The news for the next several months will be about very “inside baseball” legal maneuvers. As of April 1, there were 1,854 Suboxone lawsuits included in the MDL. The case for case management is clear. Important, yes – but it feels a little remote from the larger goal of achieving justice for the patients who were hurt.
Now may be an opportunity to fall back, regroup, and consider how a group of vulnerable people recovering from opioid addiction were further injured by a dangerous drug. Perhaps others will not be harmed in the future.
Part of the responsibility lies with the pharmaceutical industry’s widespread practice of product hopping.
Suboxone Tooth Decay Lawsuits
The opioid buprenorphine and the opioid antagonist naloxone are the active ingredients in Suboxone. The tablet form of Suboxone was approved in 2002 and is prescribed to treat opioid use disorder and acute, chronic pain. Indivior held exclusive rights to sell Suboxone in tablet form until 2009. Competitors were poised to offer a cheaper generic tablet form of the buprenorphine/naloxone combination as soon as Indivior’s exclusivity lapsed.
In 2010, citing allegedly unfounded pediatric safety concerns, Indivior launched Suboxone sublingual film (dissolvable strips). The introduction of the oral film form of Suboxone entitled Indivior to extended monopoly protection – just in the nick of time to protect its market.
Suboxone, however, is highly acidic, a factor that did not pose significant dangers to patients using the tablets. However, the sublingual film version is to be held in the mouth for 5 to 10 minutes and has been linked to tooth decay and loss.
The final score: a win for Indivior, a loss for market competition, a loss for patients’ pocketbooks, and a loss for patients’ dental health. There is only one winner here, and it wasn’t the folks who needed the help in the first place.
Product hopping
In the pharmaceutical industry, product hopping is a strategic maneuver where a brand-name company transitions patients from a drug nearing its patent expiration to a newer, patent-protected reformulation. This tactic is designed to extend market exclusivity and obstruct generic competition, often costing the U.S. healthcare system billions of dollars annually.
Critics, including generic manufacturers, consumer advocates, and government regulators like the Federal Trade Commission (FTC), argue that these minor product tweaks often offer little to no significant clinical advantage over the original product and keep drug prices artificially high. They contend that this practice costs patients, insurers, and government health programs billions of dollars annually, undermining the pro-competitive spirit of the law.
Furthermore, exclusivity periods can be stacked. When a brand company launches a “new” version of a drug, even with minor changes, it can be eligible for new periods of market protection.
Pharmaceutical behemoths use several strategies to accomplish the “hop.” One, the “new and improved strategy” is a classic marketing ploy familiar from everything from detergents to pain relievers. These improvements may improve patient outcomes, but generally only at the margins. An alternative gambit involves changing the delivery mechanism from, for example, oral medication to topical patch or tablet to sublingual film, as Indivior did.
What’s the harm?
The harm from this maneuver has many sides. Consumer advocates contend that:
- Although the benefits of the improvements are often exaggerated, the costs are real;
- The intent is anti-competitive; and
- The strategy misallocates resources because it encourages companies to invest R&D dollars in making trivial modifications to existing blockbusters rather than pursuing riskier but more meaningful research into new cures for unmet medical needs.
Sadly, Suboxone’s move to sublingual film was even worse. No “minor tweak,” the new delivery mechanism actively harmed vulnerable people who were already struggling to overcome life-threatening addictions.
Federal enforcement actions
READ MORE SUBOXONE TOOTH DECAY LEGAL NEWS
The FTC, in collaboration with the Department of Justice’s (DOJ) Antitrust Division have taken legal action against manufacturers’ use of “product hopping” schemes. The FTC accused Reckitt Benckiser/Indivior of violating antitrust laws with Suboxone, which led to a $60 million settlement. Proposed legislation, such as the Drug Competition Enhancement Act, aims to declare these practices as unfair, anti-competitive, and in violation of antitrust law.
What about patients who have already lost teeth?
Legal and legislative action to curtail product hopping is not the whole story, of course. These efforts may, at most, protect patients from future injuries. For people in recovery who have already suffered harm from Suboxone, a dangerous drug lawsuit is still probably the best alternative, slow as the process is.
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