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Why Lawsuits Matter: The Case of the New England Compounding Center

The other day, I sat on an airplane next to a surgeon. We were heading to Boston. He is a surgical chief at one of the Harvard hospitals. He was on his cell phone, bemoaning the fact that many of his patients were exposed to drugs formulated by New England Compounding, the company that mass-produced pain medications infected with a deadly strain of meningitis. The injectable drugs, known as methylprednisolone acetate, have now killed at least 29 people, and caused disease in 377 more. Over 14,000 patients have been exposed. Many in pubic health are calling this one of the worst public health disasters since the 1930s. They have referred to the facility as one that lacked “basic clean room principles.”

New England Compounding supplied many of America’s most influential and busiest hospitals, including systems at Harvard, Yale, and the Mayo Clinic.

America’s largest and best health care institutions trusted New England Compounding to provide safe and effective medications for their patients. As Dr. Gerard Martin, of Children’s National Medical Center told the New York Times last week, the hospitals trusted New England Compounding because they trusted the FDA as well as state regulators to insure safety. “You believe that when a company is being regulated they’re following good practices, “ Dr. Martin told The New York Times.

After the fact, the FDA has released a report highlighting some if its findings. But before, the FDA and the state missed all of it. The company, apparently aware that its “sterile” rooms were inundated with bacteria and mold, kept it quiet, kept making drugs, and caused a national catastrophe.

After the fact, the FDA has found “greenish-yellow residue” on the company’s sterilization equipment. It found surfaces coated with mold and bacteria that “exceeded the company’s own environmental limits.” And the FDA determined that the company purposefully shut down its air conditioning each night despite the well recognized medical fact that temperature and humidity control are essential to containing the growth of mold and bacteria.

What’s more, the pharmaceutical company was only 100 feet away from an active recycling plant that was responsible for processing 16,000 tons of material each year, including mattresses, batteries, furniture, asphalt roof shingles, carpeting, and plastics. Neighborhood complaints regarding dust clouds from the factory were frequent. Turns out the pharmaceutical company’s air conditioning vents are only 100 feet away from the active area of the recycling plant.

Are you sitting down? It also turns out, according to The New York Times, that one of the owners of the pharmaceutical plant, Gregory Conigliaro, is also an owner of the recycling plant bearing his name, Conigliaro Industries.

Federal and state regulators are limited in their ability to prevent disasters and insure safety. This is where the justice system has a chance to shine. Lawsuits filed on behalf of the innocent victims of this crisis will reveal the truth, provide fair and appropriate compensation to the patients and their families, but also deter this egregious conduct in the future.

My hunch is Mr. Conigliaro is a proponent of tort reform. He and his companies are Composite Exhibit “A” for why Americans deserve open access to justice, and why citizen juries should be given the equalizing power to address this type of negligent conduct.

For a copy of the FDA’s after the fact report, click here.