If there was ever any doubt that big drug companies put profits over safety, it has been erased by the events of the last few months.
In separate developments, pharmaceutical giants Abbott Labs and Johnson & Johnson have recently been hit with fines and judgments in the billions of dollars for mishandling the marketing of certain drugs. Abbott Labs’ problems stem from their anti-seizure drug Depakote. Not content to rake in millions from the legitimate use of the drug, Abbott Labs admitted that from 1998 through 2006, it employed a specialized sales force to push Depakote to nursing homes for use in treating aggression and agitation in elderly Alzheimer patients. It also admitted that it marketed Depakote from 2001 through 2006 in combination with atypical antipsychotic drugs for use in treating schizophrenia. The problem with these practices? Neither of these uses of Depakote was approved by the FDA and neither was supported by credible scientific evidence of their safety and effectiveness. After pleading guilty to criminal and civil charges, Abbott Labs agreed to pay criminal fines and civil settlements totaling $1.6 billion. U.S. Attorney Timothy Heaphy of the Western District of Virginia said, “Abbott’s misconduct exposed elderly nursing home residents and schizophrenia patients to serious side effects from a drug that was not proven effective, at a cost of hundreds of millions of dollars to government health care programs.”
Abbott Labs’ plea deal is just the most recent example of big drug companies being caught pushing their products for off-label, unsafe and scientifically unsupported uses. In April of this year, Johnson & Johnson was hit with a $1.2 billion verdict by an Arkansas state court judge for multiple violations of Arkansas’ Medicaid fraud laws. The verdict involves J&J’s long-term marketing of the antipsychotic drug Risperdal as a “chemical restraint” for use in nursing homes. The U.S. Department of Justice has alleged that the drug company illegally promoted this off-label use of Risperdal and engaged in an illegal kickback scheme with the nations’ largest provider of drugs to nursing homes. Johnson & Johnson promoted Risperdal for use as a chemical restraint even though studies showed the drug increased the risk of death in patients with dementia. The $1.2 billion verdict follows a $158 million settlement of a Texas lawsuit, a $258 million Louisiana verdict and a $1 billion settlement with the U.S. Department of Justice., all arising from the illegal promotion of Risperdal.
In November 2011, pharmaceutical giant Merck agreed to pay $950 million to settle criminal and civil claims brought about by the Department of Justice relating to its marketing of Vioxx. This widely used painkiller was pulled from the market in 2004 after a study revealed the drug increased the risk of heart attacks.
In October 2011, British drug maker GlaxoSmithKline reached a $3 billion settlement relating to its marketing of the diabetes drug Avandia. And in 2009, drug makers Pfizer and Eli Lilly reached settlements of $2.3 billion and $1.4 billion arising from their drugs Bextra, Lyrica and Zyprexa. These settlements are just a few among many multi-million dollar pharmaceutical settlements over the last few years, including:
Date: March 2011
Details: AstraZeneca agreed to pay $68.5M to 36 states to settle allegations that the company marketed its anti-psychotic drug Seroquel for off-label uses. The lawsuits also alleged that the company failed to adequately disclose the potential side effects of Seroquel to healthcare providers and withheld negative information contained in scientific studies regarding the safety and efficacy of the drug.
Date: September 2010
Details: Novartis agreed to a $422.5 million settlement for its off-label promotion of Trileptal and other allegations relating to drugs Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.
Date: September 2010
Details: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received a fine of $313 million. The settlement also covered Forest’s off-label promotion of Celexa for children’s use.
Date: September 2010
Details: Allergan’s $600 million settlement with the Department of Justice was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.
Date: July 2010
Details: The Irish drugmaker was hit with a $203.5 million fine for its marketing of Zonegran, an epilepsy drug. Also, the company’s U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.
Johnson & Johnson
Date: April 2010
Details: Two of the drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.
Date: April 2010
Details: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company allegedly misled doctors and patients about the drug’s safety.
Date: September 2009
Details: Thirteen states filed suit against Eli Lilly for Zyprexa marketing issues, but the company was ordered to pay $25 million to Connecticut in this ruling.
Date: August 2009
Details: Merck and Schering-Plough agreed to pay $41.5 million to settle class-action lawsuits relating to their cholesterol drugs Vytorin and Zetia after a 2008 clinical trial showed that their drugs were no better at reducing plaque buildup than generic Zocor, a cheaper drug that had been on the market for years.
Date: January 2009
Details: After seven years of off-label promotion on nine of its best-selling drugs, GSK was ordered to pay $400 million to the U.S. Attorney’s office in Colorado.
Date: January 2009
Details: In the first Zyprexa settlement, the Department of Justice leveled $1.4 billion in fines against Eli Lilly. Also, as part of the settlement, the company pled guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act.
When will they learn?
Despite these record fines and settlements, the big drug companies have apparently not learned their lesson. Just this week, a U.S. Senate Committee launched an investigation into an organization called The American Pain Foundation.
The group claims to be a non-profit organization focused on helping pain patients, but 90% of its funding comes from big drug companies. Additionally, the organization’s drug guides allegedly play down the risks associated with opioid painkillers and exaggerate their benefits. In letters to The American Pain Foundation and its members, the Senate Finance Committee questioned the group’s purpose. One letter stated that:
“It is clear that the United States is suffering from an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers. . . . There is growing evidence pharmaceutical companies that manufacture and market opioids may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs’ safety and effectiveness.”
In a press release, Senator Max Baucus stated that, “When it comes to these highly-addictive painkillers, improper relationships between pharmaceutical companies and the organizations that promote their drugs can put lives at risk.”
What can the public do?
As this most recent episode indicates, “big pharma” seems to view multi-billion dollar fines and judgments as just another cost of doing business. So long as profits for new blockbuster drugs routinely run into the multi-billions of dollars, and the FDA essentially relies on big drug companies to police themselves, the public will remain vulnerable to the unscrupulous practices of these corporate crooks. While many people view trial lawyers with disdain thanks in large part to the multi-million dollar PR campaigns of corporate America and big insurance companies, the truth is that trial lawyers remain the last bastion of protection for millions of Americans. By holding the big drug companies accountable for their acts of fraud and negligence, trial lawyers help keep the marketplace for prescription drugs safer for all.
If you or a loved one has suffered harm from a pharmaceutical product, the lawyers at Heygood, Orr & Pearson may be able to help. Contact us for a free case evaluation.