By Steve Esack
Pennsylvania has joined a majority of states in filing a lawsuit against three drug manufacturers, claiming they have illegally profited off the opioid addiction and overdose crisis sweeping America.
State Attorney General Bruce R. Beemer announced Thursday that his office and 35 other attorneys general filed an antitrust lawsuit against the makers of Suboxone, a federally approved prescription drug used to ease addicts' cravings for heroin-based prescription pills or street-bought dope. The lawsuit alleges three companies conspired to jack up consumer prices by creating an unnecessary change to the Suboxone that prevented other companies from making cheaper generic versions of it while they enjoyed $1 billion in monopolized sales.
"This conduct forced consumers to pay more for Suboxone and severely limited their options for treating their opioid addictions," Beemer said in a statement.
Depending on strength, Suboxone retails for between $137 and $477 for a 30-day prescription, according to the online consumer price guide, drugs.com.
The lawsuit, filed in U.S. District Court in Philadelphia, seeks to recoup costs associated with the prescription opioid-related overdose epidemic that federal statistics show killed more than 265,000 people between 1999 and 2014.
The number of Pennsylvanians who died from opioid overdoses rose 23 percent to 3,383 between 2014 and 2015. The deaths have triggered a wave of legislation proposed by lawmakers and backed by Gov. Tom Wolf. A joint session of the House and Senate may be held next week addressing the issue with the governor.
State Rep. Doyle Heffley, R-Carbon, one of the Legislature's leading advocates for laws to curb opioid abuse, said he had not seen the attorney general's lawsuit, but welcomed it. The lawsuit appears to be going after companies that put profit above consumers and taxpayers, he said, which has been the case with other pharmaceuticals, including the maker of Narcan, an anti-overdose tool that spiked in costs.
"It's important the attorney general's office stays on top of this," Heffley said.
The lawsuit accuses Reckitt Benckiser Pharmaceuticals and Indivior of conspiring with another company, MonoSol Rx, to switch Suboxone from a tablet to a dissolvable, digestible film so the company could keep its federally sanctioned patent and maintain a monopoly.
Attempts to reach Reckitt Benckiser and Indivior, both based in the United Kingdom, were unsuccessful. MonoSol, whose U.S. headquarters is in Warren, N.J., also could not be reached.
Indivior received approval in 2002 for the tablet form of Suboxone, according to online records at the U.S. Food and Drug Administration. Approval came with a seven-year patent meant to allow the company to recoup costs associated with development testing and regulation requirements. The patent also prevents other companies from copying the recipe.
The Suboxone tablet was then discontinued after the company got FDA approval in 2010 for the digestible film, which is about the size of breath mint strip.
The FDA describes the drug as a "prescription medicine used to treat adults who are addicted to prescription opioid drugs or illegal heroin as part of a complete treatment program. ..."
If abused, Suboxone drug can be just as addictive and deadly as the drugs it is trying to wean addicts from, FDA warns, because it contains buprenorphine.
The lawsuit claims Reckitt allegedly converted the market away from the tablet to the film through marketing, price adjustments and other methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the Suboxone tablet from the United States market.
The lawsuit claims the pill-to-strip change was illegal "product hopping," a term used to describe how companies make modest changes to its product to extend patent protections so other companies can't offer cheaper generic alternatives. The Suboxone film provided no real benefit over the tablet, the lawsuit claims, while Reckitt continued to sell the tablets in other countries even after removing them from the U.S. market under "unfounded safety concerns."
A patent lawsuit is fine legal avenue to pursue, but Rep. Gene DiGirolamo, R-Bucks, said he'd prefer the attorney general's office sue all opioid drug manufactures for creating and fueling the addiction and overdose crisis for corporate profit.
Suboxone is set up to continue the crisis, he said, because all it takes is visiting a doctor for a 39-day prescription. Soboxone is flooding Pennsylvania's drug market, he said, and being sneaked into county prisons.
In June, Rep. Thomas R. Caltagirone, D-Berks, introduced a resolution to have the Legislature back a state lawsuit like the one DiGirolamo described. It has seven sponsors.
Other states or local governments have sued drug companies over opioids, some successfully. In 2007, Purdue Pharma paid a $600 million fine and pleaded guilty to federal criminal charges that it promoted the drug OxyContin for non-legal purposes and downplayed its addictive risk.
Also suing are ...
Alabama, Alaska, Arkansas, California, Colorado, District of Columbia, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington and Wisconsin
(c)2016 The Morning Call (Allentown, Pa.)