Today, the U.S. House of Representatives is debating whether to impose its contaminated political judgment on every local judge and jury in America. Well, not every local judge and jury, but certainly any deciding a lawsuit against the health care industry. And not just medical malpractice cases, mind you. The bill they are debating today, H.R. 5, would limit the liability of the pharmaceutical and medical device industries, nursing homes, and even insurance companies and HMOs that refuse to pay legitimate claims.
Singled out for extra special protection are drug companies with FDA-approved drugs. Proponents of this bill - generally the "anti-federal government" crowd - apparently trust the federal government to get it right every time when it comes to the safety of drugs and medical devices. Does this strike anyone as odd?
Well, there are four stories out today that highlight big problems with this notion. What they show is that the FDA continues to fall down on the job, and when left to their own devices, manufacturers will cut safety corners and often harm the public. When it comes to some of our country’s most dangerous products, lawsuits are often the only way to prevent the wholesale destruction of public safety.
First, there’s a front page New York Times story about how a U.S. Supreme Court decision last year has blocked thousands of injury lawsuits against generic drug companies. This is an issue that could be fixed by either Congress or the FDA. Given what’s happening on the House floor today, no sane person could possibly expect this Congress to restore rights to drug injury victims. However, the FDA could. But so far, it won’t. As the Times writes:
Public Citizen, a consumer advocacy group, has petitioned the Food and Drug Administration to give generic companies greater control over their labels, a rule change that could allow users of generic drugs to sue, but the agency said earlier this month that it needed more time to decide. “Congress can make this problem go away, and the F.D.A. could, too,” said Allison Zieve, the director of Public Citizen Litigation Group. “But we haven’t seen signs that either of them is paying much attention.” A spokeswoman for the F.D.A. declined to comment.
Moving on. The FDA has a special rule –510(k) of the Federal Food, Drug, and Cosmetic Act – whereby drugs and devices that are “substantially equivalent” to a device already on the market are not required to go through more rigorous FDA approval. This allows companies to market dangerous products for uses never really "approved" by the FDA, yet with the stamp of FDA approval! This is just what Johnson & Johnson did according to a story from Bloomberg today about vaginal meshes. The FDA approved surgical meshes for procedures like abdominal surgery. But J&J began marketing them for use in a women’s vaginal area, treating problems like incontinence. Subsequently, hundreds of women became severely injured and some died as the meshes began disintegrating, growing into tissue and becoming impossible to remove. Over 500 women have now sued and finally, after J&J marketed the device for three years, the FDA is saying that the company should not have used 510(k) to fastrack these. Not exactly quick work by the agency. And had H.R. 5 been on the books, J&J might be immune from any punitive damages for what they did.
If you are still not convinced that when given the choice to help patients or make money, the drug industry’s priorities are completely screwed up, consider another article in the New York Times today. This article is about a generic drug called tranexamic acid, which slows bleeding and could be saving lives. And it’s cheap! But, writes the Times,
[I]ts very inexpensiveness has slowed its entry into American emergency rooms, where it might save the lives of bleeding victims of car crashes, shootings and stabbings — up to 4,000 Americans a year, according to a recent study. Because there is so little profit in it, the companies that make it do not champion it. …
The slowness of American hospitals is due to “inertia,” said Dr. Ian Roberts, clinical trials director for the London School of Hygiene and Tropical Medicine and leader of the 2010 trial, which was called Crash-2. “The people who do the urging and the talking about new drugs are the pharmaceutical companies, and if they’re not interested, it’s not done.”
Finally, we certainly don’t want to ignore the FDA’s other main regulatory area - food. While food lawsuits may not be covered by the drug and device industry protections in H.R. 5, the FDA’s failures to regulate in both these areas are quite similar. Today, the Center for Justice & Democracy at New York Law School is releasing a new study called Our Fatal Food Attraction: Regulatory Failures and the Civil Justice System. This study,
[F]inds that the regulation of food safety, particularly by the Food and Drug Administration (FDA), is inadequate to keep Americans safe and properly informed of foodborne illness dangers. The study explores the dangerous impact of both privatization of key government functions and the lack of transparency by government agencies. It also recognizes the important role that lawsuits play in protecting Americans, providing both a critical layer of food industry oversight and disseminating key public safety information to the public.
There’s some wild stuff in here that everyone should know. And as they say, everything’s connected. So don’t forget to call your member of Congress today (1-888-291-9824 to reach the U.S. Capitol switchboard), and ask them to oppose H.R. 5. Today’s the day. Speak up, loud and strong.