Articles Posted in Product Liability

shutterstock_1768652843-225x300Choosing whether to formula feed or breastfeed a baby is a big decision for new parents, and the decision can be fraught. Generally, the formula provides babies with nutrients they need to thrive; however, contaminated products can lead to risky situations. Those who believe that contaminated or unsafe formula caused their babies to suffer injuries should contact a Michigan product liability attorney.

Premature babies require extra nutrition to support their developing systems. Parents should feel confident that companies developing and manufacturing baby formulas take all steps to ensure the quality of their products. In addition to quality control, companies should clearly list all potential risks and side effects of using their products. The failure to do so can lead to life-long or deadly consequences for these vulnerable babies.

Recently, in light of a Centers for Disease Control (CDC) investigation, Abbott Pharmaceuticals recalled more Similac baby formula. The recall comes in response to a tragic situation where a child consumed the formula before getting a severe bacterial infection and dying. The CDC believes the infection may have contributed to the child’s death. The company stated that they found evidence of the bacteria in their Michigan facility but have not discovered any evidence of Salmonella.

Photograph of Close Look at Retina of the EyeMedications are meant to bring relief and peace of mind, but when your treatment begins to attack unrelated areas of your body, that peace of mind can be compromised. In June 2020, the Food and Drug Administration (‘FDA’) issued a Labeling Change related to the prescription drug Elmiron used for a bladder condition. This label change gave warning that Elmiron can cause issues with eyesight. Although there has been no recall, users were advised to get regular eye exams and stop using it if they notice problems with their vision.

Elmiron is used to treat pain and discomfort from interstitial cystitis (‘IC’), a painful (and common) bladder condition which is difficult to treat and often mistaken for urinary tract infections. Elmiron is believed to help with the pain from this condition by attaching to the bladder wall and creating a barrier to prevent more damage. Elmiron has been prescribed to treat this condition for decades and is the only drug approved by the FDA to do so.

After a troubling study at Emory University in 2018, researchers wrote a letter to the Journal of Urology stating they found that long term use of Elmiron can cause serious damage to the retina. This “pigmentary maculopathy” comes from injury to the outer layer of the retina. Physicians at Kaiser Permanente took this warning seriously and reviewed medical records of over four million of their patients and were able to actually study 91 of them who had been taking Elmiron over a long period of time. Around one-quarter of the patients examined were found to have significant damage to the retina which had previously—and unfortunately—been attributed to other diseases that affect the eyes.

Courthouse-300x200In May of 2020, speculation began that the multi-district litigation (MDL) regarding the German chemical giant, Bayer, and its weed killing product, Roundup, was close to settling. Hundreds of thousands of claims have been made claiming the product causes serious long-term health conditions, most notably, leukemia, B-cell lymphoma, non-Hodgkin lymphoma or multiple myeloma.

In late June, that speculation seemed to be well supported, as Bayer disclosed its intent to settle tens of thousands of cases for a sum of $10 billion, while continuing to sell the product with new warning label. As a result, the Judge presiding over the matter, the Honorable Vince Chhabria, paused the massive litigation until November, allowing the parties to work out the particulars of the complex agreement.

Now, last Thursday, August 27th, Bayer announced that the majority of the settlements it had previously declared resolved, were in-fact in jeopardy of falling apart. Where Bayer had told the court that 75% of the 125,000 Roundup claims were resolved, only 32,000 cases were actually resolved—12,000 of which were in state courts, rather than the federal MDL over which Judge Chhabria presides.

Soldier-200x300On July 28, 2020, a Florida federal court ruling breached the central defense against claims certain military earplugs were defective, damaging the ear and causing hearing loss. The lawsuits claim the earplugs were improperly designed, and did not completely block loud noises common to the military, such as gunfire and or the operation of heavy machinery or vehicles. Neumann Law Group has previously written about the earplug litigation, and you can read that article here.

The defendant, 3M, attempted to invoke the ‘government contractor defense,” a doctrine that would relieve it of any liability even if it were proven to have produced and sold a defective product to the military. The Supreme Court articulated the government contractor defense in Boyle v. United Technologies Corporation, 487 US 500 (1988), which involved a wrongful death complaint made against a company that produced military helicopters—the plaintiff alleged the escape system in the helicopter was poorly designed, causing the death of a pilot.

The jury in Boyle found that the manufacturer was in fact negligent when it designed the helicopter, but the Supreme Court would eventually uphold an appellate reversal of the verdict. It outlined the strong federal interest in military equipment and concluded those interests outweighed any state law claims, but only when the federal government gave reasonably precise specifications for the equipment, the equipment conformed to the specifications, and the supplier warned the federal government of the danger involved in using the equipment to the best of its knowledge.

Dark-Hospital-300x191In the 1990s, the use of a neurovascular stent for a procedure call “stent-assisted coiling” was considered a breakthrough treatment for treating brain aneurysms. The medical device offered a non-surgical method to address weak spots in blood vessels in the brain. An aneurysm occurs when a weak point in a vessel allows blood to bulge out the vessel wall. If the aneurysm bursts, it can cause traumatic consequences, particularly when the aneurysm is located in the brain.

A non-stent assisted coiling treatment for an aneurysm involved running a stint from a patient’s leg up into the location of the aneurysm in the brain. The catheter would then inject a string of soft platinum into the aneurysm, which coils upon itself within the “bubble” of the aneurysm. After the platinum was fully deployed, the blood in the aneurysm clots along the coil and eventually fills the either aneurysm, such that is no longer poses the threat of rupture.

The procedure described above worked well, unless the aneurism had a “wide neck.” Where a normal aneurysm looks like a bubble stuck on the side of the vessel, a wide neck aneurysm looks more like a semi-circle. Instead of having a small weak spot in the vessel bulge out into a bubble, the wide neck variety involves a larger weak spot that expands the vessel in a distorted manner. Introducing the platinum coil into the aneurysm is not feasible, as the coil is too exposed to the blood flow and will not remain in place.

“Yeah, that’s going to be a problem. That’s going to be a problem for them.”

In so few words, Jackie Chiles, legendary consumer rights warrior, issued a battle cry, distilling public safety litigation into its most primal essence. Dangerous products impose a cost upon the consumer. Product liability lawsuits reallocate the cost wChiles-Top-of-Bloghere it belongs: the manufacturer. A dangerous product is a problem, but this time, it will be a problem for them.

This article is the first installment in a series that explores the evolution of personal jurisdiction as it relates to product liability litigation, concluding with a discussion of two personal jurisdiction cases pending before the Supreme Court. In those consolidated cases, Ford Motor Company is asking the Court to severely limit the number of courts that can hear a case against a company that serves a regional or national market.

pistol-and-bullets-300x200In 2005, President George W. Bush signed the Protection of Lawful Commerce in Arms Act, 15 U.S.C. § 7901 (2005), et seq., (“PLCAA”)into effect. The PLCAA prevents gun manufacturers and dealers from being sued in relationship to the production and/or sale of firearms, subject to a few exceptions. Historically, these exceptions have been construed narrowly, and as a consequence, manufacturers and dealers have been immune to most types of lawsuits.

The PLCAA permits certain commercial suits, such as a contractual dispute or a claim for breach of warranty. § 7903(5)(A)(iv). Further, immunity does not extend to the defective design or manufacture of a firearm. § 7903(5)(A)(v). Gun manufacturers are subject to the same rules as any other manufacturer of consumer goods. If a manufacturer places a firearm into the stream of commerce which malfunctions due to defective parts or improper assembly, or if it was designed in a dangerous manner and poses an unreasonable danger when operated, the manufacturer can be held liable for resulting injury.

Other exceptions apply when dealers provide firearms to people who should not have one in their possession. One such exception involves negligent entrustment. § 7903(5)(A)(ii). The PLCAA defines negligent entrustment as the act of supplying a firearm to someone the seller knew, or should have known, would likely injure others with the gun. § 7903(5)(B). Similarly, if a dealer knowingly provides a gun to a person intending to commit a crime of violence or engage in drug trafficking, the dealer is susceptible to suit. § 7903(5)(A)(i).

Newborn-gentle-300x200Neocate baby formula is designed for children with difficulty digesting common proteins for a host of reasons, including serious illness. Where traditional baby formula contains long, complex proteins, “elemental formulas” are comprised of amino acids—the building blocks of larger proteins—which are more readily digestible. Despite being an effective product to deliver protein, it does not provide the amount of phosphorus necessary for healthy bone development, ultimately leading to bone fractures and the skeletal disorder rickets. Since Neocate is a “product” for the purposes of an action in tort, strict liability attaches and those injured need only demonstrate that the product was defectively designed.

Nutricia, a subsidiary of Groupe Danone, manufactures Neocate, which is one of the most popular elemental formulas on the market. As with traditional baby formula, Neocate is designed to be “whole nutrition,” i.e., the manufacturer’s intent is for the Neocate to be the only nutrition consumed by the child. Consequently, Nutricia had the duty to ensure that the product was properly formulated to provide all necessary nutrients.

Neocate was popular and widely prescribed, as it proved effective in providing nutrition to sick infants and children. However, in 2015, physicians began to notice high instances of broken bones and rickets associated with Neocate. Rickets is a condition where children develop soft or brittle bones, sometimes caused by a severe phosphorus deficiency. Nutricia was made aware of the problem no later than October of 2015 but did not begin researching phosphorus deficiency—hypophosphatemia—in relationship to Neocate until 2016. When it undertook this research, the company instructed physicians prescribing Neocate to monitor each patient’s blood phosphorus level.

hospital bed

Photo Credit: Stokkete / Shutterstock.com

A catheter is a medical device, essentially a tube, used in a wide range of medical procedures.

Certain catheters are designed to access veins and arteries. Vascular catheterization allows a physician to perform certain diagnostics that are otherwise impossible, such as sampling blood directly from the heart; measuring blood flow in the heart’s chambers; or evaluating blockages or abnormalities in the blood vessels outside the heart, such as the arms and legs.

hoverboard

Photo credit: maxbelchenko / shutterstock.com

As a general matter, companies are responsible for the safety of products that they make, sell, market, and distribute. When a product is unreasonably dangerous or defective in any way, each of these parties can typically be held liable for any injuries caused by the product. However, Michigan product liability law is vast, and many cases arise in a legal gray area.

The Sixth Circuit Court of Appeals recently heard one such case involving a purchase on Amazon.com. In that case, a family purchased a hoverboard for their son from Amazon. It was undisputed that Amazon did not own the hoverboard, and that a third party listed the item for sale on Amazon’s website. However, the item was shipped in an Amazon box from a warehouse owned by Amazon, and the plaintiffs believed that they had purchased the hoverboard from Amazon.

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