Lack of Legislation Keeps Tainted Drugs on the Market

In December 2012, the family of Douglas Wingate sued Insight Imagining alleging that Douglas died of fungal meningitis 12 days after being injected with a contaminated drug.  According to the lawsuit, Wingate went to Insight Imaging to relieve pain from a pinched nerve in his neck.  After receiving an epidural steroid injection, the 47-year-old began to suffer symptoms experienced by meningitis victims.  Wingate suffered several strokes before dying of meningitis.

The lawsuit claimed the clinic told patients at Insight that they were getting a safe, name-brand drug.  Patients were even billed for the FDA-approved drug made by pharmaceutical giant Pfizer, when according to the suit, the injection was a dangerous “knock-off” manufactured in unsafe conditions at New England Compounding Center (NECC).  The lawsuit alleged that Insight “put profits over patient care.”

Wonder how this could happen?  Compounding pharmacies like NECC produce compounded medicines, which are drugs mixed to meet an individual patient’s needs; they are not allowed to manufacture pharmaceuticals for the mass market which would require oversight by the FDA. Because they are not FDA approved, they are not required to register with the FDA or disclose what products they are making.  In fact, compounding pharmacies do not have to even inform the FDA that they are in business.  This makes it difficult to inspect them or enforce rules, and typically result in a reactive rather than proactive effort by the FDA.

Wingate was among the hundreds of patients sickened by tainted steroid injections produced by the Massachusetts compounding pharmacy; 64 people in 20 states died and more than 750 became seriously ill during the October 2012 meningitis outbreak. New England Compounding filed for bankruptcy and gave up its license to avoid responsibility for its gross misconduct.

According to the Washington Times, NECC’s four owners received more than $16 million in wages and payments as the company grew increasingly prosperous in its final months.  The company now lists assets of about $1.6 million and liabilities of $885,000 from its unsecured creditors, not including any court judgments against it.  In its initial bankruptcy filing, NECC reported that 130 people had filed lawsuits, and said the company won’t have sufficient funds to adequately compensate victims. The company said the purpose of its Chapter 11 filing was to set up a fund to fairly pay victims.  How many victims do you think the $16 million would have helped?

Although thousands of lawsuits against the compounding company have been on hold pending the bankruptcy proceedings, Wingate’s case was allowed to proceed in state court because it did not name New England Compounding as a defendant. The settlement was recently finalized; Insight Imaging made official its agreement to pay a lump sum of $4.5 million to the estate.

While congratulations are in order for the Wingate’s, thousands of other innocent victims may be stripped of their rights because NECC used bankruptcy to deny them compensation for damages.  How will they get justice when they are compensated at pennies on the dollar in bankruptcy court?

Since the October 2012 meningitis outbreak, there have been a total of 27 bills or resolutions filed across 16 states relating to compounding pharmacies; 10 have been adopted or enacted into law.  Ten states in almost a year-and-a-half.  This is not good enough.  For the health and safety of the American people, the FDA needs the oversight authority to assure these kinds of outbreaks do not happen again.