Federal agents in Baltimore helped lead an operation that this week seized and shut down nearly 700 U.S.-based websites linked to the sale of counterfeit pharmaceutical drugs as part of an international effort to upend the global online drug trade.
The local operation, known as Bitter Pill, was part of an international initiative led by Interpol that spanned 100 countries and confiscated 3.7 million doses of counterfeit medications worth an estimated $10.5 million, according to federal officials.
The drugs being offered on the websites included antibiotics, anti-cancer medications, weight loss and food supplements, and erectile dysfunction pills, officials said. Customers were not targeted by the investigation, in part because they are largely unwitting victims purchasing drugs they have "absolutely no idea what's inside of," said Justin Cole, a U.S. Immigration and Customs Enforcement spokesman with the National Intellectual Property Rights Center.
"They're not trying to buy a knock-off handbag on the side of the road; they're trying to buy a cancer medication or some other lifesaving drug," Cole said.
Agents out of Baltimore's Homeland Security Investigations unit, which falls under the ICE, took the lead on Bitter Pill in conjunction with the IPR Center in Washington and the Maryland U.S. attorney's office.
"Getting all the international partners together to focus on counterfeit pharmaceuticals at one time, and for us to be a part of that initiative, is fantastic," said Todd Horton, HSI Baltimore's assistant special agent in charge.
The Baltimore office was chosen because of its experience investigating such cases and its close working relationship with U.S. Attorney Rod J. Rosenstein, Horton said. Rosenstein's office said no indictments have been entered. Operators of the seized websites were not named in federal affidavits.
Some digital rights groups have expressed concerns about the Bitter Pill seizures and others like them, saying they ignore the due process rights of website operators. The groups also object to the categorization of domain names as property rather than outlets for protected free speech.
Broad seizures could also ensnare legitimate operators and leave them without their domain presence for months on end until they are able to clear their names or successfully challenge the seizure, digital rights advocates said.
"Seizing a domain name isn't exactly like closing down a storefront," said Sherwin Siy, vice president of legal affairs for the Washington-based digital rights advocacy group Public Knowledge. "It's not just a question of, 'Did we shut down bad guys?' but it's a question of, 'Are there procedures in place and are we doing this constitutionally to make sure we aren't shutting down good guys as well?'"
The Bitter Pill investigation, which is continuing, came to a head Wednesday when Baltimore cybercrimes agents executed federal seizures of 686 website addresses. Leads on those websites, whose seizures were announced Thursday, were first developed by the IPR Center last year and shared with the HSI Baltimore agents, who conducted investigations and obtained warrants for the seizures, Horton said.
"We did several undercover purchases from these websites directly, and then when we received the medicine, we sent it off to the labs for testing," Horton said, noting that a handful of major pharmaceutical manufacturers helped test the drugs. "They all came back with counterfeit trademark violations, and some of the pills also came back with extra ingredients that could be health concerns and violations."
Some of the websites seized offered knockoff medications by their brand names — allegra180mg.com, buyingvaltrex.org, buyingviagra50mg.com. Others appear to have pitched themselves as international hubs for medications — canadian-pharmacy.com, canadian-viagra.com. Still others appear to have attempted to seem linked to legitimate, well-known businesses, as in drugswalmart.com.
Siy said digital advocates don't mean to question the importance of blocking dangerous drugs from reaching markets, but said there are other, more legally sound means of interrupting such transactions while court cases are introduced and tried.
"Usually, the statutes that are used to seize these things were really originally built to seize contraband itself, to seize drugs, to seize counterfeit stuff, things that were in and of themselves illegal, things that could be used as evidence, things that could be used to create counterfeit things. And the intention was to prevent the destruction of the product being investigated," Siy said. "A domain name isn't going to go anywhere. Nobody is going to be able to flush a domain name down the toilet."
While a domain could be deleted, investigators could document and save everything available online before announcing their investigation, Siy said.
"In the meantime, if you want to prevent that site from continuing operation, you can actually get a court order instead, get an injunction, instead of going through a seizure procedure," he said.
Affidavits in the case, however, which argued that the websites violated federal laws against the trafficking of counterfeit goods, contended that a restraining order or injunction blocking use of the websites while a case was tried would be an "insufficient" solution. Only an outright seizure would prevent "third parties from acquiring the name and using it to commit additional crimes," one affidavit said.
Horton said counterfeit drugs threaten public safety and must be pursued aggressively, and Bitter Pill is far from over.
"We'll be working with our headquarters office and the IPR Center over the next few months to pursue additional leads because I'm sure there's going to be spinoffs," he said. "If you don't get to the folks behind the actual websites, then others will pop up, so it's a constant challenge."
Horton said that because the investigation is continuing, he could not discuss pending arrests in the case or what quantities of drugs were purchased to facilitate the drug testing in the case. He also declined to say how many operations were targeted, but acknowledged that not every website address seized constituted an independent operation.
Apart from falling under the international operation, in its fifth year and called Pangea V, Bitter Pill was also part of a sustained U.S.-based law enforcement initiative known as Operation In Our Sites, which began two years ago. The websites seized Wednesday bring the total number of sites seized by the domestic operation to 1,525. Individuals who have an interest in the websites can file a petition in federal court to contest the seizures.
Visitors to the seized websites will now be shown a banner image saying that the website has been seized and explaining that knowingly trafficking counterfeit goods is a federal crime carrying a penalty of up to 10 years in prison and fines, forfeitures and restitution.