Dangerous Drugs – Consumer Rights
Nearly 7 in 10 Americans take at least one prescription drug and more than half take at least two. The Mayo Clinic reports 20 percent of Americans are taking five or more prescription medications.
When designed, manufactured, prescribed and administered correctly, prescription drugs can provide therapeutic and even life-saving benefits to people suffering from a range of conditions, from heart disease to chronic pain to contagious illnesses.
However, Boston dangerous drug attorneys at The Attorney Injury Group know that far too often, these drugs are rushed to market, inadequately tested, overprescribed, poorly-monitored or wrongly-administered. When this happens, resulting in serious illness, injury or death, patients and loved ones may seek remedy through the civil justice system.
The recognition of consumer rights regarding expectation of safe, effective drugs was first established in the U.S. with the 1906 Pure Food and Drug Act, also referred to as the “Wiley Act.” This legislation was enacted to prevent the manufacture, sale or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines and liquors. It was the start of the Bureau of Chemistry, which later became the U.S. Food & Drug Administration.
It’s an agency that promises to protect the public from unreasonably dangerous medications and other products. Unfortunately, the pharmaceutical industry has proved a powerful one, and these protections – and remedies against violators – have weakened over the years.
Still, there may be opportunity for compensation with help from an experienced, knowledgeable, well-resourced legal team.
AMERICA’S DRUG PROBLEM
The conversation about drug misuse and abuse in America tends to center primarily on the availability of illegal substances. These include drugs like:
- Marijuana (still in some states)
- Crystal Meth
It is estimated that some 20 million Americans – or about 8 percent – regularly use illegal drugs. However, America’s Drug Problem is much bigger than that, and involves an estimated 70 percent of Americans use prescription drugs. Over 52 million people in the U.S. over the age of 12 have used prescription drugs non-medically in their lifetime, with 6.1 million using them non-medically in the last month. The U.S. accounts for 5 percent of the world’s population, but consumes 75 percent of its prescription drugs.
According to the federal government, those who abused drugs were most likely to take:
- Painkillers – 5.1 million users
- Tranquilizers – 2.2 million users
- Stimulants – 1.1 million users
Of course, the majority of prescription drugs are used legally and responsibly. But that doesn’t mean there is no danger associated with their use.
Annually, the number of people who die from overdose of prescription drugs was more than 20,000 in 2013, according to the Centers for Disease Control and Prevention. That’s more than double the number of people who die in drunk driving accidents, and it doesn’t include deaths that were attributed not to overdose but rather contamination or some other drug-related complication.
A driving force behind America’s drug problem is the rate at which physicians are Overprescribing these drugs. A study published in 2015 by the Journal of the American Medical Association revealed the prevalence of people taking five or more prescription drugs nearly doubled from 2002 to 2012.
Part of the increase can be attributed to obesity, considering eight of the 10 most commonly-prescribed drugs are for conditions like heart failure, diabetes and hypertension – diseases directly related to obesity.
However, doctors who negligently overprescribe medications – particularly powerful painkillers and other potentially lethal drugs – are subject to liability when they fail to use proper care. In order to prove medical malpractice, plaintiffs need to present expert witness testimony from a professional in the same field indicating the doctor’s actions deviated from acceptable care standards. Such claims will consider:
- Medical history
- How the condition is normally treated
- The doctor’s experience in treating this patient
- Doctor’s objective medical findings;
- Previous history or problems with addiction
Such claims often require in-depth investigation and complex analysis, but they can be successful with the right legal strategy.
Legally distributed drugs in the U.S. have to be FDA-approved and are only allowable for certain uses or certain patients. The drug label provides information about the type of drug, the approved doses, how it should be given and for which medical conditions.
When a drug is used in a way that deviates from the label, this is an Off-Label Use. A drug is off-label when it is:
- Used for a different medical condition or disease;
- Given in a different way;
- Provided in a different dose.
It’s estimated by the medical trade publication Hematology & Oncology News & Issues that between 40 and 60 percent of all prescriptions in the U.S. are written for off-label uses. An example would be a chemotherapy drug approved for treatment of leukemia being prescribed to a patient with lung cancer.
Off-label use of a drug is not necessarily illegal, but the health care provider needs to be educated about that drug and potential consequences. In some cases, “investigational drugs” – or those not yet approved – may have early promising results for serious and life-threatening conditions, and patients may be able to obtain a prescription, even though they are not yet approved.
Too often, drug manufacturers heavily promote off-label uses of drugs to doctors and patients in an attempt to boost sales. But such advertising can be reckless and damaging when the effects of that drug for that use are not clearly known.
Major drug manufacturers have paid billions of dollars in fines and penalties for marketing drugs for off-label uses.
LACK OF TESTING
There is a widespread erroneous assumption by the American public that prescription drugs would not be on the market if they weren’t thoroughly vetted by federal government regulators. This is not true.
Although the U.S. Food & Drug Administration does require testing for new drugs, there are a number of loopholes. Even when drugs are thoroughly tested before hitting the shelves, it’s the manufacturer that funds and oversees that testing, which calls into question the legitimacy of the results.
This Lack of Testing stems from the fact that even though the FDA has a Center for Drug Evaluation and Research, this branch does not do any actual testing of drugs itself. It may conduct limited research in certain areas of drug effectiveness, safety and quality. Primarily, though, it’s the manufacturers who pay huge sums to individuals and institutions to conduct this research. When the science is motivated by profits, the results are inevitably skewed.
Although the approval process for new drugs is supposed to take years, the FDA can choose to accelerate or hasten this process for certain products deemed “groundbreaking.” A huge portion of the FDA’s budget is derived from fees paid by manufacturers to obtain accelerated approval of their drug or medical device.
PROFITS OVER PEOPLE
The coincidence is tough to ignore: At a time when the federal government reported sharp rises in health care costs over the next 10 years, the report from a major pharmaceutical company unveiled a new earnings report indicating explosive profits of new drugs.
In 2014, government health care spending reached $3.1 million, or nearly $10,000 per person. It increased 5.5 percent in a single year and drug spending alone increased by 12.6 percent. Meanwhile, Gilead Sciences, manufacturer of two newer drugs, reported profits totaling $8.2 billion, which was a 26 percent increase from just a year earlier.
This manufacturer is on the small side. These companies rake in billions of dollars every year, and advertising revenues speak volumes about the way these companies place Profits Over People. According to The Pew Charitable Trusts, the pharmaceutical industry spent more than $27 billion on drug promotion just in 2012 alone – with $24 billion of that spent marketing to physicians. More than $3 billion was spent marketing to consumers, mainly via television commercials.
Direct to consumer ads really took off when the FDA changed its advertising rules in 1997 to allow drug companies to name their products in public ads. The Nielson Co. estimates there are now 80 drug ads on every hour of every day on American television. Now, people ask doctors for them by name, and those requests are often honored – despite the fact that these drugs are often not fully tested and the side effects not totally known.
GENERIC VS. NAME BRAND
In most product liability cases, cases are brought against the designer, manufacturer or distributor of a given product. However, when it comes to Generic vs. Name Brand drugs, plaintiffs may be frustrated to learn there are different rules.
This started with the U.S. Supreme Court’s ruling in Pliva v. Mensing, in which the court ruled 5-4 that makers of generic drugs (which account for 75 percent of prescriptions dispensed nationally) may not be sued under state law for failing to warn customers about risks associated with their products. That’s because manufacturers of generic drugs have to use the same warning labels as their brand name counterparts; they aren’t allowed to alter them.
But this effectively left consumers in a lurch when it came to compensation for injuries caused as a result of ineffective warnings. They couldn’t sue the brand name manufacturer – which didn’t make the drug – and they couldn’t sue the generic manufacturer, which didn’t create the label.
Consumers also couldn’t sue a generic manufacturer for the composition of the drug, because these companies by law have to keep the same formulation as the brand name. This was decided by the U.S. Supreme Court in 2013 with the case of Mutual Pharmaceutical Co. v. Bartlett.
However there have been some subsequent cases, for example Wyeth Inc. v. Weeks, from the Alabama Supreme Court in 2014, in which courts have ruled brand name companies can be held liable for damage caused by generic drugs, even though they didn’t make or market those drugs. That decision was then effectively reversed in 2015 by SB80, passed by the Alabama state legislature.
The FDA in December 2015 established a final rule intended to be released in 2016 that would allow generic drug companies to update labels with new safety information. This effectively nullifies Mensing because it gives generic manufacturers authority they did not previously have.
It is unlikely, however, that plaintiffs will be able to apply the rule retroactively to injuries sustained due to generic drugs prior to 2016.
KNOWN DANGEROUS DRUGS
Drug manufacturers can be liable for injuries caused by their products via several theories, including:
- Strict liability (does not require proof of negligence, only of harm);
- Failure to adequately warn;
- Breach of implied warranties (the drug was not reasonably safe);
- Breach of express warranties (the drug did not perform as the company expressly promised it would).
There are a number of Known Dangerous Drugs that our Massachusetts product liability lawyers have identified, including:
- Testosterone Replacement Therapy
If you have taken any of these drugs and have suffered negative side effects, an experienced injury lawyer can help you understand whether you may be entitled to compensation for medical bills, lost wages, pain and suffering and more.
PREGNANCY AND BIRTH DEFECTS
There are a number of medications that could be dangerous for a baby if taken by the mother during the course of pregnancy. These are identified as “teragenic drugs.”
Pregnancy and Birth Defects must be considered by designers, manufacturers and distributors of medication. These can range from alcohol to acne medicine to antibiotics. Medical science can’t always predict how exposure to a certain drug is going to affect a developing fetus, and sometimes, it can be dangerous for a woman or fetus to immediately stop taking a certain drug.
A number of lawsuits have cropped up recently involving a drug called Zofran, a cancer drug marketed for the off-label use of quelling nausea, sometimes with the side effect of birth defects in babies. Other lawsuits have focused on the effect antidepressant medications had on their pregnancies, despite being assured that such medications were safe.
OVERDOSE AND DEATH
The U.S. Center for Disease Control & Prevention reports that every day in the U.S., some 44 people die as a result of prescription opiod overdose. That doesn’t include those who die or are seriously injured by overdoses of non-painkiller prescriptions. The number of national overdose deaths from prescription drugs has nearly tripled from 2001 to 2014.
In fact were nearly 44,000 people who died as a result of drug overdose deaths in the U.S. in 2013. That’s more than the 30,000 people who die annually in car accidents in this country. Of those, 23,000 – or about 52 percent – overdosed on prescription drugs. That’s more than double the 10,000 who died in DUI crashes that year. The issue is especially problematic for those between the ages of 24 and 64.
Additionally, drug abuse and misuse results in about 2.5 million emergency department visits.
But when prescription drugs are involved, is the doctor ever liable? The answer is: It depends.
While doctors cannot always be expected to know when a patient will misuse or abuse medication, they are required to abide by applicable standards of care. If a doctor is providing patients with long-term pain management with powerful painkillers, problems with these drugs are well-known and the risk of Overdose and Death is high; thus, appropriate care must be exercised.
MENTAL ILLNESS AND PRESCRIPTION NARCOTICS
The National Alliance on Mental Illness (NAMI) estimates 1 in 4 adults in America – about 61.5 million – experience mental illness in any given year. Further, about 1 in 5 youth between the ages of 13 to 18 suffer severe mental disorders.
While medications can in some instances help to ease some of the worst symptoms, they can also do more harm than good. When multiple medications are prescribed for the same individual, there may be a high potential for overdose. Because of the significant problems that can arise between Mental Health and Prescription Narcotics, doctors must use great caution in prescribing and drug manufacturers owe a responsibility to ensure these drugs are reasonably safe.
In some cases, doctors have sought to treat mental health disorders with sleep medications. This can be effective sometimes because sleep disorders are known to have a direct correlation to mental health. The problem is many of these drugs – namely Xanax, Valium, Ativan and Librium – are highly addictive and potentially dangerous. Even drugs like Lunesta and Ambien can be habit-forming and there is potential for serious side effects and overdoses, particularly when combined with other medications.
STATUTE OF LIMITATIONS
Those seeking compensation for illnesses, injuries or wrongful death related to dangerous drugs have just three years in which to file a claim in Massachusetts. This is true whether the claim is for:
Personal Injury, Mass Gen. Laws Ann. ch. 260 § A
Medical Malpractice, Mass. Gen. Laws Ann. ch. 260 § A
Products Liability, Mass Gen. Laws Ann. ch. 260 § A
Wrongful Death, Mass. Gen. Laws Ann. ch. 229 § 2
In some circumstances, the statute of limitations may be “tolled” – or extended – if the cause of action was inherently unknowable for a period of time.