Welcome Visitor, Sign Up for Free!

Settlements In Cases Regarding Pharmaceutical Companies

There are certain drug companies in the pharmaceuticals markets who say that the millions of dollars that they pay to physicians just for speaking or consulting undeniably compensates for their part in educating their colleagues regarding their drugs.  However a series of pending lawsuits and litigation brought into court by former employees of these companies are alleging that the money was often used for illegal purposes for the lucrative financial rewards that would be dispensed to doctors for writing prescriptions for the medications that they were advocating for.

In many instances, the former employees say that the physicians were told to impose “off-label” uses for the drugs in question such as those not approved by regulators such as the FDA, which is a distinctly illegal marketing tactic sanctioned by federal law.  Within the past 3 years, pharmaceutical companies have doled out close to $7 billion for settlements for cases.

Angela Maher, who was a former drug-sales representative for Ortho-MacNeil Pharmaceuticals, sued the company in a federal court in Massachusetts back in 2003 in a suit alleging that the company pushed an anti-seizure drug for 27 off-label uses.  Ortho-MacNeil, she alleges, vigorously tracked their payments to the physicians.

In an interview, she said that she would hear about the exploits of the company in propositioning these doctors into pushing their drugs and through the advocacy of these physicians, overall sales of these certain drugs would exceedingly go up.

The drug company in Maher’s case settled for $81 million in early 2010 and also pleaded guilty to misdemeanor charge of misbranding certain drugs.  Angela Maher was awarded $3 million.  The allegations of other whistleblowers in other lawsuits provide a rare glimpse into the way drug marketers operate.

Allergan, the company that manufactures and markets Botox, created fake advisory boards exclusively to “reward hundreds of its top injectors,” federal prosecutors have charged in 2010.  More than 200 doctors were lavished in an oceanfront resort in Newport Beach, CA in 2005 and 2006 and paid $1500 to listen to presentations, according to the memorandum of the sentencing hearing.

In 2010, Allergan had settled with the federal government for $600 million and pled guilty to a misdemeanor charge for allegedly misbranding Botox.  The company said in a statement that its “committed to conducting its business with the highest ethical standards and in compliance with all applicable laws.”

A pharmaceuticals company named Forest Laboratories had launched what it called “preceptorship” programs in which physicians were paid up to $1000 each to allow sales representatives to spend time in observing their practices.  However in reality, the company used this mechanism to apply pressure to physicians to prescribe Celexa and Lexapro, two antidepressants, in a 2009 complaint filed by federal attorneys in Massachusetts.  The representatives filled out “return on investment” forms to justify the payments from a timespan reaching from 1999 to 2003.  One representative noted that a certain psychiatrist’s prescription numbers were trending upward and “we need to keep a good thing going as long as we are still getting this kind of growth,” according to the complaint.

A subsidiary of Forest pled guilty to two misdemeanors and one felony.  The company paid a settlement of $313 million in civil and criminal damages and fines.  In a statement filed by Forest’s CEO cited that the firm had improved its “compliance program since the events at issue in this investigation, which [had] occurred a number of years ago.”

Wyeth Pharmaceuticals, in a 2005 lawsuit pending in the state of Pennsylvania, was accused of hiring certain speakers till the year 2003 based on the stipulations of how often they prescribed the kidney transplant rejection medication Rapamune.  According to an amended complaint filed in 2010 by two former pharmaceutical representatives, Wyeth’s management excluded speakers who didn’t promote Rapamune and rewarded speakers who did with honors and repeated speaking engagements.  Speakers found “unfavorable or even unenthusiastic” about the drug were counseled by pharmaceutical representatives on the multitude of ways in which they could advocate the benefits of the drug, according to the complaint.

It is worth noting that the federal government has taken over the lawsuit which is pending in federal court in the state of Pennsylvania.  The pharmaceutical company Pfizer, which owns Wyeth, has said in a statement that the company’s “committed to ensuring that information provided to physicians on the uses, benefits and risks for Rapamune is consistent with its FDA-approved label.”  In 2009, Pfizer paid $2.3 billion to settle allegations for other cases that alleged that it had illegally promoted its drugs.

The company Cephalon was accused of rewarding even poor speakers if they were to heavily prescribe the narcotic lollipop Actiq and other drugs, filed in an amended complaint in 2008 by a former sales manager.  Physicians were regularly paid to attend speaker training workshops even though it was never the intent of the company to have them speak.  Some physicians were paid even when no one had shown up to hear them, alleged in the complaint filed in a federal court in the state of Pennsylvania.  According to the lawsuit, even the best available public speakers had been dropped by Cephalon if experience had shown that they hadn’t written substantial off-label prescriptions themselves.

Cephalon pled guilty in the year 2008 to a misdemeanor charge of selling misbranded drugs and paid a settlement of $425 million in penalties.  In a company statement, an official had said that the company had put a “strong compliance infrastructure” in place that improved accountability from their employees and ensured transparency in their actions.

One company had continued to pay doctors to advocate their products even after it had settled a lawsuit that had singled out those physicians speaking on the behalf of those drugs for alleged misconduct.  The cased which had been filed against the drug company AstraZeneca detailed how a certain psychiatrist named Rimal Bera discussed the antipsychotic drug Seroquel for “conduct disorders” in small children even though it isn’t approved for that certain use.  AstraZeneca settled with the federal government for $520 million in April of 2010.  Like other firms, it had signed a corporate integrity agreement disclosing future compliance with federal rules.

It is worth noting that the company paid Bera at least $10,530 for speaking in the year 2010, as is denoted by AstraZeneca’s company data.  It had paid another doctor named in the case almost $42,000.  An AstraZeneca company official wouldn’t discuss Bera but had said that sponsored speakers are terminated if it has been found that they violate company standards.  In a separate interview, Rimal Bera has said that he’s become more conscious of when is an appropriate time to discuss off-label uses for drugs.  According to the transcript of the interview, Bera stated that the speakers had done a better job as advocates.  He also suggested that the pharmaceutical industry as a whole has done a better job of reinforcing this.