Tort reform is a scam that punishes people to protect profits.
The law firm of Thompson, O'Neil, & VanderVeen in Traverse City, Michigan posted today about what "reform" has done to Michigan. These products bear an additional risk for Michigan residents, since after tort "reform" the seller of the product is not legally responsible for defects or injuries they cause. Further, the Chinese government doesn't allow its industries to be sued (particularly since most are government-owned). As a result, when a "Thomas" occurs in Michigan, if it causes catastrophic injuries to someone, no one is responsible and has to stand behind it. Source: TOV Blog: Product injuries and the Flat Earth So what happens if a person on public assistance gets hurt by say, poisonous toothpaste from China? Why, the generous taxpayers of Michigan get to pick up the tab for their treatment. Even if they bought the toothpaste from a wealthy store like Wal-Mart, Target, etc. That the "reformers" talk up the supposed "tort tax" but refuse to acknowledge the costs of "reform" to taxpayers speaks volumes as to their dishonesty.
And not greedy trial lawyers, surprisingly. “The psychology of the industry is that, if you are first, the price should be high,” [Elan CEO] Martin tells The Financial Times. “The economic structure is unsustainable. The tension will grow and something has to give.” Source: Pharmalot » What Did He Say? Elan CEO: Lower Prices Of course if you're first to market, your prices are going to be high. It's just refreshing to read a CEO admit thaty and not claim it's because of the tort system.
The National Association of Manufacturers just yesterday posted about the incredibly flawed study done by the Pacific Research Institute about the supposed costs of the tort system: 
"Out-of-control litigation and a broken legal climate cost Americans the equivalent of almost $10,000 for every family of four, a study by the Pacific Research Institute has determined. Here to describe his findings from "Jackpot Justice: The True Cost of America's Tort System" is the study’s author, Lawrence J. McQuillan, PRI’s Director of Business and Economic Studies. Renee Giachino of The American Justice Partnership adds the AJP's latest news and views on tort reform. America’s aging infrastructure is a major factor in manufacturing’s ability to compete. John Horsley, executive director of the American Association of State Highway and Transportation Officials, highlights a new report that lays out the full scope of the problem." (Emphasis added.) Source: This Week on America's Business It would have been better if NAM had never cited the PRI's study, but it's embarrassing they cited it this late in the game. Note that just one paragraph later they point out a real problem to manufacturers...
Another development in the Avandia story is the claim that Dr. John Buse was improperly pressured by GlaxoSmithKline to keep quiet about his concerns about the drug. The entire article at the NY Times is worth a read, but the portion below really jumped out at me: "In a recent interview, Dr. Peters said that she had previously received money from Glaxo as a speaker on behalf of Avandia, but had resigned because she was worried about the drug’s risks. About five years ago, she said, she helped change the formulary — or list of preferred drugs — for Los Angeles County so that patients in her clinic would get prescriptions for Actos rather than Avandia. “The Avandia people, it was just so surprising, they asked me what I wanted to keep Avandia on the formulary,” Dr. Peters said, recounting events that occurred sometime in the 2000-to-2002 period. “They asked me, “What can we give you that will have you keep it on the formulary?’ ” Dr. Peters said that she asked the company to establish a database at the clinic that would track the outcomes of patients on both drugs. When she asked for the database, which would have cost several thousand dollars, she said, a company representative replied: “That’s all you want? Other doctors ask to go to the Caribbean.” Dr. Peters said that Glaxo representatives first asked her to write a proposal, then asked her to go to Philadelphia to meet with company officials before the database could be approved. She decided to purchase it herself." (Emphasis added.) Source: Doctor Says Drug Maker Tried to Quash His Criticism of Avandia - New York Times If it's true that doctors ask for and receive "free" vacations to lie about the safety and efficacy of drugs, we need to put concerns about medical liability aside and focus on medical reliability. If this practice is occuring, I hope it's investigated and those involved see actual jail time. And when I say "those involved" I don't just mean the sales rep, but I mean the executives who approved the purchase orders. Cross-posted to TortDeform
The Statesman Journal reports that Oregon citizens injured by Vioxx but unable to sue because the statute of limitations expired may get justice after all: Some Oregon lawsuits against the manufacturer of Vioxx could proceed under a bill that the Oregon House passed Tuesday. House Bill 2448, which went to the Senate on a 58-0 vote, would fix a glitch in Oregon law that blocks some people from suing Merck. Vioxx was introduced in 1999 as a medication to relieve pain from arthritis, but was withdrawn in 2004 because of an elevated risk of heart attack and stroke. The Supreme Court ruled in 2001 that liability suits had to be filed within two years of an injury, regardless of when the plaintiff discovered the connection between the injury and the product in question. The 2003 Legislature changed the law to allow a lawsuit two years after such a discovery, but the law applies to injuries occurring after Jan. 1, 2004. The bill would allow suits by those injured after the court's 2001 decision but before the Legislature's 2004 fix. -- Peter Wong Source: 2007 Legislature - StatesmanJournal.com Relevant portions of the bill are below: (2) A civil action for injury, including any product liability action under ORS 30.900 to 30.920 and any action based on negligence, resulting from the use of a COX-2 inhibitor must be commenced not later than four years after the date on which the plaintiff first discovered, or in the exercise of reasonable care should have discovered, the injury and the causal re- lationship between the injury and the product, or the causal relationship between the injury and the conduct of the defendant. (3) A civil action for death, including any product liability action under ORS 30.900 to 30.920 and any action based on negligence, resulting from the use of a COX-2 inhibitor must be commenced not later than six years after the date on which the plaintiff first discovered, or in the exercise of reasonable care should have discovered, the causal relationship between the death and the product, or the causal relationship between the death and the conduct of the defendant. Source: House Bill 2448 Here's hoping that the bill becomes law.
It's no secret that the pharmaceutical industry is a big proponent of tort "reform." That industry is lobbying heavily for laws that will basically eliminate the ability for individuals to sue over defective prescription drugs - like the law we have in Michigan.
Part of their argument for such immunity is the notion that the companies would never knowingly release a defective drug and that pharmaceutical companies are good, ethical companies.
Here is just a sampling of posts regarding fines, convictions, and guilty pleas of pharmaceutical companies and executives. All of these are pulled from one of my new favorite sites, Pharmalot. As you'll notice, there are quite a few examples. And all of them have been reported since May 1st.
Before we pass laws to benefit this industry, why don't we regulate the industry in an effective manner that forces them to comply with the laws they routinely break? It seems foolish to grant lawbreakers protection from the law.
Continue reading "The Pharmaceutical Industry and Tort Reform" »
My new favorite site Pharmalot has coverage of another off-label marketing scandal: Medicis agreed to settle allegations the company violated the False Claims Act concerning claims submitted to Medicaid, the Justice Department announced today. The settlement resolves charges Medicis promoted a topical skin preparation, Loprox, for use on children under the age of 10, without FDA approval. The US and four former Medicis employees alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians, urging the docs to use Loprox as a treatment for diaper rash. Loprox, which is approved as a fungicide for kids over 10, isn't a “medically accepted indication” for the treatment of diaper dermatitis and other skin disorders in children under 10. Source: Pharmalot: Medicis: $9.8M For Off-Label Marketing; Four Fomer Sales Reps To Share $1M This is especially bad for two reasons. First, off-label marketing is dangerous because the drugs have not been tested or approved by the FDA for this purpose. Thus, Medicis put infants at risk just to make a buck. Second, many of these prescriptions were paid for by Medicaid under false pretenses; because Medicaid won't approve prescriptions for off-label usage, the taxpayers got ripped off. Medicis is settling for $9.8 million dollars. A little over 1 million is going to the former employees who helped bring Medicis to justice. Without the qui tam provisions of the False Claim Act, the odds are Medicis never would have been caught. Since qui tam provisions are so effective in catching crooked corporations, I bet you won't be surprised to know that the gang at Overlawyered and much of the rest of the "reform" movement want to limit or abolish qui tam.
It's not uncommon to hear corporate shills and other tort "reform" advocates claim that the reason we don't have more vaccines is because of the threat of litigation. Like most reform claims, this one isn't based on facts. "Simply stated, the reason is limited profit and large risk. At best, vaccines bring in $6 billion worth of revenues, about 1.5% of the current total annual pharmaceutical market worldwide. The market is splintered among more than a dozen pediatric vaccines and another dozen or so for travelers, other at-risk individuals, and the military. As a result, the market for any given vaccine is substantially below the $500 million per year threshold that a pharmaceutical company considers as a viable product to develop. While companies may start to see an expanded return on R&D investments for certain products due to the over-the-counter market, that is not currently possible for vaccines due to requirements for parental administration (except for some oral and nasal) and the requirement for a "cold-chain" of most vaccines due to stability issues. Thus, the current average cost of bringing a vaccine to market is larger than can be borne by the market for most of the current vaccines. Although there are some vaccines which have the potential for a greater than $1 billion dollar market (e.g., hepatitis B virus, human papilloma virus), the total vaccine market is so limited that the required return on investment for commercial pharmaceutical and biotech companies does not justify investment in vaccine development." (Emphasis added.) Source: The Scientist : The Vaccine Conundrum Does the tort system deter the development of vaccines? Perhaps to some extent. But the real deterrent must be the fact that there isn't enough demand for vaccines for them to be profitable! The authors make several suggestions on how to bridge the funding gap so as to encourage the development of new vaccines. That pharmaceuticals are busy pumping out weight loss and impotence drugs instead of developing life saving vaccines would make Jonas Salk roll over in his grave.
"Reform" advocates often claim that trial lawyers and the lawsuits they file prevent many people from getting access to needed medicines. Supposedly, the threat of product liability lawsuits is so scary that pharmaceuticals aren't releasing perfectly safe drugs. To hear them tell it, "reformers" are actually consumer advocates, working to ensure more people have access to better medications. If increasing access to medications is one of their goals, I would hope that "reform" advocates will work to end the practice of "reverse payments" or "reverse settlements" in the pharmaceutical industry. Reverse payments allow large pharmaceuticals to pay their competitors not to bring generic drugs to market. Here are some relevant articles about the practice: "To qualify for the program [The program that simplifies the approval process for generic drugs. - Justinian], however, the generic lab must show that the original drug's patent is either expired or invalid. When generic labs opting for the latter route -- known as "Paragraph IV certification," after the section of the application attesting to the patent's invalidity -- file their ANDA, they automatically create a patent-infringement cause of action against them by the pioneer drug company. In return for imposing the burden of litigating that patent's validity on a generic manufacturer, the Hatch-Waxman Act rewards it with a 180-day exclusivity period so that it can get a jump on other generic labs if the patent is declared invalid. If the pioneer company is insecure about the validity of its patent, it may simply choose to reach a "reverse settlement" with the generic entrant -- i.e., it pays the generic manufacturer to drop the case and agree not to bring the generic version to market. An arrangement of this sort between pharmaceutical giant Zeneca and generic manufacturer Barr Laboratories is at the heart of a case up for consideration on Friday by the Court, Joblove v. Barr Labs (No. 06-830). At issue is the patent for tamoxifen, a drug used to treat breast cancer that has become the most widely used cancer drug in the world." (Emphasis in original.) Source: Philip Brooks' Patent Infringement Updates: Reverse Payments "AstraZeneca paid Barr $56.9 million to delay its generic version of the breast-cancer drug Tamoxifen, and supplied Barr with Tamoxifen for resale in the US under a royalty arrangement." Source: Pharmalot: DOJ To FTC: Reverse Payments Are OK Conveniently, Philip Brooks already emphasized a very important part of his article. The Hatch-Waxman encourages generic drug manufacturers to bring patent challenges, because if the challenge is successful, the generic manufacturer is rewarded with a six-month period of time in which it will be the only manufacturer allowed to market the generic drug in question. This is a strong incentive for generic manufacturers to bring patent challenges - which is good for consumers as it leads to cheaper generic drugs. But it is unquestionably bad for consumers when pharmaceuticals are allowed to bribe generic manufacturers to keep their factories idle. It will be interesting to see how the Supeme Court resolves the Barr Laboratories case. Even if the Court continues to allow these bribes, the practice still may be doomed: "The Senate Judiciary Committee today passed a bill that takes aim at the growing problem of brand-name drug manufacturers using pay-off agreements to delay the public’s access to generic medicines. The bipartisan Preserve Access to Affordable Generics Act (S. 316) would prohibit brand-name drug companies from exploiting a loophole in the Hatch-Waxman Act to pay generic drug companies to delay entry of new generic medicines into the market." (Emphasis in original.) Source: Philip Brooks' Patent Infringement Updates: Reverse Payments Groups like the American Tort Reform Association are generously funded by the drug manufacturers who bribe their competitors. Will the ATRA bite the hand that feeds it and prove they really are consumer advocates and oppose the loophole? Or will they show their true color is green and support the "right" of their funders to deny people access to lifesaving medications? If the latter, I would hope the ATRA will have the integrity not to accuse trial lawyers of denying consumers access to the medications the ATRA's funders are spending millions to keep off the market.
I saw an interesting article at Pharmalot about the sales tactics pharmaceutical sales reps use to push products onto doctors. We strictly regulate how lawyers may solicit for clients, but we allow people with no medical degree - and sometimes not even a Bachelor's degree - to recommend which medicines a doctor should prescribe. "During training, I was told, when you’re out to dinner with a doctor, 'The physician is eating with a friend. You are eating with a client.' " - Shahram Ahari... Reps may be genuinely friendly, but they are not genuine friends. Drug reps are selected for their presentability and outgoing natures, and are trained to be observant and personable...Personal information may be more important than prescribing prefernces... A photo on a desk presents an opportunity to inquire about family members and memorize whatever tidbits they are offering...Reps scour a doctor's office for objects - a tennis racquet, Russian novels, seventies rock music, fashion magainze, travel mementos, or cultural or religious symbols - that can be used to establish a personal connection with the doctor. They then list eight different types of doctors: friendly and outgoing; aloof and skeptical; mercenary; high prescribers; prefers a competing drug; acquiescent; no-see, no-time, and finally, the thought leader. And they provide insights into all the methods a sales rep may use to wear down each one in hopes of getting more scrips written. For instance, with the 'friendly and outgoing doc,' Ahari (that's him to the right) says that he would 'frame everything as a gesture of friendship. I give them free samples not because it's my job, but because I like them so much. I provide office lunches because visiting them is such a pleasant relief from all the other docs. My drugs rarely get mentioned by me during our dinners. Just being friends with most of my docs seemed to have some natural basic effect on their prescribing habits. When the time is ripe, I lean on my 'friendship' to leverage more patients to my drugs...say, because it'll help me meet quota or it will impress my manager, or its crucial for my career. Outgoing, friendly physicians are every rep's favoriate, because cultivating friendship is a mutual aim. While this may be genuine behavior on the doctor's side, it is usually caclulated on the part of the rep." (Emphasis added.) Source: Pharmalot: The Doctor Is Not Your Friend! I wonder how many victims defective drugs were given their prescription just to help a sales rep "meet quota." Perhaps Congress should introduce legislation to prohibit pharmaceuticals from giving gifts to physicians - something similar to the crackdown on lobbyists, for example. They could even require them to register as "medical lobbyists." Cross-posted to TortDeform.com
I came across this older article about Ford and how its in-house legal department handles the myriad of legal issues that an automaker will have to deal with. I was impressed that in order to save the lives of police officers, Ford installed free gas tank shields on 350,000 cars. What most impressed me was that it did so in response to accidents that happened when Crown Victorias were rear-ended at 75+ mph, which is not a required Federal standard. "The Arizona summit resulted in the creation of a blue-ribbon panel composed of Ford engineers and managers, and law enforcement officials. But unlike some of these committees, this one was ordered to come up with solutions quickly -- in 90 days -- and it did. Ford agreed to install free shields to protect the fuel tanks in all police Crown Vics on the road (about 350,000). It test-crashed cars at 75 mph to confirm their effectiveness. And the company established a Web site to suggest how officers should position their vehicles during traffic stops. A short time later NHTSA closed its 10-month investigation, satisfied that the car was safe. In 2003 the New York State Senate held hearings, then closed its investigation shortly afterward. Within weeks California's state senate dropped its own inquiry without even holding a hearing. The first class action claiming the car was defective went to trial in 2004, and a jury in St. Clair County, Ill. -- which tort reformers label a "judicial hellhole" -- found for Ford in 75 minutes. That case was followed last year by the first personal injury trial. A Missouri jury found that the company was not liable for the officer's death (a finding of even 1 percent liability could have put the company on the hook for full damages). Few of the lawsuits remain; the company settled most of the personal injury cases, and the majority of the class actions were withdrawn or dismissed following the Illinois verdict. " Source: Ford: Teamwork Is Job 1 Ford did the right thing, and even a jury from "Judicial Hellhole #1" made the right decision.
Remember Vioxx? The "safe" drug that Merck yanked from the market after a few pesky deaths and heart attacks hurt the shareholders? Merck apparently is trying to forget it; Merck has been trying to bring "Arcoxia" to the U.S., a drug so similar to Vioxx that some have dubbed it " The Son of Vioxx." Thankfully, the FDA panel of experts reviewing the drug have recommended by a landslide 20-1 that the FDA not approve the drug for sale: From Reuters: "The Food and Drug Administration's panel of outside experts voted 20-1 against recommending clearance for the drug, called Arcoxia.
The agency is not required to follow panel recommendations but usually does. Merck said it expects a final FDA decision on Arcoxia by month's end.
The company had argued Arcoxia was as safe as other pain relievers on the market and would be a valuable alternative for arthritis patients who do not respond well to current options. "
Hmmmm... Do you think they made that safety argument while Vioxx was still on the market?
Honestly, I'm surprised that the vote was 20-1, considering three of the FDA panelists have substantial financial ties to Merck. I wonder if the 1 who did vote for it is one of the three.
Dr. Sidney Wolfe testified before the FDA advisory committee and not only recommended that Arcoxia be banned in the U.S., but that Merck should (voluntarily) withdraw the drug the rest of the world: From Public Citizen: "It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs. The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval...
In addition to strongly urging your committee and the FDA to reject Merck’s effort to approve etoricoxib in the U.S., I urge prompt removal of Arcoxia from the market in the 60+ countries where it is causing unacceptable risks to the hundreds of thousands of people using the drug."
Color me skeptical, but I don't think Merck is going to yank Arcoxia from the rest of the world market. Unless of course it's not profitable.
No doubt the blogosphere will be aflame with corporate propaganda about how the FDA is keeping "much needed" and "safe" medicines from the market. You know what I say to that? If two out of the three doctors that are on Merck's payroll or own Merck's stock say the drug isn't safe... the drug isn't safe.
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