# Supreme Court rules Drug Companies exempt from Lawsuits



## lovetogrow (Jan 25, 2011)

Supreme Court rules Drug Companies exempt from Lawsuits

http://healthimpactnews.com/2013/supreme-court-rules-drug-companies-exempt-from-lawsuits/

Excerpts:
In case readers missed it with all the coverage of the Trayvon Martin murder trial and the Supreme Court's rulings on gay marriage and the Voting Rights Act, the US Supreme Court also made a ruling on lawsuits against drug companies for fraud, mislabeling, side effects and accidental death. From now on, 80 percent of all drugs are exempt from legal liability.

In a 5-4 vote, the US Supreme Court struck down a lower court's ruling and award for the victim of a pharmaceutical drug's adverse reaction. According to the victim and the state courts, the drug caused a flesh-eating side effect that left the patient permanently disfigured over most of her body. The adverse reaction was hidden by the drug maker and later forced to be included on all warning labels. But the highest court in the land ruled that the victim had no legal grounds to sue the corporation because its drugs are exempt from lawsuits.
Karen Bartlett vs. Mutual Pharmaceutical Company
In 2004, Karen Bartlett was prescribed the generic anti-inflammatory drug Sulindac, manufactured by Mutual Pharmaceutical, for her sore shoulder. Three weeks after taking the drug, Bartlett began suffering from a disease called, 'toxic epidermal necrolysis'. The condition is extremely painful and causes the victim's skin to peel off, exposing raw flesh in the same manner as a third degree burn victim.

Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs' warning labels going forward.

Now, nine years after the tragedy began, the US Supreme Court overturned the state court's verdict and award. Justices cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs. In short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.

Immediately upon the Supreme Court's ruling, both drug manufacturers and Wall Street investors were celebrating. As one financial analyst pointed out, drug company profits should skyrocket going forward. Not only do the pharmaceutical companies no longer have to worry about safety or side effects, they are exempt from the multi-million dollar court-imposed settlements awarded to victims of their drugs.

One industry critic was quoted by Reuters after the verdict. "Today's court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients," Michael Carome, director of Public Citizen's Health Research Group told the news outlet.
Senate Judiciary Committee Chairman Patrick Leahy (D-VT) was quick to react to the ruling by writing a stern letter to FDA Commissioner Margaret Hamburg, "A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug."

But an attorney for the drug companies, Jay P. Lefkowitz, took the opposing position saying, "It makes much more sense to rely on the judgments of the scientific and medical experts at the FDA, who look at drug issues for the nation at large, than those of a single state court jury that only has in front of it the terribly unfortunate circumstances of an adverse drug reaction."

In other words, if the FDA says something is safe, it doesn't matter if that decision is wrong or the result of lies, fraud or deception on the part of the world's pharmaceutical companies. And there's no way to sue the FDA for being wrong and costing millions of unsuspecting Americans their lives. That result leaves 240 million Americans unprotected from an industry responsible for more preventable deaths in the US than any other cause.

Read the Full Story Here: http://www.whiteoutpress.com/articl...rt-rules-drug-companies-exempt-from-lawsuits/


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## Sentry18 (Aug 5, 2012)

Never underestimate the darkness that can overcome someone whose loved ones were taken early because of something as shady as hiding negative side effects of a drug. They were probably better off with lawsuits.


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## lovetogrow (Jan 25, 2011)

I agree. The ruling applies to 'generic' drugs (at this stage). The OP article states that 80% of prescribed drugs in the U.S. are 'generic' (cheaper).

It's interesting to note in the article published below in 2010 http://www.reuters.com/article/2010/05/19/medco-children-idUSN1924289520100519

that:
"Medco is forecasting overall pharmaceutical spending to rise up to 18 percent through 2012, driven by diabetes, cancer and rheumatology treatments. Spending is expected to rise 3 percent to 5 percent this year, and 4 percent to 6 percent the next two years.
Overall increases will be somewhat held down by some $46 billion in branded drug sales that will succumb to competition from cheap generic versions by the end of 2012."

Full Article (link above)

* 1-in-4 children took drugs for chronic conditions in '09
* Juvenile use of diabetes drugs, antipsychotics on rise
* Medco medical director calls child data a "shocker"
* Medco sees overall pharma spend up 18 pct through 2012 (Adds comment from Medco medical director, disease category details, byline)

By Bill Berkrot

NEW YORK, May 19 (Reuters) - Children were the leading growth demographic for the pharmaceutical industry in 2009, with the increase of prescription drug use among youngsters nearly four times higher than in the overall population, according to a report by Medco Health Solutions Inc MHS.N.

More than one in four insured children in the United States and nearly 30 percent of adolescents aged 10 to 19 took at least one prescription medicine to treat a chronic condition in 2009, according to an analysis of pediatric medication use conducted as part of Medco's drug trend study issued on Wednesday.

*Medco is forecasting overall pharmaceutical spending to rise up to 18 percent through 2012, driven by diabetes, cancer and rheumatology treatments. Spending is expected to rise 3 percent to 5 percent this year, and 4 percent to 6 percent the next two years.
Overall increases will be somewhat held down by some $46 billion in branded drug sales that will succumb to competition from cheap generic versions by the end of 2012.

But the increases in prescription drug use by children for chronic conditions could fuel significantly higher health care costs as those young patients enter adulthood, Medco said.*

"Looking at children was the real shocker for us," Dr Robert Epstein, Medco's chief medical officer, said on a conference call from Medco's drug trend symposium in Orlando, Florida.

Over the past nine years, the most substantial increases in the medicating of children were seen in drugs for conditions not typically associated with them, such as for type 2 diabetes and antipsychotics, Medco said.
Some long-standing childhood maladies also saw large increases, such as asthma.

OBESITY LINK
"What's surprising is the type of drugs these kids are taking. All these adult drugs are popping up in children, which is really disturbing," Epstein said.
"The obesity problem is contributing not just to diabetes but to a lot of other problems," he said, noting a 50 percent increase since 2001 in use of cholesterol lowering drugs among those aged 10 to 19, a 24 percent increase in use of blood pressure medicines, and a whopping 147 percent jump in adolescents taking heart burn and acid reflux drugs.

Medco and other pharmacy benefit managers, or PBMs, administer prescription drug benefits for employers and health plans and also run large mail-order pharmacies. Data for the study was collected from Medco's top 200 clients, representing more than 40 million people.

Childhood use of medications for type 2 diabetes, a disease once referred to as adult onset diabetes, rose 5.3 percent in 2009 and is up more than 150 percent since 2001, the study found. Girls between the ages of 10 and 19 showed the greatest jump at nearly 200 percent over nine years.

"We've got to get our arms around some very fast lifestyle modification or we're going to have a real problem, having these adult illnesses show up in children who will have a changing life expectancy if they're going to be sick from a very young age," Epstein cautioned.

ANTIPSYCHOTICS
Among the trends was the rise in children taking antipsychotics -- powerful drugs traditionally used to treat schizophrenia, but increasingly prescribed for other conditions, such as depression and anxiety.
Use of such drugs has doubled since 2001 and more than doubled for girls, according to Medco's nine-year analysis.
Use of some antipsychotics has also been associated with significant weight gain and increased risk of developing type 2 diabetes, potentially compounding health problems.

There was a 23 percent drop since 2004 in use of antidepressants by youngsters. That decline followed U.S. Food and Drug Administration warnings of the increased risk of suicidal thoughts by children using those drugs.
Rates of childhood asthma are also on the rise, Medco found. Respiratory drug use grew 5 percent among children in 2009 and is up 42 percent since 2001.

Use of drugs for attention deficit hyperactivity disorder (ADHD), often cited in reports on the over-medication of children, is also on the rise. But surprisingly, the increase was more pronounced among young adults.
Overall ADHD drug use was up 9.1 percent last year, leading to a 23.8 percent rise in spending growth. But the utilization increase was 21.2 percent among those aged 20 to 34. (Reporting by Bill Berkrot; Editing by Tim Dobbyn)


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## lovetogrow (Jan 25, 2011)

What do you think about the safety factor in using generic drugs (beyond the fact that some drugs like anti-psychotics for kids/adults should imo not even be on the market) or is this just a big scare tactic by big pharma to steer the profits away from those producers?


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## lazydaisy67 (Nov 24, 2011)

lovetogrow said:


> What do you think about the safety factor in using generic drugs (beyond the fact that some drugs like anti-psychotics for kids/adults should imo not even be on the market) or is this just a big scare tactic by big pharma to steer the profits away from those producers?


Are you refering to ALL anti-psychotics, or just some that have shown some negative side effects? I've worked with handicapped people for a very long time. Almost 85% of them are capable of living in a 'assisted living' type environment and can hold down jobs in the community because of anti-psychotic meds. Without them, they'd end up dead in a fairly short amount of time. 
Having said that, I think it's not so much the meds as it is the doctors prescribing them. With any med you have GOT to have follow-up and certainly for those with a psychotic disorder or depression you have to have a minimum of phone access to the doctor if issues develop. You cannot just quit taking meds cold turkey, which is very prevalent among bi-polar, depressed and some psychotic individuals. 
Holding drug companies accountable is a good thing, but I don't think it should come in the form of lawsuits and settlements. I think it should be regulated WAY before there's any damage or death in the general public. This ruling is only going to serve to drive the prices up on all meds, safe or not.


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## camo2460 (Feb 10, 2013)

Have you ever seen a psychotic person who has gone off of his/her medication, have you ever had to deal with a psychotic person who doesn't take their meds? I promise you it is not pretty, and more often than not down right dangerous.


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## lovetogrow (Jan 25, 2011)

lazydaisy67 said:


> Are you refering to ALL anti-psychotics, or just some that have shown some negative side effects? I've worked with handicapped people for a very long time. Almost 85% of them are capable of living in a 'assisted living' type environment and can hold down jobs in the community because of anti-psychotic meds. Without them, they'd end up dead in a fairly short amount of time.
> Having said that, I think it's not so much the meds as it is the doctors prescribing them. With any med you have GOT to have follow-up and certainly for those with a psychotic disorder or depression you have to have a minimum of phone access to the doctor if issues develop. You cannot just quit taking meds cold turkey, which is very prevalent among bi-polar, depressed and some psychotic individuals.
> Holding drug companies accountable is a good thing, but I don't think it should come in the form of lawsuits and settlements. I think it should be regulated WAY before there's any damage or death in the general public. This ruling is only going to serve to drive the prices up on all meds, safe or not.


No certainly not referring to all anti-psychotics (I worked in primary health care for years, and it was always a challenge to help people suffering from schizophrenia to stay/get back on their meds - took a whole lot of assisted living community care treatment team work).

Absolutely critical that a patient's meds are regularly monitored (sadly that is not the reality in a whole lot of cases). I also agree that the good standard of care is for a controlled, well monitored weening period from anti-psychotics and anti-depressants (again the reality is people fall through the cracks (or should I say holes) either due to their own lack of knowledge, negligence, and/or their health care givers' lack of good standard practice/care.

Ideally yes, standard regulations that prevent pain and suffering (again, unfortunately not always the reality...) Unfortunately you may be right - an increase in FDA approved drugs could drive consumer costs up 

From op link
"some 80% of all drugs consumed in the United States, are exempt from liability for side effects, *mislabeling or virtually any other negative reactions *caused by their drugs..."


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## lovetogrow (Jan 25, 2011)

camo2460 said:


> Have you ever seen a psychotic person who has gone off of his/her medication, have you ever had to deal with a psychotic person who doesn't take their meds? I promise you it is not pretty, and more often than not down right dangerous.


Yep, Yep, and right - not pretty.


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## camo2460 (Feb 10, 2013)

Didn't mean any disrespect, lovetogrow I've had to deal with and fight 'em for far to long.


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## lovetogrow (Jan 25, 2011)

camo2460 said:


> Didn't mean any disrespect, lovetogrow I've had to deal with and fight 'em for far to long.


No problem camo - never entertained the thought 

Not saying you have, however I have experienced a fair measure of burnout here and there along the way. Working in a high stress profession can be extremely taxing :beercheer:


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## Meerkat (May 31, 2011)

Some drugs make people suicidal. I dealt with VN vets that ended up killing themselves who would leave the VA with a bag full of drug's, I know this fro a fact because I took a couple of them to pick them up.

One of them got shot and went back got shot twice more. He walked like a zombe and ended up shooting himself In the head at the old age of ' 28 '. He was such a nice young man before then.

Now they force our troops to take drugs some should never be taken together. It makes me so mad. What happens to dr.s who can do this to their own conrade's, 

Most kids who take drugs to settle down don't need them. Kids are suppose to be spastic. Especially now a days not releasing energy.

They tried to put my daughter on valuims in the 60s when she was just 3. I never got any rest she was so hyper only slept 2 or 4 hr.s at a time. I has no way.When she was about 5 she outgrew it. She had to be tied up at times after she took off for 4 hours when she was 3. Happiest day in my life was seeing the cops coming down the walk with that curly headed little Road Runner.I had just had C-section,no bikini cuts back then it was navel to non mention. I had blood filling up my shoes and up to my neck from running around with 2 more babies looking for her. 22 more steel claps just came out. That's when dr said that's it, I said no. I layed in the floor and pulled my insides back together taped em up and took a bus to the hospital with the little speedster on a lease for the bus ride .Don't tell me your kid needs drugs.Only a very few do.

My nephews 2 sons are on those damn drugs. They climb walls in their big money pit because there is no yard to play in. He could have got a place in the country and turned them loose to run and play. But their mother is an idiot who bought a house they will never pay for. So her sons are drug addicts since age 4 and 6. I guess it goes with all the other crazy things going on now.


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## Bobbb (Jan 7, 2012)

> Now, nine years after the tragedy began, the US Supreme Court overturned the state court's verdict and award. *Justices cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs.* In short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.


People always want to have their cake and eat it too. They complain about the high cost of brand name pharmaceuticals and want lower drug prices. A good part of the need for high drug prices is to cover legal expenses. The FDA authorizes generic manufacturers to copycat drugs that are now off patent and which have already gone through an FDA approval process. If the generic manufacturer deviates from from permissible procedure then the FDA requires them to undertake a lengthy and expensive certification process, which simply raises the price of the drugs. The intent is to produce drugs cheaply and to do that the generic manufacturers need to be protected from lawsuits for simply doing what the FDA has approved them to do.

If patients want to have the ability to sue drug makers then they should buy brand name drugs and pay the price asked for those drugs, a price which includes provisions for defending lawsuits and paying out awards.

People complain a lot about lawyers, lawsuits, corporations changing product characteristics in order to minimize exposure to lawsuits and corporations charging an arm and a leg in order to deal with the lawsuits filed against their products and they claim that they want a streamlined commercial environment where there isn't this implicit legal tax on every damn product they buy. Well, generic drugs can offer lower prices precisely because they're shielded in this fashion.

You can't have the ability to sue and not expect the company to jack up prices to provide provisions for legal and award expenses. The solution here is simple - if you want to have the right to sue, then kill off generic drugs as a category and deal with a marketplace where every drug is brand name.


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## lovetogrow (Jan 25, 2011)

The gap in price between generic and brand name drugs in many cases is significant enough to mean the difference in the ability to meet basic needs for some families.

The FDA doesn't have the 'best' track record when it comes to full disclosure on the deadly side effects of pharmaceuticals - as whistleblowers and insiders have disclosed in the past. Has there been a significant shift since 2005? One could only hope.

"The following interview with Dr. David Graham (senior drug safety researcher at the FDA) was conducted by Manette Loudon, the lead investigator for Dr. Gary Null. This interview contains jaw-dropping insights about the corruption and crimes that take place every day inside the Food and Drug Administration. This is no outside critic, either: these are the words from a top FDA employee who has worked at the agency for two decades. If you've ever wondered how the drug industry could pull off the greatest con of our time -- and turn the human body into a profit-generating machine -- you're about to learn the shocking answers in this interview."

Learn more: http://www.naturalnews.com/011401_Dr_David_Graham_the_FDA.html#ixzz2YpyPveVy


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## FatTire (Mar 20, 2012)

Nah, I just want my cake to sit there and look pretty.. 

Heres a concept, lets hold snake oil makers accountable to make products that live up to claims and not poison people. Doesnt seem like too much to ask of a multi billion dollar industry.

If a corporation is a person, what sort of person is it?


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## lovetogrow (Jan 25, 2011)

Meerkat said:


> Some drugs make people suicidal. I dealt with VN vets that ended up killing themselves who would leave the VA with a bag full of drug's, I know this fro a fact because I took a couple of them to pick them up.
> 
> One of them got shot and went back got shot twice more. He walked like a zombe and ended up shooting himself In the head at the old age of ' 28 '. He was such a nice young man before then.
> 
> ...


People really need to do as much homework as they can about the pharmaceuticals they are prescribed. Unfortunately a whole lot of that info is either sketchy or not readily available. Another problem I believe, is that a large percentage of people still have this blind trust in their physicians and don't ask the questions they really need to ask. Not saying do not trust your physician - but believe me they are not God and they do not have all of the answers.


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## lovetogrow (Jan 25, 2011)

More later on reform legislation (2012) and some responses to the ‘working group for pharmaceutical safety’ that has grown out of the legislation.

Going on a roadtrip with a three of my grandsons (teens) this weekend (where’s the vallium? ) Have a great weekend folks!


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## Bobbb (Jan 7, 2012)

lovetogrow said:


> The gap in price between generic and brand name drugs in many cases is significant enough to mean the difference in the ability to meet basic needs for some families.


And everyone recognizes this, hence generic makers getting the road ahead paved for them by the FDA. They're not doing independent research, they're not doing clinical trails, they're simply taking drugs which are no longer under patent protection and manufacturing them to produce identical chemical formulations as the brand name makers.

The brand name makers must charge more because they're not protected from lawsuits, because they incur and have incurred more expenses.

If you as a consumer want to reserve the ability to sue pharmaceutical companies then buy just name brands. It's idiotic to strike a bargain - low prices for no ability to sue, reap the benefit of the low prices and then demand the right to sue.



FatTire said:


> Heres a concept, lets hold snake oil makers accountable to make products that live up to claims and not poison people.


Generic makers don't make the claims that you attribute to them. They're simply copycat manufacturers who operate on very lean margins in order to produce low cost drugs.

If you want the ability to hold corporations accountable for their claims, then buy brand name drugs, pay the price for those drugs, and the world will be as you want it to be.


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## FatTire (Mar 20, 2012)

sorry, i had the silly liberal notion that poor folks shouldnt be poisoned, and should have consumer protections.. my bad...


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## ContinualHarvest (Feb 19, 2012)

This is what happens when the FDA is run by corporate executives and decisions are made by activist judges.


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## Meerkat (May 31, 2011)

They found out that some of the ingredients from some genetic drugs had fillings from filthy septic products in them.

Most insurance corporations will not pay for drugs other than generic. So we are forced to take very dangerous meds in many cases.


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## Jim1590 (Jul 11, 2012)

Does this at least mean that I will stop getting those telemarketing calls about partaking in a class action lawsuit?

In all seriousness, I can understand some form of protection for the original makers of the med, not the generic. The original developer has to make so many steps for FDA approval. So many studies have to be done. So much money spent. What I am curious about is if generic makers have to go through the same process to certify the med as safe.

The rampant rise in medical costs need to be put under control before Obamacare kicks in and really destroys the system, but I think there are far better places to put tort reform in. After all you can sue for millions because of an unforeseen issue that occurred but you now can not sue because you lost 3 of 4 limbs after the cough syrup from wherever was filled with bleach.


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## Bobbb (Jan 7, 2012)

FatTire said:


> sorry, i had the silly liberal notion that poor folks shouldnt be poisoned, and should have consumer protections.. my bad...


The problem here is the FDA. If they give blanket protection to generic makers because the drugs have passed FDA scrutiny, then if the drugs are hazardous the issue is with the FDA approval which was granted.

Secondly, these generic manufacturers are not doing original research so why should they be sued for a fundamental flaw which arises from the chemical formulation of the drug? They're just manufacturers. Think of it this way - should bakers be sued for the harm that falls on people with Coeliac disease who eat the bread produced by the bakery? The bakers are simply taking wheat flour and making products according to recipes, they're not concocting wheat flour in the lab.

The FDA decided that low cost drugs was an important goal and so shielded generic makers from lawsuit. If you don't like that situation then fault the FDA and Big Government and have them repeal the lawsuit shield and be prepared for more expensive drugs as the generic makers factor legal costs and settlement awards in their pricing models.

Well, what's it going to be? Choose.


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## FatTire (Mar 20, 2012)

Thats all well and good bobbb, sadly my rose colored glasses wore out somewhere around the time the fda started being a temp agency for the very corporations it was suppossed to regulate. The problem isnt the fda, but rather the underlying system that pertuates greed and corruption in rhe name of increased profits. 

Lets stop pretending that the rules of the game matter and people play by the rules, k?


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## drfacefixer (Mar 8, 2013)

FatTire said:


> Thats all well and good bobbb, sadly my rose colored glasses wore out somewhere around the time the fda started being a temp agency for the very corporations it was suppossed to regulate. The problem isnt the fda, but rather the underlying system that pertuates greed and corruption in rhe name of increased profits.
> 
> Lets stop pretending that the rules of the game matter and people play by the rules, k?


Actually, the problem is the decreasing funding of the FDA which forces it to outsource some of what it was created to do.I won't argue that there may be serve serving principles at work from the pharmaceutical corp. Bobbb did a great job explaining the brand vs generic legal aspects.


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## lovetogrow (Jan 25, 2011)

Bobbb said:


> The problem here is the FDA. If they give blanket protection to generic makers because the drugs have passed FDA scrutiny, then if the drugs are hazardous the issue is with the FDA approval which was granted.
> 
> Secondly, these generic manufacturers are not doing original research so why should they be sued for a fundamental flaw which arises from the chemical formulation of the drug? They're just manufacturers. Think of it this way - should bakers be sued for the harm that falls on people with Coeliac disease who eat the bread produced by the bakery? The bakers are simply taking wheat flour and making products according to recipes, they're not concocting wheat flour in the lab.
> 
> ...


No choice really


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