Who trusts profit-grabbing companies to prevent perilous supply snafus?

babewithbottle-300x293Americans keep suffering the dire consequences of corporations’ relentless pursuit of profits, their stifling of beneficial competition, and their failure to secure the production of their products. These now include desperately needed, specialized baby formula and contrast dyes used in diagnostic imaging studies for seriously ill and injured patients.

A special place in perdition needs to be reserved for those who have put infants at risk of hunger and illness by allowing the feeding crisis to explode and for boobs who are rushing in with finger-snapping, fact-light, and unworkable actions for parents to respond.

Let’s be clear that the formula mess, bad for all families across the country, hits hardest at the working poor and the poor. As the New York Times reported:

“[Some d]octors are encouraging new mothers to increase the amount of milk they pump and breastfeed as much as possible. Some are unable to breastfeed, however, because of inadequate supplies or other health issues, and health care workers said that many mothers working in fast food, retail, or other low-wage jobs may be unable to afford the time to breastfeed. Parents … whose children require special diets also do not have that option. In some cases, those parents already were struggling to afford baby formula cans that can cost more than $100 each.”

Norah Weinstein, co-CEO of Baby2Baby, a nonprofit providing items to families living in poverty, explained to the Washington Post poorer parents quandary with nationwide formula shortages, especially if they are receiving support through the federally funded Special Supplemental Nutrition Program for Women, Infants, and Children (WIC):

“The combination of product recalls, rising prices, and supply chain issues have particularly affected the availability of formula distributed through the WIC program ‘The families we serve don’t have the luxury to hoard formula. They don’t have access to big-box stores. They can’t afford to buy in bulk, and they don’t have access to Internet deals,’ said Weinstein. ‘All of these things expose the fragility of the formula supply chain, which is so damaging for families in poverty.’ In Virginia, the WIC program expanded formula options available to participants after a February recall of Abbott-made formula, but low inventory has forced many parents to search multiple stores, Paula N. Garrett, the state WIC director, said in a statement. Even state efforts to order formula directly from distribution warehouses came up short because supplies are backordered and out of stock, she said. Officials with the WIC program in D.C. and in Maryland did not immediately return calls seeking comment.”

Experts have cautioned parents against diluting formula to stretch supplies, an action that could malnourish babies. Infants with special dietary needs and allergies should not be fed cow’s milk or other products that do not address their conditions.

Families also should not DIY formula, as homemade concoctions cannot be made with the care and hygiene necessary to ensure infants are not harmed by contamination or imbalances in ingredients and liquids, the New York Times reported, noting “there have been a handful of case studies that speak to the potential dangers of going the do-it-yourself route. One 4-month-old baby went into cardiac arrest after being fed a homemade baby formula that included sea moss, hemp seeds and coconut water for a month.”

Experts, while saying that hoarding will only worsen current shortages of formula, have said that it may take time to untangle the manufacturing foul-ups that have led to this sorry situation, as the news site Vox reported:

“[T]this is the worst formula shortage in decades. It’s also the latest example of how the U.S. health system’s failures consistently fall hardest on people with complex medical conditions and people who are socioeconomically disadvantaged. The shortage can be traced back to a contamination problem at an Abbott factory that produces much of the Similac formula, as well as several other brands, for the U.S. market. Abbott voluntarily shut down the factory in February, amid consumer complaints about contaminated formula that was linked to two infant deaths. As of mid-May, it’s still not up and running again. As Politico reported this week, it’s not exactly clear why Abbott and the FDA have failed to come to an agreement that would allow the plant to resume producing formula and help alleviate the shortage. That factory’s prolonged shutdown, combined with general supply-chain problems for the formula ingredients and packaging, have led to formula stock drying up fast. Nationwide, about 40% percent of the most popular baby formula brands were out of stock as of April 24, according to the Wall Street Journal, much higher than the 10 percent average in normal times.”

Critics have ripped Abbott for allowing sanitary conditions to decay so much at its formula plant, as well as for successfully pushing for complex regulations that improve its market dominance and block competitors, particularly international suppliers, from providing needed supplies. Members of Congress have pointed out that lack of competition and consolidation has left this country with just four major makers of formula, with Abbott controlling just under half the market and able to push product prices ever higher.

Federal regulators have negotiated with Abbott to reopen its shuttered factory, meaning it will produce supplies after a few weeks of ramp-up. President Biden has invoked the Defense Production Act to boost domestic production, as well as to allow for overseas flights to bring in carefully inspected foreign supplies that meet U.S. regulations. While Biden critics have howled about this country’s failure to import suitable supplies, for example, from neighboring Canada, they conveniently neglect to note that a trade treaty struck during the previous administration imposes steep tariffs on such goods. House Democrats also are moving on bills to provide more aid to poor parents for formula buying and to ease tight restrictions on federal programs’ choices for suppliers of products allowed under assistance programs.

A crisis with contrast dyes

Patients who require diagnostic scans also are suffering with the consequences of corporate profit maximizing, though the supplier of contrast dyes argues that its supply chain meltdown should be blamed on the coronavirus pandemic.

GE Healthcare, as the Washington Post reported, has a stranglehold on the U.S. market for a key component of medical imaging:

“[C]ontrast media [is] an iodine solution that medical staff inject into blood vessels to allow a device such as a CT scanner or fluoroscope to see inside the body. Contrast media, also known as dye, is used virtually every hour in hospitals across the country to help measure arterial blockages around the heart, guide placement of stents in catheter labs, diagnose and treat strokes, and more. Oncologists use contrast to monitor cancerous tumors.”

A factory in Shanghai is the world’s chief producer of this invaluable product, especially for GE Healthcare, but manufacturing there has ground to a near halt due to China’s shutdown of one of its major metropolises in hopes of curtailing coronavirus cases there. The shockwaves of the factory shutdown have been felt sharply across the United States, the newspaper reported:

“[W]ith contrast supplies dwindling because of the manufacturing shutdown halfway around the world — part of stringent Chinese covid policies that kept workers at home and forced factory closures — doctors at many U.S. health systems are scrambling. They are prioritizing the most seriously ill patients and postponing more routine tests for those who can safely wait until contrast stocks are replenished.”

Matt Davenport, a University of Michigan radiology professor and vice chair of the American College of Radiology Commission on Quality and Safety, explained to the Washington Post the problematic roots of the dye shortage, noting 50 million scans using contrast — or nearly 1 million a week — are conducted annually in the United States:

“In addition to reliance on a limited number of overseas factories, hospitals negotiate discounts by pledging to purchase nearly all of their supply from a single vendor. ‘It’s an all-eggs-in-one-basket problem, where the supply chain is concentrated in one city and one country, and the health systems engage in preferred-vendor contracting,’ Davenport said. ‘This means that the vast majority of contrast they might use comes from a single vendor. When that vendor is not available, they have nowhere to go for that contrast.’”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, efficient, and excellent health care. This has become an ordeal due to the soaring cost, complexity, and uncertainty of treatments and prescription medications, too many of which turn out to be dangerous drugs.

My partners and I see the heartbreaking cases in which babies and children suffer injuries, and it is unacceptable to contemplate how weak oversight of profit-ravenous formula makers will cause so much duress for parents and the possibility of hunger and health harms for vulnerable infants. My partners and I also see the ravages that can be inflicted on consumers by defective and dangerous products, and it is painful to see how profit-boosting grabs for market share and manufacturing consolidation lead to shortages of a valuable, working medical solution.

The coronavirus pandemic has shocked us all at the fragility of supplies for a U.S. economy whose might has meant that few of us have contemplated that we can’t have it all, all the time, as the Washington Post noted, referring especially to medical products:

 “The [contrast dye] disruption, which began to unfold in the past two weeks, reveals once again how overseas, poorly diversified supply chains are vulnerable to a global health crisis. Shortages have crippled the U.S. health system again and again in the past two years. Health workers struggled under shortages of N95 masks and other personal protective equipment, ventilators, and sedatives and other drugs. Lack of raw materials and manufacturing equipment hampered vaccine production. Meanwhile, hospitals temporarily suspended elective procedures such as knee replacements, first to limit infections and then, later in the pandemic, in response to staff shortages that forced them to close beds.”

We have much work to do to recognize potential challenges to getting goods we need and to resolving these, including by tougher oversight of corporations and the practices they engage in that boost their bottom lines but can come back to harm all the rest of us.

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