7 ms·

I actually used to work for them as a lawyer, indirectly. My view is likely a bit skewed in the other direction, but to me this is mostly evidence of how expens

I actually used to work for them as a lawyer, indirectly. My view is likely a bit skewed in the other direction, but to me this is mostly evidence of how expensive and impossible it is to do business in healthcare in the United States. How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines? Part of it is a question of Pfizer's investment in compliance - which I assure you is massive - but also it's a lack of clarity and shifting goal posts. False claims act litigation, for example, is responsible for the second largest settlement listed on this site (phen fen is #1), a notorious and utterly incomprehensible regime where all of the big money settlements relate to aggressive fringe theories asserted by DOJ.

mulletbum 4y ago
I didn't go through all of the False Claims litigation, but the penalties were related to pricing, nothing to do with their science.
forgetfreeman 4y ago
Pffffft. Explain why Pfizer keeps making epic regulatory faceplants when much smaller organizations, ostensibly with less industry experience, routinely manage to navigate regulations in the US without issue?
- unmole 4y ago
  A behemoth like Pfizer is a more attractive target for enforcement agencies?
  - forgetfreeman 4y ago
    Nah. Regulators have performance metrics same as everyone. They'll gleefully target 150 headcount biotech firms in a heartbeat if they think there's a win to be had and smaller firms generally dont have the legal war chest required to fight a complianceviolation beef. See Also: OIG going after United Therapeutics on light pretext.
  - spamizbad 4y ago
    Pfizer has more "surface area" but beyond that, no. Prosecutors love shooting fish in a barrel: it actually makes smaller biotech firms more attractive regulation targets.
    - johndhi 4y ago
      Disagree. Every civil prosecutor I've ever worked with wants a big "story." They are driven by headlines. Taking down local mom's pharmaco is the opposite of the narrative people want to read in the paper. We like the headline of this article: megacorp pfizer is evil. That's why we're in this thread, right?
      - forgetfreeman 4y ago
        You may disagree but the history of the Office of Inspector General crapping on sub-200 headcount biotech and pharma startups doesn't mesh with any of that. Keep in mind smaller firms don't put up anywhere near the fight a multinational like Pfizer is capable of, and the OIG knows this.
  - willcipriano 4y ago
    We are told the opposite fairy tale when it comes to the IRS. "They have to go after regular people and small business owners because corporations have too many lawyers!"
    - clucas 4y ago
      Interesting, who makes that argument?
      - willcipriano 4y ago
        I can find someone making that case with a quick Google: https://www.april15th.com/irs-problems/why-irs-audits-more-small-businesses-than-big-corporations/ https://www.april15th.com/irs-problems/why-irs-audits-more-s... > The IRS brings in more dollars per hour auditing small mom and pop businesses, than they do auditing medium and large companies. > Why is that the case? Because the larger companies keep impeccable records and have tax experts to defend them; Enrolled Agents, CPAs, or tax attorneys that usually know more about the Tax Code than the IRS auditor-employee. I've found it in my conversations with people justifying the recent increases in IRS agents and the new $600 reporting requirement.
        clucas 4y ago
        Reading that link, it appears they are saying the IRS is concentrates its efforts on small businesses because they have the best chance of recovery. You called it a fairy tale, do you believe that big corporations are actually bigger tax cheats than small businesses, and they're just getting away with it somehow?
        willcipriano 4y ago
        I do not have any of direct evidence of anything, I'm just a guy with a brain. This is one of many in a long series of "coincidences" that when put together starts to become nonsensical. Look at where we started. Pfizer gets fined more beacuse they are a bigger company and have more surface area, the law is complex and everyone is breaking it all the time so action against them doesn't mean they did anything wrong. In and of itself fine, that may be true. Then those same people will later say, the IRS went after that Mexican restaurant instead of Pfizer beacuse they are so big, and run such a tight ship that it would almost impossible to find any wrong doing. The tax code is very complex, so is drug regulation. Is the idea that Pfizer is hyper competent in tax law but incompetent when it comes to the core business? That doesn't hold water for me.
- RcouF1uZ4gsC 4y ago
  Because Pfizer is a bigger target? Kind of like 3 Felonies a Day, lots of times the laws/regulations are so labyrinthine that if they look at you closely, they will find something.
- hoffs 4y ago
  Because you make example of big player, not small one.
  - themaninthedark 4y ago
    But the opposite is claimed with respect to IRS audits. With that we are told the IRS goes after and fines the little guy because the rich can spend money for defense. Shouldn't we expect to see similar behaviors across regulators?
    - wbl 4y ago
      There are very different incentives for different regulators who operate with different bodies of law and degrees of compliance.
- jollyllama 4y ago
  I'll join the sibling comments in speculation: They're so big that they can either get away with it in aggregate or when they can't, can count on favorable judgements, like the comment about J&J. Favorable in the sense that the individuals personally responsible won't face the ramifications.
  - forgetfreeman 4y ago
    Nailed it in one. I'm old enough to vividly remember the first time Pfizer the corporations-are-people business entity was convicted of a felony. In the decades since not only have they failed to substantially alter their approach to compliance issues, most of the largest industry players have followed suit since the profit/loss ratio for ignoring regulations has been shown by Pfizer's financials.
dec0dedab0de 4y ago
How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines? Without having any knowledge of said people and laws, I would say that some of those smart people are making decisions to help their personal bottom line while putting the company at risk. Anyone working at a large company sees this all the time.
JacobThreeThree 4y ago
Pfizer gets plenty of fines outside the United States too.
qwerty456127 4y ago
> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines Perhaps they don't really care to? Apparently paying penalties is just a part of the business model, net profits/savings made thanks to the violations still exceeding net fines. I'm not sure about Pfizer but I feel almost sure this is the way Google and other big tech corporations providing "free" services work paying huge fines for privacy violations every now and then. Google will still spies on you and records everything it can about you no matter how much do you tweak your settings and how hard does the EU try to protect your privacy rights, doesn't it?
- shadowgovt 4y ago
  I can't speak to medical specifically, but in one of the spaces I used to work the thinking was "The law is ambiguous because it's reactive; we're so far out on the bleeding edge that nobody actually knows what's legal until someone tries it and someone else makes a case of it. So pushing the envelope is a net positive for society because we end up blazing a trail of bright-line precedent rulings that other companies can follow. You can tell the pioneers because they're the ones with the arrows in their backs." A bit self-serving but there's some meat on the bones of that logic; the real meaning of the law is path-dependent and determined by the rulings, not the words on the paper.
  - thatguy0900 4y ago
    In fairness there's Noone you can call up in the government to ask for certain if something is legal or not past a certain point. Only a judge can decide that, and they don't do hypothetical cases.
- forgetfreeman 4y ago
  It's also worth noting that the parent claim of unclear compliance guidelines is less of a statement of fact and more a commentary on your average pharma industry lawyer. There are more suites of standardized compliance applications than you could shake a stick at, that's not at issue. The problems usually start with a department of contract lawyers who can't be assed to skill up on industry specifics. Throw in a CFO with little or no experience managing CRO's and you've got the perfect recipe to get dumped on by the OIG.
krisoft 4y ago
> False claims act litigation, for example, is responsible for the second largest settlement listed on this site (phen fen is #1), a notorious and utterly incomprehensible regime where all of the big money settlements relate to aggressive fringe theories asserted by DOJ. Well. I looked the case up. Here is how i am understanding it: Pfizer wanted a drug to be approved for a specific use. The FDA rejected it as too risky, approved it for other uses. Pfizer nevertheless was pushing the drug for this unaproved, off-label use. The drug later proved to be dangerous in this off-label use and were whitdrawn from the market. Am I reading this wrong? What part of this is controversial? If you ask for permission for something, then been told no you do it anyway and in that process people suffer harm what should happen then?
- johndhi 4y ago
  Off label litigation is a great example of my point. Extremely muddy waters. Physicians constantly ask pharma about and explore off label drug prescriptions. This is legal: psychiatrist can tell you to take a drug approved for nerve pain for depression. There is research showing it works for depression but it has not technically been added to the label of the drug yet following fda approval. Pharma can provide the studies and answer limited questions on the topic (but no clear guidance) but cannot "promote" this. Is presenting the research promotion? Is the rep discussing it with the doctor promotion? Etc
  - esel2k 4y ago
    Just to add how difficult these off-label uses are beeing managed. Every content we provide (be it in a discussion, or a comment in one if our forums or as part of a symposia) needs to be checked for offlabel use. This is a nightmare and every single screen of my apps or of the content that is uploaded needs to be reviewed by medical teams/compliance. Its a nightmare. Now tell me what is “was promoted by pfizer”? A doctor saying it in a comment/presentation that he tried this with on patient and storing this on one of our digital platforms? It’s really grey water… And add to this hard times for medical reps after covid.
  - isitmadeofglass 4y ago
williamscales 4y ago
> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines? They aren't. What is clear is that a huge corporation of smart people simply don't care about fines. The answer is to make the fines much bigger, big enough that a single one would threaten the existence of Pfizer.
- mym1990 4y ago
  This is silly, there should be a middle ground. A 1 strike policy would just stifle any innovation coming out of a company.
  - williamscales 4y ago
    Yeah, I wouldn't advocate a 1 strike policy. Fines should escalate with repeated violations. The fines should be tied to revenue and after some violations they should reach the point where the business cannot continue.
- johndhi 4y ago
  Based on what research is this a good idea? The US system is unique and we're entrenched. This is too big a change.
busyant 4y ago
> I actually used to work for them as a lawyer, indirectly. I was a small-time expert witness (on the plaintiff's side) against them in a very small lawsuit. It was the first and last time I served in that capacity. A child was born with horrific birth defects. Parents claimed that a specific medication caused it. Pfizer obviously said otherwise. The whole thing left me feeling dirty. Experts charging $600 / hour (this was over a decade ago, so God knows what they charge now) to say, with diamond-hard confidence, whatever their side wanted them to say. Plaintiff's experts: "That drug _definitely_ caused the birth defects." Defense experts: "There is no possible way that drug could cause birth defects." Basically, here was a tragedy, and we all feasted on it. One of the other experts told me I could be "good at this" (selling myself out as an expert), but it just left me feeling dirty.
- rnikander 4y ago
  A woman once told me that she made $300K/year as an "expert witness", on various topics. She was smart and she said she would study a bit and go testify. It blew my mind. I didn't understand whether she was working for the mafia, or if this was legal, or what. I said something like, "but, wait, you're not an expert. The court allows this?" She didn't understand my problem. She seemed entitled; despite her IQ she may not have understood what an actual expert was. I never got to the bottom of it and lost track of her.
  - vorpalhex 4y ago
    The court does not want a deep guru on every topic. It effectively wants a bridge between a specialized domain and the court itself (which is made of lay people.) I would expect an Expert to study on the particulars of a case. In general as long as they are sufficiently narrow I don't see a problem here.
    - mschuster91 4y ago
      I'd rather expect someone as a court-appointed expert that they have relevant, certified experience. In Germany, while judges are legally free to appoint whoever they want as experts unless there exist specially certified experts for the class of assessment[1], the parties involved usually present actual experts to the judge for selection - and the opposing side would challenge the selection of non-qualified experts. [1] https://www.gesetze-im-internet.de/stpo/__73.html https://www.gesetze-im-internet.de/stpo/__73.html
avgDev 4y ago
Pfizer product issues: During the mid-1980s, watchdog organizations such as the Public Citizen Health Research Group charged that Pfizer’s widely prescribed arthritis drug Feldene created a high risk of gastrointestinal bleeding among the elderly, but the federal government, despite reports of scores of fatalities, declined to put restrictions on the medication. A June 1986 article in The Progressive about Feldene was headlined DEATH BY PRESCRIPTION. The Food and Drug Administration expressed greater concern about reports of dozens of fatalities linked to heart valves made by Pfizer’s Shiley division. In 1986, as the death toll reached 125, Pfizer ended production of all models of the valves. Yet by that point they were implanted in tens of thousands of people, who worried that the devices could fracture and fail at any moment. In 1991 an FDA task force charged that Shiley had withheld information about safety problems from regulators in order to get initial approval for its valves and that the company continued to keep the FDA in the dark. A November 7, 1991 investigation in the Wall Street Journal asserted that Shiley had been deliberately falsifying manufacturing records relating to valve fractures. Faced with this growing scandal, Pfizer announced that it would spend up to $205 million to settle the tens of thousands of valve lawsuits that had been filed against it. Even so, Pfizer resisted complying with an FDA order that it notify patients of new findings that there was a greater risk of fatal fractures in those who had the valve installed before the age of 50. In 1994 the company agreed to pay $10.75 million to settle Justice Department charges that it lied to regulators in seeking approval for the valves; it also agreed to pay $9 million to monitor valve patients at Veterans Administration hospitals or pay for removal of the device. In 2004 Pfizer announced that it had reached a $60 million settlement of a class-action suit brought by users of Rezulin, a diabetes medication developed by Warner-Lambert, which had withdrawn it from the market shortly before the company was acquired by Pfizer in 2000. The withdrawal came after scores of patients died from acute liver failure said to be caused by the drug. In 2004, in the wake of revelations about dangerous side effects of Merck’s painkiller Vioxx, Pfizer agreed to suspend television advertising for a related medication called Celebrex. The following year, Pfizer admitted that a 1999 clinical trial found that elderly patients taking Celebrex had a greatly elevated risk of heart problems. In 2005 Pfizer withdrew another painkiller, Bextra, from the market after the FDA mandated a “black box” warning about the cardiovascular and gastrointestinal risks of the medication. In 2008 Pfizer announced that it was setting aside $894 million to settle the lawsuits that had been filed in connection with Bextra and Celebrex.
simonebrunozzi 4y ago
> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines? Unless these big fines are because such corporation has been really, really bad...
kilroy123 4y ago
I work in health care for a health care start. Literally my co-workers and I were just talking about this. How it's all such a racket and way too expensive and complicated. How do we get out of this hole? How do we fix health care and fix these issues?
nowaymrjose 4y ago
This is rediculous. J&J knowingly sold talcum powder laced with asbestos. They have known about it for over 50 years. This company is basically evil and as they cannot fight the facts they use trickery to absolve liability. https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/ https://www.reuters.com/investigates/special-report/johnsona... You should be ashamed of yourself.

mulletbum 4y ago

I didn't go through all of the False Claims litigation, but the penalties were related to pricing, nothing to do with their science.

forgetfreeman 4y ago

Pffffft. Explain why Pfizer keeps making epic regulatory faceplants when much smaller organizations, ostensibly with less industry experience, routinely manage to navigate regulations in the US without issue?

unmole 4y ago
A behemoth like Pfizer is a more attractive target for enforcement agencies?
- forgetfreeman 4y ago
  Nah. Regulators have performance metrics same as everyone. They'll gleefully target 150 headcount biotech firms in a heartbeat if they think there's a win to be had and smaller firms generally dont have the legal war chest required to fight a complianceviolation beef. See Also: OIG going after United Therapeutics on light pretext.
- spamizbad 4y ago
  Pfizer has more "surface area" but beyond that, no. Prosecutors love shooting fish in a barrel: it actually makes smaller biotech firms more attractive regulation targets.
  - johndhi 4y ago
    Disagree. Every civil prosecutor I've ever worked with wants a big "story." They are driven by headlines. Taking down local mom's pharmaco is the opposite of the narrative people want to read in the paper. We like the headline of this article: megacorp pfizer is evil. That's why we're in this thread, right?
    - forgetfreeman 4y ago
      You may disagree but the history of the Office of Inspector General crapping on sub-200 headcount biotech and pharma startups doesn't mesh with any of that. Keep in mind smaller firms don't put up anywhere near the fight a multinational like Pfizer is capable of, and the OIG knows this.
- willcipriano 4y ago
  We are told the opposite fairy tale when it comes to the IRS. "They have to go after regular people and small business owners because corporations have too many lawyers!"
  - clucas 4y ago
    Interesting, who makes that argument?
    - willcipriano 4y ago
      I can find someone making that case with a quick Google: https://www.april15th.com/irs-problems/why-irs-audits-more-small-businesses-than-big-corporations/ https://www.april15th.com/irs-problems/why-irs-audits-more-s... > The IRS brings in more dollars per hour auditing small mom and pop businesses, than they do auditing medium and large companies. > Why is that the case? Because the larger companies keep impeccable records and have tax experts to defend them; Enrolled Agents, CPAs, or tax attorneys that usually know more about the Tax Code than the IRS auditor-employee. I've found it in my conversations with people justifying the recent increases in IRS agents and the new $600 reporting requirement.
      - clucas 4y ago
        Reading that link, it appears they are saying the IRS is concentrates its efforts on small businesses because they have the best chance of recovery. You called it a fairy tale, do you believe that big corporations are actually bigger tax cheats than small businesses, and they're just getting away with it somehow?
        willcipriano 4y ago
        I do not have any of direct evidence of anything, I'm just a guy with a brain. This is one of many in a long series of "coincidences" that when put together starts to become nonsensical. Look at where we started. Pfizer gets fined more beacuse they are a bigger company and have more surface area, the law is complex and everyone is breaking it all the time so action against them doesn't mean they did anything wrong. In and of itself fine, that may be true. Then those same people will later say, the IRS went after that Mexican restaurant instead of Pfizer beacuse they are so big, and run such a tight ship that it would almost impossible to find any wrong doing. The tax code is very complex, so is drug regulation. Is the idea that Pfizer is hyper competent in tax law but incompetent when it comes to the core business? That doesn't hold water for me.
RcouF1uZ4gsC 4y ago
Because Pfizer is a bigger target? Kind of like 3 Felonies a Day, lots of times the laws/regulations are so labyrinthine that if they look at you closely, they will find something.
hoffs 4y ago
Because you make example of big player, not small one.
- themaninthedark 4y ago
  But the opposite is claimed with respect to IRS audits. With that we are told the IRS goes after and fines the little guy because the rich can spend money for defense. Shouldn't we expect to see similar behaviors across regulators?
  - wbl 4y ago
    There are very different incentives for different regulators who operate with different bodies of law and degrees of compliance.
jollyllama 4y ago
I'll join the sibling comments in speculation: They're so big that they can either get away with it in aggregate or when they can't, can count on favorable judgements, like the comment about J&J. Favorable in the sense that the individuals personally responsible won't face the ramifications.
- forgetfreeman 4y ago
  Nailed it in one. I'm old enough to vividly remember the first time Pfizer the corporations-are-people business entity was convicted of a felony. In the decades since not only have they failed to substantially alter their approach to compliance issues, most of the largest industry players have followed suit since the profit/loss ratio for ignoring regulations has been shown by Pfizer's financials.

dec0dedab0de 4y ago

How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines? Without having any knowledge of said people and laws, I would say that some of those smart people are making decisions to help their personal bottom line while putting the company at risk. Anyone working at a large company sees this all the time.

JacobThreeThree 4y ago

Pfizer gets plenty of fines outside the United States too.

qwerty456127 4y ago

> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines Perhaps they don't really care to? Apparently paying penalties is just a part of the business model, net profits/savings made thanks to the violations still exceeding net fines. I'm not sure about Pfizer but I feel almost sure this is the way Google and other big tech corporations providing "free" services work paying huge fines for privacy violations every now and then. Google will still spies on you and records everything it can about you no matter how much do you tweak your settings and how hard does the EU try to protect your privacy rights, doesn't it?

shadowgovt 4y ago
I can't speak to medical specifically, but in one of the spaces I used to work the thinking was "The law is ambiguous because it's reactive; we're so far out on the bleeding edge that nobody actually knows what's legal until someone tries it and someone else makes a case of it. So pushing the envelope is a net positive for society because we end up blazing a trail of bright-line precedent rulings that other companies can follow. You can tell the pioneers because they're the ones with the arrows in their backs." A bit self-serving but there's some meat on the bones of that logic; the real meaning of the law is path-dependent and determined by the rulings, not the words on the paper.
- thatguy0900 4y ago
  In fairness there's Noone you can call up in the government to ask for certain if something is legal or not past a certain point. Only a judge can decide that, and they don't do hypothetical cases.
forgetfreeman 4y ago
It's also worth noting that the parent claim of unclear compliance guidelines is less of a statement of fact and more a commentary on your average pharma industry lawyer. There are more suites of standardized compliance applications than you could shake a stick at, that's not at issue. The problems usually start with a department of contract lawyers who can't be assed to skill up on industry specifics. Throw in a CFO with little or no experience managing CRO's and you've got the perfect recipe to get dumped on by the OIG.

krisoft 4y ago

> False claims act litigation, for example, is responsible for the second largest settlement listed on this site (phen fen is #1), a notorious and utterly incomprehensible regime where all of the big money settlements relate to aggressive fringe theories asserted by DOJ. Well. I looked the case up. Here is how i am understanding it: Pfizer wanted a drug to be approved for a specific use. The FDA rejected it as too risky, approved it for other uses. Pfizer nevertheless was pushing the drug for this unaproved, off-label use. The drug later proved to be dangerous in this off-label use and were whitdrawn from the market. Am I reading this wrong? What part of this is controversial? If you ask for permission for something, then been told no you do it anyway and in that process people suffer harm what should happen then?

johndhi 4y ago
Off label litigation is a great example of my point. Extremely muddy waters. Physicians constantly ask pharma about and explore off label drug prescriptions. This is legal: psychiatrist can tell you to take a drug approved for nerve pain for depression. There is research showing it works for depression but it has not technically been added to the label of the drug yet following fda approval. Pharma can provide the studies and answer limited questions on the topic (but no clear guidance) but cannot "promote" this. Is presenting the research promotion? Is the rep discussing it with the doctor promotion? Etc
- esel2k 4y ago
  Just to add how difficult these off-label uses are beeing managed. Every content we provide (be it in a discussion, or a comment in one if our forums or as part of a symposia) needs to be checked for offlabel use. This is a nightmare and every single screen of my apps or of the content that is uploaded needs to be reviewed by medical teams/compliance. Its a nightmare. Now tell me what is “was promoted by pfizer”? A doctor saying it in a comment/presentation that he tried this with on patient and storing this on one of our digital platforms? It’s really grey water… And add to this hard times for medical reps after covid.
- isitmadeofglass 4y ago

williamscales 4y ago

> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines? They aren't. What is clear is that a huge corporation of smart people simply don't care about fines. The answer is to make the fines much bigger, big enough that a single one would threaten the existence of Pfizer.

mym1990 4y ago
This is silly, there should be a middle ground. A 1 strike policy would just stifle any innovation coming out of a company.
- williamscales 4y ago
  Yeah, I wouldn't advocate a 1 strike policy. Fines should escalate with repeated violations. The fines should be tied to revenue and after some violations they should reach the point where the business cannot continue.
johndhi 4y ago
Based on what research is this a good idea? The US system is unique and we're entrenched. This is too big a change.

busyant 4y ago

> I actually used to work for them as a lawyer, indirectly. I was a small-time expert witness (on the plaintiff's side) against them in a very small lawsuit. It was the first and last time I served in that capacity. A child was born with horrific birth defects. Parents claimed that a specific medication caused it. Pfizer obviously said otherwise. The whole thing left me feeling dirty. Experts charging $600 / hour (this was over a decade ago, so God knows what they charge now) to say, with diamond-hard confidence, whatever their side wanted them to say. Plaintiff's experts: "That drug _definitely_ caused the birth defects." Defense experts: "There is no possible way that drug could cause birth defects." Basically, here was a tragedy, and we all feasted on it. One of the other experts told me I could be "good at this" (selling myself out as an expert), but it just left me feeling dirty.

rnikander 4y ago
A woman once told me that she made $300K/year as an "expert witness", on various topics. She was smart and she said she would study a bit and go testify. It blew my mind. I didn't understand whether she was working for the mafia, or if this was legal, or what. I said something like, "but, wait, you're not an expert. The court allows this?" She didn't understand my problem. She seemed entitled; despite her IQ she may not have understood what an actual expert was. I never got to the bottom of it and lost track of her.
- vorpalhex 4y ago
  The court does not want a deep guru on every topic. It effectively wants a bridge between a specialized domain and the court itself (which is made of lay people.) I would expect an Expert to study on the particulars of a case. In general as long as they are sufficiently narrow I don't see a problem here.
  - mschuster91 4y ago
    I'd rather expect someone as a court-appointed expert that they have relevant, certified experience. In Germany, while judges are legally free to appoint whoever they want as experts unless there exist specially certified experts for the class of assessment[1], the parties involved usually present actual experts to the judge for selection - and the opposing side would challenge the selection of non-qualified experts. [1] https://www.gesetze-im-internet.de/stpo/__73.html https://www.gesetze-im-internet.de/stpo/__73.html

avgDev 4y ago

Pfizer product issues: During the mid-1980s, watchdog organizations such as the Public Citizen Health Research Group charged that Pfizer’s widely prescribed arthritis drug Feldene created a high risk of gastrointestinal bleeding among the elderly, but the federal government, despite reports of scores of fatalities, declined to put restrictions on the medication. A June 1986 article in The Progressive about Feldene was headlined DEATH BY PRESCRIPTION. The Food and Drug Administration expressed greater concern about reports of dozens of fatalities linked to heart valves made by Pfizer’s Shiley division. In 1986, as the death toll reached 125, Pfizer ended production of all models of the valves. Yet by that point they were implanted in tens of thousands of people, who worried that the devices could fracture and fail at any moment. In 1991 an FDA task force charged that Shiley had withheld information about safety problems from regulators in order to get initial approval for its valves and that the company continued to keep the FDA in the dark. A November 7, 1991 investigation in the Wall Street Journal asserted that Shiley had been deliberately falsifying manufacturing records relating to valve fractures. Faced with this growing scandal, Pfizer announced that it would spend up to $205 million to settle the tens of thousands of valve lawsuits that had been filed against it. Even so, Pfizer resisted complying with an FDA order that it notify patients of new findings that there was a greater risk of fatal fractures in those who had the valve installed before the age of 50. In 1994 the company agreed to pay $10.75 million to settle Justice Department charges that it lied to regulators in seeking approval for the valves; it also agreed to pay $9 million to monitor valve patients at Veterans Administration hospitals or pay for removal of the device. In 2004 Pfizer announced that it had reached a $60 million settlement of a class-action suit brought by users of Rezulin, a diabetes medication developed by Warner-Lambert, which had withdrawn it from the market shortly before the company was acquired by Pfizer in 2000. The withdrawal came after scores of patients died from acute liver failure said to be caused by the drug. In 2004, in the wake of revelations about dangerous side effects of Merck’s painkiller Vioxx, Pfizer agreed to suspend television advertising for a related medication called Celebrex. The following year, Pfizer admitted that a 1999 clinical trial found that elderly patients taking Celebrex had a greatly elevated risk of heart problems. In 2005 Pfizer withdrew another painkiller, Bextra, from the market after the FDA mandated a “black box” warning about the cardiovascular and gastrointestinal risks of the medication. In 2008 Pfizer announced that it was setting aside $894 million to settle the lawsuits that had been filed in connection with Bextra and Celebrex.

simonebrunozzi 4y ago

> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines? Unless these big fines are because such corporation has been really, really bad...

kilroy123 4y ago

I work in health care for a health care start. Literally my co-workers and I were just talking about this. How it's all such a racket and way too expensive and complicated. How do we get out of this hole? How do we fix health care and fix these issues?

nowaymrjose 4y ago

This is rediculous. J&J knowingly sold talcum powder laced with asbestos. They have known about it for over 50 years. This company is basically evil and as they cannot fight the facts they use trickery to absolve liability. https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/ https://www.reuters.com/investigates/special-report/johnsona... You should be ashamed of yourself.