Consumer Alert! Urgent! Taking Generic Drugs? All The Risk Is On You

The Cartwright Law Firm issues these Consumer Alerts! Urgent!, whenever information comes to our attention that we feel the public needs to be especially aware of as they make decisions as consumers. This Consumer Alert is in our view especially important, as it applies to your rights under the Constitution, and to your actual safety regarding prescription drugs.

Today, most people filling a prescription from their doctor are more likely than not to get a generic equivalent drug, usually because their insurance will only cover these cheaper alternatives. But what you most likely do not know is that if that generic drug causes dangerous, or deadly, reactions, you have no legal remedies against the generic manufacturer of that drug. That’s right – zero recourse: you cannot sue them or their insurance company, because of a loophole that protects generic drug makers against the Constitutional protections you currently enjoy against brand-name drug makers.

An FDA-funded study by researchers at Kaiser Permanente examined medical and pharmacy records showing the synthetic hormone Drospirenone, used in contraceptives like Yaz and the various generic versions that soon followed, which can double the risk of blood clotting compared to earlier oral contraceptive formulas. Following the release of the study the FDA required Bayer to improve drug warning labels to include information about the increased blood clotting risk related to the drug. Use of Yaz subsequently dropped following highly publicized lawsuits against Bayer and the makers of other brand-name drugs using the same base hormone. While never admitting fault,pharmaceutical companies have paid out settlements to people claiming injury and death from their products, and additional suits are still moving forward. Alarmingly, oral contraceptives based on Drospirenone, both brand name and generic, are still being prescribed and sold. But this is just the beginning of the problem.

If you’re taking a brand name drug you can sue the drug’s manufacturer for problems with side effects up to and including death, but if these problems occur because of a generic drug, you have no legal remedy available to you.

Since 1992, generic drug labels were required to match the brand name versions, with all the cautions and warnings as we expect from any legitimate medication. This was to assure doctors and patients that generics were equivalent to brand names. But a series of United States Supreme Court cases since then has led to sweeping protections for the makers of generics.

In one case, Pliva v. Mensing, the court ruled that you cannot hold generic drug manufacturers liable for failing to warn consumers of risk because the generic label is a copy of the brand name as required by the FDA. This presented a huge victory for generic manufacturers and the insurance companies that cover them.

Today, generics account for 80 percent of all prescriptions and the FDA is finally considering a rule change. It would allow generic manufacturers to update labels independent of brand name counterparts. Such a rule change by the FDA could open generic manufacturers to liability. But as you may imagine, the Generic Pharmaceutical Association is fighting the proposed changes and has asked the FDA to take more time considering them. In a letter to the FDA the GPhA wrote, “The changes as proposed will have far reaching consequences affecting patient safety as well as health care costs.” Which of course means more delays and more possibilities of you or your loved ones being harmed by generic drugs that are sold with zero consumer protections.

So, what can you do about this foolish policy? The public comment period for the proposed rule change by the FDA closes in March of this year, but a decision from the FDA could take months, even years. But you can make your voice heard. To first understand the actual rule change proposed, see the FDA website here for all the details. And to make your own comments about this issue, go to this page and raise your voice.

Left to their own, these makers of generic drugs enjoy an immunity against liability that few other makers of products enjoy in the US. Until this insanity is changed, The Cartwright Law Firm offers some timely advice – Caveat Emptor. Or pay the higher price out of pocket for the brand name drug, if only to preserve your Constitutional rights.