Archive for the ‘drug safety’ Category
Tuesday, June 5th, 2012
[Also posted on Postscript]
When drugmakers lie to doctors about a drug’s safety or effectiveness, health plans pay more for substandard care, and patients suffer.
Case in point — the recent guilty plea and $1.5 billion settlement for illegal promotion of the drug Depakote revealed how Abbott Labs misled doctors for nearly a decade. They went to great lengths, profiling doctors, training their salespeople, and inappropriately funding and influencing Continuing Medical Education to get doctors to prescribe Depakote for unapproved treatment of seniors with dementia. Why? Because such off-label promotion instantly expands a drug’s market, and thus the drugmaker’s potential profits.
Unfortunately, class action lawsuits on behalf of consumers and health plans challenging such illegal marketing have met significant legal hurdles, and have been dismissed. This leaves consumers and private market health plans paying billions because of this fraud, while millions of patients receive inappropriate treatment, and are unnecessarily put at risk of side effects, which are often serious.
But progress is being made by State Attorneys-General and the Department of Justice bringing legal challenges under false claim laws. As a result, six of the biggest drugmakers have admitted or pled guilty to illegal promotion of unapproved uses of drugs since 2004. These investigations, most often initiated by whistleblowers, have led to the largest fines in U.S. history, and billions will be recovered this year alone.
But while all these enforcement actions are a welcome development, a recent jury verdict in a trial by the State of Arkansas may become a game-changer in the fight to stop the illegal marketing or promotion of drug products.
This past April, Arkansas Attorney-General Dustin McDaniel won a staggering verdict against Johnson & Johnson for their illegal promotion of the off-label uses of the antipsychotic drug Risperdal. In a trial before a jury, the state won $1.19 billion (yes, that’s ‘b’ ) in fines for violations of the state Medicaid anti-fraud law.
A hefty billion-dollar fine like this from one state sends a very big message — drug companies can no longer pursue profits by scoffing at the laws designed to protect safety-net health plans and the patients they serve.
Even more encouraging is the fact that most of the $1.19 billion in fines will go to the State Medicaid fund, which is looking at a $400 million budget shortfall next year.
What could be better than a deterrent that also helps stabilize funding for a state’s Medicaid plan during these tough economic times? Well, the only thing that could make this victory even better would be for Arkansas’ Medicaid program to earmark some of these recovered funds to correct the misinformation spread by Johnson & Johnson. Setting aside even a small amount of funds to allow trained independent medical professionals to go out into the field and teach doctors about the appropriate and effective alternatives to the unapproved uses of Risperdal will help prevent any ongoing inappropriate use of Risperdal, improving the quality of patient care and protect patients from being harmed by the significant side effects of the drug, like weight gain and diabetes. (See more about such education programs here.)
As we have seen in drug pricing (here and here) and universal coverage, the States often take the lead in on innovative ways to protect consumers. Based on this successful prosecution by the Arkansas Attorney-General, it wouldn’t be a bad idea for the remaining States to beef up their anti-fraud laws and enforcement staff, and go after the drug industry.
– Wells Wilkinson
Director, Prescription Access Litigation
Staff Attorney, Community Catalyst
Tuesday, June 5th, 2012
[Also posted on Postscript]
The guilty plea and $1.5 billion settlement by Abbott to resolve their illegal off-label promotion of Depakote revealed a saga of extensive industry abuses and influence peddling that put millions of vulnerable seniors at risk. Abbott’s extensive promotion of the unapproved uses of the anti-convulsant drug Depakote to treat both seniors with dementia and to treat children is shocking. But it is even more alarming that this not the first major drugmaker to plead guilty to illegal marketing tactics that have targeted this exceptionally vulnerable population of seniors.
Many may recall that Eli Lilly was caught illegally promoting the unapproved, or “off-label” use of the antipsychotic drug Zyprexa to treat seniors with dementia, despite their internal studies showing that the risk of death from this drug increased in elderly patients.
Marketing these drugs to nursing homes for use on patients who ‘act up’ or are unruly has been a lucrative strategy for drugmakers. In response, we applaud the Department of Justice and the State Attorneys-General for their increasingly aggressive litigation to penalize these dangerous and unconscionable marketing practices.
But unfortunately for the millions of seniors who may be given Depakote or Zyprexa today or in the near future, the record-breaking $1.4 and $1.5 billion settlements respectively may not translate into improved care, unless further action is taken.
We urge Medicare and Medicaid officials at the federal and state level to move quickly to develop and implement safeguards, such as prior approvals or mandatory second opinions, that could be put in place to protect these vulnerable seniors from any unwarranted or inappropriate use of the drug Depakote to treat their dementia.
Looking forward, it’s time that all off-label settlements by the DOJ or the states include a requirement that the drugmaker pay to correct the misinformation that off-label marketing creates – i.e. that a drug is safer or more effective than it really is. Using lawsuits to fund corrective educational campaigns has a long history, both in public and private sector litigation. (See description here.)
To help stop the inappropriate and potentially harmful overuse of Depakote, Zyprexa, or Risperdal from continuing, doctors should be retrained to undo the misinformation campaigns by Abbott, Eli Lilly, and Johnson and Johnson. Several states, including Pennsylvania and New York have implemented “academic detailing” programs that send independent medical experts, usually nurse practitioners and pharmacists, to provide doctors with the truth about how effective drugs are from an objective, evidence-based perspective. Many state programs specifically address mental health drugs such as Zyprexa and Depakote. Indeed, one of the first of these education programs designed by Dr. Jerry Avorn, who spearheaded the concept in the 1990’s, recommended that a little tender loving care by nursing home staff could reduce the inappropriate use of sedatives, common at that time. A similar conclusion was reached by some nursing homes profiled in an inspiring Boston Globe article addressing the overuse of Depakote.
– Wells Wilkinson,
Director, Prescription Access Litigation
Staff Attorney, Community Catalyst
Tuesday, May 29th, 2012
Posted May 29th, 2012
The Affordable Care Act created some desperately needed means to start controlling ever-rising health care costs. Many — like preventive care or delivery reforms — will take some time to realize savings. In contrast, new anti-fraud efforts look to be paying off right away, in amounts much bigger than expected.
The health reform law provided $350 million over ten years to increase anti-fraud investigation and enforcement resources for the Department of Justice (DOJ) and State Attorneys-General. The goal? Saving $6.4 billion over the next decade. Given that some estimate that fraud and waste cost as much as $60 billion a year, or $600 billion over a decade, saving one percent of that amount seems a pretty modest impact.
But wait! New estimates project that current or pending settlements of drug fraud litigation by the DOJ and the Attorneys-General will top $8 billion in FY2012 alone, according to the group Taxpayers Against Fraud. (See list below.) This is not the culmination of hundreds of lawsuits; it’s just the eight biggest. So it looks like this anti-fraud effort under the ACA will meet and then surpass its ten-year goal in less than two years!
To be fair, most of these eight drug fraud investigations were undoubtedly underway before the increased funding for anti-fraud efforts reached the DOJ and State Attorneys-General offices. But there is little doubt that providing these over-worked regulators with increased resources was a big help in increasing enforcement. DOJ probably has fewer lawyers working on all their pending drug fraud cases than some of the biggest drugmakers hire to defend a single lawsuit. But despite these disparities, these results show that very modest government investment in fighting fraud, coupled with hard work by government lawyers and whistleblowers, can pay off big.
For example, earlier this week drugmaker Abbott Labs in Chicago settled a civil and criminal investigation of their illegal promotion of the anti-convulsant drug Depakote as an unapproved treatment of dementia in seniors, and of various conditions in children. Abbott pleaded guilty to promoting these unapproved, or ‘off-label’ uses of Depakote, and agreed to pay $1.6 billion – one of the biggest settlements for the illegal promotion of a single drug.
There could be as many as a couple hundred pending whistle-blower lawsuits that are filed under seal and being investigated now by the federal or state regulators. These pending lawsuits may add up to billions of dollars of additional fines and settlements.
Some critics have warned that even billion-dollar fines are an inadequate deterrent when a drug company can make far in profits on illegally promoted sales of a drug.
For instance, the $1.4 billion record-breaking settlement with Eli Lilly in 2009 for illegal promotion of their antipsychotic drug Zeprexa was less than 5 percent of Lilly’s gross sales. Eight months later, DOJ shattered this record with an even bigger $2.3 billion settlement, which amounted to 14 percent of Pfizer’s gross sales of eight illegally marketed drugs (see here).
Similarly, this month’s $1.6 billion Depakote settlement is nearly 12 percent of the drug’s $13.8 billion in gross sales revenue from 1998 to 2008. Furthermore, DOJ is pioneering two mechanisms to deter future illegal conduct by Abbott, along with this hefty fine.
First, the Depakote settlement places Abbott on probation and imposes a corporate compliance and monitoring program, for five years. If Abbott violates the compliance agreement or significantly violates the law, the government can exclude Abbott, and all their drug products, from federal health care programs. That would cost Abbott billions in lost sales on numerous drugs.
The settlement also aims to hold Abbott’s corporate leadership personally accountable. Abbott’s CEO must personally certify compliance and the board of directors must review and report on compliance each year. If the CEO or the board is lax in these duties, they could be excluded from their positions at Abbott. And if CEO or board intentionally lie to the government to cover up any misconduct, they could face personal criminal liability under the federal False Statements Statute. (Find the plea agreement and related documents here.)
Sadly, Abbott’s illegal promotion of ineffective and dangerous uses of Depakote has both harmed and put at risk what is arguably the most vulnerable patient population – seniors suffering from dementia, who live away from their families in nursing homes. Undoubtedly millions of seniors were, and likely continue to be given Depakote inappropriately as a result of Abbott’s illegal promotional campaign.
Check back soon for more on (1) actions that Medicare and Medicaid can take to address the continuing effects on patients of illegal promotions of off-label use of drugs and (2) how the Arkansas AG fought prescription drug fraud, winning huge fines to plug the state’s Medicaid budget deficit.
Director, Prescription Access Litigation
Staff Attorney, Community Catalyst
Projected Drug Fraud Settlements in FY 2012, excerpted from the Taxpayers Against Fraud website.
||Off-label marketing of Vioxx — settled
||Series of drug frauds, said to be settled in principle.
||Off-label marketing of Depakote, settled.
||Illegal marketing of Aranesp, funds reserved.
||Illegal marketing of protonix, projected settlement amount.
|Johnson & Johnson
||Off-label marketing of Risperdal, civil settlement is expected.
||Adulteration of HIV drugs, settlement in excess of $400 million expected.
||AWP pricing fraud, settled.
A version of this blog was posted earlier on Health Policy Hub and Postscript.
Wednesday, August 4th, 2010
Posted today by the PostScript blog at Community Catalyst:
Posted on: August 4, 2010; 11:53 am
Yesterday, Senator Michael Bennet (D-CO) unveiled new legislation that seeks to improve the safety of America’s drug supply. The Drug Safety and Accountability Act of 2010 is an important first step in solving a growing problem. It mandates improvement of industry safety and quality standards for both prescription and over-the-counter drugs, provides increased FDA oversight, and gives the FDA much-needed authority to actively protect the drug supply through mandatory recall of dangerous products, as well as to subpoena documents and witnesses. The bill also improves enforcement through whistleblower protections and civil monetary penalties for industry violations.
In announcing the filing of the bill, Sen. Bennet shared his concerns about the issue and his commitment to ensuring the American drug supply is safe no matter where its drugs are made. “Making sure pharmaceutical drugs meet the highest standards for safety and quality is important to me, not only as a U.S. Senator, but as the father of three little girls as well,” said Sen. Bennet in a press conference organized by the Pew Prescription Project. “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply and protect Colorado consumers.”
Americans are concerned about the drug supply, says a Pew Prescription Project survey released yesterday, and they have reason to be.
Manufacturing of pharmaceuticals has changed dramatically in recent years, with more than 80 percent of the active ingredients in all U.S. prescription drugs now originating overseas, often in countries with weak regulatory and enforcement infrastructures such as China and India. In these counties, where quality standards differ from our own and where responsibility for drug purity is murky at best, it is increasingly difficult for the FDA to ensure the safety and efficacy of a drug when they cannot track the uncertain and complex manufacturing processes.
According to the Pew Prescription Project survey, the confidence Americans have in drugs made in some countries overseas is next to none. While three out of four Americans believe drugs made in the U.S. are contaminate-free, only one in 10 believes the same for drugs made in China or India. What’s more, most believe Congress should do more to legislate in this area and over half of those surveyed favor FDA inspection of overseas drug companies.
The recent recalls of Johnson & Johnson’s children’s Tylenol and other cough & cold medicines were another wake-up call to protect Americans from the risks of unsafe drugs, but they were also the most recent in a long line of issues.
The numbers are telling
- In June, drug manufacturers recalled intravenous bags of certain antibiotics manufactured in India found to be unsterile and at least in one case to contain mold.
- In May, the FDA sent a warning letter to a pharmaceutical company for failing to set quality standards for its outsourcing that allowed them to skirt important safety practices.
- There were more than 1,700 drug recalls in 2009 – four times more than in 2008. Most of the recalls were for problems related to manufacturing quality and testing.
- In 2007 and 2008 a contaminated blood thinner, heparin, made in China entered this country and more than 100 Americans died in that case.
Community Catalyst is collaborating with the Pew Prescription Project to spearhead work on this issue in the best interest of American consumers. The impact of drug safety problems is potentially enormous, given that adults and children alike have increasingly come to rely on pharmaceuticals for the cure and management of a wide variety of common, chronic and serious medical conditions. Indeed, Kaiser reports that the use of prescription medications has risen 39 percent in the last decade in the U.S. while the population grew 9 percent. Today 90 percent of seniors and 58 percent of other adults rely on a prescription medication on a regular basis. Among children, a 2009 survey found that 56 percent had used at least one medication in the previous week, and most of those were over-the-counter products (Pediatrics, August 2009).
With the goal of addressing this problem by strengthening the regulation of the manufacturing process for drugs, Community Catalyst supports Sen. Bennet’s legislation and is working to educate and assemble national and state groups to do the same.
– Jessica Hamilton, Program Associate
You may view the latest post at: http://postscript.communitycatalyst.org/?p=1549
Monday, July 19th, 2010
Following up on last week’s blog discussing the FDA hearing underway to determine the safety of the prescription diabetes drug, Avandia, the FDA advisory review panel concluded a two-day hearing last Wednesday by recommending 20 to 12 that Avandia remain on the market with label revisions and other restrictions. This deeply divided panel included 17 votes to add warnings or restrictions on the drug, and 12 votes to remove the drug from the market.
The members voting for Avandia’s removal said the drug “has no unique benefits and therefore the benefits of the drug do not outweigh the risks.” They also pointed out that Avandia’s primary competitor, Actos, is an acceptable alternative to Avandia and therefore there is no therapeutic necessity to keep Avandia on the market.
Even the use of Actos has been called into question. Harvard researchers based at the Independent Drug Information Service (www.RxFacts.org), note that “in mid-2007 the FDA added black-box warnings cautioning that both rosiglitazone (Avandia) and pioglitazone (Actos) increase the risk of congestive heart failure.” These safety concerns, “along with an increased risk of fracture, have greatly dampened enthusiasm for use of both of these drugs.”
The ultimate fate of Avandia now rests in the hands of the FDA who stated that they “took the panel’s advice seriously and that [the FDA] would consider its regulatory options.” If the proposed additional warnings and restrictions are implemented, scientist Steve Nissen, who published the first study documenting the cardiac risks of Avandia in 2007, estimates that 95 percent of Avandia’s use will end. “Effectively, this drug is gone.”
Interestingly, the committee also recommended by a vote of 19-11 that the trial currently underway comparing Avandia to its rival Actos be continued, though at least one member questioned the ethics of this, given the potential risks.
Litigation yields access to studies, helps expose risks
Litigation plays a valuable role in exposing industry schemes to withhold safety data. For instance, GSK’s earlier suppression of studies showing risks associated with the drug Paxil lead to litigation and settlements that required GSK to post information on-line about all their clinical trials. It was this posted information that Nissen and fellow researcher Kathy Wolski of the Cleveland Clinic used to perform their 2007 analysis of over 40 studies that showed that Avandia raised the risk of heart attack, stroke and death in comparison to Actos.
Another example of the benefit of litigation is seen by the PAL-member class action lawsuit concerning the drug Zyprexa whichyielded hundreds of documents, some of which revealed Eli Lilly’s own internal studies documenting the increased risks that Zyprexa posed as a treatment for dementia in elderly patients.
New evidence, studies bring risks to light
Ongoing investigations by Senator Grassley and almost a dozen new studies documenting the risks of Avandia have kept the issue alive, prompting the FDA’s ongoing review, including last week’s hearing.
One comparative effectiveness study by David Graham of the FDA was published this past June. Graham worked with researchers at the Centers for Medicare and Medicaid Services to collect records from nearly a quarter million Medicare recipients. Elderly diabetics, who used Avandia instead of its competitor, Actos, had a 68 percent increase in the risk of heart attack, stroke, heart failure or death. Graham stated:
“We estimate that about 48,000 excess cases of [heart attack], stroke, heart failure, or death were attributable to the use of [Avandia] rather than [Actos] from 1999-2009.”
Graham additionally stated “the RECORD study would have been dismissed as ’garbage’ if it had been used to seek the drug’s original approval.”
The question of whether the FDA will allow Avandia to remain on the market is still up in the air. Beyond that, what else can we do to stop such illegal and hazardous industry behavior—the same behavior that resulted in the Vioxx tragedy, which lead to up to 60,000 deaths? As litigation and other sources have revealed suppression of drug risks concerning Vioxx, Paxil, Celexa, Zyprexa, and many other drugs, the problem seems endemic.
To begin to address this problem, the FDA needs the resources and authority to examine all relevant clinical studies for data-tampering. Government and private consumer lawsuits must continue, including possible criminal prosecution. Finally, we should all remember that what you read on your drug label or hear in a TV ad may not be the whole story. Skepticism is warranted and further regulation is critical to all of us–we need medical care we can trust.
Friday, March 12th, 2010
(The following blog was posted yesterday on Community Catalyst’s Postscript blog. It highlights an exchange between FDA Deputy Commissioner Joshua Sharfstein an Congressman Dingell concerning the need for increased FDA authority and resources to effectively regulate drug safety.)
March 11th, 2010
Yesterday, the House Energy and Commerce Subcommittee on Health heard from FDA Deputy Commissioner Joshua Sharfstein on the safety of the drug supply and current agency practices to ensure the safety of marketed drugs.
Sharfstein, who has been a strong advocate for drug safety, both at the agency and previously as health commissioner in Baltimore, made a forceful case for what FDA needs to keep drugs safe: “FDA needs additional tools to move our oversight capabilities into the 21st century. FDA needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement,” he said.
The hearing was notable for the bipartisan consensus that securing the safety of the drug supply is a national priority with high stakes, and unanimous agreement that the FDA’s ability to ensure that safety must be shored up. It convincingly framed drug safety as an equally urgent next step to a food safety measure that passed the House by a wide margin last year.
But perhaps the hearing’s most compelling arguments for a safer drug supply came in this stage-worthy exchange between Sharfstein (JS) and Chairman Emeritus John Dingell (JD), who has worked to support the agency’s drug safety efforts for much of his recent career.
JD: Dr. Sharfstein, I want you to understand these are friendly questions. I want yes or no answers. You are familiar with the heparin crisis, which caused 81 American deaths. Does FDA currently have the adequate resources, personnel, and authorities to prevent another heparin crisis?
JD: Do you have the ability to control the safety of imported pharmaceuticals?
JS: Not to the extent we’d like.
JD: Do you have the authority and resources to address the safety of components being now imported into this country?
JS: No, not to the extent we’d like.
JD: Do you have authorities and resources to see to it that good manufacturing practices (GMPs) are properly observed overseas?
JS: Not to the extent we’d like.
JD: Would you please submit to the committee the number of people that you have at the different ports to ensure the safety and the inspection of pharmaceuticals coming into this country, and also would you give the number you need to see that this is done. Please submit that for the record.
JD: Do you have adequate authority to keep out unsafe drug shipments at the border?
JD: Do you have authority to require manufacturers to ensure the safety of their supply chain?
JD: Do you have the authority to see to it that GMP are observed in this country on both food and drugs, and abroad? Yes or no?
JS: No, not to the extent we’d like.
JD : Do you have adequate authority to require mandatory drug recalls?
JD: Do you need that authority?
JS: We would like it that authority, yes.
JD: Would you like it or do you need it?
JS: I’d say we need it.
JD: [refers to the Food and Drug Administration Globalization Act of 2009 and its cosponsors] [FDAGA] would give you significant authorities to address your current lack of capabilities?
JS: That legislation has very important elements, yes.
JD: It would also give you the [financial resources] you need by enabling you to collect fees from both manufacturers of food and pharmaceuticals? Is that right?
JS: It does have that provision, yes.
JD: And you can do that both at home and abroad, is that right?
JS: I believe so, yes.
JD: Are those resources and fees included in your budget submissions to the Congress?
JS: For food it is.
JD: How about pharmaceuticals?
JS: I don’t believe so, no.
JD: Now it’s a curious situation I’ve observed, that you are in the awkward place at FDA of having somebody be able to bring unsafe foods into the United States, and you can’t catch them at the point of entry. But you also have the problem that if you do catch them, you don’t have authority to seize, impound or to destroy. Is that right?
JD: So you send them back out?
JS: I believe so. Often that’s what happens.
JD: And they then often bring them back in, through another point of entry?
JS: I think they can try, yes.
JD: Do you have that same problem with pharmaceuticals?
JD: So that problem exists in both places. So you have problems with unsafe commodities being brought in—foods and pharmaceuticals. You also have some that are over-aged, improperly stored, contaminated, filthy, improperly packaged. Counterfeit. And you also have some that are full of inert substances, you mentioned talcum powder…Do you have authority to deal with those?
JS: We have some authorities. But not–
JD [interrupts] Do you have enough?
JS: We don’t have enough.
JD: As proven by heparin.
JS: Yes, in part.
JD: And you have coming into this country from China on a fairly regular basis—and from Mexico and other places—unsafe food and pharmaceuticals. I can recall mushrooms. I can recall berries. I can recall tomatoes and jalapeno peppers. I can recall the heparin scare. And a large number of others. This is an ongoing and continuous problem, is it not?
JD: And you lack the Congressional support, both in authority and money, to do the job that you need to do to protect the American people? Isn’t that right?
JS: Well, we very much want to do more.
JD: I don’t want you to be afraid to say that we haven’t given you the authority you need—
JS: No we want more authority—
JD: —If it’s the truth, because we’re going to try to get it for you.
–Kate Petersen, PostScript blogger
Tuesday, September 29th, 2009
Last week, the American College of Physicians (ACP), a 129,000-member group of internal medicine physicians, and second-largest doctors group in the US, called for increased FDA authority and funding to help protect consumers from the risks of newly-approved prescription drugs. Their six recommendations were:
1) increased funding for FDA staff and technological capability to keep pace with the increased workload due to the number and scientific complexity of new products submitted for pre-approval, globalization, and emerging safety challenges.
2) increased FDA authority and capacity to regulate drugs manufactured outside the US;
3) expanded FDA authority and involvement in the design of clinical trials to better evaluate safety and efficacy, through longer trials with larger, more representative target populations;
4) a ban on clinical studies of ‘bundled’ drug products that reduce access to drugs;
5) Improvements that increase reporting of adverse events by doctors and others; and
6) limits on direct-to-consumer advertising in the first 2 years a drug is on the market.
Increased FDA funding:
The ACP report notes that FDA’s “ability to approve and monitor new drugs has been compromised by chronic underfunding, limited regulatory authority, and insufficient organizational structure.” ACP recommends that FDA funding is increased, to improve their “ability to approve and monitor prescription drugs….”
Regulating drug manufacturing overseas:
The ACP should be praised for bringing attention to severe under resourcing at FDA, particularly as it affects the Agency’s ability to ensure the safety of drugs manufactured overseas. Today’s globalized pharmaceutical supply chain has rapidly outgrown FDAs capacity, and FDA is not able to inspect foreign sites with any meaningful frequency. A 2008 GAO study found it would take FDA 13 years to inspect each foreign manufacturing establishment once, while domestic sites are inspected on average every 2.7 years.
ACP points out that a provision for increased foreign inspections were included in a bill (H.R.759) introduced by Reps. Dingell, Pallone and Stupak in January this year. A similar bill (S.882) championed by the late Senator Kennedy and Senator Grassley also seeks to increase foreign site inspections by FDA. Both bills establish new industry user fees to pay for this expanded oversight, but also require annual increases in other appropriations to ensure sustainability. ACP importantly indicates that both types of financial support are needed, and mentions a number of other key provisions in the House bill, including a requirement for dedicated foreign inspection staff.
Facilitating increased physician reporting of adverse events:
The ACP also recommends FDA pursue efforts to “educate physicians on how and when to report an event that is potentially drug-related.” They also proposed streamlining the reporting systems and ensuring anonymity to “facilitate reporting by health professionals.”
DTC advertising of new drugs:
The report acknowledges that direct-to-consumer (DTC) advertising can “dramatically increase [use] of a new drug and … may expose large numbers of people to a drug with undocumented safety concerns.”
The best example of this concerns was seen in the rapid use of the pain-killer Vioxx upon hitting the market. The aggressive DTC advertising and other promotional activities by manufacturer Merck lead to Vioxx’s use by over 20 million consumers, which then lead to 88,000-139,000 cardiac events, and an estimated 35,000-55,000 deaths. Adverse reactions and safety concerns arose with the drugs Zyprexa and Bextra, among many others
To address this concern, ACP recommended that FDA ‘limit’ the DTC advertising of newly approved prescription drugs, and require that labels and ads indicate that data related to the new drug’s “risks and benefits … are less extensive than those [for older] products…”
Prohibiting clinical trials of ‘bundled’ products:
In addition, ACP also makes a recommendation that would help FDA avoid placing itself in the position of helping drug manufacturers introduce ‘bundled’ or combination drug products designed to protect a drug from generic competitors.
For example, the report describes how, in 2005, the drug manufacturer “Pfizer submitted plans to the FDA to begin conducting large trials to test the cholesterol drug torcetrapib in combination with the popular and widely used statin Lipitor.” By allowing clinical trials of the ‘combination drug’ rather than just torcetrapib alone, approval of the new combination drug product would insulate Lipitor from competition. This then puts FDA, in approving the study design, in the awkward position of helping the drug manufacturer avoid anti-trust prohibitions, the report said.
This concern is similar to the claims in the PAL member lawsuit on the drug Norvir, where drug manufacturer Abbott Labs bundle their HIV protease inhibitor cocktail drug Norvir in a new bundled-product-drug Kaletra, in order to increase market share.
ACP recommends that FDA not approve clinical trials which seem to be designed to ‘bundle’ a new drug with an existing brand name drug, and thus perpetuate the patent-protected sales of the new combination product.
To read the full report, visit http://www.acponline.org/advocacy/where_we_stand/policy/fda.pdf
Wednesday, March 4th, 2009
Today, the Supreme Court rejected arguments by the prescription drug industry that having their labels approved by the Food and Drug Administration should be a shield from state law tort liability. In a rousing victory for consumers of prescription drugs, the Supreme Court rendered a decision preserving consumer rights to access the courts when injured physically or financially by prescription drugs.
In the case Wyeth v. Levine, the Court ruled 6 to 3 that the FDA’s approval of a drug label does not preempt consumer’s rights to sue the manufacturer for their failure to warn of knows risks associated with the drug.
The lawsuit was brought by Diane Levine, a musician from Vermont who while suffering from a migraine was given the anti-nausea drug Phenergan. Her physician’s assistant did so in a manner that caused the drug to contact her arteries, which caused gangrene and resulted in the loss of her arm. Ms. Levine sued and settled with her doctor. She also sued the drug’s Manufacturer, Wyeth. In its defense, Wyeth argued that the FDA’s approval of the label under federal law preempted Ms. Levine’s rights under state law, but lost. After a 5-day trial, a Vermont jury concluded that the drug maker did not adequately warn of the known risks of gangrene associated with the use of the drug, and awarded Ms. Levine $7.4 million.
After losing in appeals all the way up to Vermont’s Supreme Court, Phenergran’s manufacturer, Wyeth appealed to the U.S. Supreme Court. The Court accepted the case, and addressed the issue
whether federal law preempts Levine’s claim that Phenergan’s label did not contain an adequate warning about using the IV-push method of administration.
In today’s decision, the Court decided that there was no preemption, and found in favor of Ms. Levine.
The Court first noted that it was not impossible for the drug maker to comply with both state law and federal requirements in preparing the drug’s label. The court concluded that the drug maker could have added warnings to the label at any time to reflect the risks of gangrene that had occurred to over twenty people since the labeling was approved by FDA. Wyeth had incorrectly argued that the federal regulations prohibited their changes to the label, because they must have been based on “newly acquired information….” The Court countered that Wyeth was incorrect, and that they could have added warnings to reflect the 19 amputations that had arisen from Phenergan’s use before Ms. Levine’s case.
The Court also concluded that Wyeth suffered from a “more fundamental misunderstanding” about the duty to warn consumers of the risks of prescription drugs. The Court noted that
Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.
Wyth also argued that the Ms. Levine’s lawsuit should be preempted because it interferes with “Congress’s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives.” The Court rejected this argument as being both out of line with the intent of Congress, and as based on “an overbroad view of agency’s power to pre-empt state law.”
On the first point, the Court notes that “[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA’s 70-year history” like it did with a 1976 amendment allowing “express pre-emption … for medical devices….”
The Court also spoke to the FDA’s role in the preemption debate, especially it’s position in favor preemption announced in the preamble to the 2006 regulations that redesigned the format and content requirements for prescription drugs. The Court also assessed how much weight to give an agency position that “state law is an obstacle to achieving its statutory objectives….” The Court found that in cases lacking express authority by Congress, the deference given to an agency “depends on its thoroughness, consistency, and persuasiveness.” Based on this, the Court decided that FDA’s position “does not merit deference.”
First, the Court pointed out a glaring procedural lapse by FDA in adopting the position that their regulations and approval of drug label preempts state law. In proposing the draft rule in 2000, the FDA had stated that the rule would “not contain policies that have federalism implications or that preempt State law.”
Despite this, FDA adopted a position in favor of preemption upon publishing the final rule in 2006. FDA did so “without offering States or other interested parties notice or opportunity for comment….” As a consequence, the Supreme concluded that “[t]he agency’s views on state law are inherently suspect in light of this procedural failure.”
The Court also noted that the FDA position on preemption “is at odds with … Congress’s purposes, and it reverses the FDA’s own longstanding position….” The Court summarized the history of FDA’s relationship to state law, noting that
the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market,and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.
The Court also stated that
State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.12 The agency’s 2006 preamble represents a dramatic change in position.
We recognize this decision as an important victory for consumers, and we applaud the Court for this decision.
We hope to post more details on this decision, and its potential impact on our other lawsuits, soon.
You can read the full decision at
Thursday, May 15th, 2008
We’ve often gotten on the soapbox here at the Prescription Access Litigation blog to preach against the evils of preemption. Preemption is the constitutional doctrine that when state law and federal law are in conflict, the federal law trumps or “preempts” state law.
Pharmaceutical companies and the FDA have been arguing aggressively in the past few years that consumers should not be allowed to sue drug companies under state law when they are harmed, injured or killed by defective or dangerous drugs, as long as those drugs have been approved by the FDA. For years, the FDA’s position was the lawsuits under state law did not interfere with the FDA’s regulation of drug safety. But that position changed abruptly under the current administration.
The issue has been a hot one – the Supreme Court recently decided (in Riegel v. Medtronic) that consumers’ lawsuits against medical device manufacturers are preempted. In October, the Supreme Court will hear arguments in Wyeth v. Levine, and will decide whether consumers’ cases against drug companies are also preempted.
Yesterday, the House Committee on Oversight and Government Reform, chaired by the indefatigable Rep. Henry Waxman (D-CA), held a hearing on preemption, “Hearing on Whether FDA Regulation Should Bar Liability Claims.” (One mainstream media story on the hearing, from the Associated Press, can be found here).
The hearing had numerous noteworthy and learned people presenting testimony, but most of them were not the source of the press attention that is certainly unusual for an issue as arcane as federal preemption. It was actor Dennis Quaid, who testified, who was the source of the sudden press interest in this arguably vital but obscure constitutional debate.
Dennis Quaid testified because his newborn twins nearly died when they were given 1,000 times the correct dose of the blood thinner heparin. The overdose was the result of a mixup, caused by the fact that the labels of the vial for the correct dose and the vial for the dose that is 1,000 times higher are virtually indistinguishable. Quaid and his wife have sued the manufacturer, Baxter. He testified against limiting consumers ability to file lawsuits to hold drug companies accountable for the kind of harm that his newborn twins suffered.
We blog about this here today because Mr. Quaid’s testimony is so harrowing and so underscores the need to protect consumers’ access to the Courts. Rather than offer our own commentary on this subject, we’ll let Mr. Quaid’s testimony speak for itself. We repost here in its entirety. (You can also find links to the other panelists that testified here, on the Committee’s website.)
Here is Dennis and Kimberly Quaid’s written testimony:
Testimony of Dennis Quaid and Kimberly Quaid Before the Committee on Oversight and Government Reform of the United States House of Representatives May 14, 2008
Chairman Waxman and Members of the Committee:
Thank you for inviting my wife, Kimberly, and me here today to share our experience as parents of two infants harmed by the negligence of a prescription drug manufacturer. As I’ll explain, our newborn twins nearly died because of a drug company’s failure to put safety first. It is our hope that these proceedings will raise public awareness of the issue before the Committee today: When the U.S. Food and Drug Administration (FDA) approves the sale of pharmaceutical drugs, does that preempt the right of consumers to sue the manufacturer if the drug later causes injury or death?
This is an issue, I’m sure, most Americans are not aware of, but it is one that could adversely affect all Americans, our family included. As many of you already know, our twins received a potentially fatal overdose of the bloodthinning medication Heparin last year.
Our Life-Altering Story
Thomas Boone and Zoë Grace Quaid were born on November 8, 2007.
They were four weeks premature, but healthy and beautiful, and, after three days in the hospital, we took them home to begin our new life as a happy, much-expanded family.
On their eleventh day of life, Kimberly noticed an irritation on T-Boone’s belly button and Zoë Grace’s finger. Being nervous new parents, we took TBoone and Zoë to the pediatrician immediately, and, after examining them, he sent us to Cedars-Sinai Medical Center – one of the top hospitals in Los Angeles – for a more in-depth diagnosis. Lab tests at Cedars revealed that both of our twins had a staph infection, and we were told that they would have to be admitted to the hospital to be put on a continuous intravenous drip of antibiotics. Our hearts sank as we accompanied the twins to the pediatric ward, where they were placed in a room to begin their treatment.
At about 11:00 am the next day, a nurse came to the room and said she needed to replace the now empty bags of antibiotic. According to standard procedure, the nurse was supposed to clean the IV lines connected to our twins’ little arms with 10 units of a blood thinner medication called Hep- Lock, the idea being that the very small dose of heparin contained in Hep- Lock allows the IV to flow freely. What was not standard procedure was that she mistakenly injected the twins with a massive overdose of 10,000 units of the drug Heparin, which is 1,000 times the normal 10-unit dose of Hep-Lock our babies should have received. This happened while Kimberly and I were present in the room.
Unaware of the catastrophe that had just occurred, Kimberly and I spent the afternoon and early evening standing vigil over our twins until our doctor suggested we go home and get some rest. We were exhausted, not having slept the night before. The twins seemed to be resting comfortably, so we decided to go home, but not before leaving express instructions to the doctors and nurses to call us if anything changed in our infants’ condition. We had no way of knowing at that point that the potentially lethal quantity of Heparin in their tiny bodies was turning their blood to the consistency of water.
After we left, a nurse on duty noticed that Zoë Grace had an abnormal seepage of blood coming from a place on her foot where blood had been drawn. No alarms were raised. Incredibly, sometime after 7:00 pm, both babies were injected with yet another 10,000-unit overdose of Heparin. One nurse prepared the medication, and then handed it to the instructor nurse, who then handed it to the nurse in training as the instructor lectured the trainee on how infants must only receive a 10-unit dose of Hep-Lock. They then left the room and continued their rounds.
At about 9:00 pm, Kimberly and I were at home trying to get some restless sleep when Kimberly was suddenly struck with a hammer blow of overwhelming dread. She became inconsolable, crying out with a mother’s intuitive certainty that our babies were in trouble: “They’re passing,” she said. This did not make sense to me. I had called the nurse’s station an hour and a half earlier and had been told that the twins were fine. But, to calm Kimberly’s fear, I called again and was put through to the nurse in our room. Kimberly wrote down the time for some reason. The nurse told me in a measured tone that the twins were fine. I was assured. Kimberly became less frantic, and we both eventually fell into a fitful sleep.
But the twins were not fine. In fact, they were fighting for their lives. Their now water-thin blood was flowing out of every place that they had been poked or prodded. They faced the very real possibility of hemorrhaging through a vein or artery, causing massive brain damage or failure of one of their vital organs.
Our babies could have died that night, and we would not have been there for them.
Early the next morning, Kimberly and I arrived at the hospital, only to be met at our babies’ room by our pediatrician and hospital staff. We were taken aside and told what had happened. Suffice it to say, it was the beginning of the most frightening day of our lives. It was spent helping tend to our infants who were still bleeding profusely and severely bruised from internal bleeding. They were both screaming in pain, and God only knows what they were feeling. I am not sure even a lab rat had ever received such a high dose of the Heparin that was causing them to bleed out. At one point as the doctors tried to clamp shut a bleeding wound in the remnant of TBoone’s umbilical cord, blood spurted six feet across the room and splattered on the wall. The bleeding went on all day. Although the twins had been administered Protamine, a medication to counteract the Heparin overdose, their blood’s inability to coagulate literally remained off the charts all day and into the night. Kimberly and I did a lot of praying.
Finally, after more than forty hours, their coagulation levels dropped into the measurable scale and continued to fall, eventually back into the normal range. T-Boone and Zoë Grace had survived, apparently with no damage so far, thank goodness. But we have no way of knowing what the long-term effects may be.
We Were Not Alone
How had this happened? The answer became apparent after interviewing the doctors and nurses. We discovered that the bottle of 10-units of Hep-Lock and the 10,000-unit bottle of Heparin – both manufactured by Baxter Healthcare Corporation – were deadly similar in labeling and size. The 10,000-unit label is dark blue, and the 10-unit bottle is light blue. And if the bottles are rotated slightly, as they often are when stored, they are virtually indistinguishable.
We later learned that the similarity of the labels for the two products had led to the overdose of infants at a hospital in Indianapolis little more than a year earlier, in September 2006. Just like with T-Boone and Zoë Grace, hospital staff used the 10,000-unit Heparin product, rather than the 10-unit Hep- Lock, to flush the infants’ IV lines. Tragically, three infants died, and three others were severely injured.
More than four months after the Indianapolis incident, Baxter sent out a warning to hospitals concerning the potential for deadly mix-ups in the two products. A full seven months after that – in August 2007 – Baxter submitted changes in the labeling of the higher-concentration Heparin to the FDA. Baxter was permitted by FDA regulations to revise its labels, without prior FDA approval, to add or strengthen a drug warning or precaution, or to enhance drug safety by strengthening an instruction about a drug’s dosage and administration. So, although the FDA did not approve the changes to the Heparin label until December 2007, Baxter starting using its new labels in October 2007. Baxter described the changes to the Heparin labels as “an increase of 20 percent font size, a unique color combination, and a large cautionary tear-off label” warning that the product is not intended for “lockflush.”
Baxter explained that the new labeling was designed to help reduce the risk of medication errors. But, shockingly, Baxter failed to recall the misleadingly labeled bottles that were still on the market and stocked in hospitals ready for use. Kimberly and I think that this was a dangerous, potentially deadly decision, made by Baxter for financial reasons. Companies recall automobiles, they recall toasters, they even recall dog food, but Baxter failed to recall a medication that, due to its labeling, had killed three infants and severely injured three others. More than a year after the Indianapolis tragedy, the same medical nightmare happened to our twelve-day-old infants – and all because Baxter had not acted as a responsible corporate citizen.
Baxter knew that an estimated 7,000 Americans die each year as a result of medication errors, knew that 61 percent of life threatening or lethal errors involve intravenous drugs such as Heparin, and also knew that Heparin was among eight high-alert products that were involved in more than 31 percent of all medication errors that caused harm to patients. Yet, even with all of this knowledge, Baxter did not change the labeling of its Heparin injection products until months after the Indianapolis tragedy. And Thomas Boone and Zoë Grace would have to fight for their lives because the new product labeling, introduced by Baxter only one month before, had not yet made it to the shelves of Cedars-Sinai, and Baxter had done nothing to see that the look-alike Heparin products were removed from pharmacy shelves immediately.
Although mistakes occurred at Cedars-Sinai hospital, doctors, nurses, pharmacists, or other staff who make medical errors are not bad people. Indeed, choosing a career devoted to curing the sick and easing the suffering of others is one of life’s highest callings. But the overdosing of our twins was the result of a chain of events, and the first link in that chain was Baxter Healthcare. Because of Baxter’s inaction, a tragedy was waiting to happen again.
What Can Be Done?
Since this brush with tragedy, I have found out that medication errors are unfortunately all too common. Approximately 100,000 U.S. patients die every year because of medical errors in hospitals alone. It’s a toll we would never tolerate in aviation, nearly the equivalent of a full 747 crashing every single day.
I have also learned a lot about the legal system – and it was surprising, I have to tell you. Like many Americans, I believed that a big problem in our country was frivolous lawsuits. But now I know that the courts are often the only path to justice for families that are harmed by the pharmaceutical industry and medical errors. Yet the law is stacked against ordinary people.
For instance, in my home state of California, a 1975 law caps compensation to malpractice victims. The cap has never been raised for inflation. The practical effect is that people without the wealth to pay legal fees up front are unable to get their cases before a judge or jury.
Now we face something with potential to be even more sweeping and even more unjust: federal preemption. The Supreme Court is about to decide whether to bar most lawsuits over drugs and their labeling, as long as the drug was approved for marketing by the FDA. After many years of rejecting arguments that FDA actions should preempt lawsuits involving injuries from products regulated by the FDA, White House appointees at the FDA reversed that position in 2002, and now argue that FDA approval immunizes the manufacturers of dangerous products from liability for the deaths and injuries they cause.
We sued Baxter Healthcare Corporation in November 2007. Baxter has filed a motion to dismiss the case, relying on the same preemption argument that the drug industry and the FDA has made before the Supreme Court – that when the FDA allowed its Heparin drug onto the market, it gave Baxter the government’s seal of approval – a “get out of jail free” card that denies us the right to hold the company accountable. (Of course, Baxter never mentions the FDA regulations that encourage and sometimes require manufacturers to fix their drug labels immediately, without getting the FDA’s permission first.) So, says Baxter, our suit may not be heard by a judge or jury.
It is hard for me to imagine that this is what Congress intended. You tell me, Mr. Chairman: When it passed the Food, Drug, and Cosmetic Act in 1938, did Congress intend to give appointed bureaucrats at the FDA the right to protect a drug company from liability, even when the company cuts corners and jeopardizes our safety?
A federal ban on lawsuits against drug companies would not just deny victims compensation for the harm they experience. It would also relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered – years after their drugs are on the market.
Permitting bureaucrats who are under pressure from their bosses and the drug companies themselves to yank our access to the courts is incomprehensible. We have all heard about understaffing and backlogs at the FDA, and about drug-safety scrutiny that is patchy at best. If the Supreme Court rules in favor of the drug companies, it will eliminate one of the most effective deterrents to letting the bottom line win out over public health and safety.
I am in the entertainment industry, but what happened to us, and what is happening in the courts of our country, is no fiction. It is all too real. That is why I have decided to speak out and try to do something.
Kimberly and I have established a non-profit foundation to call attention to medical safety issues and seek ways to improve medical safety from the bedside up. Everybody gains from a safer health care system—from patients to nurses and doctors to hospitals and insurance companies.
We are meeting with experts from all over the country to formulate a strategy for safer health care. Americans pioneered the safest aviation system in the world; though highly complex, it is 99.9% error free. The human body is also very complex and hard to perfect. But we should strive for perfection, and we know that at the very least we can do much better. We can hope that the Supreme Court will not put more barriers in front of patients who are harmed by drug companies. But if the Court goes along with the FDA and rules for the drug companies, I respectfully ask this Congress to pass corrective legislation on an emergency basis, just as it should do immediately to correct the recent Supreme Court decision immunizing the makers of defective and mislabled medical devices. We Americans need some balance on the scales of justice in our country.
My family blessedly survived a huge drug error, triggered by the misconduct of a drug manufacturer. Others are not so fortunate. If they are denied access to our courts, they will have no compensation for their injuries, and society will lose one of the most effective incentives for safer drugs.
Monday, March 24th, 2008
The state of Alaska is suing Eli Lilly (NYSE:LLY) for failing to disclose health risks (like diabetes and weight gain) allegedly associated with Lilly’s hugely profitable “atypical antipsychotic” drug Zyprexa. Last week, attorneys for the state rested their case, at which point the lawyers for Eli Lilly asked the Judge to dismiss the case, saying that the matter was one for the Food and Drug Administration, and not for individual states.
The Judge disagreed, and refused to dismiss the case, offering an opinion from the bench as to the FDA’s ability to police drug safety. Here’s how the Anchorage Daily News described it:
Without lawsuits like the one the State of Alaska brought against Lilly, claims that drugs cause health problems “might well go unaddressed,” Anchorage Superior Court Judge Mark Rindner said from the bench this week.
The jury was out of the room. The state had just rested. Lilly asked the judge to issue an immediate verdict in its favor, a routine step at that point in a trial.
Rindner was reacting to an assertion by Lilly lawyer George Lehner that drug regulation is a matter for the federal Food and Drug Administration, not any state. Alaska’s Unfair Trade Practices and Consumer Protection Act shouldn’t apply to drugs, Lehner told the judge.
Rindner disagreed. Evidence presented by the state over the past two weeks established that the FDA “isn’t capable of policing this matter,” he said.
This isn’t the first time that a Judge addressing allegedly illegal Zyprexa marketing by Eli Lilly has dismissed the notion that the FDA was adequate to ensure that Zyprexa was safe and properly marketed. As we reported back in June 2007, U.S. District Court Judge Jack Weinstein, soundly rejected this notion in refusing to dismiss a class action lawsuit brought by consumers and health plans (including PAL coalition member Sergeants Benevolent Association Health and Welfare Fund. That case alleges that Eli Lilly illegally and improperly promoted Zyprexa for “off-label” uses, that is, uses that the FDA has not approved as safe and effective. In his ruling (available here), Judge Weinstein said:
“Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs’ bar, the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs.” (Opinion, pp. 3-4)
And he went on…
“Allowing this and like suits to proceed may or may not increase the cost of pharmaceuticals and the efficacy of medical treatment in this country. It does, however, furnish backstop protection against under-regulated potentially dangerous activity by a market where caveat emptor largely rules.” (Opinion, p. 12)
What happens in the Alaska case will be closely watched, as 9 other states have similar lawsuits against Eli Lilly. A potentially incriminating email in which a Lilly vice president appears to advocate marketing Zyprexa for off-label purchases was revealed in the Alaska trial several weeks ago, the New York Times reported on March 14, 2008 (Lilly E-Mail Discussed Off-Label Drug Use). As Alex Berenson of the Times reported:
In the message, Dr. Lechleiter, who was then the company’s executive vice president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, he said.
“The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” Dr. Lechleiter wrote in the message. He also encouraged Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase the drug’s sales.
The Judge in the Alaska case refused to admit the email into evidence in the trial because that case does not concern off-label use. The email, however, is likely to be an issue in the off-label cases, such as the one before Judge Weinstein. In that case, Judge Weinstein will hear from both sides this week on a motion to certify the case as a national class action. These “class certification” motions are a vitally important stage in a class action case, as they determine whether or not the defendant (here, Eli Lilly) will face the claims of potentially millions of individuals and thousands of health plans.
These two Judges have acknowledged what by now is common knowledge: the FDA lacks both the resources (money, staff) and the political will to hold drug companies accountable and to force them to disclose safety risks associated with hugely profitable drugs. In the face of the FDA’s abdication of its core mission, the Courts are a vital safety net to ensure that drug companies cannot rip off and injure consumers with impunity. In the past few years, vital information about dangerous drugs has come to light only through litigation (for more on this, see “The Role of Litigation in Defining Drug Risks,” Journal of the American Medical Association, 2007; 297: 308-311)
To receive updates about the national Zyprexa class action that PAL members are involved in, as well as about other class actions concerning illegal marketing and pricing tactics by drug companies, fill out the form here. To learn more about the Zyprexa class action, go here.
Hat tip: Pharmalot