Archive for the 'Court' Category

Big Pharma Penalized, U.S. District Courts Rules in Favor of Maryland’s Price-Gouging Law

Pharmaceuticals have not been enjoying the greatest couple years when it comes to the court of public opinion. From Martin Shkreli’s infamous price jacking to recent price fixing convictions against Heritage Pharamaceuticals CEO Jeffrey Glazer, the hits have kept on coming as pharmaceutical scandals come out of the woodwork. Now, pharmaceutical companies have taken a hit in District Court as a judge has handed the first round victory to an anti-price gouging law out of Maryland targeting generic pharmaceuticals.

Despite the many instances of abuses on the part of pharmaceutical companies in the last few years, Congress has been slow to take any meaningful action on the issue. This has left the states to take action on their own and Maryland’s law–taking effect on October 1st just a few weeks back–is the first successful law of its kind.  However, pharmaceutical interests were very keen to see that was not the case. After the law was passed back in May, the Association for Accessible Medicines (AAM)–a group of generic pharmaceutical companies–quickly challenged the law as unconstitutional and sought a preliminary injunction to prevent the law from taking effect while their lawsuit was ongoing.

While the recent district court ruling shot down the potential of an injunction, the lawsuit is still far from over. Let’s take a look at the details of the statute out of Maryland, the AAM’s challenges to the law, the ruling of the court, and the trends of similar laws across the country.

big pharmaUnderstanding the Maryland’s Statute

The price gouging law, passed with a substantial bipartisan majority, is focused exclusively on off-patent and generic medications. It does not apply whatsoever to name brand drugs under patent protection.

It’s primary provision allows for Maryland to look into claims of unconscionable increases in the prices of generic medication. Where such an increase is found by the attorney general of Maryland, a fine of up to $10,000 can be levied against the manufacturer or distributor for each violation. The attorney general can also require companies to return money to consumers lost as a result of price gouging, order a stop to price gouging activities, an require a drug manufacturer to make a drug available to Medicaid participants at the pre-gouging price for up to a year.

In pursuing these investigations, the law allows the attorney general to require the accused company to produce records and justify their price changes. An opportunity to explain their increases is generally required under the law before levying fines. The information given in these explanations is held confidential by the attorney general where necessary.

The exact amount or percentage increase that would constitute “unconscionable” is not precisely defined in the law. However, “unconscionable” is far from a new legal concept and is often brought  up in the context of contract law as a situation where terms are so egregiously unjust in the favor of a party with greater bargaining power that a reasonable person would never agree to them. For example, where a life saving medicine is made incredibly expensive-beyond all market forces-but a purchaser has an option of either paying that price or suffering extreme consequences. This ambiguity when it came to the term unconscionable was central to AAM’s challenge to the law.

What are the AAM’s Arguments for Unconstitutionality?

AAM, as generic drug manufacturers, obviously didn’t care much for the law. Their challenges, however, were not frivolous attempts to slow down its progress. They made two primary arguments. First, the law overreached Maryland’s bounds by effecting potential pricing in states beyond just Maryland. Second, that the law itself was unconstitutionally vague.

The first argument hinged on a fairly uncommon argument in this day and age-the dormant commerce clause. The commerce clause is the power of the federal government to regulate commerce involving multiple states. However, in its current interpretation, the dormant commerce clause is a product of this power which prevents states from passing legislation which favors one state over the other. The dormant commerce clause also requires a balancing test where a law places a burden on commerce between states. However, it is exceedingly rare to see a law struck down on this basis in recent history. What’s more, merely burdening interstate commerce faces a much less rigorous test for constitutionality than favoring one state over another in a law.

The second argument, that the law was void for vagueness, pointed at the lack of concrete definition to the term “unconscionable” and said that the law was unconstitutional because manufacturers couldn’t know when they were violating it. In general, a law is unconstitutional were it doesn’t give the public notice of when they are violating it, impinging on their constitutional due process rights.

What was the District Court Ruling?

In deciding on the case, the District Court did several things which amount to handing a rousing victory to Maryland. First, it denied all injunctions and allowed the law to go forward as planned. Preliminary injunctions require, among other things, a showing that the plaintiff is particularly likely to succeed. The court just didn’t think that likelihood was here for AAM.

Second, the court outright dismissed AAM’s claims regarding the dormant commerce clause. They ruled that the law applies neutrally to all interstate commerce and thus the argument held no weight.

However, it wasn’t a clean sweep for Maryland here. The court didn’t rule in favor of AAM’s vagueness argument, but they did allow litigation on the issue to go forward. The judge felt the arguments were reasonable enough to bear fully exploring. Even then, the judge went out of his way in his ruling to note he didn’t think the arguments were necessarily winning ones.

This case is far from over. Even with the vagueness argument making its way through the ruling, AAM have already made it clear that they look to appeal and believe their case will succeed in the higher courts. For now though, it’s a victory for Maryland and the price gouging law will continue as planned.

Good News: Maryland’s Law is a Growing Trend

Maryland’s price gouging law may be the first to be passed, but it looks to be part of a concerted effort by the states to address this issue where the federal government has not. 36 states have introduced, if not passed, nearly 200 bills related to pharmaceutical pricing in the last year. Nevada passed a law in June, a month after Maryland, which requires drug manufacturers to release price and profits on insulin every year. Ohio has an upcoming vote on a law which would make it illegal for the state and its agents to buy drugs at a higher price than the U.S. Department of Veteran Affairs.

At least for Maryland’s law, AAM and a few others have criticized it for targeting generic drugs. They say that generic drugs are driving down medical costs and going them doesn’t make sense. However, this argument is a bit tone deaf in the of the off-patent Daraprim being the very drug at the center of Martin Shkreli’s infamous price hikes.

Regardless of how you feel about Maryland’s law, there’s little question that price gouging on necessary medications is an issue to be addressed. Living with an illness such as diabetes in difficult enough without wondering whether your insulin may suddenly skyrocket in price. For now, Maryland has won this round. However, this is a trend to keep an eye on–both out of the states and the federal government.

Preventing Rapists from Obtaining Child Custody

Many child custody cases are heart-breaking, but the most horrific cases involve children who were forcibly conceived. The law struggles with what appears to be the easiest of questions: do rapists have child custody rights?

The Horrific Case of Tiffany and Christopher Mirasolo

In September 2008, 12 year old Tiffany and her sister slipped out at night to meet a boy. The boy’s older friend, 18 year old Christopher Mirasolo, offered to take the girls on a car ride. Instead, Mirasolo held them captive in a vacant house for two days. After raping Tiffany, he released the girls, but threatened to kill them if the girls reported him.

When Tiffany became pregnant, Mirasolo was arrested. He was sentenced to a year in county jail, but only served half a year, to look after his sick mother. Mirasolo was arrested for a second sex assault on a teenage victim two years later. He only served 4 years in prison.

Meanwhile, Tiffany struggled to support the son she gave birth to as a pre-teen. She skipped high school and went straight to work to support her boy. Unfortunately, Tiffany did not make enough money to support her child, so she applied for welfare. Shockingly, state welfare services would not help her unless she named who the father was. When Tiffany named Christopher Mirasolo as the father, state support service filed a support claim on Tiffany’s behalf. The support claim resulted in Tiffany sharing joint child custody with her rapist.

child custodyWhy Would the Judge Grant Joint Legal Custody?

Many states have guidelines and/or laws limiting how welfare is distributed. When Tiffany applied for welfare as a single mother, the state likely has an automatic process whereby it attempts to obtain child support from the father before providing welfare. The goal of course is to save taxpayer money and to transfer the obligation of supporting the child to the responsible party, the other parent.

In order for the state to order a man to pay child support, he must be proven to be the father of the child. Ordinarily, this would be a reasonable policy. The state cannot force people to be couples, but it can try to force people to be responsible for the offspring they create. However, all these reasonable policies and assumptions break down when it is obvious that the mother and father should not be in the same room. Judges have discretion to determine custody arrangements, but judges are bound by state law. Unless there is a statute that prohibits a judge from granting joint custody, most judges will err on the side of joint custody.

However, states vary in how they approach rape and child custody. In 20 states and the District of Columbia, a rape conviction is required before termination of parental rights is allowed.  Five states, Wyoming, North Dakota, Minnesota, Alabama and Maryland, do not have any laws prohibiting rapists from obtaining child custody. Since criminals are primarily state laws, the most the federal government can do is encourage states to enact laws barring child custody to rapists. The Rape Survivor Child Custody Act, signed by President Obama in 2015, gives states funds for passing laws that prevent convicted rapists from obtaining child custody. That’s the extent of the federal government’s involvement in custody and criminal cases though.

How Can We Change Course?

According to the American Journal of Obstetrics and Gynecology, about 5% of rape victims become pregnant as a result of rape; that’s about 32, 101 pregnancies per year. In percentages, the number is not high. However, each pregnancy because of rape brings out legal and ethical issues that impact both the mother and the child.

First, raising a child together is arguably a more intimate relationship than sex itself.  I have sat through custody hearings where the judge reminds young parents that “you will likely see each other at your child’s teacher-parent meeting, soccer games, college admission tours, wedding, and the birth of your grandchildren. The commitment you made when you decided to have a child together is not a commitment that ends in 18 years; it is a lifetime commitment.” Normally these are words of wisdom. Forcing a rape victim to forge this daily and emotional relationship with the rapist would only lead to more traumas and would likely reduce the victim’s ability to take care of herself, let alone her child.

Second, forcing the child to spend time with the rapist/father would endanger the child. If someone like Mirasolo was willing to kidnap and rape a 12 year old, there is no guarantee that he would not rape his child. Although the child in the Michigan case is a boy, rape is about power. Endangering the child’s life or threatening to do so would allow someone like Mirasolo to further control his victim. Even if professional supervised visitation is an option, it would not prevent the “father” from using the legal system to further exploit his control over the victim and the child.

If the father is convicted of raping the mother in a criminal court, it is imperative that the law extinguish the father’s custody rights. The risk to both mother and child are too great. Arguably, it might be in the best interests of the child to know where he or she came from. However, if the child wants to undertake that journey, they can do so when they are an older and independent adult, able to understand what rape is and why the man who conceived his or her existence is not a good person. If the judge does believe the child might have an interest in being raised by both the victim and the rapist, the judge should at least appoint an independent counsel for the child so that rapist’s arguments do not just outweigh the victim’s interests.

Can You Refuse To Vaccinate Your Child During a Divorce?

Rebecca Bredow was sentenced to a week in jail after she refused a court order to vaccinate her nine year old son. Bredow and her ex-husband had initially agreed to vaccinate their nine year old son, but Bredow later decided against it. Bredow argues that the parents had initially agreed not to give their child a vaccination and that it was her husband who changed his mind, in order to obtain leverage over their custody dispute. Their son will be in the care of Mr. Bredow until Ms. Bredow is released from jail.

Michigan allows parents of public school children to waive vaccination for their child, but the parents have to attend an education seminar on the benefits of vaccination first.  Health officials are worried that if children are not vaccinated, diseases such as measles will return. The reappearance of diseases that Americans have not been exposed to in a generation would result in a devastating outbreak. On the other hand, the parents want to waive vaccination are worried that the vaccines will give their children autism. However, scientific studies have largely debunked such claims.

vaccinateAlthough the medical benefits outweigh the falsely reported disadvantages of vaccinations, Bredow was not sentenced because of her opinions on vaccines; the legal facts determined her conviction.

Avoiding Confrontation with the Judge

The default in child custody is joint custody for both parents. People often mistake “joint custody” for “50/50%,” but family law judges will discourage parents from thinking about child custody in percentages. Children are not sacks of flour to be divided between disputing parties. Joint custody is the default child custody because the law presumes that it is in the best interests of the children to have both parents in their lives, not because it is fair to the parents. However, judges can deviate from the default joint custody if joint custody stops being in the best interests of the children.

Ms. Bredow made two mistakes that led to her week long jail sentence. First, she told the judge that it was against her beliefs to give her children vaccines. In a child custody case, the beliefs of the parents are not the deciding factor. In fact, asserting a personal belief in a custody battle can be harmful, since the judge might interpret that statement to mean that the parent is more concerned about his or her personal beliefs than the well-being of the children. In a child custody case, it is always preferable to relate the case back to the best interests of the children instead of arguing about other factors. Instead of saying that vaccines are against her beliefs, Bredow should have argued that the vaccines were potentially harmful to the children.

Second, Bredow publicly stated that she would refuse to obey the court order. There are many legal ways to challenge a court order. Bredow could have appealed the order. She could have filed a motion to reconsider the matter. Or Bredow could have chosen not to stipulate to an agreement in the first place. The worst thing to do though would be to agree to certain terms and then violate the court order to enforce the agreement that the parties made.

Massachusetts Rules Field Sobriety Tests Can’t Prove You’re High While Driving

As marijuana–either medical or recreational–has seen increasing legalization across the country, the implications of that legalization have led to any number of legal concerns. One of the chief among those has been how police officers will be able to establish that somebody is intoxicated for the purposes of a driving while intoxicated (DWI) charge. Out in Massachusetts, there has finally been a ruling on the issue. However, it has made it even more difficult than ever before for Massachusetts police to prosecute somebody for driving while high.

Massachusetts approved the “”possession, use, distribution, and cultivation of marijuana,” recently. The legalization, taking effect January 1, 2018, is conditioned on regulating marijuana in the same vein as alcohol. Stores selling marijuana have been pushed back to June 2018 over concerns over lack of legal preparation to deal with widespread legalized marijuana.

The Massachusetts Supreme Judicial Court made a ruling last week which, in some ways validates these fears.  They have ruled that-for the most part-the usual field sobriety tests can’t be used as evidence that somebody is driving under the influence of marijuana.

sobriety testMr. Gerhardt’s Sticky Situation

The case itself dealt with a man named Thomas Gerhardt. Mr. Gerhardt was pulled over for not having his lights on. However, once he was pulled over the officer reported smelling burned marijuana from his car. When asked if he had marijuana, Mr. Gerhardt responded that he had a couple of marijuana cigarettes in his ashtray-pointing to a couple of mostly consumed marijuana cigarettes. When asked when they were smoked, one passenger said about twenty minutes prior while Mr. Gerhardt said around three hours ago. When asked how much marijuana he had smoked, Mr. Gerhardt replied about a gram.

The officer had Mr. Gerhardt perform several field sobriety tests, standing on one leg, the heel-to-toe walk test, following a finger with his eyes, and reciting the alphabet. For the most part, Mr. Gerhardt had no issues with the tests. However, he was incapable of understanding the instructions of the walk and turn test despite several explanations. In the end, he was incapable of performing the test properly, walking normally instead of heel-to-toe. He was also unable to stay balanced while standing on one leg. The officer took this to imply that that Mr. Gerhardt was impaired by marijuana. This led to charges of driving while under the influence of marijuana-obviously still a crime regardless of legalization.

However, Mr. Gerhardt’s attorneys challenged this evidence. They argued that the tests are fine for establishing that alcohol has impaired a person’s ability to drive but aren’t suited to testing how impaired a person is who has smoked marijuana. After all, a DUI doesn’t happen just because you’ve drank-it’s because you’ve drank to a point of impairment agreed upon to be over .08% BAC after much scientific testing. By the same token, the crime of driving under the influence of marijuana is due to the impairment from the marijuana. But to be guilty, that impairment must be established. The Massachusetts Supreme Judicial Court felt that the research on the correlation between these field tests are being impaired by marijuana just wasn’t there yet.

Scientific Tests as Evidence

There is a strong, well scientifically tested, relationship between these field tests and impairment due to alcohol consumption. That scientific testing simply hasn’t happened when it comes to marijuana. Without diving too deep into the issues of evidentiary law, anything that tends to prove any fact of consequence to a case-or provide a link in a chain towards doing this-is relevant and admissible evidence barring several exceptions.

Scientific tests have the potential to be considered more weighty than they actually are due to a bias towards accepting the validity of such tests. Scientific evidence must be based in sufficient evidence and be a product of reliable principles and methods. This evaluation has largely replaced a previous test requiring the acceptance of a scientific test by the scientific community at large. However, in practice, both tests can be thought of similarly. To be admissible, a test needs to be generally accepted by the scientific community to produce reliable results on an issue. The court didn’t think these field tests had been suitably vetted by the scientific community when it came to marijuana impairment.

In fact, there is quite a bit of disagreement in the scientific community over how effective tests like this are when it comes to detecting marijuana impairment. This is partially because marijuana’s effects vary enormously from person to person. Marijuana also operates very differently from alcohol, so the same tests may not produce as concrete results. Either way, the potential for a jury to look at these tests and weigh them too heavily made their use to prove impairment inadmissible.

How These Tests Can Be Used

This doesn’t mean these field tests can’t be admitted. It just means they can’t be relied on as evidence of actual impairment. They can still be used to show balance, coordination, mental acuity, etc. What’s more, the court ruled that a jury can still use their common sense to translate this into whether somebody was impaired. An officer could testify to appearance (red eyes, etc.), behavior or demeanor, but they couldn’t say somebody was impaired or “high.”

What’s more, under the ruling, no officer or expert could testify that somebody passed or failed such a test as that would imply the test had scientifically conclusive results. Similarly, a witness could not say somebody was or was not impaired based on the results of a field test. In fact, a witness couldn’t even call the field tests a “test” in the first place as this would imply scientific credibility.  Essentially, the ruling says that, no matter what, it must be crystal clear that field tests have no ability to directly test for marijuana impairment.

A Complicated Practical Issue

This ruling makes sense, the scientific research isn’t there to support using field tests to determine marijuana impairment. However, the ruling also highlights a serious issue. State marijuana legalization is becoming more widespread as more and more states vote for medical or recreational legalization. Along with this will come a greater need for law enforcement to be prepared to deal with situations such as pulling somebody over for driving under the influence of marijuana. We’ll need tests sooner rather than later to judge impairment where we can’t use a breathalyzer or similar device to reliably establish how impaired somebody is. Even then, such a device assumes that each person is equally impaired while studies show widely varied effects of marijuana on different people. The law and the technology of the law has some catching up to do–and it needs to do it fast.

Death Wish Coffee Initiates FDA Recall Over Potential for Toxin in Brew

In a twist of irony, a manufacturer of cold-brew coffee by the name of “Death Wish Coffee” (named such for how strong their coffee is) has discovered that its manufacturing process has the potential to lead to growth of a toxin known as botulinum-a poison that can cause botulism. While there have been no reported cases of anybody actually getting sick, Death Wish has notified the FDA that it will still being moving forward with a product recall of all their 11 ounce cans. Those who’ve bought their coffee in stores–most places that sold the coffee were on the East Coast of the U.S.–can return the cans for a full refund with a proof of purchase. If you bought any cans online, you can throw them out and Death Wish will provide a full refund if you request one in the month and a half or so.

Death Wish has described the recall as a proactive step in the interest of protecting their customers. This is an admirable stance to take. However, there is also an element of protecting their company from liability. U.S. law requires companies to initiate recalls in certain situations. What’s more, a recall can potentially protect a company from future liability when a real defect exists. Let’s take a look at how product recalls are handled in the U.S and how they relate to how you might sue if you’ve been heard by a recalled product or a product that is eventually recalled.

death wishProduct Recall Law

If you make, import, distribute, or sell goods to the public, U.S. law can legally obligate you to report potential issues with your product and potentially issue a recall. If you don’t do so, or don’t do so in a timely enough manner, it can result in criminal or civil penalties for you and your company. As you might imagine, it’s incredibly important to know these reporting requirements to protect your business.

In the U.S. recalls are generally handled by one of six agencies–the Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA), the Environmental Protection Agency, Food Safety and Inspection Services, the National Highway Traffic Safety Administration, and the Coast Guard. Each agency has its own set of rules that need to be followed for reporting potential safety issues with products. In Death Wish’s case, the FDA is handling the process as they tend to handle food products.

Exactly when and how your company needs to report an issue for a potential recall varies a fair bit depending on what your product is and which agency you need to report to. However, as a rule, you’ll to report any defect in your products that could create a substantial risk of injury to customers or an unreasonable risk of serious injury or death. There are also a number of regulatory and statutory situations where you may need to report, such as where a kid is seriously hurt playing with a toy you produce.

When you become aware of an issue with your product, you’re required to report it immediately. The exact meaning of “immediately” can vary. However, you basically need to report within 24 hours of discovering information which reasonably indicates a reportable matter such as those discussed above. This doesn’t mean you can’t investigate such an issue to make sure, but don’t take your time with it. Taking longer than a week or so to investigate can land you in hot water. You’re considered to have been made aware of an issue as soon as it is received by you or somebody who works for you who should reasonably be able to recognize the significance of the information before them. After that point, agencies give you less than a week-the CPSC gives you five days tops-to get that information to the an officer of your company.

It should be noted that being potentially dangerous doesn’t require a recall in and of itself. Many products-like pocket knives-present a certain amount of danger by their very nature. Being sharp wouldn’t require a recall, being likely to shatter into many sharp pieces when used as intended likely would-a recall report generally takes into account the nature of the product to be recalled.

Most agencies recommend a policy of reporting if you’re in doubt. However, this is a bit of an oversimplification of the issue. Obviously, if you might face criminal charges for not reporting then you should report. However, there is the middle ground such as Death Wish’s recall. Their manufacturing process has the potential for danger to their consumers but there is no evidence their existing products have any issue. Recalling is probably a good idea, however there is certainly a serious publicity hit to announcing a recall. Death Wish may have a death wish because many companies have seen a recall effectively end their business. That being said, announcing a recall can protect a company from liability to some extent. If you make the recall public then a member of the public who ignores the warning may lose their case against you. Depending on how a company handles their recall it can be viewed as a subsequent remedial measure-steps taken to make an earlier injury or harm less likely to occur in the future. When this is the case, a plaintiff often can’t use these steps (the recall) as evidence of negligence of a defective product. However, this doesn’t mean that these companies are shielded from liability completely. It’s quite often to see a recall give rise to a class action lawsuit of people hurt by the defective product before the recall was announced. These lawsuits come in a number of forms, but are generally negligence or product defect lawsuits. It’s important to understand how these work if you’ve been hurt by a product that is later recalled.

Product Defects

Product defect cases exist in a few types of situations. Where there is a defect in the way a product is designed that is known as a design defect. Where there is a problem in the manufacturing process-as it was with Death Wish Coffee-that is known as a manufacturing defect. Finally, where a product fails to include clear warnings of dangers associated with normal use that is known as a labeling defect. In all these situations, a company that is any part of a distribution chain for a product may be held liable for injuries caused by a defective product.

Product defects are generally a standalone cause of action against a company. However, depending on where you live the strength of the laws may vary. Even where product defect liability isn’t available, there may be a negligence case if the company has not followed the standard safety practices of their industry.

Death Wish has taken steps to make sure nobody ever gets hurt by their product. This is both an admirable decision and potentially a preemptive step to avoid liability which could end a fledgling company such as theirs. However, while no issue with botulism has been reported, they may still face lawsuits from those who were injured but did not make the connection. That being said, they’ve protected themselves from liability if somebody gets sick after not choosing to simply chuck out their coffee. Understanding this balance–as well as you are required to report–is crucial to running a business. At the same time, understanding your rights a consumer is important when a recall such as this is issued. If you’ve been hurt by a product, you may well be able to recover for your injury or the economic losses from purchasing the product.