April 9th, 2008

Counterfeit Heparin Death Toll Rises From 19 to 62

The FDA revealed yesterday that the death toll from counterfeit heparin rose from 19 to 62 over the last 15 months starting in January 2007. I had previously discussed this issue in the context of Baxter’s potential liability for distributing counterfeit drugs (see, Counterfeit Heparin and Baxter Liability).

The 66 deaths come from a total of 103 deaths of patients taking the blood thinner. The 62 deaths resulted from allergic reactions or hypotensive (low blood pressure) events related to the counterfeits. The others would have been due to underlying medical conditions.

The FDA released a table of data showing that in 2006 there were 55 deaths from heparin users, but that only three were due to allergic reactions or hypotension as a medical event, similar events to the cases that prompted the heparin recall in 2008.

According to Baxter, however, only 38 deaths are attributable to their contaminated product and that four of those deaths were from unexplained allergic reactions.

The FDA is continuing to receive information on adverse events related to heparin, so this total is not expected to be final. As a result of all the publicity surrounding the recall, as well as the high-profile overdose of heparin to Dennis Quaid’s twins, one would reasonably expect an increase in healthcare providers submitting adverse event reports to the FDA.

See also:


March 26th, 2008

California Delays Plan to Track Prescription Drugs

Bad news for prescription drug users out of California. The pharmaceutical industry has once again beaten back attempts at greater consumer safety.

The state had put together a bill to electronically track prescription drugs from the manufacturer all the way to the consumer, to insure that the supply chain was not infiltrated by counterfeit drugs. Every bottle of pills sold to consumers would be tagged. The plan was to go into effect on January 1, 2009, but according to today’s New York Times, the drug companies have been given a two year reprieve. The electronic pedigrees were first supposed to have been in place on January 1, 2007, so this is the second delay that they have won.

Drug manufacturers and wholesalers complained that such safety would cost them money.

But if you think the battle for increased safety is over with the new date in place, you would be wrong. Pfizer is claiming they need another five to seven years, though they have somehow managed to put such practices in place for their high revenue drug Viagra.

And for those looking at the big picture of trying to determine when drugs will finally have documented pedigrees from manufacturer down to consumer, the first legislation on the subject was the Prescription Drug Marketing Act of 1987. That dealt with paper pedigrees and was never put into place.

So the industry has thus far succeeded in delaying for 21 years. And I’m guessing that 21 years from now we still won’t have it. As Stan Goldenberg, a Los Angeles pharmacist and member of the state’s Board of Pharmacy said in today’s Los Angeles Times, “In 2011, they’ll want 2013. In 2013, they’ll want 2015. They’ll keep the ball in the air until something bad happens.”

And when something bad does happen (as it did to Tim Fagan), you can be sure, as sure as the lord made little green apples, that the drug companies will find ways to ask for immunity from the inevitable lawsuits. And they will try to blame “greedy plaintiffs’ lawyers” for the fall out.

For more info:


March 20th, 2008

Counterfeit Heparin and Baxter Liability

Counterfeit heparin may be responsible for at least 19 deaths in the United States and hundreds of allergic reactions. The news came from federal regulators yesterday that part of the anti-clotting drug made by Baxter was an unapproved ingredient from China that was altered to mimic the real thing. Baxter has pulled the drug from the market.

In exploring the potential liability of Baxter below, I first offer up this personal background: I previously represented Timothy Fagan, a 16 year-old New Yorker who had been injected with counterfeit Epogen after an emergency liver transplant. It was one of the few counterfeit drugs cases ever brought in this country, which gives me a unique perspective on the issues that may be encountered should suit be brought against Baxter. His experience was part of a 60 Minutes segment (as well as many other news reports) and featured in a book by Katherine Eban, Dangerous Doses. Legislation named for him, Tim Fagan’s Law, is pending in Congress. I have a page at my web site devoted to the subject (Counterfeit Drug Resource Page), have written on the subject here a number of times (though not in the last nine months), and spoken at pharmaceutical conferences on the subject.

Tim’s experience, like the one with Baxter’s heparin, resulted from problems in the pharmaceutical supply chain. For Tim, the counterfeiting took place after the drugs left the hands of drugmaker Amgen, and low dose vials were “uplabled” with counterfeit labels to appear to be 20x the strength, reportedly by a criminal gang in Florida. The vials were also mishandled, leading to apparent adulteration. Tracing how the drugs moved through a web of secondary wholesalers was a critical part of the investigation.

Baxter now faces a similar problem of supply chain management, though the problems exist upstream instead of downstream. The problems result from outsourcing critical manufacturing to others while also failing to verify the integrity of the product. Any investigation as to Baxter liability will no doubt turn on whether the company turned a blind eye to the product’s sourcing, perhaps because the price was so good.

Litigants will also face a critical set of problems that will arise in any drug counterfeiting case:

  1. The evidence was destroyed at the time it was injected or ingested and the packaging discarded.
  2. Doctors will generally assume that a failure to get better is the result of the underlying condition, not a counterfeit drug.
  3. Since the patient was already sick (or they wouldn’t be getting the drug), proving that death or further disability came from the counterfeit, as opposed to an underlying cardiac condition that they were perhaps being treated for, will represent a real causation issue even if you know the counterfeit was injected/ingested.
  4. The drug may not be trackable back to Baxter due to shoddy record keeping regarding the supply chain, which still contains loopholes that allow the “pedigree” of a drug to be washed by “authorized distributors of record” so that prior owners of the drug are unknown.

Litigants will start with an essential fact: It is a prohibited act to sell counterfeit drugs and Baxter appears to have done just that. Most lawyers refer to that as negligence per se.

Since Baxter appears to have committed that prohibited act (assuming the accuracy of press reports), it must therefore try to defend itself with a claim that the company owed no duty of care to the end-user, as there was no direct relationship between the two.

A savvy litigant will respond, however that the since the Food, Drug and Cosmetic Act prohibits introducing defective drugs into interstate commerce, it is not enough to say that Baxter simply didn’t know that this is what their sourcing companies were doing. The United States Supreme Court, in the little known 1975 case of US v. Park, has already stated that the Act “imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur.” The Act, according to the Court, punishes “neglect where the law requires care, or inaction where it imposes a duty.”

Since the measure of Baxter’s duty to the end-user will be measured by the foreseeable risk, and counterfeiting is not only a clearly foreseeable risk (see the links back at my resource page), but one that has received much attention lately due to counterfeits coming out of China in particular, the foreseeability issue is easily approached.

Thus, a plaintiff would argue that it is not whether Baxter owes its customers a duty of care, which has existed for decades, but rather, the scope of that duty.

The legal issues of whether a duty of care exists between manufacturer and consumer also might be addressed from the breach of warranty angle. In that respect, relief may exist (among other places) in its uniform commercial code. New York’s UCC 2-318, for example, provides that: “A seller’s warranty whether express or implied extends to any natural person if it is reasonable to expect that such person may use, consume or be affected by the goods and who is injured in person by breach of the warranty. “

Baxter counsel will argue, in essence, that the company deserves immunity, and will scratch around for any argument that fits that bill. Since any case will likely be faced with a motion to dismiss right away, it is critical that each of the potential issues be addressed in the complaint with proper allegations. There are no cookie cutter forms for this type of complaint, and each of the allegations and potential responses must be thought through and specifically tailored.


  • Baltimore Sun says 21 deaths and 700 injured)
  • Senator Edward Kennedy released a statement that said, in part:

    “It is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering. Whether this contaminant was introduced intentionally or by accident, the full force of the law must be brought to bear to bring those responsible to justice. To guard against future abuses, every drug manufacturer needs to inform FDA of where it sources its ingredients and what it is doing to ensure that these ingredients are pure and potent.”

General counterfeit drug links:

Counterfeit heparin links:

Update 3/27/08:


June 19th, 2007

Counterfeit Drugs and the American Enterprise Institute

Counterfeit Drugs is the subject of a paper released today by the conservative American Enterprise Institute, entitled Bad Medicine In the Market.

The authors, Roger Bate and Kathryn Boateng, do a nice job of summarizing the problem of the dangers of fake drugs, which can find their way into anyone’s home if there are weaknesses in the drug distribution system. The authors stop short, however, in suggesting any solution other than curtailing the use of generic drugs that had not been tested.

So with that, I’d like to remind readers of Tim Fagan’s Law, first introduced by Rep. Steve Israel in 2005, and currently pending. Named for one of my teenage clients, who was injected in 2002 with counterfeit Epogen after an emergency liver transplant, it provides for the following to help plug up a porous supply chain through which counterfeits enter the mainstream distribution system:

  • Increases criminal penalties. The current federal law is three years in prison. Israel’s bill increases penalties and includes up to life in prison.
  • Mandates that a manufacturer must alert the FDA of a counterfeited drug in 2 days. Currently, there is no mandate. The pharmaceutical industry has said that it would voluntarily tell the FDA about counterfeited drugs within 5 business days.
  • Provides the FDA with the authority to require companies to use anti-counterfeiting technology, as the technology becomes feasible and available.
  • Mandates that the FDA implement the paper pedigree rule that was mandated in 1988 and has been postponed for 17 years. It also closes the “authorized wholesaler” loophole and includes manufacturers as needed to start the pedigree.
  • Authorizes $60 million for spot-checking for counterfeits for each year between fiscal years 2006 and 2010.
  • Authorizes $5 million for each year between fiscal years 2006 and 2010 for educating the public and health care professionals on how to identify counterfeit drugs.
  • Provides recall authority to the FDA for prescription drugs. Currently, the FDA can only recall equipment and can only encourage private companies to recall their drugs.
  • Authorizes the FDA to issue subpoenas with respect to preventing threats to public health.

The law is spear-headed by Tim’s congressman, Steve Israel. It would be nice to see the AEI get on board with this legislation, given its concerns over the issue.

Related links:


May 16th, 2007

Counterfeit Drugs and Push for RFID In FedTech Magazine

The issue of counterfeit drugs and the push for radio frequency identity tags is raised in the cover story of FedTech Magazine.

The article, which features my client Tim Fagan and his injection with counterfeit Epogen back in 2002, can be found here: Tag & Release.

This is the lede:

The Fagan family of Long Island, N.Y., thought they were out of the woods when their 16-year-old son, Tim, came through a lifesaving liver transplant in 2002. Yes, he would need to take immune-suppressing drugs for the rest of his life, but his prognosis was good.

Among the drugs in Tim’s regimen was Epogen, an anti-anemia medication prescribed to help boost his production of red blood cells. Tim’s mother administered a weekly injection of the drug, bought from the local branch of a national pharmacy. But hours after the shot, Tim would wake up screaming in excruciating pain. His doctors had no explanation, and no one would have guessed the cause was fake pharmaceuticals.

“The first night I thought someone had broken into his room and was attacking him,” says Tim’s father, Kevin Fagan. “It was a very emotional and very painful thing to watch our son suffer. To find out two months later that he was taking counterfeit drugs just blew us out of the water. We couldn’t believe counterfeit drugs even existed.”

For more on the subject, click on the counterfeit drugs label at this blog or visit my firm’s Counterfeit Drugs Resource Page.