Pain is a frequent consequence of pregnancy – lower back pain, pelvic pain, and even migraine headaches are particularly common. When the pain becomes acute, it is tempting for a doctor to prescribe opioids to ease the pain. Indeed, at least one study has found that more than one in five Medicaid-enrolled pregnant women fill an opioid prescription at some point in their pregnancy. Opioid use during pregnancy, however, carries significant legal risks.
Commonly Used Opioids
The opioids most commonly used by pregnant women include codeine, hydrocodone, morphine, and oxycodone. Common brand names include:
- Troxyca ER
- Xartemis XR
- Xtampza ER
FDA Risk Categorization
The US Food and Drug Administration places most prescription opioids within pregnancy category C. This category includes medications for which animal studies indicate potential harm to a fetus even though evidence based on human studies is insufficient. Oxycodone, however, belongs to the pregnancy category B, which includes medications for which animal studies show no evidence of harm to the fetus and evidence from human studies remains inconclusive.
Opioid Risks for the Infant
According to the Centers for Disease Control and Prevention (CDC), opioid use by a pregnant woman, or while she is breastfeeding her infant, carries with it the following risks for the baby:
- Neural tube defects: Problems in the development of the infant’s brain or spine
- Congenital heart defects
- Gastroschisis: A birth defect of a developing infant’s abdomen, including a condition in which the intestines protrude outside the body
- Hydrocephalus (“water on the brain”).
- Congenital heart defects such as ventricular and atrial septal defects, tetralogy of Fallot, pulmonary valve stenosis, and hypoplastic left heart syndrome
- Premature birth along with its associated problems
- Stillbirth (the death of the infant during pregnancy)
- Neonatal abstinence syndrome (see below)
Codeine and Tramadol can be particularly dangerous to a breastfeeding infant.
Opioid Use Disorder (Opioid Addiction)
The obvious danger of opioid use is to the mother, independent of her pregnancy. If opioid use disorder develops, as it often does, the consequences include dependence, cravings, physical tolerance (needing more and more of the drug to produce the same effect), inability to moderate use, possible overdose, and continued use despite negative consequences.
Given the ready availability of illegal opioids on the black market, an opioid-dependent mother might be tempted to continue using opioids even after her doctor stops prescribing it to her.
Neonatal Abstinence Syndrome (NAS)
Opioid use by a pregnant woman can greatly increase health risks for the infant. If the mother is addicted to opioids during pregnancy, however, NAS is more than a risk – it is a near certainty.
Immediate symptoms of NAS in an infant include:
- Excessive crying
- Gradual weight gain
- Hyperactive reflexes
- Loss of appetite
- Mottled skin
- Pathologically increased muscle tone
- Rapid breathing
- Stuffy nose
These symptoms often appear within 24 hours after birth but may be delayed up to 10 days after birth. Long-term effects can include:
- Attention Deficit Disorder (ADD)
- Behavioral problems
- Cognitive deficits
- Growth delays
- Inability to function independently
- Lifelong infertility
Babies born with severe NAS may need medicines such as morphine and methadone for up to six months after birth. Even after that, special care and attention may be required.
Quitting Opioids While Pregnant
Despite the dangers of opioid addiction during pregnancy, sudden withdrawal from opioids can result in even more serious health risks for both mother and infant. The possible consequences of a “cold turkey” withdrawal by an opioid-addicted mother include premature birth and its associated consequences as well as fetal distress and even stillbirth.
Methadone treatment is the most common remedy recommended by doctors for opioid withdrawal during pregnancy, even though it is not formally sanctioned by the FDA for this use. Even methadone treatment has its limitations – it can alter the infant’s heart rate and it causes NAS in 60-80% of cases
Buprenorphine therapy is an alternative treatment that is sometimes used to treat opioid addiction in pregnant women. Doctors often prefer methadone treatment, however, because relapse rates are lower, because the infant’s exposure to drugs is reduced, because certain negative medical outcomes such as low birth weight are less likely, and because the mother’s daily trip to the clinic to receive methadone increases the opportunity for frequent monitoring.
Since 2017, hundreds of opioid lawsuits have been filed against pharmaceutical companies and distributors, pharmacies, and health care providers. Many of these lawsuits were filed on behalf of infants who suffered or even died because their mothers took prescription opioids while pregnant or breastfeeding. Even cities and state governments have filed suit, and the findings of criminal investigations have been used to provide a factual basis for these lawsuits.
Product Liability Opioid Lawsuits
Under product liability law, a manufacturer, distributor, or retailer of a product can be held liable for any injuries or deaths caused by an unreasonably dangerous defect in the product. The defect doesn’t have to concern the product directly. Deceptive marketing of a product can be used to support liability against any actor in the chain of distribution of the product as long as the deceptive marketing actually caused the harm complained of.
The problem with hundreds of lawsuits being filed against the same defendants simultaneously is that similar tasks have to be completed hundreds of times, once for each plaintiff. As a consequence of this state of affairs, the many state law opioid-related lawsuits that are based on product liability have been combined by the federal Judicial Panel on Multidistrict Litigation into one action, under a concept known as Multidistrict Litigation (MDL).
If your claim ends up in MDL, you won’t lose control over it. MDL means that a designated federal court will handle all discovery and pretrial proceedings for the lawsuits, and it may negotiate a settlement. You don’t have to agree to any settlement. After preliminary proceedings are completed, you are free to take your case to trial or reach a private settlement.
The MDL Process
In the discovery process, the parties to a lawsuit obtain information from each other. One party’s lawyer may cross-examine the other party or the other party’s witnesses out of court (but under oath), for example, or one party may demand documents from the other party. Instead of hundreds of lawyers subpoenaing the same documents and interviewing the same witnesses, MDL combines all of this into one proceeding to avoid duplication.
Subsequently, the court will select a few plaintiffs to conduct trials. The results of these trials will clarify the strengths and weaknesses of each side’s claims and assertions, making it easier for the majority of plaintiffs who were not included in the trials to assess their claims more realistically. In most cases, either a global settlement is reached that applies to all plaintiffs or the claims of all plaintiffs are dismissed. In some cases, individual plaintiffs proceed all the way to trial.
Plaintiffs’ Product Liability Claims
The opioid-based products liability lawsuits that have been combined into the current MDL mega-lawsuit allege that the defendant pharmaceutical companies developed a “well-funded, sophisticated, and deceptive marketing scheme targeted at physicians and consumers,” thereby encouraging doctors to overprescribe opioids without fully appreciating the dangers of doing so. The lawsuit alleges that pharmaceutical companies exaggerated the benefits of opioids and downplayed their risks, especially the risk of addiction.
Medical Malpractice Opioid Lawsuits
An alternative to filing a product liability claim against an opioid manufacturer or distributor is to file a medical malpractice claim against the doctor who prescribed them to you. Typically, a medical malpractice claim is more difficult to win than a product liability claim. Nevertheless, hundreds of Berkowitz Hanna clients have won medical malpractice lawsuits or received generous settlements.
Some of the most common bases for medical malpractice lawsuits over opioid use include:
- Your doctor misdiagnosed or failed to diagnose neonatal abstinence syndrome (NAS). The symptoms of NAS can look similar to symptoms of other conditions, which could tempt a negligent medical professional to jump to conclusions and misdiagnose NAS as some other condition. Obviously, it is going to be impossible to effectively treat your baby until the doctor knows what is wrong with him.
Other factors that might contribute to a misdiagnosis include negligent updating of medical records (or damage to or loss of these records); all of which count as medical malpractice. Of course, if you deliberately concealed your opioid use from your doctor, this could be used by the defense.
- Your doctor failed to warn you of the dangers of the medicine even though he knew of them. If a pharmaceutical company failed to warn the doctor, you could have a product liability claim against the pharmaceutical company. But if it was your doctor who failed to warn you, you might have a medical malpractice claim against your doctor.
- Your doctor, or the hospital, failed to properly monitor your infant after birth so that any adverse consequences of opioid use could be responded to immediately. If your infant develops NAS, for example, failure to monitor could lead to complications such as jaundice and dehydration, which might even result in death.
Act Quickly – the Clock Is Ticking
If you were prescribed opioids while pregnant, or if you were treated for opioid addiction during your pregnancy or after delivery, you might be able to win compensation from a pharmaceutical company or your healthcare provider if your infant was born with a congenital defect or if he developed an opioid-related medical condition soon after birth.
Since the statute of limitations deadline for filing a lawsuit is short in Connecticut; and since, if it runs out, even a private settlement will be unavailable to you; now is the time to act decisively. Call the product liability and medical malpractice lawyers at Berkowitz Hanna, or contact us online for a free initial case evaluation. We take cases from all over Connecticut through our offices in Stamford, Bridgeport, Danbury, and Shelton.