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The Most Severe Outbreak in FDA History

In May 2015, a federal judge approved a $200 million settlement to compensate victims who become ill or died due to defective medications produced by the New England Compounding Center.

During the first week of January 2017, the criminal trial against co-founder and head pharmacist of the New England Compounding Center, Barry Cadden, was set to begin. He is being charged with 25 counts of murder and racketeering for his role in the deaths of 64 patients and the illnesses of hundreds more who became infected with fungal meningitis because of tainted steroid injections.

A supervisory pharmacist of the New England Compounding Center, Glenn Chin, was also charged with 25 counts of murder and racketeering. Another 12 individuals connected to the New England Compounding Center were charged with a total of 81 counts of mail fraud, conspiracy, and violations of the Food, Drug, and Cosmetics Act.

The Investigation Leading to the Trials

Investigations indicate that methylprednisolone acetate (MPA) steroid injections produced by New England Compounding Center were produced in conditions that were not sterile, leading many of the injections to be contaminated with fungal or bacterial strains that lead to a variety of infections. The steroid injections were sold as treatments for pain and swelling caused by arthritis and other joint disorders to 76 outpatient surgery centers in 20 states across the country.

Over 800 patients who received the MPA injections produced by New England Compounding Center developed infections after receiving contaminated drugs in 2012. About half of the treated patients developed a rare form of meningitis caused by fungus spreading through the blood to the spinal cord. The fungus caused the affected patients to develop swelling of the brain and spinal cord, which lead to the deaths of 64 victims.

The New England Compounding Center was manufacturing MPA steroid injections without approval from the Food and Drug Administration (FDA), which requires that the drug manufacturer proves the safety of the injections produced.

Food and Drug Administration Inspections Unravel the Details

On September 25, 2012, after multiple meningitis infections at a single clinic in Tennessee, the Tennessee Department of Health contacted the Centers for Disease Control (CDC) to investigate the outbreak. The CDC then notified the FDA of the possible product contamination. Following a preliminary notice of investigation, the New England Compounding Center voluntarily recalled the three lots of the contaminated MPA steroid injection and discontinued its production.

Within a week, the FDA began investigating the facilities of the New England Compounding Center for traces of meningitis. During microscopic examination of sealed vials of the injections, the FDA was able to identify the fungus that caused the outbreak.

Over a month-and-a-half, the FDA continued collecting and analyzing various samples of drugs produced at the New England Compounding Center. Multiple pathological contaminants were found in three different injectable drugs manufactured on-site.

Officials from the FDA contacted customers of the pharmaceutical company to notify them of the contamination, and they were warned to stop dispensing drugs purchased from the New England Compounding Center. The incident was the most serious and adverse in the history of the FDA, and it would have far-reaching effects on new standards required of compounding centers across the nation.

Unclean Standards at the New England Compounding Center

Prosecutors in the trial claim that the New England Compounding Center used expired ingredients in its manufacturing of the steroids and failed to follow sanitation standards in the process. One of the workers affirmed that there was mold growth in the room where drugs were prepared, a room that was supposed to be sterile to avoid contamination.

Workers at the New England Compounding Center were said to have placed incorrect labels on the injections, covering the fact that the batch had expired or had never been tested. The indictment brought against the supervisory pharmacist, Glenn Chin, states that he instructed his technicians to prioritize production over cleaning and inspecting and suggested that they falsify cleaning logs.

In an effort to increase production of the steroid injections and decrease overall costs, the New England Compounding Center sacrificed their standard duty of care to maximize profits. In doing so, they knowingly sold the drug to patients even though there was a risk of the injections being contaminated.

New Food and Drug Administration Regulations Following the Meningitis Outbreak

In a direct response to the meningitis outbreak caused by New England Compounding Center, the Drug Quality and Security Act was passed in 2013. The law amended the Food, Drug, and Cosmetics Act to grant the FDA more authority in the regulation and oversight of compounding centers. It created a system for registering pharmaceutical companies that compound certain complex drugs and required that they meet safety standards to prevent a future outbreak caused by contaminated medications.

The act also requires the FDA to complete priority inspections of compounding centers that produce sterile drugs based on a risk-based model that looks at historical adverse event reports, inspection data, and reports of quality problems. These inspections are required under the act, and the compounding centers that are licensed to manufacture sterile drugs must comply with FDA quality standards to maintain compliance.

The meningitis outbreak of 2012 was the most serious and wide-reaching incident caused by a compounding center in U.S. history. The FDA has an obligation and duty to protect consumer patients from possible drug contamination and has taken measures to better regulate these manufacturers.

Patients Affected by the New England Compounding Center

Although a settlement of $200 million was approved to compensate the victims of the New England Compounding Center, a dollar-sum that meets the damages owed cannot reasonably be met.

Hundreds of patients who received steroid injections contaminated with a fungal strain that caused meningitis will be entitled to receive the largest proportion of the total settlement. Surviving family members of the 64 patients who died due to the infection will also receive money to cover the damages caused by New England Compounding Center’s malpractice. Patients infected with other less-severe pathogens will also receive compensation to cover damages they incurred.

A price cannot be put on a person’s life, but the settlement will cover outstanding medical bills, lost wages, and pain and suffering. In settling a compensation program for victims, indicting executives of the New England Compounding Center, and amending legislation to improve the FDA’s regulatory capabilities, justice was sought for the hundreds of patients affected by the meningitis outbreak of 2012.

As we can see by the case against the New England Compounding Center, defective drugs can pose a major risk to the health of individuals across the nation. If you or a loved one has suffered illness or death because of a defective drug, call us at (833) 606-DRUG [3784] or email us through our Contact Us page to schedule your free case evaluation. At Dolman Law, we stand to protect the rights of individuals against reckless and negligent institutions and organizations.

Sibley Dolman Gipe Accident Injury Lawyers, PA

800 North Belcher Road

Clearwater, FL 33765

(833) 606-DRUG [3784] https://www.dolmanlaw.com/legal-services/defective-medication-attorneys/