Diclofenac is becoming an increasingly popular medication in workers’ compensation and auto accident cases. It is a nonsteroidal anti-inflammatory drug available as a pill or as a topical medication.

Cliff Goldstein

The U.S. Food and Drug Administration approved 1% diclofenac as a topical treatment to provide pain relief. The 1% concentration is sold over the counter under a variety of generic labels or under the brand name Voltaren, usually selling for about for $12-$25 per tube.

In workers’ compensation and auto accident cases, an alarming trend is sweeping the market. Instead of telling patients to pick up some 1% diclofenac at the supermarket or drug store, some doctors are prescribing 3% diclofenac for pain. Typically, patients are directed to certain “workers’ compensation” or other “specialty” pharmacies to obtain this drug.

This practice is disturbing for two reasons: It jacks up the cost of the drug from about $12 to about $2,700, and 3% diclofenac is not FDA-approved for pain, with limited high-quality evidence demonstrating superior effectiveness over approved alternatives.

The FDA approved 3% diclofenac for only one indication: treatment of pre-cancerous skin lesions known as actinic keratosis. But certain doctors are prescribing 3% diclofenac for everything from elbow pain to radiculopathy. 

Why do some doctors prescribe 3% diclofenac for pain when it is not FDA-approved as a pain treatment and when there is no strong empirical evidence to suggest that 3% diclofenac works better for pain than less potent versions approved for pain, or the oral pills, which result in greater absorption?

There may be several reasons that relate to money.

The drug can be hideously expensive. With the standard three automatic refills, the price charged for 3% diclofenac by some workers’ comp pharmacies can be over $7,000.

High drug expenses can be of benefit to plaintiffs and claimants pursuing settlements. As a rule of thumb, the higher the medical expenses incurred in a case, the higher the value of a potential settlement. A quick and “painless” way to jack up medical expenses and therefore improve the opportunity for a large settlement is to have a doctor prescribe 3% diclofenac from a workers’ comp pharmacy. It can be delivered by mail, and it is impossible to prove or disprove that the drug is helpful or even used.

Most auto accident plaintiffs’ lawyers and workers’ comp claimants’ lawyers work for contingent fees. The higher the settlement, the more money the lawyer makes. The more burdensome the drug bills are to the insurer or self-insured, the more eager the companies are to settle.

By prescribing 3% diclofenac and other treatments that are not FDA-approved for pain, doctors can help attorneys boost the value of their cases. Attorneys can help doctors by continuing to supply a steady stream of referrals, not just for treatment, but for the highly profitable report and testimony/deposition business that often flows from seeing comp/auto patients.

Another reason that some doctors may prescribe 3% diclofenac may relate to financial incentives. Some regulators, payers and investigators have raised concerns about potential financial incentives and referral relationships in certain cases, although practices vary widely and not all providers engage in such conduct. 

There are case reports and allegations that some prescribers, pharmacies or intermediaries may have financial relationships, including the use of complicated deals based on the receivables relating to the drug bills. Some doctors, lawyers, PBMs and workers’ compensation pharmacies may benefit from high-priced 3% diclofenac. Less clear is whether patients can.

There appears to be no peer-reviewed, double blind study proving that 3% diclofenac is any better for pain than 1% diclofenac. On the contrary, there is some evidence that the percentage of diclofenac is not as important as the absorbability and availability of the drug based on the delivery medium. More diclofenac does not necessarily mean more effectiveness. Every NSAID has its own therapeutic curve; at a certain dose, it reaches its maximal effect, and additional amounts do no further good while increasing the risks of side effects and reactions.

There is also scant evidence that 3% diclofenac works better than oral diclofenac pills, which cost just pennies each, or that 3% diclofenac works better than the dozens of oral and topical medications on the market that sell for similarly low prices.

Further investigation into the physicians prescribing 3% diclofenac, and the pharmacies dispensing this product, and their motivations, is necessary to determine the propriety of prescriptions for 3% diclofenac and to enhance strategies for combatting prescription drug pricing abuses. 

Cliff Goldstein, Esq., formerly the CEO and a Senior Litigator at Chartwell Law, has 35 years of experience in litigating complex workers' compensation cases. He now concentrates on addressing excessive pricing, fraudulent practices, abuse and waste regarding drugs used in workers' compensation cases. He can be reached at 215-588-4901 and cliffagoldstein@gmail.com.