Change in Chicago: Boomerang
When it comes to branded and generic drugs, the listing of key issues in this image misses a trick. The labels are identical.
This lack of difference is a consequence of the 1984 Hatch-Waxman Act which after two decades of dispute staked out a boundary between generic and branded pharmaceutical companies, part of which in the case of their drugs required the generic companies to take over the label of the branded drug when they entered the market.
The Cost of Drugs
The issue of branded and generic took shape in the 1950s. Before then the primary way companies controlled drug niches – monopolized on the sale of profitable drugs – was through branding rather than patents. This meant there were a lot of branded generics and a lot of companies who manufactured drugs for other companies who branded and marketed.
The branding and marketing cost money and was the major component of a drug’s price – that and profit taking. If consumers could access “raw” medicines the same way they can access unbranded other products, they would be able to save money. And driving down the price of drugs was the main goal of Estes Kefauver’s hearings on the pharmaceutical industry that led to the 1962 Amendments to the Food and Drugs Act.
Kefauver failed in his goal of containing prices. Other changes his amendments introduced, such as the need to prove a drug worked before marketing and the use of controlled trials to achieve this, drove the price of drugs up. As prices rose during the 1960s, for a variety of reasons support for the idea of increasing the flow of generic drugs began to grow.
The main block to the use of generics was legal. Most American states for instance had anti-substitution laws, meaning that, if a doctor wrote a script for a branded drug, a pharmacist could not substitute a cheaper generic drug.
Battle lines were drawn between the consumer movement, a relatively powerful lobby in the 1960s, and the branded industry who for the most part were operating behind a shield of doctors.
The push to repeal anti-substitution laws and greater use of generics was portrayed as a push for socialized medicine and an infringement of the sacred relationship between doctor and patient. Do you want your doctor to give you the best or the cheapest drug?
Pharmacists were warned about the risks of being sued by patients if they were to intervene and swap drugs and something then went wrong.
Staring in 1974 with Kentucky a trickle of states repealed their anti-substitution laws, while Oklahoma refused to do so. The key moment came in 1978 when New York opted to allow substitution. This was key because where other states had lists allowing twenty or thirty drugs to be substituted, using cloak and dagger methods Bill Haddad in New York had created a list of 800 FDA supported substitutions. It was this rather than Haddad’s later involvement with Orrin Hatch and Henry Waxman that brought generics into play.
Tidying Up?
Hatch-Waxman tidied up the loose ends. It gave the branded industry a modest amount of patent extension and streamlined the process for generic drugs to enter the market.
A central element of the deal involved the label generic companies would run. Generic companies can make chemicals but the branded companies run the trials and collect the early data on a drug that makes the label and transforms a chemical into a medicine. The best deal seemed to be for generic companies to take over the branded label lock stock and barrel.
When the Supreme Court ruled in 2011 that generic companies could not be sued in a failure to warn case, because they had not done the warning, this set up a predictable clash. In 2001 when Prozac went off patent and Barr Laboratories brought out a generic fluoxetine, it was clear that at some point the question of suicide on a generic SSRI would become an issues.
The Dolin case is where the rubber hits the road. Some higher court will have to decide on the merits of allowing GlaxoSmithKline to be sued when Stewart Dolin committed suicide while taking generic paroxetine rather than Paxil. This may take some years to sort out, with every iteration in the legal process cementing Stewart Dolin’s name in legal history.
Boomerang
Meanwhile, the cost of branded drugs around 1962 was less than $10 Billion per year. In 1984, the year of Hatch-Waxman, it was slightly over $20 Billion per year. It is now a $1,200 Billion per year operation.
Somehow every action in the pharmaceutical sphere has a way of turning out exactly the opposite of what its promoter intended.
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Watchdog fines GSK £37m for paying to keep generic drugs out of UK market
The pharmaceuticals giant says it is appealing the decision
By Julia Bradshaw
10:25AM GMT 12 Feb 2016
http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/12153450/Watchdog-fines-GSK-37m-for-paying-to-keep-generic-drugs-out-of-UK-market.html
The Competition and Markets Authority claims GSK paid a number of pharmaceuticals companies, including Generics UK Limited and Alpharma Limited, more than £50m between 2001 and 2004, aimed at delaying the entry of generic varieties of paroxetine, an anti-depressant, into the UK.
GSK’s own branded version of paroxetine, Seroxat, was a blockbuster product with UK sales of more than £90m in 2001.
“The CMA has also found that GSK’s conduct, in making payments to Generics UK, Alpharma and one further company, Norton Healthcare Limited, to induce them to delay their efforts to enter the UK paroxetine market independently of GSK, infringed the competition law prohibition on abuse of a dominant position.”
The CMA opened the case after a tip-off from the European Commission in 2010.
U.S. Food and Drug Administration
https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm
FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.
David
Interesting thought, but might it not be a little late for GSK, having already recognised the right of the court in Chicago, and their need to defend themselves, to turn round and say it was not their product after all? Surely they needed to contend that in the first place?
Though no doubt they will not stop at anything.
GSK never “consented” to being held responsible for what happened to people on generic versions of Paxil. As a matter of fact, before the trial they appealed to a higher court to shut down Wendy Dolin’s lawsuit and reverse the district court judge’s ruling that she could sue GSK.
The higher court (the U.S. Seventh Circuit) didn’t make a decisive ruling in favor of Dolin. But they did tell GSK that they would not intervene to reverse the judge’s ruling or stop the lawsuit. In effect they said: Take this to trial, and if you lose, come back with that argument on appeal.
This is an issue that’s likely to go all the way to the Supreme Court … We owe the Dolin family a real debt of gratitude for their willingness to see it through!
Thanks Johanna – that sounds like an answer. What convolutions!
Expert Analysis
the proper question is whether GSK could be liable for conduct “extrinsic to the manufacturing process and that contributed to [the] [p]laintiff’s injury.” Phrased this way, the court easily answered the question in the affirmative.
Ill. ‘Innovator Liability’ Case Is Setback For Drug Cos.
https://www.law360.com/articles/518651/ill-innovator-liability-case-is-setback-for-drug-cos
Examining each of these fours factors in turn, the court first decided that Stewart Dolin’s injury was reasonably foreseeable. Under the Hatch-Waxman Act, “it was well understood that any generic manufacturer would be required by law to use GSK’s design and warning label,” which is similar to reasoning used by the few courts that have found brand manufacturers owe a duty to those who take generic drugs.
GSK was responsible for the design and warning label of not just Paxil, but also paroxetine.
Importantly, the court also noted “that any defects later discovered could only be cured by GSK,” which, though not necessarily related to foreseeability, further supports the finding that GSK owed a duty to plaintiff. For the same reasons the court found the likelihood of injury was not “so remote as to undo GSK’s duty of care.”
As to the third and fourth prongs, the court found that guarding against the alleged injury “could be as simple as updating the warning label,” and that GSK would face no additional burden in doing so because GSK was already obligated to update the label for Paxil.
Rejecting GSK’s Counterarguments
The court next disposed of GSK’s argument that it could not be liable as a matter of law because it did not manufacture the drug that was ingested. Emphasizing that “GSK has offered no reason why it should be held liable only for those injuries caused by its negligence as a manufacturer,” the court reiterated its finding that no legal theory barred recovery if GSK had been negligent in designing paroxetine and drafting its label.
Catch-22
The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable.
— Wendy Dolin
http://missd.co/wp-content/uploads/2016/07/DOLINLAW360Catch-22.topostpdf.pdf
Glaxo has known for two decades that Paxil can cause people of all ages to commit suicide.
https://ssristories.org/breaking-gsk-hit-with-3m-verdict-for-reed-smith-attys-suicide-law360/
If Dolin prevails, the stakes will be high for generic-drug patients across the country. Her attorneys believe it would likely set the stage for the Seventh Circuit to address the issue for the first time in the event of a GSK appeal. In that scenario, the question before the court would be whether branded-drug makers can be held liable for injuries caused by generic-equivalent drugs that they did not themselves make. If the Seventh Circuit were to answer the question differently from the few other federal appeals courts that have done so — the Fourth and Sixth circuits have ruled against the idea that a branded-drug maker could be liable for a generic-drug injury — the suit could very well
wend its way up to the nation’s highest court.
“The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable,” Dolin said. “I’d love this case to be the one that says, ‘This is no longer acceptable.’”
GSK, which has taken a whopping 30 depositions in the case over a one-and-a-half-year period, has designated more than two dozen witnesses, including company witnesses and about nine experts.
“GSK is not responsible for Mr. Dolin’s death and we’ve submitted our position in filings to the court,” spokeswoman Jenni Ligday told Law360 in a statement.
The BOOMERANG EFFECT could work in ‘Wends’ favour ..
Wendy Dolin asserted her husband’s behavior was caused by the paroxetine, and she further asserted GSK failed to adequately warn on Paxil’s label – which, under FDA regulation, also was placed on the generic paroxetine – that the drug had an increased risk of suicide in adults.
“GSK was responsible for the [warning] label,” said Dolin’s lead attorney Brent Wisner of Baum, Hedlund, Aristei and Goldman P.C. in Los Angeles. “If that label caused Mr. Dolin’s death, that is old-fashioned negligence…”
“GSK was not held liable for Paxil, but statements about Paxil,” he continued. “A brand-name drug maker creates a label and knows other generic drug makers are going to copy that label. That’s federal law. That’s reasonably foreseeable.
“In our trial transcripts, we had our experts up there. They said the label is what killed Stewart Dolin, not just the drug. Wendy Dolin’s position is not to have Paxil taken off the market; the whole point is, if you’re going to sell Paxil, just tell people that it could cause adults over 24 to kill themselves.”
Forbes
https://truthman30.wordpress.com/2017/06/13/great-new-article-from-forbes-about-the-paxildolin-trial/
Label Or Liability: GSK Faces $3M Verdict Over Product It Didn’t Make
“GSK is not responsible for Mr. Dolin’s death and we’ve submitted our position in filings to the court”
So, who is then?
If we look at the defence of GSK at trial we see that they shifted the blame onto the FDA, Stewart’s prescribing doctor and Stewart himself. Ergo, they are blaming someone.
The label, for which they were/are responsible, was inadequate. The jury, it appears, agreed.
No argument really.
Well said! If GSK feel that they are ‘blameless’ – why did they try to push the blame elsewhere? Why didn’t they keep to the statement that it was not their product and continue with that? Since the label on their product, as well as on the generic version, is inadequate it seems fair to place blame with them as original suppliers surely?
Then we have Johanna’s explanation of what’s gone on – basically “you’ll get your chance to protest in appeal if you don’t like the outcome of the trial” – what a mess!
As Johanna says, the Dolin family is showing true strength in this drawn-out string of events – surely their suffering has been difficult enough without this addition.
Let’s have a bit of a re-run ..
“If someone has, again, an irresistible impulse, you know, I actually have trouble working that bloody machine. I mean, if you had akathisia, why would you buy a ticket. I mean, you just jump over the thing and run down.”
Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy
http://fiddaman.blogspot.co.uk/2017/04/dolin-vs-gsk-last-man-standing-return.html#.WULAsIWcGZ8
Opinion piece:
GSK’s Paxil Loss Forces 7th Circ. Generic Liability Showdown
http://www.curtis-lawgroup.com/uploads/resources/GSKsPaxilLossForces7thCirc.pdf
Plaintiffs’ lawyers like Andy Vickery of Vickery & Shepherd, who helped win the very first
verdict
against GSK on the issue of Paxil’s suicide and homicide risks in a 2001 case, said the
unique power that brand manufacturers have to alter drug labels means they shouldn’t be allowed to hide
behind traditional tort law as a defense.
“[GSK] well knows that the generic manufacturers cannot change their label until [GSK]
changes their label, and they know that the Supreme Court has insulated generic manufacturers
from liability,” Vickery told Law360. “I hope the Seventh Circuit will see through that and hold
them accountable.”
If it does, it could become the first federal appellate court to do so.
“If I were on the Supreme Court or advising the Supreme Court, I think I would wait to see if the FDA takes it up,” Klein said.
GSK says it stopped selling Paxil in the United States in 2014, when it “divested
responsibility” for the drug to Apotex Inc. Company spokeswoman Frances DeFranco says the company still sells Paxil outside the United States.
The U.S. Food and Drug Administration has proposed a rule that would allow generic
companies to unilaterally update their warning labels, but Scott Gottlieb, who was nominated by
President Donald Trump to head the agency, has publicly derided the rule.
“The FDA should scrap this draft rule immediately,” Gottlieb wrote in a Wall Street Journal
column in August.
“If I were on the Supreme Court or advising the Supreme Court, I think I would wait to see if the FDA takes it up,” Klein said.
Let’s have a bit of a re-run ..
“If someone has, again, an irresistible impulse, you know, I actually have trouble working that bloody machine. I mean, if you had akathisia, why would you buy a ticket. I mean, you just jump over the thing and run down.”
Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy
I came out of court once and went and bought a train ticket and had a very intense impulse to jump in front of a train. It was very intense but having around the time read up on a case about impulsive behaviour on antidepressants I suspected it was the tablets doing it and run out of the station and rang the police in panic and fear because I did not actually want to commit suicide, it was just a thought and very intense impulse to do it. It then passed and I then got on a train again to a friends but had the police calling me back on the phone to see where I was and if I was OK, (that I have to thank the police for). I have no doubt that these very intense impulses of akathisia suicide do happen. I feel there are different severity’s of it and the people who do commit suicide are suffering the extreme form. it really does happen and I know it does from personnel experience.
Sorry I would like to add that it was very “SUDDEN” and Intense impulse because that’s exactly what it was.
Totally agree with you Anne-Marie – it is ‘sudden’ as in a split second isn’t it. Coming off Seroxat cold turkey, we were warned to watch Shane 24/7 for ten days. This was done. In observation, I noticed that he would often seem to be fighting against his thoughts but declined to enquire too much as to what was going on in his mind for fear of pushing him into a negative reaction. I remember sitting there with him on, roughly, the fifth day, just chatting about the day etc. when he suddenly leapt off his bed into the en-suite and cut himself with a razor. It all happened in FAR less time than it’s taken me to write this sentence. The speed of movement was incredible!
Train Tracks ..
Struck by a Train
http://antidepaware.co.uk/struck-by-a-train/
Sarah Boseley health correspondent
Monday 22 May 2000
Impulse to Suicide
https://www.theguardian.com/science/2000/may/22/drugs.uknews
“All the drugs have been licensed as both safe and efficacious on the basis of data from clinical trials. But Dr Healy believes that there are serious problems with the reporting of side-effects in these trials, and that this has allowed drugs to be handed out to millions around the globe without their true risks being understood.
Dr Healey has written to the Medicines Control Agency, which licences medicines in the UK, expressing his concern and pointing out that he believes patients who today become suicidal on SSRIs are in a state of “legal jeopardy”.