In July of this year, The Supreme Court of the United States (SCOTUS) issued an Orwellian 5-4 opinion that shields generic drug manufacturers from liability for harm caused by generic ‘equivalent’ drugs. Karen Bartlett, a New Hampshire resident, sued a generic drug manufacturer after the drug caused permanent disability and disfigurement. After Ms. Bartlett emerged from a coma, she endured thirteen surgeries, and remains legally blind. Justice Alito, who authored the majority opinion, called her situation “tragic,” but then essentially told her and all others in her life-altering situation to go pound sand.
To put it mildly, this SCOTUS decision is horrendous, because it leaves people like Karen Bartlett and others, who are harmed by generic drugs no recourse whatsoever. As Justice Sotomayor states in her dissent:
If manufacturers of products that require preapproval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products. And consumers injured by those products will have no recourse.
What Justice Sotomayor is saying in her dissent is that when Congress passed the Food and Drug Act, it meant to protect people; it did not pass a law that says one has no remedy when harmed, by removing any basis for a lawsuit in the state courts.
In this case, the label in question did not mention the side effect that caused the injury (which took the form of third-degree burns on much of the plaintiff’s body). The answer is that the plaintiff cannot sue the manufacturer. Because the FDA has approved the product and the label, the state court cannot impose damages for harm from using the product.
Ironically, had Ms. Bartlett taken the brand version of the same drug (Clinoril, marketed by Merck), she could have sued Big Pharma, when she suffered from Stevens-Johnson Syndrome, the life-threatening skin condition that she contracted after taking sulindac, the generic version of Clinoril. In an article titled Supreme court rules it’s o.k. for drugs to hurt you, Eric L. Zielinski explains:
In March 2009, the Supreme Court ruled that consumers could sue Big Pharma companies for damages if they were harmed by brand-name drugs.
Directly going against this historical landmark decision, the Court’s decision against Bartlett surprisingly gives generic drug companies a new-found immunity. However, this is not the first time the Court has ruled against common sense and integrity.
According to L.A. Times, “The court has now handed down two rulings that have closed the door to lawsuits from people injured by a generic drug.” With 80 percent of FDA-approved drugs on the market being made by generic sources, this puts most Americans at an unreasonable risk of being harmed and having no retribution.
The Elephant in the Room: Brand versus Generic
What is not addressed in the SCOTUS ruling is this elephant in the room: While generic drugs may contain the same key ingredient (in some amount) as the brand drugs, nobody purchases a generic drug because it is more effective than the brand version. People purchase generics because they are cheaper. Often, these generics are less effective or even ineffective. As David DiSalvo of Forbes explained in October of 2012:
For years we’ve been told that generic drugs are equivalent to brand names in every way that matters. Well, guess what, that’s not necessarily so; the Food and Drug Administration (FDA) just pulled a generic for the antidepressant Wellbutrin off pharmacy shelves for not being as effective as the brand name.
Are you surprised? I am not. I suffer from debilitating migraine headaches, so when the drug I take to abort these headaches (Imitrex) came off patent, making the cheaper generic version available, I was elated. However, effectiveness of the generic version of Imitrex is not the same as brand. Just last month, I ended my relationship with CVS pharmacy, because they sold me sumatriptan (generic Imitrex) that not only was ineffective; it made the headache worse. When I reported my experience to the pharmacy, they refused to look into it.
Victoria L. Dunckley, M.D. reported for Psychology Today in 2012:
I recently met a rep from a well-known chemical company (whose name I won’t mention) who had traveled to India to visit their generic drugs plant. “Let me tell you something,” she said. “Anyone that says that generic drugs are the same as brand name is lying.” She went on to tell me how appalling the plant conditions were, and that there were major safety and contamination concerns.
With this SCOTUS ruling, generic drug manufacturers are off the hook. What is extra appalling is the transparent double standard that once again favors the rich. If you are wealthy enough to purchase brand-name drugs, remedy is available through state court, in case of a harmful drug-related event, but if you are not all that well-off (and that includes the 80 percent of America that consumes generics), and you experience a generic drug-related harm, there is no remedy.
note: The history, analysis, events, opinion and related opinions of this case (Mutual Pharmaceutical Co. v. Bartlett), including the Petition for Certiorari and briefs are available here. The “80 percent” number, and other statistics on pharmaceutical spending are in the report titled The Use of Medicines in the United States: Review of 2011, by IMS Institute for Healthcare Informatics.
Also, at the end of the video is a link, with more information.