A Chinese court just found in favor of New Balance in a trademark case. This is a big win for the American sneaker manufacturer. After all, it has been traditionally very difficult for companies to win IP suits in a country that has many times been accused of turning a blind eye to counterfeits.

The Chinese court ruled that three companies in China–New Boom, New Barlun, and New Bunren–all infringed upon New Balance’s logo, a distinctive N. The three companies owe a combined $1.5 million to New Balance. But while that sum may not seem like much, it’s more than American companies usually get. And it may pave the way for other American companies to be successful in IP disputes in China.

In the past, American companies usually ended up as losers when contesting trademarks. In 2016, Apple lost a lawsuit against a Chinese company using the “iPhone” trademark. Pfizer has lost multiple fights over its Viagra trademark. And Michael Jordan went through a protracted battle over the use of his own name. Most of these losses were based on the fact that Chinese law grants a trademark to whoever filed for it first, and most big American companies were just not quick enough.

But, that may be changing. The U.S. has put pressure on China to tighten its IP laws. China revamped its trademark law in 2014, allowing courts to award higher damages. Scott Palmer, a New York-based IP lawyer told the New York Times:

I don’t think this is a one-off. This is a fairly high-profile case, but I think that it falls squarely within a trend, in which the direction is more toward more significant damage awards when indeed it is warranted.

It doesn’t seem likely that American companies will necessarily start winning IP cases in China left and right. But for companies frustrated with their treatment in one of the world’s largest markets, this could be a good sign for the future.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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According to a long line of Supreme Court cases, death is different. Because it is the ultimate penalty, every aspect of a trial and sentencing are subjected to the highest levels of scrutiny when the death penalty is involved. As a society, we fall short of the high standard of care that we hope to achieve in these cases but we instinctively feel that cases involving execution are special.

Much attention is paid to the process of trying, convicting, and sentencing for capital offenses, but recently, attention has also been paid to the execution process itself. In May, Pfizer, one of the largest pharmaceutical companies in the United States, announced that it would be taking steps to block states from purchasing its drugs for use in executions. Some states feel that only lethal injection is an appropriately humane method. Some allow the use of the electric chair as well. In Utah, the use of a firing squad is once again an option. For states that do not allow methods other than lethal injection, these restrictions are creating a shortage of the cocktail of drugs involved, impacting the state’s ability to execute those they have sentenced.

Blocking states’ ability to purchase these drugs limits their ability to execute those convicted of capital crimes by that method but it merely delays these executions until other methods can be approved or the drugs are acquired some other way. It isn’t an effective method for changing capital punishment as a policy. But companies in the United States, and all over the world, have used their power to refuse to sell these drugs to protest the death penalty with mixed consequences.

The Process

Lethal injection as a method of execution is surprisingly complicated. One would think that the process of killing a prisoner would be simple, but in most states that is not the case. Executions typically involve a cocktail of three different drugs. First a sedative, typically some kind of barbiturate, to render the condemned unconscious. Then a paralytic, which affects one’s ability to breathe. Finally, potassium chloride to stop the heart.

This Forbes article goes into detail regarding the specific drugs and their effects on the human body, but essentially, the potential to cause suffering through misapplication of this method is very high. In the video below from CNN, Dr. Sanjay Gupta also gives a brief explanation of the process here, specifically in regard to the “botched” execution of Clayton Lockett.

As explained in the video, the execution process failed to go as planned even though Oklahoma was following a protocol that had been approved and is not considered to be inhumane. In fact, the Supreme Court recently upheld the protocol–specifically the use of the drug midazolam as the sedative–finding that it is not in violation of the 8th Amendment prohibition against cruel and unusual punishment. Oklahoma increased the amount of that drug used in its executions since the Lockett execution, but the essential three-step drug protocol is the same.

This is the central problem that Pfizer is trying to address with its sales ban. Like other companies and the European Union, which also bans the sale of drugs used in executions to state facilities, Pfizer does not want its products used to carry out executions. These products, Pfizer argues, were meant to promote health for its clients and using them in an execution is antithetical to its purpose as a company.

But these efforts, although they may assuage the consciences of the companies and nations that employ them, are not without cost. They make it just difficult enough for states to acquire these drugs that the process becomes less transparent and more dangerous, but not difficult enough to stop executions altogether. States have come up with various methods to circumvent these restrictions. For example, reviving the firing squad as an option in Utah is in part a response to the difficulty getting lethal injection drugs.

States also now turn to “compounding pharmacies” to get the necessary drug cocktail. These companies purchase the drugs by themselves, since the state cannot buy them due to company restrictions, and combine them for use in an execution. They aren’t regulated to the same degree as a traditional pharmaceutical company, which means figuring out how effective the drugs will be in making execution as humane as possible is more difficult. States also may try to use straw men purchasers in order to get the needed drugs.

In order to facilitate these executions by lethal injection, as opposed to another method such as the electric chair, Virginia and a few other states have proposed allowing pharmacists who assist the state to remain secret. This video provides some of the arguments against this proposal and a look at some of the legal issues surrounding it.

Allowing pharmaceutical companies who assist the state in executions to remain secret or to hide the sources of the drugs creates a host of concerns. Firstly, it prevents lawyers from getting the necessary information to challenge an execution that they feel was cruel and unusual. They won’t be able to get evidence about the protocol used in that particular execution, making it harder to stop a protocol from being repeated the future. Secondly, it prevents lawyers from finding out where the drugs are coming from before the execution as well, so they would be unable to challenge the use of drugs from a company that had a history of errors in other medical contexts.

It also eliminates the fear of being sued or criminally charged for mistakes made in the preparations of the drugs, which is one of the most powerful incentives for pharmaceutical companies to behave properly. In the absence of adequate regulation, the power to be economically damaged by a lawsuit is one of the ways that consumers can ensure product safety. Getting rid of that tool for death penalty drugs could allow the negligent behavior to go unchecked. While there are lobbying groups who oppose the death penalty that put pressure on pharmaceutical companies, there is not the same widespread social concern for this issue that would give companies an incentive to be responsible, for fear of a boycott, as there would be for a product like aspirin. The heinous nature of the crimes that these prisoners have committed means that many people aren’t concerned about whether they are executed humanely. Even in cases where the execution was extremely painful, so-called “botched” executions, it isn’t a top priority for most to change how we execute criminals.

Humane For Whom? 

Moves by pharmaceutical companies to prevent their drugs from being used in executions has sparked an interesting debate. Most would argue that they should have the right to restrict these sales, but in doing so they are actually increasing the likelihood that states will botch executions. Several executions have been delayed but a state is more likely to turn to a compounding pharmacy or get the drugs from another state than it is to revert to an alternate method of execution. So far only Utah and Oklahoma have gone outside the box–with firing squad and gas chamber respectively–that our interest in “humane” executions has placed us in. We tend to think of lethal injection as the best method because it is the most medically supervised and modern practice used. But 7 percent of executions by lethal injections are “botched,” meaning 7 percent of the time someone made a mistake that could have left the prisoner sensible to pain or prolonged their death for many minutes or hours. Although it is less often used, the percentage of botched firing squad executions is zero.

Despite its cheapness and efficiency as a method of execution, the guillotine has not seen a resurgence of popularity either, although it was originally invented as a more humane alternative to hanging as a means of execution. If the condemned were acting rationally they would choose the guillotine rather than lethal injection as their method of choice because, like a firing squad, a prolonged execution is less likely. From that viewpoint, it is a more humane method. Yet we continue to employ lethal injection because it is considered a more humane method by the observers.

There is a case to be made for pharmaceutical companies to work together with states. If these companies want to improve humane executions, while keeping the death penalty intact, working with states rather than against them might be the best option. Pharmaceutical companies have access to the best research available and thousands of drugs that are used in life-saving therapies that might be helpful in executions as well. When companies decide to restrict the use of their drugs for executions, advocacy groups generally applaud them, but they may want to work together to improve the current system first. If lethal injection is really the best method, then these companies and advocacy groups might be able to better serve the people they wish to protect by advocating for better lethal injections, even if they are continuing to advocate for an outright ban at the same time.

Conclusion 

Pfizer’s announcement has been ridiculed by many as simply a PR move to appeal to a constituency that opposes the death penalty. Especially since those who support the death penalty don’t typically care enough about it to protest a company that opposes it. It is impossible to know if Pfizer’s concerns are genuine but they aren’t alone in their attempts to ban the use of these medications in a practice they find unethical. Companies commonly take moral stands on issues and either grant or refuse their support based on those values. But Pfizer and companies like it may be doing more harm to their cause than good. Rather than forcing states to make an end-run around their restrictions, thereby making executions less transparent and less humane, pharmaceutical companies should work with states to ensure that their products are being used as humanely as possible.

Resources 

NPR: Utah Brings Back Firing Squad Executions

Death Penalty Info: State Lethal Injection

Forbes: The Pharmacology and Toxicology of Execution by Lethal Injection

CNN: Clayton Lockett Oklahoma Execution

NPR: Supreme Court Says Oklahoma’s Use of Midazolam in Lethal Injection Is Legal

Wall Street Journal: Pfizer Tightens Controls to Block Use of Its Drugs In Executions

New York Times: Pfizer Blocks the Use of Its Drugs in Executions

Death Penalty Info: Some Examples Post-Furman Botched Executions 

Atlantic.com: The Case For Bringing Back the Guillotine

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Death Is Different: Restricting the Sale of Lethal Injection Drugs appeared first on Law Street.

Pfizer’s announcement on Friday that it will enforce the distribution restriction of its drugs that are used in lethal cocktails makes it the last FDA-approved pharmaceutical company to do so. Which means states that still carry out executions are forced to go underground to find drugs, or go back to very outdated options.

Pfizer stated:

Pfizer makes its products solely to enhance and save the lives of the patients we serve. We strongly object to the use of any of our products in the lethal injection process for capital punishment.

We are committed to ensuring that our products remain available and accessible to the medical professionals and patients who rely upon them every day. We have implemented a comprehensive strategy and enhanced restricted distribution protocols for a select group of products to help combat their unauthorized use for capital punishment.

Pfizer is the second largest pharmaceutical company in the world, and its stance on the issue is important. However, it’s hard to know exactly how big of an impact it will have on the actual business of executions because of the secrecy surrounding the process. There are 32 states still using death penalty, and of those, a majority are not open about their drug sources because of fear of  violent actions from execution opponents.

As Law Street has reported earlier, the lethal injection crisis has been going on for a few years. This is due to drug manufacturers’ refusal to provide drugs for this purpose, and export restrictions from European nations, where capital punishment is no longer in use. This has led to the use of drugs that could cause unnecessary suffering, or drugs from compounding pharmacies, resulting in some drawn-out and seemingly painful deaths. To not have to break the law to carry out executions, some states have actually turned to old-fashioned options such as the firing squad, electric chairs, or even gas chamber as possible solutions. Others have just delayed executions again and again, waiting to find the right drugs.

Emma Von Zeipel

Emma Von Zeipel is a staff writer at Law Street Media. She is originally from one of the islands of Stockholm, Sweden. After working for Democratic Voice of Burma in Thailand, she ended up in New York City. She has a BA in journalism from Stockholm University and is passionate about human rights, good books, horses, and European chocolate. Contact Emma at EVonZeipel@LawStreetMedia.com.

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Counterfeit drugs pose both domestic and global threats, presenting serious health risks worldwide. Although the issue is most prevalent outside the United States, Americans aren’t immune to the illegal market’s reach, as there have been far-reaching counterfeit drug cases in the U.S. As a result, there’s been a large effort to combat the problem in America. Read on to learn more about the proliferation of counterfeit drugs, and what’s being done to stop them.

What are counterfeit drugs?

According to the World Health Organization (WHO):

Counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

The issue was first addressed in the 1995 WHO Conference of Experts on Rational Drug Use in Nairobi, Kenya. Since then, the market has expanded, but preventive measures have also multiplied. Most counterfeited drugs consist of antibiotics, hormones, analgesics, steroids, and antihistamines. In all, counterfeit drugs are divided into six categories: products without active ingredients (32.1 percent of counterfeits), products with incorrect quantities of active ingredients (20.2 percent of counterfeits), products with wrong ingredients (21.4 percent of counterfeits), products with correct quantities of active ingredients but with fake packaging (15.6 percent of counterfeits), copies of an original product (1 percent of counterfeits), and products with high levels of impurities and contaminants (8.5 percent of counterfeits).

The FDA believes the growth in the counterfeit drug market may be due to the escalating costs of prescription drugs, advanced technologies to develop counterfeit drugs, and the anonymity and ease of the internet.

Health Risks

The severity of the risk factors for any specific counterfeit drug will vary. Generally, they can actively cause unexpected side effects, an allergic reaction, the worsening of the existing medical condition, and/or prolong treatment periods.

A counterfeit drug that substitutes an inert substance for the active ingredient will not improve a person’s medical condition. For example, the main ingredient in Lipitor (a commonly counterfeited drug in the U.S.) is atorvastatin. Its purpose is to lower high cholesterol and triglyceride levels, and therefore reduce the risk of stroke and heart attack. If a patient believes he/she is taking atorvastatin, but in fact is consuming an inert substance, the consequences could be deadly. Even worse, in some cases, not all substituted or added substances are inert, but are instead hazardous.

 U.S. and Global Statistics About Counterfeit Drugs

The international counterfeit drug market amasses $200 billion a year. Internet sales make up $75 billion of that market. Most counterfeits are made in China and India. In the United States, 80 percent of counterfeit medicine is brought into the country from outside.

The WHO estimates that up to ten percent of the drugs sold internationally are counterfeit. In some countries this number can reach up to 50 percent. Developed countries that have strict regulations and institutions like the FDC, are estimated to sell less than one percent of counterfeit drugs. However, the United States has seen its share of highly publicized cases. With a few exceptions, the United States counterfeit market is generally focused on “lifestyle” drugs like diet, erectile dysfunction, and hair growth pills.

The counterfeit market is growing in the U.S. In 2014, an estimated 60 various Pfizer products were being counterfeited compared to just 20 in 2008. One of the most popular counterfeited pharmacy items is ChapStick. China reported holding 1,300 alleged counterfeiters and confiscating $362 million worth of counterfeit product in 2013.

According to the WHO, an estimated 200,000 people die a year due to “ineffective, fake, and substandard malaria drugs” that don’t eliminate parasites from a person’s system. To make matters worse, the fake drugs often contain a smaller dosage of the active ingredient than necessary. Thus the fake drug cures symptoms without curing the disease and fuels drug-resistant strands.

Counterfeit Drugs in the U.S.

A counterfeit maker of Avastin, a cancer drug, accessed the U.S. supply chain in 2012. This was the first major exception to the notion that counterfeits in the U.S. were limited to lifestyle drugs. Undetected, doctors and purchasing managers for oncology clinics “bought and administered the counterfeit medicines to their patients.”

In May 2012, a counterfeit version of Teva Pharmaceutical’s Adderall 30 mg tablets entered the market. The FDA labeled the counterfeit “unsafe, ineffective, and potentially harmful.” The counterfeit version did not contain the active ingredients dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amephtamine sulfate. Instead, it contained ineffective ingredients tramadol and acetaminophen. The original product is orange and peach in color with markings, while the counterfeit is white and devoid of any markings. Entering the counterfeit market for Adderall was probably seen as a lucrative opportunity, as Adderall is on the FDA’s drug shortage list, which means that it is dispersed only when available.

The drug Procrit, used to treat anemic patients with “cancer and other serious diseases,” had a large counterfeit scare in 2013. FDA investigators found three fake batches bearing three different lot numbers and expiration dates. The fake medicines contained a clear liquid with no active ingredient and two life-threatening strains of bacteria. Not only was patients’ anemia going unchecked, but already-weak patients were consuming potentially deadly bacteria. The FDA dispersed a warning to the public and provided ways to check the authenticity of the product.

Precautions to Avoid Counterfeit Drugs

There are ways to help ensure that patients and customers purchase legitimate prescription drugs. Most counterfeited drugs are sold through the internet. The National Association of Boards of Pharmacy investigated 10,000 pharmaceutical sites and found that only three percent of the sites appeared “to be in compliance with pharmacy laws and practice standards.”

Internet sites to be avoided include those outside the United States; those that don’t offer a physical address; those that don’t display a license by the applicable state board of pharmacy;  those that don’t provide a licensed pharmacist to answer questions; and sites that don’t require a prescription. Consumers should also look for the Verified Internet Pharmacy Practice Sites (VIPPS) seal. There are over 30 online pharmacies that display this seal, which was created by the National Association of Boards of Pharmacy to combat sites selling counterfeit drugs.

Consumers must also be cautious when inspecting the packaging of their product by looking for altered or unsealed containers or any physical differences in the appropriate packaging or product appearance. A change in taste and side effects could signal counterfeits as well.

 Actions Against Counterfeit Drugs

In 2012, the United States and 110 other countries participated in INTERPOL’s Pangea sting operation. The operation resulted in:

11,000 illegal online pharmacies being shut down, the removal 19,000 ads for fake drugs on social media sites, the seizure of 9.4 million doses of phony medicines…Google agreed to spend $50 million annually over the next five years to crack down on advertising for illegal online pharmacies.

Pharmaceutical companies also have their own internal investigations to fight against counterfeit medicines. For example, one method is similar to fingerprinting. Pfizer designed an infrared spectrometer that analyzes a product’s chemical bonds. Every drug has unique “reflected and absorbed wavelengths.” A graph will produce peaks and valleys–like a fingerprint–depending on the ingredients and their quantities. Those in the Pfizer lab can superimpose fake “fingerprints” over the real ones on the computer and note the differences. Further testing with X-ray diffraction can show exactly what ingredients the fake is composed of.

In 2014, Eli Lilly, an Indianapolis-based pharmaceutical company, invested $110 million in creating traceable, unique stamping codes for all of its products sold globally. The stamping codes will allow the company to trace each product from manufacturing facility to patient, and combat fakes.

The Legal Side of Drug Counterfeiting

The Prescription Drug Marketing Act of 1987 (modified in 1992) effectively closed off the United States supply chain. The law directly aimed at protecting American consumers and avoiding counterfeit drugs by providing legal safeguards. It “provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product’s manufacturer.” It also provides uniform standards for all distribution channels including hospitals and wholesalers.

The Food and Drug Administration Safety and Innovation Act was enacted in July 2012. It granted the FDA new and enhanced powers to regulate prescription drugs and combat counterfeit drugs in the U.S. The FDA, for example, can now “administratively detain drugs believed to be adulterated or misbranded, and the authority to destroy certain adulterated, misbranded, or counterfeit drugs offered for import.”

The 2013 Drug Quality and Security Act “outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” Pharmaceutical companies must implement a tracking system by 2015 and tag serial numbers to each singular unit sold in the U.S. by 2017.

Conclusion

The counterfeiting of medicines is not a problem secluded to developing countries. Without proactive enforcement, counterfeit drugs could erupt in the United States. It is a highly lucrative industry for the black market. Pharmaceutical companies and consumers alike need to be responsible with prescription drugs, as the potential health risks can be deadly. This is a global problem that requires global cooperation.

Resources

Primary

FDA: Counterfeit Drugs, Questions and Answers

CDC: Counterfeit Drugs

FDA: Counterfeit Drugs

Additional

Nova Next: Cracking Down on Counterfeit Drugs

CBS News: Your Anemia Drug May Be Fake

Fierce Pharma: Lilly Steps up War on Counterfeits With $110M Serialization Program

HRF: 20 Shocking Counterfeit Drug Statistics

Medscape: Counterfeit Version of Adderall Unsafe, Ineffective, FDA Warns

PhRMA: Counterfeit Drugs

National Center for Biotechnology Information: The Prescription Drug Act of 1987

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

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