who reportedly blew the whistle on the company.
PME, a 501 (c) (3) nonprofit organization, worked relentlessly not only to get at the truth about the harm adulterated Ranbaxy drugs have caused patients, but also to get these drugs off the market and out of PEPFAR. We remain grateful to all those who assisted in our efforts. In particular, PME would like to recognize the patients, physicians, and pharmacists who came forward, and the state and federal authorities and officials who listened and took action.
Why PME took on Ranbaxy
In 2002, when PME’s founder, Anne Patenaude, was working as a volunteer patient advocate, she began noticing a possible link between medical problems patients were experiencing and certain Ranbaxy generic drugs they were taking. Ironically, she has subsequently prescribed a generic antibiotic manufactured by Ranbaxy and, as a result, is now permanently disabled.
In spite of her poor health, Anne and PME worked tenaciously to try to get and keep adulterated Ranbaxy drugs off the shelves, identify potential problems, fight for patients who have been harmed, and educate people about drug safety issues. She and PME uncovered, tracked, and helped corroborate dozens of incidents of suspected patient harm caused by adulterated Ranbaxy generic drugs. Their findings were reported to the appropriate authorities. In addition, PME has collaborated with other organizations, authorities, and officials to help prevent other patients from taking adulterated drugs.
Justice for patients who took adulterated Ranbaxy drugs
At the time of their Import Alert and ban, the FDA indicated that the adulterated drugs that were already in the country were safe for patients to continue to take. Despite calls, state and federal authorities were not able to seize them. FDA’s current official position is that even when the FDA issues a Warning Letter deeming drugs adulterated, most of the time patients can continue to take adulterated drugs. So, to date, Ranbaxy has never acknowledged that its adulterated generic drugs are linked to harm in any patients.
Unfortunately, no adulterated Ranbaxy drug patients, including those identified by the nonprofit whose cooperation undoubtedly helped the government obtain the reported $500,000,000 settlement, will ever be acknowledged as victims by the government or the courts. Instead, in the court of law, only the government and the Ranbaxy insider who went to an attorney before going to federal officials to blow the whistle were eligible for victim’s compensation and/or whistleblower reward money. If the government or a court granted victim status to individual patients who are harmed and reimburses and/or compensates them directly, the patients’ private and government insurance carriers, and in certain situations, the government itself could legally claim these funds. The end result is that the very individuals who may be harmed by taking adulterated drugs are often left to navigate an overly complex regulatory and legal system, and wind up shouldering some or all of the
increased costs themselves. Jodi Ireland is one of those individuals.
“It’s so frustrating to think I never would have gone through all this if I hadn’t taken the generic Ranbaxy antibiotic. I’m so grateful to Anne and PME for figuring it out. They also helped me when my insurance company refused to pay for my IV treatments. Anne is definitely one of the most selfless people I know… her desire to not have people go through what she’s been through — it amazes me.”
Jodi was on a longterm course of oral antibiotics because of the late diagnosis of a serious bacterial infection. She had been steadily improving, and her condition had stabilized when earlier symptoms suddenly returned along with debilitating headaches. Clinical and diagnostic tests showed that the infection was once again rampant and had spread to her brain and caused a lesion. She was put on IV antibiotics and gradually began to improve. Suspecting that an adulterated generic drug may have been the root cause, PME’s Anne Patenaude contacted Jodi. After an extensive examination to rule out other factors, Anne discovered that shortly before Jodi’s symptoms escalated, her prescription antibiotic had been switched from a brand name to the Ranbaxy generic. This drug was later put on the FDA’s September 2008 list of banned drugs.
“I was in disbelief when Anne showed me the documents,” says Jodi. “So were my doctor and my pharmacist. It never crossed my mind that the medication could have anything to do with getting sick again. I just thought all generics were the same, only cheaper.”
The setback affected Jodi and her family on many levels:
- She was very ill for over a year
- She needed daily IV treatments for over a year
- She needed surgery twice, to insert and remove an IV port
- The IV therapy affected her gallbladder, and she needed gallbladder surgery
- As the result of IV treatment, Jodi needed to use heparin. Some of Jodi’s heparin was contaminated, and she developed complications
- She must continue taking oral medication
- She now has fewer insurance choices and higher premiums and out of pocket costs
- She lost income because she was unable to effectively run her business
- She and her husband lost their home, due in part to her lost income
Several years later Jodi had a recurrence of the infection and was also diagnosed with a coinfection. Because she received prompt treatment with unadulterated generic oral antibiotics, she only required a standard course of treatment. It reaffirmed to her and her doctor that not all generic drugs are created equally – the earlier Ranbaxy antibiotics that she took were adulterated and had never worked properly.