Roche, Genentech sued for allegedly overfilling Herceptin vials


Buyers are hopping mad at Roche ($RHHBY) for allegedly overfilling vials of its best-selling cancer drug, Herceptin. Now, some of them are banding together in a putative class action suit against the company over related claims.

On behalf of plaintiffs, Oklahoma’s Comanche County Memorial Hospital is suing Roche and Genentech for “unlawful, unfair, and fraudulent” conduct in regards to Herceptin, it said in a court filing. Plaintiffs are asking the U.S. District Court for the Northern District of California for a jury trial to hear the claims.

The lawsuit follows a BMJ article by Peter Bach, who heads up Memorial Sloan Kettering's Center for Health Policy and Outcomes. Bach contended that cancer drug vials tend to be overfilled, boosting revenue for drugmakers while passing excess costs on to payers and patients. Packaging drugs in smaller vials could save $3 billion in the U.S., he figures.

Roche disputes the claims.

Herceptin vials are labeled as having 440 mg of the drug. Genentech’s prescription information says that a reconstituted multi-dose of Herceptin has 21 mg of the drug per each mL of solution.

But the plaintiffs cite an apparent discrepancy between the amount of drug Genentech said was in the vial and the actual amount. Under two different scenarios laid out in the case, Genentech either sold less Herceptin than it claimed to be selling, or the company lied about the concentration of the reconstituted drug.

In the latter situation, a patient could have a Herceptin overdose. Providers and patients would also be “forced” to buy more of the drug than they actually needed, plaintiffs said in the suit. Herceptin already runs at about $70,000 for a 52-treatment course, the suit pointed out, which leaves patients and providers grappling with high costs.  

Genentech and Roche’s “unfair business practice” caused plaintiffs “substantial harm in the amount of thousands of dollars spent on purchasing unnecessary Herceptin,” the suit said. Patients are requesting compensatory and other damages to make up for the loss, as well as court and attorney fees.

Plaintiffs are also asking the court to force Genentech to stop marketing and packaging the allegedly overfilled vials of Herceptin.

As a shock to no one, Genentech does not see eye to eye with plaintiffs. "Decisions on how we manufacture and package our medicines are taken very seriously and all of our medicines, including Herceptin, are packaged to meet FDA regulations and specifications. There is no merit to the plaintiffs’ allegations, and we intend to vigorously defend ourselves in the lawsuit," the company told FiercePharma in an email.

Some public health experts such Bach have said that requiring companies to sell chemo drugs in multiple vial sizes could reduce overspending or waste. But Bach and his team could be overlooking a bigger point about production cost, according to a recent Health Affairs Blog post from Sherry Glied, the Assistant Secretary for Planning and Evaluation at HHS, and Bhaven Sampat, the associate professor in the Department of Health Policy and Management at Columbia’s Mailman School of Public Health.

Much of the cost of a chemo drug doesn’t depend on unit size, Glied and Sampat said, but rather on demand. Patients are willing to pay for an expensive med if it comes with the promise of extending their lives, as is seen in the case of Herceptin.

Even if drugmakers were required to sell products in more vial sizes, patients would still be willing to pay for the drugs, Glied and Sampat pointed out. The average consumer would then end up paying “about the same amount for a course of treatment,” the pair said.

- here’s the suit (PDF)
- read more from Health Affairs Blog

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