Under the Food, Drug, and Cosmetic Act, drug manufacturers must submit a new drug application before it is able to market a new brand name drug. Additionally, the United States Food and Drug Administration must approve of the drug before it may be marketed. In the new drug application, a sample of the drug’s label must be included. This sample must include any warnings, precautions, and adverse reactions. In addition, its contraindications, indications, and usage must also be included.
Another law, called the Hatch-Waxman Act, governs some of the matters involving generic drugs. Under this law, a generic drug manufacturer is able to submit a less detailed new drug application so long as it claims that the generic drug is biologically equivalent to a drug that has already obtained FDA approval. Using this method, a generic drug manufacturer does not have to go through the lengthy and expensive clinical trial process to obtain approval for a drug. The law does state that the generic drug manufacturer must “show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug.” Therefore, name brand drug manufacturers and generic drug manufacturers have different drug labeling duties.
According to FDA regulations, a brand name drug manufacturer must update warning labels “as soon as there is reasonable evidence of a serious hazard with a drug.”
The case against Novartis Pharmaceutical Corporation
In December of 2017, the Supreme Court of California handed down a decision that impacts how drug manufacturers must label their drugs. The case, T.H. v. Novartis Pharmaceutical Corporation, was filed over injuries a drug allegedly caused to twin babies while they were developing in the womb.
According to the court’s opinion, the pregnant mother was prescribed terbutaline, which is a generic form of the brand name drug Brethine. The terbutaline was prescribed to stop premature labor. The twins were born full term; however, their parents soon noticed that the twins suffered developmental delays. By the time the children were 5 years old, they were both diagnosed with autism. The parents argued in their lawsuit that the manufacturers of terbutaline knew or had reason to know that terbutaline could interfere with fetal brain development. They argued that the drug’s labeling did not include any warnings about this serious risk.
Under federal law at the time the lawsuit was initiated, only brand name drug manufacturers had a duty to provide warnings for both its own labels and its generic counterparts. Additionally, only the brand name drug manufacturer had the power to modify a drug label by altering its warnings. Generic drug manufacturers were forced to use the same exact warnings as the brand name drug manufacturers. Therefore, the company that manufactured Brethine was in charge of the label for terbutaline as well.
Novartis Pharmaceuticals Corporation (hereinafter Novartis) manufactured and distributed Brethine until the end of 2001. At that point, aaiPharma Inc. (hereinafter aaiPharma) bought the rights to manufacture the drug. aaiPharma continued to use the same label that Novartis had been using. The plaintiffs argued that the warning label on Brethine failed to address the risks posed to pregnant women and their developing children and that Novartis should have anticipated that aaiPharma may not change the label.
Novartis attempted to shield itself from liability by arguing that it only had a duty to provide a proper label for Brethine—not the generic form of the drug. Additionally, they argue that, because they did not manufacture Brethine at the time the twins were injured, they should not be liable. Novartis argued that aaiPharma was responsible for labeling the drug at this point.
However, in 1976, a Swedish doctor published a small study that concluded that terbutaline was both safe and effective as a drug that could halt early labor in pregnant women. Terbutaline was originally designed and marketed as an asthma treatment. However, once it was discovered that terbutaline worked well as a tocolytic (a drug that stops premature labor), none of the drug companies that manufactured the substance attempted to gain FDA approval for this use. Subsequent studies questioned how safe terbutaline really was for pregnant women. A group of American researchers tried to replicate the results of the 1976 study and could not. Interestingly enough, they could not find any benefit that terbutaline provided to pregnant women. Additional research on rats showed that just one dose of terbutaline could impact brain development.
A study from the 1980s also concluded that children whose mothers had taken a similar drug while pregnant exhibited weaker academic ability and were more likely to suffer language development impairment, as well as vision problems. Eventually, the American College of Obstetricians and Gynecologists issued a bulletin that provided warnings about drugs like terbutaline.
The Court’s decision
The court acknowledged that a drug manufacturer does not have to provide warnings about risks that may be “merely speculative or conjectural, or so remote and insignificant a to be negligible.” Additionally, if drug manufacturers provide good warnings to prescribing physicians, they do not have to provide direct warnings to consumers.
However, the court emphasized that the brand name drug manufacturers have complete control over generic drug labels. It added that imposing “warning label liability is likely to be effective in reducing the risk of harm to those who are prescribed (or are exposed to) the brand-name drug or its generic bioequivalent.” Additionally, the court noted that successor manufacturers are likely to trust the judgment of the previous manufacturer and may not thoroughly investigate all of the literature on the substance.
Therefore, brand-name drug manufacturers must ensure that their warning labels are appropriate and account for all foreseeable risks, including in generic drugs.
The case impacts California law, however, a decision made by one state is often mirrored in others in subsequent court rulings. Therefore, the decision by California’s Supreme Court will likely have a serious impact on drug manufacturers throughout the country.
What do you do if you have been injured by a drug?
If you believe that a drug has caused your injuries, you should consult with an experienced drug injury attorney immediately. There are numerous deadlines in place that limit how long claimants have to file a lawsuit against drug manufacturers. If a claimant misses these deadlines, the claimant may be responsible for all of the financial harm he or she has suffered as a result of the injury.
Before you meet with your attorney, make a timeline of your health before taking the drug, while taking the drug, and since taking the drug. Notes about any symptoms you have experienced will be helpful. Note which doctor prescribed the medication to you and for what reason. Providing copies of your medical records is also helpful.
With a drug injury attorney on your side, you are much more likely to prevail in your claim.
If you were injured by a drug, call Parker Waichman LLP today
At Parker Waichman LLP, we are experienced in various types of drug injury claims. To schedule your free consultation with our drug injury lawyers, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
Were you or a family member injured by a defective or recalled medication?Click To Get A Free Case Review