Will Big Pharma Change Labeling Today-If They Have To Pay Tomorrow?
By Mark York (August 15, 2018)
(Mass Tort Nexus Media) In December of 2017, California’s Supreme court ruled that consumers are now able to file lawsuits against Novartis AG and other makers of brand-name pharmaceutical products over injuries blamed on generic versions of the drugs manufactured by other companies.
The California Court’s ruling broke with the recent legal leanings nationally to the contrary and created potentially massive exposure for brand-name drugmakers who could be sued in the state for failing to warn users about the risks of cheaper, generic versions of their drugs. This has generally been an area of law that name brand drugmakers have been excluded from and now it seems that the litigation flood gates may open wide, at least in the State of California.
Leslie Brueckner, the plaintiffs’ lawyer, said this decision was the only current one where a state’s top court ruled in favor of consumers who were prescribed generic drugs, and have legally been prevented from filing suit against generic drugmakers for not warning about their products’ risks.
“This is just a huge victory for public health and safety, and this victory will be felt nationwide,” she said.
Novartis, whose appeal had the support of industry groups including the U.S. Chamber of Commerce, said it disagrees with the court’s decision to potentially hold it responsible for an injury caused by a different company’s product. This has been the primary defense of Big Pharma when defending themselves, from legal claims against generic makers of the products that Big Pharma brought to the marketplace originally, Big Pharma has had a get out of jail free card in play for years. In many medical circles the view is, generics are based on the formula and R&D developed by Big Pharma labs, so why shouldn’t they be held responsible for their pharmaceutical progeny, which they created.
The decision came in a lawsuit centered on two twin children who were diagnosed with developmental delays and autism after their mother while pregnant took a generic version of Brethine to suppress premature labor. This may open a floodgate of litigation in many other states where the same medical issues are considered to be caused by Novartis designed drugs.
MASSACHUSETTS SUPREME COURT JOINS CALIFORNIA
Federal law prevents people injured by generic drugs from suing generic drugmakers, but in another recent court ruling plaintiffs injured by generic drugs can sue makers of the brand-name versions.
The rulings apply to people harmed by generic drugs in Massachusetts and California. Brand-name drugmakers may be liable for injuries caused by generic drugs they did not manufacture or sell.
Generic drugs can cause the same side effects as the brand-name drugs they’re copying. Generic drugs must carry the same label as the brand-name versions. Only makers of brand-name drugs may add warnings to drug labels without approval from the FDA.
The U.S. Supreme Court says courts may not order generic drugmakers to violate the law by changing their labels. So, federal law bars lawsuits that accuse generic drugmakers of failing to warn of dangerous side effects, based on preemption.
Now two state supreme courts said brand-name drugmakers may be responsible for problems caused by generic drug labels. They ruled to allow people harmed by generic drugs in the two states to sue the brand-name companies.
The latest ruling came March 16, 2018, from the Massachusetts Supreme Court. The case involved a generic version of Merck’s drug Proscar.
The court ruled patients who take generics may sue brand-name drugmakers when they intentionally fail to warn of dangers. Patients can also sue if a maker of a brand-name drug fails to warn when it should have known of serious danger. Lawsuits can’t just claim negligence, a lesser standard, the court said.
The Massachusetts ruling comes just three months after the December 2017 California Supreme Court ruling, which involved the Novartis drug Brethine.
In 2007, a pregnant woman with twins, who is unnamed in the lawsuit, was prescribed the generic version of the drug Terbutaline in order to prevent premature labor. Although Terbutaline is an asthma medication, it has been used “off-label” in order to prevent premature births. She claims that it caused the two children to suffer brain injuries that led to developmental problems, including autism.
Terbutaline was sold by the pharmaceutical company, Novartis, under the name Brethine until it sold the rights to the drug in 2001. Studies from as far back as the 1970s have shown that Terbutaline should not be used by pregnant women, but the Plaintiff’s alleged that Novartis shucked all responsibility for the children’s injuries during the trial by stating that it could do nothing about the warnings on the generic-product’s label.
Currently, generic-drug’s labels must only match the brand-name’s. The court’s decision further states that the brand-name manufacturer is still liable for discrepancies between its label and the generic’s, even if the brand-name drug has stopped being manufactured. Generic medication manufacturers cannot change the warning labels on the drugs they produce without approval from either the FDA or current generic manufacturer.
The generic-drug manufacturer, however, is still liable for injuries if they purposefully change the label from that of the brand-name counterpart, if there is an issue in the manufacturing process, and if the generic manufacturer suggests a use different from that of its FDA approved functions.
Will these rulings have large implications for the pharmaceutical industry since the ruling was so close, and it deviated from decades of precedent. It is possible that if other state courts rule with the same mindset as the California Supreme Courts, they will pressure the US Supreme Court into reviewing the existing federal regulations.
Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels.
The father of the children, referred to in court papers as T.H. and C.H., instead sued Novartis, which made Brethine until 2001, and aaiPharma Inc, which bought the rights to it in 2007 while their mother was taking the generic version.
Novartis argued its duty to warn consumers did not cover those taking generics and that a contrary ruling would effectively make it the market’s insurer. Even though the genric maker uses the drug warning label developed and approved by Novartis.
The court disagreed. Justice Mariano-Florentino Cuéllar wrote that brand-name manufacturers are the only entities with the ability to strengthen a warning label. This seems correct since generic makers have zero ability to add warnings or change the label of a drug based on existing law. Perhaps now the long term view of Big Pharma and drug labelling may change if more states are holding them accountable tomorrow for their lack of ethical drug labelling conduct today.
“So a duty of care on behalf of all those who consume the brand-name drug or its bioequivalent ensures that the brand-name manufacturer has sufficient incentive to prevent a known or reasonably knowable harm,” Judge Cuéllar wrote.
The court also held 4-3 that Novartis could be sued despite divesting itself of Brethine because its failure to update the warning label before the sale could foreseeably cause the children harm.
The case is T.H. v. Novartis Pharmaceuticals Corporation, California Supreme Court, No. S233898
IN THE SUPREME COURT OF CALIFORNIA
(Dec. 21, 2017 Opinion Excerpt)
We do not doubt the wisdom of crowds in some settings. But the value of an
idea conveyed by or through a crowd depends not on how loudly it is proclaimed or
how often it is repeated, but on its underlying merit relative to the specific issue at hand.
Despite the impressive case authority Novartis has collected on its behalf,
none of it purports to interpret California law. Yet it is California law that we must construe
and apply in this case. In doing so, we find that brand-name drug manufacturers have a
duty to use ordinary care in warning about the safety risks of their drugs, regardless of
whether the injured party (in reliance on the brand-name manufacturer’s warning) was
dispensed the brand-name or generic version of the drug. We also conclude that a brand-
name manufacturer’s sale of the rights to a drug does not, as a matter of law,
terminate its liability for injuries foreseeably and proximately caused by
deficiencies present in the warning label prior to the sale.
We therefore affirm the Court of Appeal.