Meningitis Alert

Meningitis Outbreak: Congress, State Laws and Marjorie’s Story

AAJ’s Take Justice Back campaign is also featuring the story of Tennessee meningitis victim, Marjorie Norwood, as told through her courageous daughter, Melanie. Melanie traveled to Washington to tell the story of her family’s struggles to Rep. Ed Markey and Rep. Jim Cooper on the day of the Congressional hearings into the deadly meningitis outbreak. The AAJ post also mentions the efforts in Tennessee to close the courthouse doors. Click here to view full story and video.

Woman Files Lawsuit For Tainted Steroid Injections

by Marcus Washington –

NASHVILLE, Tenn. – Since the meningitis outbreak more and more attorneys have heard from victims who are scared and families facing some of their toughest times.

The daughter of one woman whose mother received two epidural shots at Saint Thomas Hospital said the pain just got worse until she ended up in the hospital.

Family members said the 71-year-old mother and grandmother inspired them for years. Now Willie Mae Devine looks to them for inspiration to continue her very personal battle.

“She had an epidural shot at St. Thomas because she had back pain where she had surgery for years prior to that,” said daughter Barbara Arnold.

It wasn’t until Devine went back to the doctor a third time that she was told she had been given one of the tainted steroid injections.

Devine was diagnosed with a fungal infection and has hired an attorney.

“I think it’s going to bear out that there are several parties at fault. However, some may have much more fault that others, but we don’t know yet,” said Blair Durham of Bart Durham Injury Law.

Wednesday Durham and another client went to Washington D.C. to sit in on the Congressional hearings looking for answers in the fungal meningitis outbreak.

“There seemed to be a bipartisan feeling that what happened should never have happened and should never happen again. Hopefully they will be able to work together to come to a resolution where it doesn’t ever happen again,” said Durham.

What Durham said seemed to anger Congress and family members of victims, was how the man in charge at NECC, Barry Cadden, responded to every question.

“I wasn’t surprised that he took the Fifth Amendment to every question and that he wouldn’t answer, but it’s a shame because if anyone has the knowledge to potentially save people’s lives in the future or at least clear up treatment plans for the current people that are suffering it would be him,” said Durham.

Arnold said she and her family will continue to fight for her mother to get better and someone to answer the question “Why?”

“That whatever can be done to make sure that these people or whoever is responsible, it never happens to anyone else,” said Arnold.

Arnold said her mother was still in the hospital. They hoped Devine would return home as soon as Friday.

New England Compounding Center, NECC, will likely file for bankruptcy – which Durham said could make suing the company harder.

WZTV FOX 17 – Top Story

Several victims in the midstate are doing what they can to make sure no one else will be a victim of health issues like the fungal meningitis outbreak. One family in particular is seeking legal action to hold those responsible accountable.

Fox 17’s Erika Kurre spoke with Bellshire resident Barbara Arnold today.

Her mother is one of these victims now hospitalized at Skyline Medical Center.

NECC leader declines to testify on meningitis outbreak

Reported by Josh DeVine – Channel 4

WASHINGTON, DC (WSMV-AP) – Republican lawmakers challenged the country’s top medical regulator Wednesday to explain why her agency did not take action sooner against the specialty pharmacy at the center of a deadly meningitis outbreak.

Food and Drug Administration Commissioner Margaret Hamburg testified before the House Energy and Commerce Committee, which has convened the first hearing to examine the outbreak that has sickened about 440 people and caused 32 deaths across the U.S. The illness has been tied to the New England Compounding Center, which distributed pain steroids that later tested positive for contamination.

Health officials say as many as 14,000 people received the steroid shots, mostly for back pain.

Republicans lawmakers, who make up the majority of the House, focused on NECC’s history of troubles, questioning why regulators at the FDA and the Massachusetts board of pharmacy did not take action against the pharmacy years earlier.

“After a tragedy like this, the first question we all ask is: Could this have been prevented?” asked Rep. Cliff Stearns, R-Fla. “After an examination of the documents provided by the Massachusetts Board of Pharmacy and the FDA — the answer here appears to be yes.”

A timeline assembled by the Republican staff shows that the FDA inspected NECC three times since 2002 for sterility issues. The Massachusetts board of pharmacy investigated at least 12 separate complaints involving the pharmacy, dating back to its founding.

“I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass Board over 10 years ago identified contamination in the very same drug at issue in the current outbreak,” said Rep. Fred Upton, R-Mich., who chairs the Energy and Commerce committee.

Hamburg told lawmakers that the problems uncovered in inspections were “very serious,” but that the agency was obligated to defer to Massachusetts authorities, who have more direct oversight over pharmacies.

“The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take,” said Hamburg, who was nominated to head the FDA by President Obama in 2009.

In her prepared testimony, Hamburg said Congress should draft new laws and provide more funding to police large specialty pharmacies, which have long operated in an area between state and federal law.

“In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding,” Hamburg told lawmakers.

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They are typically overseen by state pharmacy boards, though the FDA occasionally steps in when major problems arise. Some pharmacies have grown into much larger businesses in the last 20 years, supplying bulk orders of medicines to hospitals that need a steady supply of drugs on hand.

Hamburg suggested putting in place a two-tier system in which traditional compounding pharmacies continue to be regulated at the state level, but larger pharmacies would be subject to FDA oversight.

Pharmacies that ship bulk product or produce complex drugs would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers. These non-traditional compounding pharmacies would also have to meet the more stringent manufacturing standards required of pharmaceutical companies.

Owner of meningitis-linked pharmacy takes Fifth

Earlier in the hearing, the owner and director of the NECC declined to testify, invoking his Fifth Amendment right to not answer questions in order to avoid self-incrimination.

After repeated questioning by House lawmakers, Barry Cadden told lawmakers: “Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment.”

Federal officials have opened a criminal investigation of Cadden and the NECC.

The Framingham, Mass.-based pharmacy has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license.

Inspections last month by state and federal officials found a host of potential contaminants at NECC’s facility, including standing water, mold and water droplets. Compounded drugs are supposed to be prepared in temperature-controlled clean rooms to maintain sterility.

Ky. victim’s widow testifies

Cadden appeared immediately after the widow of a longtime Kentucky judge, who was the first confirmed victim of the outbreak.

Speaking without notes, Joyce Lovelace told lawmakers of more than 75 Years of marriage to 78-year-old Eddie C. Lovelace, who was a circuit judge until he died Sept. 17 at Vanderbilt University Medical Center.

She asked lawmakers to implement laws to police companies like the New England Compounding Center, which distributed steroids that tested positive for contamination.

“My family is bitter, we are angry, we are heartbroken and devastated. I come here begging you to do something about the matter.”

Nashville woman attends congressional hearing

For six weeks, Melanie Norwood has watched her mother suffer the affects of fungal meningitis.

Beverly Norwood was diagnosed with fungal meningitis in early October. The 59-year-old woman received two contaminated epidural steroid injections from a St. Thomas Hospital pain clinic.

Beverly Norwood remains in a Nashville hospital and has undergone five spinal taps as she suffers the painful side effects of anti-fungal medications.

Melanie Norwood lobbied a number of congressmen Wednesday, asking for more FDA oversight into compounding pharmacies.

Both she and Nashville attorney Blair Durham, who represents a number of clients who have been stricken with fungal meningitis, were invited by Congress to attend the hearings.

For Melanie Norwood, it is difficult for her to watch her mother struggle through the pain.

“She won’t be home for Thanksgiving, and we don’t know when she will be able to come home,” she said.

Cooper says hearings will benefit public

U.S. Rep. Jim Cooper, D-Nashville, said he expects Capitol Hill will eventually strengthen the laws dealing with these kinds of facilities.

“I think you will see a definite tightening of regulation. We tried to tighten regulations in 1997, and the industry fought back and sued in federal court and actually won. This time, I don’t think they’ll win,” Cooper said.

Among the people expected to speak to lawmakers Wednesday is the widow of Kentucky Judge Eddie Lovelace.

He was one of the first people to die after getting fungal meningitis from a tainted back pain injection given by a Nashville clinic.

Copyright WSMV 2012 (Meredith Corporation). All rights reserved. The Associated Press contributed to this report.

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