Will Big Pharma Change Labeling Today If They Have To Pay Tomorrow?
By Mark York (December 22, 2017)
(Mass Tort Nexus Media) On Thursday. December 21, 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.
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 brandname 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.