In the criminal justice system, an accomplice in a crime is just as culpable for a homicide as the person who pulls the trigger, and it is not uncommon for the driver of a getaway car to face murder charges regardless if they left the car during the commission of a crime. It is the same with malpractice claims. If there was negligence on the part of a surgical equipment manufacturer and the surgeon knew a device was defective, then the surgeon and manufacturer are both legally responsible for the death of a patient, and culpability can reach all the way to regulators and inspectors tasked with ensuring a device’s safety. It is government’s responsibility to provide inspectors and regulators to guarantee consumer products are safe, but because Republicans believe regulations hinder profits, they believe businesses deserve free rein to ignore rules protecting consumers. In fact, there are instances in the past few years that resulted in tragic consequences for workers, and in each circumstance, it was the failure of self-regulation that caused accidents that killed American workers.
Willard Romney promises to “get government out of the way” of corporations he claims suffer from regulations that prevent them from increasing their already record profits. When Romney was governor of Massachusetts, he was instrumental in protecting a corporation by failing to adequately regulate a company and Americans are dying.
The fatal meningitis epidemic spreading across the country is directly attributable to then-governor Willard Romney’s failure to adequately regulate the New England Compounding Co. (NECC), the Massachusetts pharmaceutical company responsible for the public health crisis that has infected 344 people in 18 states, and killed 25 so far. According to Massachusetts state records, it is now confirmed that a Massachusetts regulatory agency found that in 2004 the pharmaceutical corporation repeatedly failed to meet accepted standards, and instead of holding the company responsible and protecting consumers across the nation, Romney’s administration withdrew a reprimand out of deference to the corporation’s business interests. For the record, owners of the New England Compounding Co have made campaign donations to Romney and Massachusetts senatorial candidate Scott Brown.
Records show that on at least six occasions, authorities cited NECC for failure to meet regulatory standards, and at least one complaint alleged that NECC’s methylprednisolone acetate failed to comply with pharmaceutical standards. It is the same drug involved in the current epidemic that has killed 25 Americans. In 2004, The Massachusetts Board of Registration in Pharmacy, a state regulatory agency reporting directly to Romney, offered NECC a consent agreement that acknowledged professional misconduct warranting disciplinary action, a public reprimand, and three years’ probation. In November 2004, an NECC letter argued that such disciplinary action would be “potentially fatal” to NECC’s business, and asserted “Once disclosed, the reprimand will surely result in investigations and inquiries in other jurisdictions, and regardless of the derivative actions taken, the attendant legal and administrative costs will be devastating.” NECC decided that instead of the state monitoring the company, NECC would “bear the burden of cost and monitoring and reporting compliance” if they were given a non-disciplinary resolution. Translation; if the state does not discipline our company, we will regulate ourselves.
Massachusetts Board of Registration (BOR) subsequently dropped the reprimand, but in 2005, NECC faced another complaint and BOR went forward with a Consent Agreement that was “more advantageous to the company than was requested by NECC.” Instead of three years’ probation, NECC received one year and a non-disciplinary agreement to prevent reporting to the National Association of State Boards of Pharmacy or other outside agencies. Subsequently, by 2006 NECC was permitted to monitor itself and in May 2006, co-owner Barry Cadden wrote regarding several safety precautions that he was “pleased to report that the following actions have been completed.”
According to Massachusetts’ General Laws, Chapter 13, Section 22, members of BOR in Pharmacy are appointed by the governor, and since they reported to Romney, he “was responsible for these agencies.” A former Massachusetts’ secretary of health and human services said “It speaks volumes about the tragic outcome of Romney’s view on regulatory issues. There are two dozen people who died needlessly. It was clearly the responsibility of the company to protect them, but it was also the responsibility of the government at various levels and they failed.” This month, NECC issued a statement saying, “We have voluntarily suspended operations while we assist authorities in this investigation. The fatalities and illnesses confirmed today by the CDC and FDA are tragic.” Regardless NECC’s voluntary suspension, three of its facilities have been shut down by authorities after 25 people died as a result of Romney’s views on regulations. In a related matter, Senator Scott Brown (R-MA) signed a letter to the Drug Enforcement Agency arguing that regulations on the compounding industry should be loosened. Brown, like Willard Romney, received campaign contributions from NECC’s co-owners for being allowed to monitor their corporation for compliance with state laws.
Romney cannot feign ignorance as governor, because after the attack that killed four diplomats in Libya, he asserted that remarks from embassy officials in Cairo represented the Obama Administration, and that any subordinate’s action is the administration’s action. Since Romney appointed members to BOR and they answered to him, their inaction in prosecuting regulations and compliance falls on him and subsequently, his position on lax or self-regulation contributed to the deaths of 25 Americans and infection of 344 other patients. According to federal authorities, the fungus responsible for the meningitis epidemic matched over 50 unopened drug vials sent out by NECC, the source of contaminated drugs, and over 17,000 vials of the tainted drug was shipped to 76 different facilities around the country; the epidemic is not over.
Government, state and federal, is responsible for protecting consumers from corporate negligence, and yet Romney campaigns on eliminating regulations that prevent corporations from earning greater profits. In West Virginia in 2010, a coal mine explosion that killed several miners was the result of criminal disregard of safety regulations, and the TransOcean oil platform explosion occurred because regulations were ignored by company officials monitoring their own operations. Romney’s remedy to regulations is allowing companies to self-regulate, and there is no greater danger to consumers than leaders in “charge of oversight who believe oversight is unnecessary.”
There are 25 dead Americans because Romney believes government oversight restricts corporate profits, and that a company with a poor safety record should be allowed to regulate themselves. He has promised to eliminate regulations under the guise of getting government out of the way of corporate profits, and if his record as governor of Massachusetts is any indication, his policy of little or no oversight will cause more American deaths than the 25 that were on his watch. Romney’s running mate, Paul Ryan, and Republicans sought to cut funding for the CDC, FDA, FAA, and EPA and if they are successful; how long before they allow airlines, food processing plants, and more pharmaceutical companies to regulate themselves to protect their profits? The Federal government has a responsibility to protect consumers from unscrupulous corporations, and if Romney allowed 25 Americans to perish as a result of one state’s self-regulatory policy, one can only imagine the death toll if he allows all industries to monitor themselves. However, if Willard can sleep knowing he facilitated the deaths of 25 Americans, he will not lose on minute of slumber when the numbers are in the thousands, so long as corporate profits continue to rise.