When Big Pharma opens its big checkbook, life-saving disclosures vanish

Abbottlogo-300x77Big Pharma loves to blast away at opposition lawyers and their clients, criticizing them for seeking justice in the civil system over claims of significant harms. But, c’mon, man, as a certain top political leader likes to say to express his flabbergasted skepticism.

Wealthy corporations and their counsel marshal enormous, costly legal resources to bully, intimidate, and just bury in paperwork plaintiffs in civil cases, as the New York Times has reported. The newspaper has detailed how this almost standard operating procedure by huge law firms has complicated the nation’s effort to safeguard a critical foodstuff for the tiniest, most vulnerable among us — infants needing formula, especially specialized varieties.

The ferocious tactics by formula makers, notably the purportedly family friendly pharmaceutical company Abbott Laboratories, has shielded the industry and the company well but to the detriment of consumers learning important information about a widely used product that was the subject of many lawsuits but that stayed out of the spotlight for years, the newspaper reported:

“Nobody was prepared for what would happen nearly a decade later [after a major, federal lawsuit heard in Iowa]. In early 2022, after several infants fell ill and regulators found unsanitary conditions at an Abbott factory in Sturgis, Mich., the company voluntarily recalled its powdered formula and shut the plant. (No proof has emerged that the problems at the Sturgis factory caused the infant illnesses and deaths.) The closing caused a severe shortage of the formula that most American infants are fed. Desperate parents struggled to feed their children. Angry lawmakers convened hearings. Government agencies opened investigations. The Biden Administration organized an airlift to import formula from overseas. The crisis focused attention on shortcomings with food safety and industry oversight. The scrutiny was new, but the phenomenon wasn’t. Over the years, newborns on rare occasions have fallen sick or died after being fed powdered formula. Until recently, however, the pattern largely lurked below the public and political radar. One big reason is that Abbott and its lawyers, at times deploying scorched earth legal tactics, have repeatedly beaten back attempts to hold the company liable.”

The Washington Post, separately, has reported in timely fashion that, absent heavy public scrutiny of federal regulatory practices — actions or inactions that regular folks often learn about only via civil lawsuits — oversight can be ponderous and spotty, at least until a crisis erupts. Then, a frenzy ensues to determine corrections and, perhaps, how a food pathogen like the bacteria Cronobacter sakazakii creeps into baby formula, causes infections that lead to debilitating brain illnesses, damage, and death.

Where were the federal watchdogs while this was occurring? As the Washington Post reported:

“Federal regulators and food safety experts have long been troubled by powdered formula’s ability to harbor cronobacter — a bacteria that is harmless for most but can be debilitating or deadly for newborns and others with weak immune systems. The Food and Drug Administration requires formula makers to inspect for cronobacter and have urged neonatal intensive care units to avoid powdered formula. But information about the risk of cronobacter infections is not trickling down to parents of healthy, full-term babies, who remain vulnerable to infection until about 2 or 3 months, according to experts. New parents are often sent home from the hospital with free samples of powdered formula — and they are rarely urged toward what food safety experts say is a safer and widely available alternative: sterile, ready-to-drink formula sealed at the factory. ‘The [Food and Drug Administration, Centers for Disease Control and Prevention], and companies know the [powdered] product is not sterile, but moms and dads do not,’ said Bill Marler, an attorney who specializes in foodborne illness outbreaks. They ‘are putting the burden of making this product safe on the consumer before it is fed to their baby.’”

The Big Pharma makers of baby formula, and their lawyers defend their aggressive moves to repel claims of flaws or shortcomings with the popular product. They argue they are properly pursuing legal remedies available, and that juries and judges have agreed after trials that makers are not to be blamed for what, the Washington Post reported, is the sustained, though unknown number of infants who get sick or die due to cronobacter and allegations that it taints formula.

The New York Times article describes how big firm lawyers, in representing Big Pharma, do not hesitate to dig into plaintiffs’ personal lives, unearthing any speck of information that casts them in bad light but may not have direct bearing on their cases. The mere raising of the material can ding up the claimant in a lawsuit. Big Pharma lawyers also appear in force, in one case the newspaper cited, making objections during witnesses’ day-long testimony roughly once every three or four minutes on average. Defendants in formula cases also moved fast after their conclusion to seal testimony and evidence, arguing it contains proprietary information.

On the regulatory side, the Washington Post reported that the rarity of cases in which experts have found hard ties between formula and cronobacter taint makes difficult federal oversight. This also is not helped that few states, as occurs with other products and problems, requires makers to report cronobacter infections and outbreaks, though these occur. Sure, international standards for baby formula differ greatly from those in this country — and, as parents discovered in the crisis, the American regulations are not necessarily the best and safest. Other nations recognize the cronobacter risk more and require greater public information about it.

As for this country, as the Washington Post reported on this issue, well: Spare data? An absence of public awareness or pressure surrounding a product or regulatory process? These kinds of factors do not make cautious medical scientists and regulators eager to act, the newspaper reported.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be done to them and their loved ones by defective and dangerous products, notably those of the medical variety.

The wealth, abundance, and materialism that Americans so relish can have not only positive but its negative elements, too. We have so many goods and services to choose from, coming to our shores from all over the planet in pursuit of our powerful dollars, that U.S. consumers have dazzling choices. We also are harder to protect, as a result, because who or what could pick, test, and provide assurances of the safety of so much plenty?

This does not mean those whose products harm us should not be held accountable. And, yes, civil lawsuits can be a powerful way to do this. But patients, as my partners as I know, must display enormous fortitude when they seek justice in the civil system for wrongs committed against them in medical care and to ensure bad things get corrected, so they do not happen to others. They also must endure legal hurdles in seeking financial redress for what may be major damages done to them and their lives, with patients often needing significant long-time or even lifetime support and medical care.

We all must push politicians, policy makers, and regulators to remind themselves they serve regular folks and not wealthy, powerful corporations, notably Big Pharma. We also need to be vigilant about our legal system to ensure that cynics’ worst beliefs never get realized — that it becomes a system that can be bought and unjust. We have much work to do to improve our health, regulatory, and legal systems.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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