US Supreme Court Rules on Immunity of Generic Drugs from Legal Liability: Where do Injured Patients Stand?
In 2004, Karen, who complained of a sore shoulder was prescribed with Sulindac, a generic anti-inflammatory drug that is manufactured by Mutual Pharmaceutical. After three weeks of medication, she started experiencing extreme pain and her skin began to peel off, exposing her raw flesh, making it look like she had a third degree burn.
The new disease that Karen developed is called toxic epidermal necrolysis, a drug’s side effect about which many drug companies fail to warn patients. Karen’s only choice was to sue Mutual Pharmaceutical (in New Hampshire state court ) for her new severe illness and for the drug firm’s failure to warn about its drug’s possible side effect. After winning the case, the US Food and Drug Administration (FDA) also took action, requiring Mutual Pharmaceutical and Merck & Co., manufacturer of the drug’s branded version, to mention (the drug’s) side effects in the warning labels.
The FDA is the government agency responsible for approving which prescription drugs (and many other kinds of products, including medical and radiological devices, food and cosmetics, biologics, veterinary drugs, and tobacco products) can be brought to the market and used as treatment for certain kinds of illnesses. Of the FDA’s six centers, it is the Center for Drug Evaluation and Research (CDER) which is directly charged in making sure that all drugs marketed in the US are safe and effective. While CDER’s Office of Testing and Research does study a drug’s quality, safety, and effectiveness before approving it, this study is only partial as the exhaustive test on the drug, including clinical trials (experiments wherein human subjects are used to determine a drug’s effectivity and the side effects it may cause), is the responsibility of the drug’s manufacturer. Clinical trials data are necessitated by the FDA as these will show whether the drug needing approval meets, or does not meet, the level of safety and effectiveness required by the FDA.
Now, considering all the studies and tests a drug is subjected to prior to actual formulation and approval, it would be very interesting to know exactly why some drugs are found and proven to be causing adverse effects, while some are even linked to patients’ death.
While some medical experts agree on the fact that a patient’s overall health condition, use of other medication, immune system and family history can directly affect a particular drug’s performance (thus while some specific drugs may work effectively in some patients, these very same medicines may cause adverse effects in others), others point out a loophole in the testing and approval process. Specifically, since clinical trials and other tests are performed and funded by the drugs’ manufacturers themselves, they have total control, therefore, of all data and test results. Due to this control some choose to commit the fraud of forwarding to the FDA only the positive results derived from the tests, while keeping or destroying the negative ones.
The two reasons stated cannot be discounted and they offer a clear proof why some drugs, including Sulindac, the generic anti-inflammatory drug mentioned above, are considered threats rather than remedy to some patients. In its website, the National Injury Law Center mentions a flaw in the FDA’s approval process and this agency’s failure to sometimes detect certain types of problems. The consequence of this flaw, however, will be seen in patients, whose health conditions may be dramatically harmed by the drug.
Another source of real worry for harmed patients is the latest US Supreme Court ruling, which exempts all manufacturers of generic drugs (which make up about 80% of all drugs consumed in the US) from any liability due to mislabeling or side effect/negative reaction that their drug/s may cause in patients.
This ruling is based on the premise that generic drugs are simply copies of their brand name counterparts, thus, they contain exactly the same formula and present the same risks. If anyone should bear liability for mislabeling or adverse effects caused by a drug, it should be, according to the Supreme Court, those who originally formulated and manufactured the brand named drugs.
Patients harmed by any type of medication should never be denied of the compensation that they have a legal right to seek due to the pains and sufferings and all other damages that they have been unjustly made to suffer. The said Supreme Court ruling, however, just made the already complex law that cover pharmaceutical products much harder to understand and deal with.