Published By: Maxwell S. Kennerly, Esquire

product liability

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[Update: A month after I posted the below article, researchers at the Radiological Society of North America’s annual meeting presented a cardiac MRI study showing that consumption of energy drinks “increased peak strain and peak systolic strain rates in the heart’s left ventricle,” which could potentially trigger arrhythmias.]

Few headlines are as cringeworthy to upstanding trial lawyers as those which include a phrase like “$85 million lawsuit alleges,” and earlier this week the New York Daily News reported “Brooklyn man killed by drinking Red Bull, $85 million lawsuit alleges.”

As Eric Turkewitz aptly explains about the “$85 million dollar” Red Bull wrongful death lawsuit, this practice is prohibited in many venues — like New York, where the case was filed — and yet lawyers do it anyway, either out of ignorance about the rules or to attract attention. At least here, though, our attention is drawn to what looks like an interesting case.

First, let’s start with the medicine: is it possible Red Bull contributed to the death of 33-year-old Cory Terry during a basketball game? I think the answer is clearly “maybe.” The article says his death certificate lists the cause of death as “idiopathic dilated cardiomyopathy.” “Dilated cardiomyopathy” is generally an enlargement of the heart’s left ventricle, which affects pumping, and “idiopathic” is medical speak for “I don’t know what happened to this patient.” (“Idiopathic” is a mashup of the ancient Greek words idios and pathos, together meaning “one’s own suffering.”)

In the medical field, idiopathic dilated cardiomyopathy is a complicated, frustrating problem. Consider this 2012 research article:

Despite recent advances in the management of patients with heart failure, morbidity and mortality rates remain high. Common causes of heart failure are ischaemic heart disease, uncontrolled hypertension and valvular disease. However, in up to 50 % of the cases its exact cause remains initially unknown; this condition is called idiopathic dilated cardiomyopathy (DCM).

We thus don’t know the cause of half of all heart failures, but we do know that stimulants, particularly cardiac stimulants like caffeine, can raise heart rates and cause palpitations and arrhythmias and thus can contribute towards heart failure in patients with cardiomyopathy. As The Cardiomyopathy Association says, “General advice is that people should minimise their caffeine intake.”

In sum, while we might not know the precise nature of his underlying heart problems, it is plausible — I would say likely — that the stimulants in the Red Bull contributed to his heart failure.

But does that make Red Bull responsible for his death? 
Continue Reading The Red Bull Wrongful Death Lawsuit Might Have Wings

Let’s take a refresher course on 1L Civil Procedure. The federal courts have limited jurisdiction; they don’t exist to hear every case, they exist to hear cases that arise under federal law. Additionally, the federal courts have “diversity jurisdiction,” a narrow addition created “to provide a federal forum for important disputes where state courts might favor, or be perceived as favoring, home-state litigants.” Exxon Mobil Corp. v. Allapattah Services, Inc., 545 US 546, 553–554 (2005). Diversity jurisdiction is disfavored — the federal courts aren’t supposed to be hearing garden-variety state-law tort and contract lawsuits — and since the founding of the country federal courts have been instructed to avoid diversity jurisdiction unless there’s really an obvious risk of home-state favoritism.

For example, “In a case with multiple plaintiffs and multiple defendants, the presence in the action of a single plaintiff from the same State as a single defendant deprives the district court of original diversity jurisdiction over the entire action.” Id., citing Strawbridge v. Curtiss, 3 Cranch 267 (1806). The Founders didn’t waste time clogging the federal courts with state-law tort cases, and would deny diversity jurisdiction to corporate defendants if even a single shareholder was in the same state as the plaintiff. See Bank of United States v. Deveaux, 5 Cranch 91–92 (1809)(“In conformity with the spirit of the constitution, the federal courts have always inquired after the real parties. Although the nominal parties are really persons competent to sue in those courts, yet they will inquire into the character of the real litigants, and if they find them unable to sue there, they will dismiss the suit. They will allow no fiction to give jurisdiction to the court where the substance is wanting.”) Applying the same rule today would preclude large publicly-owned corporations from forum shopping for federal court, and rightly so: does anyone really believe that, e.g., Wal-Mart needs the protection of the federal courts because it can’t get a fair trial outside of Arkansas?

In Glenda Johnson v. SmithKline Beecham Corp, decided last Friday by the Third Circuit Court of Appeals, a woman from Louisiana and a man from Pennsylvania born with birth defects caused by their mothers‘ use of thalidomide (more about thalidomide here) during pregnancy filed a state-law negligence and strict liability suit in Pennsylvania state court against several corporations, including GlaxoSmithKline LLC. The defendants removed the case to federal court.

As was undisputed, GlaxoSmithKline LLC is “a large pharmaceutical company that is responsible for operating the U.S. division of GlaxoSmithKline PLC, the British entity that is the ‘global head’ of the GlaxoSmithKline group of companies.” As the Court continued, “[GlaxoSmithKline LLC’s] headquarters is still in Philadelphia, Pennsylvania, where it occupies 650,000 square feet of office space and employs 1,800 people. Its management is substantively intact. .. [GlaxoSmithKline LLC’s] managers operate from … three [offices] in Philadelphia and a fourth in North Carolina.”

It’s an easy case, no? It’s a state-law tort lawsuit filed in Pennsylvania. One of the plaintiffs is from Pennsylvania. One of the defendants plainly has its “nerve center” in Pennsylvania, and so, under the “principal place of business” test established by the Supreme Court’s 2010 Hertz v. Friend decision, “the majority of [GlaxoSmithKline LLC’s] executive and administrative functions are performed” in Pennsylvania, and thus GlaxoSmithKline LLC is plainly a citizen of Pennsylvania.

The case was thus remanded back to state court, right? 
Continue Reading The Legal Fiction That GlaxoSmithKline Is In Delaware

Via Overlawyered and TortsProf, I saw that a new law review article came out last week in the Vanderbilt Law Review, “Products Liability and Economic Activity: An Empirical Analysis of Tort Reform’s Impact on Businesses, Employment, and Production” by Joanna Shepherd. As a products-liability lawyer (and an armchair economist), I was excited, so I printed out a copy, sat down with my highlighter, and, unfortunately, didn’t even make it past the third page without gnashing my teeth in frustration:

Specifically, we know surprisingly little about whether products liability law suppresses economic activity, and which, if any, reforms might improve economic conditions.4

This Article provides empirical evidence that addresses this argument. This issue is particularly salient because economic conditions are worse than they have been in decades, yet the cost of the products liability system continues to grow. Consequently, probusiness groups have intensified their demands for tort reform, maintaining that reforms are essential to improving the economy. Hence, it is imperative for lawmakers to know which reforms can help mend current economic conditions. Moreover, the tort system costs American businesses over $150 billion annually.5

4. AM. TORT REFORM ASS’N, supra note 2.

5. TOWERS WATSON, 2010 UPDATE ON U.S. TORT COST TRENDS 7 (2010)

There are two big empirical problems right out of the gate.

First, the Towers Watson report — Shepherd’s sole citation for the assertion that “the tort system costs American businesses over $150 billion annually” — has been repeatedly discredited for inflating its numbers and for relying on secret proprietary data, instead of the industry standard A.M. Best data. Similarly, as I’ve explained before, even if we corrected the numbers, the Towers Watson study still wouldn’t make any sense: the study absurdly refers to every benefit paid to an injured person as a “cost” to society. This would be an accurate analysis if injured persons took their settlement checks and promptly set them on fire.

In reality, as the Coase Theorem makes clear, money paid out in tort liability is not a “cost” to society, it’s just a transfer from one party to another, because the money goes right back into the economy through payments to medical providers and insurers (who subrogated part of the injured person’s claim). The money left after those medical and insurance costs goes towards remedying the insured person’s lost wages, and thus goes to the same healthy economic expenditures as before, like paying for their children’s education, or buying a new house, or putting food on the table. (Before someone claims, “but the lawyer’s fees are a transaction cost,” remember that, in personal injury litigation, the lawyer’s fees are not added to the defendant’s liability, but rather subtracted from the plaintiff’s recovery, and so they do not add to the overall recovery.)

Second, and even more worrisome in a study that purports to make “empirical” arguments, is the lack of any citation at all for Shepherd’s assertion that “the cost of the products liability system continues to grow.” Have the “costs” of our product liability system actually grown relative to the size of the economy? My hunch would be no; as Shepherd admits, since the 1980s, “state after state enacted legislation designed to curb the [fictitious liability insurance] crisis by limiting the scope of liability and damages,” and the federal government has enacted special liability protections for “general aviation aircraft,” “biomaterials suppliers of raw materials and medical-implant component parts,” and “manufacturers, distributors, dealers, and importers of firearms or ammunition.” I’d add to that list of political victories by product liability defendants the increasing adoption of the Third Restatement of Torts (which essentially eliminates strict liability) and the wholesale elimination of claims against generic drug manufacturers.

In short, product liability law has been increasingly favoring defendants for more than a generation, so why should we assume that the cost of the product liability system is growing relative to the economy? 
Continue Reading The Real Economic Impact of Product Liability Tort Reform

Product liability claims are doubly challenging for plaintiffs’ lawyers. First, product liability law is in a state of flux (with the trend going against injured consumers). Second, product liability cases are notoriously time-consuming and expensive to pursue: in addition to all the ordinary expenses and burdens of personal injury litigation, product cases usually require hiring a bevy of experts who then have to spend hundreds of hours examining the products and preparing their reports. It’s not unusual for lawyers to spend over one hundred thousand dollars on a product liability case in out-of-pocket expenses alone (not including lost attorneys fees), and when you start talking about complicated products like cars, you’re talking about a quarter million dollars or more.

That’s part of why product liability court opinions often have such tragic facts: the claim needs to be worth $1 million or more to justify the risk, and generally speaking, brain injury, spinal cord injury, and wrongful death cases are most likely to produce those kinds of awards. Whatever the injury is, it needs to be permanent, otherwise you’re investing six figures into a case that will, after expenses, return far less than that — or nothing at all.

Correspondingly, because the product liability suits brought involve such huge damages, they never follow the sort of routine that car accident and slip and fall cases do — where production of medical reviews and review of any police report or witness statements will answer most of the factual questions, and so the case can be settled with minimal litigation long before trial. The manufacturer or seller of a defective product will virtually never offer any sort of reasonable settlement amounts until after summary judgment and Daubert motions (testing the sufficiency of the plaintiff’s expert witnesses) have been decided.

I’m more than happy to rail all day against the unfair, sometimes downright illogical, restrictions placed on plaintiffs in product liability cases, and I’ve done so many times on this blog (e.g., railing against the Third Restatement of Torts, the learned intermediary doctrine, the judicially-created implied pre-emption doctrine). But sometimes the problem really can be traced back to the plaintiff’s case.

Via Abnormal Use, I learned of two recent product liability summary judgment opinions dismissing the plaintiffs’ respective cases, one in the South Carolina Supreme Court and the other in the federal court in Massachusetts. They’re examples of how the lack of a proper expert opinion can doom a case before it’s ever put in front of a jury.Continue Reading The Product Liability Expert Who Wasn’t There

It’s an old story, but one that bears repeating again and again, this time by Discover Magazine. People don’t make decisions the way computers do. They don’t calculate risks and rewards and weigh them against each other.  They routinely think with their guts (the “affect heuristic”) and, even if they do some basic probabilities in their heads, they’ll still get them wrong:

Our hardwired gut reactions developed in a world full of hungry beasts and warring clans, where they served important functions. Letting the amygdala (part of the brain’s emotional core) take over at the first sign of danger, milliseconds before the neocortex (the thinking part of the brain) was aware a spear was headed for our chest, was probably a very useful adaptation. Even today those nano-pauses and gut responses save us from getting flattened by buses or dropping a brick on our toes. But in a world where risks are presented in parts-per-billion statistics or as clicks on a Geiger counter, our amygdala is out of its depth.

A risk-perception apparatus permanently tuned for avoiding mountain lions makes it unlikely that we will ever run screaming from a plate of fatty mac ’n’ cheese. “People are likely to react with little fear to certain types of objectively dangerous risk that evolution has not prepared them for, such as guns, hamburgers, automobiles, smoking, and unsafe sex, even when they recognize the threat at a cognitive level,” says Carnegie Mellon University researcher George Loewenstein, whose seminal 2001 paper, “Risk as Feelings,” debunked theories that decision making in the face of risk or uncertainty relies largely on reason. “Types of stimuli that people are evolutionarily prepared to fear, such as caged spiders, snakes, or heights, evoke a visceral response even when, at a cognitive level, they are recognized to be harmless,” he says. Even Charles Darwin failed to break the amygdala’s iron grip on risk perception. As an experiment, he placed his face up against the puff adder enclosure at the London Zoo and tried to keep himself from flinching when the snake struck the plate glass. He failed.

This blog gets a couple hundred hits a day, and odds are good that a couple dozen of you will die from heart disease, cancer, stroke, or a car accident, while the odds of any of you dying from a shark attack or a terrorist bombing are tiny, even lower than your odds of winning the lottery.

And yet more of you probably worry about sharks and terrorists than you do smoking or too many cheesesteaks. It’s human nature.

That’s probably not news for many of you, and it’s certainly not news for the legal community that people can be irrational. Judge Richard Posner wrote a book about risk perception and political planning for catastrophes. (Because we’re talking about Discover Magazine and catastrophes, I’d be remiss if I didn’t mention Phil Plait’s excellent Death From The Skies.)

But there’s an aspect of risk perception that doesn’t get enough attention: risk perception is part of why we need robust tort laws. I’ve mentioned the Coase Theorem several times before on this blog (e.g., discussing “tort costs”) because it’s one of the more important intellectual tools we have in the legal-economic policy toolbox. Tort liability does not, on its own, impose any cost on society, it merely determines who has to pay for damages when they occur. When we talk about what our tort laws should be like, then, we should consider which party – the injured plaintiff or the allegedly wrongdoing defendant – was in a better position to more efficiently avoid the risk of harm in the first place.

Consider a concrete example: power saws.
Continue Reading Risk Perception and Categorical Liability

Last week The Times Leader in Wilkes-Barre reported:

A federal jury on Tuesday ruled against an area woman who was seeking more than $20 million from Toys R Us for injuries she allegedly suffered when an oversized candy dispenser fell and struck her in the head.

The jury, which heard from several dozen medical and other experts over a six-week trial, deliberated for about two hours before finding the national toy store chain was not negligent in connection with the Oct. 26, 2008, incident involving Dr. Mary Elizabeth Jordan Flickinger of Clarks Summit.

Flickinger alleged she suffered debilitating injuries, including several herniated discs, when a large M&M candy dispenser at the chain’s flagship store in New York City dislodged as she attempted to dispense candy. The dispenser struck her in the head and snapped her neck back, according to the lawsuit filed in 2010.

It’s always jarring to hear personal injury lawsuits referred to as claims for specific amounts of money (here, that “more than $20 million”) because many states, including Pennsylvania, don’t allow trial lawyers (whether plaintiffs’ or defendants’) to recommend specific sums of money to the jury. You’re allowed to introduce as evidence bills the plaintiff incurred (medical bills, funeral expenses, etc). You can have doctors, nurses, and life care planners talk about the cost of future medical care. You can even have an economist get up on the stand and give ranges for lost wages and the impact of inflation, but you can’t just tell the jury how much you think all of that adds up to.

I don’t have the slightest doubt that jurors are completely confused why the lawyers keep throwing around monetary figures and yet, when it comes to the case as a whole, the lawyers skirt around the issue of money (because they’re not allowed to) and start talking about justice and fairness and other off-putting banalities. The jury never hears how much the plaintiff believes their “pain and suffering” is really worth, they just have to figure it out on their own.

The court filings that only the judge sees, though, are filled with monetary figures, like the pretrial memoranda filed by plaintiff (a copy here), the source of that “$20 million” number claiming economic damages of $7,000,000 to $12,000,000 and pain and suffering of $5,000,000. The jury never saw that, it’s just for the judge to understand what the parties thought of the case.

An interesting point from those pre-trial memoranda (defendant’s is here) relates to the length of the trial. Plaintiffs punted on predicting the length of the trial until Daubert motions were decided; Defendant thought the case would last 12 to 15 days, or somewhere in the neighborhood of three weeks, not the six that it actually took.

Which is where I think the case went wrong for the plaintiff.
Continue Reading The Perils Of The Never-Ending Personal Injury Trial

It’s no secret that pharmaceutical companies are among the more litigious businesses in America. Up until 2003, when Congress stepped in, the big drug makers had a good thing going: whenever the patent was about to expire on one of their blockbuster drugs, they would file a new patent for trivial modifications to the medicine, and thereafter would sue generic drug manufacturers claiming that the generic version of the old drug somehow infringed on the new patent.

Here’s the kicker: the big drug makers knew these patent infringement claims were frivolous, so they would enter into a “settlement” in which the big drug company — which nominally brought the case to recover monetary damages — would pay the generic company not to manufacture the generic drug anymore. Crazy, huh?

So crazy and so hopelessly anticompetitive that in 2003 Congress amended the Hatch-Waxman Act to force the major drug companies to report all of these “exclusive-payment” patent settlements to the Federal Trade Commission. The FTC still keeps an eye on them and keeps filing amicus briefs to make sure courts realize how damaging that practice is. As I’ve discussed before, some unions and health plans, stymied by the Illinois Brick decision precluding antitrust claims by indirect purchasers, have tried recovering the inflated health care expenses by filing unfair trade practices lawsuits.

The pharmaceutical companies are also not strangers to deceiving the federal government; over the past decade they’ve paid several billion dollars in qui tam cases, the result of brave whistleblowers exposing the fraud at great personal cost.

So pardon me if I don’t think that pharmaceutical companies deserve a special exception from the basic legal responsibilities we all have to one another just because they claim litigation is expensive or because they claim that always tell the FDA the truth. That sort of special treatment is what they’re trying to get with “tort reform” in the Pennsylvania legislature, and what they’re claiming they’re owed in the courts:

In questioning during oral argument Tuesday in Philadelphia, a state Supreme Court justice characterized the drugmaker Wyeth as asserting that there is enough protection for persons harmed by prescription drugs in federal regulation of the release of drugs onto the market, and limiting plaintiffs to lawsuits for drugmakers’ alleged failures to adequately warn of risks.

Plaintiffs are arguing in a case that could change the landscape of pharmaceutical products liability law in Pennsylvania that drugmakers can be sued for the negligent design defect of their drugs.

Questioning the plaintiffs’ lawyer, Justice Max Baer also said that Wyeth asserts that Pennsylvania would chill the manufacturing of prescription drugs if pharmaceutical companies can be sued for the negligent design defect of their drugs. He asked the lawyer to address why that may not be so.

The case, Lance v. Wyeth, arises from a primary pulmonary hypertension death allegedly caused by Redux, a hopelessly dangerous diet drug that causes a host of medical conditions which was yanked from the market for causing valvular heart disease. No one credibly disputes that the drug should never have been marketed or sold in the first place: it combined two drugs known to cause cardiovascular problems. Had Wyeth (now owned by Pfizer) properly tested it, they probably would never have sold it. Had they properly warned doctors and patients of the real risks, no doctor would have prescribed it and no patient would have taken it.

If dangerous drugs were automobiles with defective air bags (like Gaudio v. Ford Motor Co.), or rollover-prone all-terrain vehicles (like Smith v. Yamaha Motor Corp.) there wouldn’t be a question of the applicable law. Everybody — you, me, lemonade stands, multinational corporations, and everyone in between — has the same general legal duty to exercise reasonable care not to cause injuries to others. If we don’t exercise that reasonable care, we’re negligent, and we’re responsible to pay for the damage we cause.

That’s how the tort of negligence works. It’s quite simple.

In addition to their responsibility to pay for all negligently caused damages, everyone who sells products — again, from the lemonade stand to the multinational corporation — has “strict liability” for all damages caused by defective products. Consider that defective air bags case above:

[W]e will briefly review the history of products liability law and the crashworthiness doctrine in this Commonwealth. Our Supreme Court first adopted section 402A of the Restatement (Second) of Torts in Webb v. Zern, 422 Pa. 424, 220 A.2d 853 (1966). To state a section 402A products liability claim in Pennsylvania, the plaintiff must prove that the defendant sold a product “in a defective condition,” that the defect existed when the product left the defendant’s hands, and that the defect caused the plaintiff’s injuries. See, e.g., Hadar v. AVCO Corp., 886 A.2d 225, 228 (Pa.Super.2005). A product is “in a defective condition” when it lacks “any element necessary to make it safe for its intended use or possessing any element that renders it unsafe for the intended use.” Azzarello v. Black Bros. Co., Inc., 480 Pa. 547, 559, 391 A.2d 1020, 1027 (1978). Because the key inquiry in all products liability cases is whether or not there is a defect, it is the product, and not the defendant’s conduct, that is on trial. See, e.g., Hutchinson v. Penske Truck Leasing Co., 876 A.2d 978, 983 (Pa.Super.2005), affirmed, 592 Pa. 38, 922 A.2d 890 (2007).

Gaudio v. Ford Motor Co., 976 A. 2d 524 (Pa. Super. Ct. 2009)(remanding for trial a crashworthiness claim).

But Section 402A of the Second Restatement of Torts has a pesky “comment k” for defective drug cases which says:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . .  Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.  The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Defense lawyers contend that comment k promises pharmaceutical companies total and complete immunity from all potential theories of liability except for a narrow class of “failure to warn” claims. Wyeth argued that the sole question is “whether the risk information conveyed to prescribing physicians was sufficient to permit them to conduct an individualized risk-benefit analysis.”

Nonsense.

The plaintiffs in Lance were smart to hire Howard Bashman, friend of the blog, for their appeal, and his excellent opening brief and reply are both online. So, too, is the joint American Association for Justice and Pennsylvania Association for Justice amicus brief.

The briefs quite adequately cover Pennsylvania law on the subject, all the Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971)(a Jim Beasley case), Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (1984), and Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (1996) a drug liability law nerd could ask for.

Personally, I think two arguments should decide Lance v. Wyeth.
Continue Reading Pennsylvania’s Defective Drug Design Laws Hang In The Balance

One thing you learn as a personal injury lawyer is that many everyday products are far more dangerous than you thought. Until I became a lawyer and began screening cases and receiving calls, I hadn’t a clue that Children’s Motrin could cause Stevens-Johnson Syndrome.

Tylenol is another example. I’ve used acetaminophen safely for years without a problem, and I thanked my lucky stars for it when 1,000mg of the stuff brought me back from the delirium caused by a 104+ fever. Every week, though, approximately ten people die and one-thousand are sent to the emergency department by acetaminophen overdosing.

Which brings us to In re McNeil Consumer Healthcare, Marketing & Sales Practices Litigation, 10-md-02190 (E.D. Pa.). The Amended Complaint is available on RECAP. The claims arise from a string of recalls of various children’s and infant’s Tylenol, Motrin, Zyrtec, and Benadryl prompted by FDA investigations that uncovered some ugly problems, like:

155. In May and June of 2009, the FDA discovered that from April through June 2008, McNeil had used microcrystalline cellulose, an ingredient used in liquid adult and children’s Tylenol products, that had been potentially contaminated with a gram negative bacteria, Burkholder cepacia.

***

160. Beginning in approximately the Fall of 2008, McNeil began receiving reports regarding musty, moldy odors emanating from McNeil Tylenol pills manufactured at its Las Piedrad, Puerto Rico facility.
161. McNeil did not fully investigate these reports for approximately one year notwithstanding McNeal’s obligation to notify the FDA of such reports within three days.
162. Only after the FDA insisted that McNeil conduct a thorough investigation was it discovered that the odor was the result of contamination by a product called 2,4,6-Tribromoanisole (“TBA”), a pesticide used on the wooden pallets that stored and
transported packaging materials for the medications.

***

169. In April of 2010, McNeil recalled approximately 40 types of children’s and infants’ products manufactured at its Fort Washington, Pennsylvania plant because of filth and contamination, including acetaminophen, cellulose, nickel and
chromium particulate contamination, involving McNeil’s liquid infant and children’s products including Tylenol, Motrin, Benadryl, Zyrtec and Tylenol Infants’ Drops.

You can read the first “Form 483” reports generated by the FDA here. Obviously something went very wrong with the McNeil compliance process, prompting recalls, an unknown amount of physical injury, and economic loss to the many consumers who bought those products (including myself).

The Amended Complaint was just dismissed, with leave to amend against Johnson & Johnson and McNeil.Continue Reading Recalled Product Lawsuits Getting Harder, Children’s Tylenol Edition

A tragic story:

SIOUX CITY — A Sioux City bank has filed a personal-injury lawsuit on behalf of a Sioux City girl against the maker of a powdered infant formula, claiming the girl got seriously ill from drinking the reconstituted formula days after she was born in 2008.

According to court documents, Security National Bank alleges the girl, Jeanine Kunkel, now nearly 3 years old, contracted neonatal Enterobacter sakazakii meningitis from the Similac formula made by Abbott Laboratories and suffered permanent brain damage. The bank, as the child’s conservator, seeks monetary damages for her care, suffering and fear of future disease.

Her parents say Jeanine changed drastically soon after drinking the powdered formula, which came in a complimentary gift bag when she was discharged from St. Luke’s Regional Medical Center.

In many ways, it seems like an open and shut case. The child was promptly diagnosed with E. sakazakii meningitis. The Centers for Disease Control and Prevention has found E. sakazakii infections through tainted powered infant formula before (as have the Food and Drug Administration and World Health Organization) and apparently doesn’t know of any other way in which infants become infected.

Moreover, her twin wasn’t infected, despite virtually identical conditions except for the formula. He’s fine. She “doesn’t walk, crawl or roll over. She eats through a tube inserted into her stomach, her father said, because her brain isn’t able to command her throat to swallow. A shunt keeps harmful fluid from building up in her brain.” Twins don’t mirror each other’s health care course, but his good health does help rule out, to some extent, the possibility of other causes.

But there’s a hitch in the case:

Surber and Troy Kunkel, Jeanine’s father, admit tests conducted on the can of powdered Similac didn’t show evidence of Enterobacter sakazakii bacteria, but Sioux City attorney Tim Bottaro said they’re confident that’s where the harmful bacteria came from.

FDA labs tested for but did not find the bacterium in the family’s kitchen, the lawsuit says.

The tort of negligence (which underlies most product liability cases) has four elements, duty, breach, causation, and damages. To recover, a plaintiff must prove them all beyond a preponderance of doubt. Even in strict liability (which underlies the rest of tainted product claims) the plaintiff must demonstrate that the defective product in question caused the harm alleged.

So how does the family prove that the infection which caused her brain damage was caused by the formula when the formula sample itself did not test positive for the bacteria?Continue Reading Proving Bacterial Infection Injuries Through Circumstantial Evidence