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Alex Sugerman-Brozan

Why Drug Lawsuits are Necessary: FDA “isn’t capable of policing” drug safety, says Alaska Judge

Cross-posted from PAL blog:

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

Alex Sugerman-Brozan: Author Bio | Other Posts
Posted at 5:10 PM, Mar 24, 2008 in Pharmaceuticals | Under-regulation
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Comments

Good for you for drawing the two judges' similar remarks on Zyprexa together. I have a good feeling about this case but am really eager for the RICO case in Connecticut. Because I feel that the only real justice for the death of my only son of profound hyperglycemia from this judge is prison time for the Lilly perpetrators. Money means nothing to them: They will just up the price.

Posted by: Sorrowful | March 24, 2008 6:15 PM

Another kangaroo court judge who feels that he should be judge, legislator and regulator all rolled into one. Here we go again - the start of more totally bogus class-action law suit in which the attorneys loot the economy further while netting their clients peanuts

Posted by: Paul W Dennis | March 24, 2008 9:35 PM

The judge is a federal law breaker. A federal marshal needs to arrest this judge federal lawbreaker. This insurrectionist against the Constitution should go to federal prison and do hard labor.

"Sorrowful" exemplifies the hate filled vengeful motive of those on the low life plaintiff side. The plaintiff refuses to face its responsibility, and seeks to scapegoat productive entities for the unjust enrichment of the lawyer. There is no evidence of any of the harm falsely alleged by the Alaska land pirate plunderer.

This blog is so idiotically biased, it mindlessly supports insurrection against the Supremacy Clause.

Posted by: Supremacy Claus | March 24, 2008 10:59 PM

States that were defrauded into paying for disasterous off-label uses, have a duty to take Lily to court. The state lost a lot of money, and it will have to pay for the ongoing damage.

Who sues for the patient who suffers the ravages of drug-induced diabetes? No one does, and he doesn't have the money to do it for himself. He is now stuck with a damaged body for life, and that life will be cut short.

We cannot rely on the acts of the FDA. We have to do our own homework and resist using drugs that don't have a good and long track record.

Sure the attorney is paid and maybe paid a lot. He also may work for years and be paid nothing. He fulfills a need that no one else will take on. He helps the damaged find a bit of comfort in their damaged lives. I don't begrudge the attorneys their fees. They make the field a bit more even, and no one else does that.

If you don't like that, come up with a better way of restoring seriously harmed people.

Posted by: Jana Hill | March 25, 2008 1:47 AM

At my local clinic the Doctors have stopped prescribing Zyprexa except as a temporary PRN for acute cases only.
WHY? for two reasons:
1) The reason they give it out at all is because it is a fine med where indicated for specific symptoms and does the job very well

2)They stopped it as daily maintenance because they believe in their own hearts that it is the worst offender over the other atypicals AND because their patients refuse to take it on account of all the bad Zyprexa PR

Posted by: Daniel Haszard | March 25, 2008 3:53 AM

Eli Lilly ZYPREXA GREED RICO Lawsuit

Attorney General Richard Blumenthal today sued Eli Lilly and Company, Inc. for illegally marketing its antipsychotic drug Zyprexa for unapproved uses, and concealing the drug's serious side effects, for more than a decade.

Eli Lilly allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children.

The deceptive marketing campaign dangerously concealed risks associated with Zyprexa, including diabetes, cardiovascular problems, and significant weight gain.

In a lawsuit filed today, Blumenthal seeks to recover millions of taxpayer and consumer dollars improperly spent on Zyprexa as a result of its illegal marketing, and millions more spent for treatment of serious side effects from Zyprexa.

"The illegal marketing campaign exploited children and senior citizens - causing severe weight gain, diabetes and cardiovascular problems," Blumenthal said. "This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects.

"Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives. Today's action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa.

"Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety. Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies and public officials nationwide who easily abandoned integrity and decency for self-enrichment. My office will fight aggressively on behalf of Connecticut citizens who continue to pay the price of Eli Lilly's illegal, senseless schemes."


Despite only limited studies on its efficacy and safety, and only limited federally approved use, Zyprexa has become the third best-selling drug in the world as a result of Eli Lilly's illegal promotions - prescribed to more than 12 million people and grossing an estimated $22 billion to date.

The Food and Drug Administration (FDA) approved Zyprexa, or olanzapine, only for use in treatment of schizophrenia and bipolar mania. In order to maximize profits, Eli Lilly created unlawful enterprises to promote Zyprexa for unapproved uses, while trying to avoid federal prohibitions against off-label drug marketing.
Under the façade of independence, doctors at "educational" forums urged peers to prescribe Zyprexa; ghostwriters published articles that promoted off-label prescribing, while omitting details about serious side effects; and public officials in various states promoted Zyprexa for unapproved uses in adolescents at detention centers and nursing homes.

In reality, Eli Lilly paid these "independent" physicians and authors generously and concealed the financial arrangements by funneling compensation through its illegal enterprises and third parties.
In some cases, Eli Lilly provided physicians and other participants tens of thousands of dollars in payments, grants and other compensation.

Eli Lilly also illegally promoted Zyprexa for the treatment of children suffering from depression, anxiety, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, sleep disorders and generally as a mood stabilizer. Zyprexa has never been approved by the FDA for any use in children, not even for children with schizophrenia or bipolar disorder.

Through the Connecticut Medical Assistance Programs (CMAP), the state pays for part or all medical benefits for enrollees, including pregnant women and newborns, adults with disabilities, people age 65 and older, and people living in nursing homes.
Between 1996 and 2006, the CMAP spent more than $190 million on Zyprexa. Millions of additional dollars have also been spent to treat injuries related to their use of Zyprexa.
Eli Lilly's illegal marketing enterprises and schemes included the following:

PEER-SELLING ENTERPRISE: Lilly compensated medical marketing firms and several physicians who routinely promoted Zyprexa to peer physicians in venues nationwide. Physicians who attended "educational" events were deceived into thinking that the events were independent of Eli Lilly. Conspiring physicians concealed information about the efficacy of Zyprexa in off-label uses and dangerous side effects, as well as the doctors' financial ties with Eli Lilly.

THE ROLE OF PHARMACIES: Eli Lilly targeted pharmacies, particularly those that serviced long-term care facilities. Typically, an Eli Lilly sales representative and a pharmacy would agree that the pharmacy formally request funding from Eli Lilly in order to present an "educational program" - for example, a program on the treatment of dementia.

Both the pharmacy and the Eli Lilly representative would agree that the program include a presentation by a doctor - hand picked by Eli Lilly - who would promote off-label use of Zyprexa for dementia. The Eli Lilly sales representative would file a formal request funds from Eli Lilly for an educational grant. Eli Lilly would issue a check to the pharmacy and the pharmacy would issue a check to the doctor, concealing compensation from Lilly to the physician.

PUBLICATION ENTERPRISE: Eli Lilly created a "Publication Enterprise" that hired writers to create articles, and then paid specialists to "author" the articles. The articles only included favorable results of Eli Lilly's own internal trials, and suppressed unfavorable results, including a clinical trial that failed to show Zyprexa's efficacy for bipolar disorder.

PUBLIC PAYER ENTERPRISE: Eli Lilly captured the Medicaid and Medicare markets by paying officials in various states, paying them substantial sums of money to spread falsehoods regarding the efficacy, safety and side effects of Zyprexa and to promote off-label use.

Eli Lilly targeted those who oversaw treatment for people with serious mental illness, including patients in mental hospitals and clinics who are on Medicaid - among the largest users of antipsychotic drugs. Lilly also influenced prescribing physicians to over-medicate senior citizens in nursing homes and adolescents in detention centers with antipsychotics.

Source: Office of the Connecticut Attorney General

Posted by: Daniel Haszard | March 25, 2008 4:19 AM

As we rush to sue every drug company, let us not forget the drug that causes the most fatalities and morbidities. It is widely used and the potential side effects are know well promoted by those who make it. It causes fatal hemmorhagic strokes, subdural hematomas, uncontrolled internal bleeding, ulcers and death. It is of course baby aspirin.

Posted by: throckmorton | March 25, 2008 8:21 AM

I have a patient with a fatal form of cancer. I contacted a drug company that is in trials of a new drug that may offer her some chance of a longer life. There is a reported case that the investigational drug has cured one patient. The company will not offer the medication outside of the trial due to liability concerns.

It is a sad state when liability risks take lives.

Posted by: throckmorton | March 26, 2008 12:59 PM

Lilly and the State of Alaska settled. The amount 15 million.

Posted by: throckmorton | March 26, 2008 9:24 PM

You don't understand, Throckmorton. The people who run this site (and the trial lawyers who bankroll it) don't give a flip about you or your patient. Actually, they would prefer that your patient die, and then try to figure out a rationale for the survivors to sue the drug company for failing to supply the drug to your patient.

The anti-tort reform crew don't care about people at all, only about extorting money from the system. Notice how quiet this site has been about Scruggs & Weiss

Posted by: Paul W Dennis | March 29, 2008 11:44 PM

The court has only rhetoric bull as a tool. It has no ability to judge medications. The land pirates will even exclude anyone with knowledge from the jury. This land pirate seeks to maintain total control over the bogus theater that is the trial, conducted by a Halloween costumed buffoon, sitting on an elevated bench, as if an Inquisitor. This farce justifies all public self-help against these rent seeking cult criminals. Patient direct action groups should take self-help to these cult criminals. There is no other recourse to protect clinical care from the plunder of this airtight, rigged system. Deter.

Posted by: Supremacy Claus | March 30, 2008 12:59 PM

Drug Strategies, the definitive site for help with drug and alcohol addiction, has compiled a comprehensive list of Drug and Alcohol Addiction Treatment Centers and Rehabilitation Programs in Alaska. Choose your nearest city for a listing of locations and contact information.
Tia smith
Alaska Drug Treatment Centers

Posted by: Tiasmith | April 20, 2009 7:10 AM