http://www.nytimes.com/2013/06/29/opinion/a-damaging-decision-on-generic-drugs.html?_r=0

Quote :

"Consumers grievously harmed by generic drugs may find it virtually impossible to win compensation for their injuries as a result of a Supreme Court decision issued on Monday. By a narrow 5-to-4 margin, the court overturned lower court rulings that had awarded a New Hampshire woman $21 million for pain and suffering and other damages. The decision leaves little recourse for people harmed by generic drugs, which now account for more than 80 percent of all prescriptions. It is imperative that the Food and Drug Administration write protective regulations holding generic companies liable for any harm their products cause. There is no doubt that the New Hampshire woman, Karen Bartlett, suffered horrific injuries after taking a generic version of an anti-inflammatory drug, sulindac, for shoulder pain. She developed a very rare but extremely severe reaction in which two-thirds of her skin sloughed off. She was left permanently disfigured, legally blind, and with permanent damage to her lungs and esophagus. The high court has now cut off her last pathway to compensation. In 2011, it ruled that generic-drug manufacturers could not be held liable for failing to warn consumers about a drug’s dangers because they must generally use the same safety label as the brand-name version they are copying. Now the court has also held that consumers cannot sue generic manufacturers for failing to design a safer drug because the generic must be chemically equivalent to the brand-name drug. The New Hampshire case involved a conflict between state laws and court decisions requiring manufacturers to design products that are not “unreasonably dangerous” (based on an analysis of whether the potential for harm exceeds the usefulness of a product) and federal laws that restrict the ability of generic companies to take corrective action on their own. The majority opinion, written by Justice Samuel Alito Jr., argued that the generic company Mutual Pharmaceutical had no way to comply with New Hampshire law because it had no power to unilaterally change the chemical composition or the warning label, and thus could not be held liable. The four dissenting moderate liberals argued persuasively that the company could, in fact, comply with state law without changing the drug’s label or ingredients. It could continue to sell the drug and pay compensation for any harm it caused as a cost of doing business, or it could remove the drug from the market. The decision leaves the regulation of generic drugs in a perilous state. A report released Monday by Public Citizen, the consumer advocacy group, listed 434 generic drugs for which no brand-name product remains on the market to initiate changes in the warning labels to flag newly discovered risks. Even so, the generic companies have an obligation to notify the F.D.A. about any risks they detect so that the agency can work with them to modify the warning labels. For a more permanent solution, the F.D.A. told the high court it was considering a rule that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in some circumstances. That could once again make them liable — and rightly so — for harm and allow consumers to sue them if they failed to warn of dangers."

The decision: http://www.supremecourt.gov/opinions/12pdf/12-142_8njq.pdf

The Wonder Brigade strikes again. I'm not sure I like this bridge of accountability they've created. They've said that the woman who had her face basically melt off due to one of the pharmaceutical company's products doesn't have legal standing because the New Hampshire law barred the company from changing the label...

[Edited on July 17, 2013 at 7:57 PM. Reason : ]

[Edited on July 17, 2013 at 7:58 PM. Reason : ]

7/17/2013 7:47:18 PM

why would they be liable for the government's mistake?

7/17/2013 9:03:46 PM

I understand the court's decision. Generic drug companies are prohibited by law to make changes to the drugs they make. Seems crappy to hold them liable for the mistakes of others. The liability should rest with the drug developer and perhaps the FDA since they're the participants in the drug approval process where things like safety information are developed. That said, the generic companies should be liable for manufacturing mistakes and will changes to the drug formulae.

The dissenting opinion is interesting to me since it states that settlements for these types of cases are just the cost of doing business and that the companies should choose not to sell drugs that prove too costly. However, I would counter with the assertion that these types of vary rare drug reactions are all but impossible to predict and can't be reliably factored into business models. If these kinds of reactions came up during the FDA testing, the drug would have never hit market in the first place.

7/18/2013 10:09:59 AM

It doesn't sound like there was anything wrong with the drug, seems like this would fall on the doctor that wrote the prescription. Look at it this way, if you eat a reeses cup and die due to peanut allergies, is that reese's fault?

7/18/2013 10:12:12 AM

It's Reese's fault depending on how good your lawyer is.

7/18/2013 10:13:44 AM

Damn you supreme court. We need more expensive drugs!

The worst thing about out medical system is how cheap it is, we need far more punitive lawsuits.

7/18/2013 9:05:23 PM

I will say SJS is no fucking joke

[Edited on July 18, 2013 at 9:59 PM. Reason : though it's not relevant, lol]

7/18/2013 9:52:40 PM

I've seen someone with Stevens Johnson syndrome. Shit is indeed no fucking joke.

Perhaps the generic manufacturer could have been negligent for not notifying the FDA, however, generic manufacturers do not do the clinical trials. The patent holder does/did the studies...

Why a lower court awarded damages against the generic manufacturer, I'm not sure. The compound was approved by the fda, they have no reason to believe it is unsafe, nor should they feel compelled to do trials.

[Edited on July 18, 2013 at 10:45 PM. Reason : i guess i didnt read what darkone wrote. lol]

7/18/2013 10:42:48 PM

I have no idea about what she was taking, but there really are some drugs that have shitty generics that aren't remotely as good as the name brand. I'd sure as hell hate to wind up with SJS because some random generic wasn't made worth a fuck, even though the FDA stupidly claims it's OMFG EXACTLY THE SAME.

7/18/2013 11:07:55 PM