Gadolinium

Gadolinium is a chemical element. Healthcare professionals use it in neutron therapy to target tumors. As noted further on Wikipedia, “is effective for use with neutron radiography and in shielding of nuclear reactors.”

Additionally, Medical professionals use Gadolinium in diagnostics. Some drugs include Gadolinium-based contrast agents. A healthcare professional injects this into a patient’s vein before certain tests, including magnetic resonance imaging (MRI) and a magnetic resonance angiography (MRA). The intent is to help improve visualization of internal organs, blood vessels, tumors, and tissues. Chuck Norris’ wife died years ago and he brought a lawsuit alleging use of these gadolinium-containing drugs can cause toxicity and ultimately injury people over time. This was a second round of lawsuits regarding gadolinium. The first concerned Nephrogenic Systemic Fibrosis (NSF).

KBA filed suit against Bayer Corporation and General Electric, among others

Working as local counsel for attorney Matt Leckman, KBA partner Derek Braslow filed a lawsuit in federal court in New Jersey. This lawsuit concerns FDA-approved gadolinium-based contrast agents (“GBCAs”) that medical professionals administer intravenously to enhance the quality of magnetic resonance imaging (“MRI”). The lawsuit alleges that the gadolinium caused “gadolinium toxicity, or Gadolinium Deposition Disease (GDD), as characterized by a multitude of symptoms,” including “skin issues including rashes,” “teeth issues including darkened teeth and spots,” “brain fog and memory loss,” and “loss of smell.”

Plaintiff asserted product liability claims, in part. In this case, Plaintiff asserted two counts for Defendants’ alleged violations of New Jersey’s Product
Liability Act (PLA), N.J.S.A. 2A:58C-2: failure to warn (Count I) and defective design (Count II). Defendants filed papers in Court to dismiss all of Plaintiff’s claims. As explained next, Defendants lost. The Court issued an opinion denying Defendants’ motion, so Plaintiff’s case continues.

Defendants filed a motion to dismiss 

A motion to dismiss asks the Court to end the lawsuit. In such cases, it argues that even if the facts Plaintiff alleges in her complaint are true, as a matter of law, she loses. There is no need for a jury trial.

As the Court set forth in its decision, “To determine the sufficiency of a complaint, a court must take three steps: (1) the court must take note of the elements a plaintiff must plead to state a claim; (2) the court should identify allegations that, because they are no more than
conclusions, are not entitled to the assumption of truth; and (3) when there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement for relief.” (Opin. at 8 (citing Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 664, 675, 679 (2009) (alterations, quotations, and other citations omitted).)

KBA’s client survives Defendants’ Motion to Dismiss failure to warn claims

The Court denied Defendants motion regarding Plaintiff’s failure to warn claim. Lawyers present a failure to warn claim as a product liability claim or a negligence claim. Accordingly, failure to warn basically means the company knew or should have known about risks, but did not put them in the label or otherwise warn doctors and/or patients.

As the Court explained, “To prove a failure-to-warn claim, a plaintiff must show: (1) the product was defective; (2) the defect existed when the product left the defendant’s control; and (3) the defect caused injury to a reasonably foreseeable user.” (Opin. at 12 (citing Lopez v. Borough of Sayreville, 2008 WL 2663423, at *15–16 (N.J. Super. Ct. App. Div. 2008) (citing Coffman v. Keene Corp., 133 N.J. 581, 593, 628 A.2d 710 (1993).) Here, Plaintiff properly pleaded failure-to-warn claims by alleging the labels were defective when they left Defendants’ control and this injured Plaintiff, a reasonably foreseeable user.

KBA’s client survives Defendants’ Motion to Dismiss preemption claims

Congress created the United States Food and Drug Administration (“FDA”) nearly a century ago, though its effective predecessor existed over a century ago. With the Agency came laws, statutes in the United States Code. This includes the Federal Food, Drug, and Cosmetic Act, which basically defines what the FDA can do and in part, what companies can and cannot do. Agencies like the FDA then create regulations, which are technically not laws because a legislative body does not pass them and an executive sign the bill. Practically speaking, they operate as laws in the sense that they circle back to the law – the Act – and so you end up violating the Act and therefore violating the law.

Because Congress allows the FDA to regulate certain products, a legal doctrine called preemption sometimes applies. This basically means because the federal government is handling something, private parties should not be able to sue over it in a way that sort of second guesses Agency decisions. In our case, Defendants argued that the Federal Food, Drug, and Cosmetic Act and related labeling regulations plaintiff’s claims.

To win, “Defendants must show by clear evidence that the FDA would not have approved the warning that Plaintiff contends state law requires.” (Opin. at 17 (citing Merk, 139 S. Ct. at 1676 (citing Wyeth, 555 U.S. at 571).) They failed to do so at this stage. The Court found that Plaintiff’s claims the Federal Food, Drug, and Cosmetic Act and related labeling regulations did not preempt plaintiff’s claims. Defendants will likely get another shot at this argument with the Court applying a different legal standard, so it is a battle victory, but the war continues.

KBA’s client survives Defendants’ Motion to Dismiss defective design claims

Plaintiff brought another product liability claim, defective design. The Court observed that “the elements for proving a design defect claim are
essentially the same as for a failure-to-warn claim.” (Opin. at 20 (citing Lopez v. Borough of Sayreville, 2008 WL 2663423, at *15–16 (N.J. Super.
Ct. App. Div. 2008) (citing Jurado v. W. Gear Works, 131 N.J. 375, 385, 619 A.2d 1312 (1993).) The Court applies “a risk-utility” test to this analysis.

The plaintiff under this test must prove either that the product’s risks outweighed its utility or that the defendant could have designed the product in a different way to minimize or eliminate the risk of harm. (Id. at 21.) Courts generally consider seven factors. The seven listed factors in the classical statement of the risk-utility analysis are the usefulness and desirability of the product, the safety of the product, the availability of a safer substitute product, the feasibility of making a safer product, the product user’s ability to avoid danger by using it safely, the user’s awareness of the inherent dangers or existence of suitable warnings or instructions, and the feasibility of spreading the loss by setting the product price or carrying liability insurance. See Grier v. Cochran Western Corp., 705 A.2d 1262, 1269 n.4 (N.J. Super. Ct. App. Div. 1998). 

In our case, we alleged that the risks outweighed their utility. We alleged Defendants could have and should have designed each product as a macrocyclic GBCA, which would have minimized or eliminated the risks. The Court concluded Plaintiff pleaded properly a viable design defect claim. (Opin. at 23.) Defendants’ preemption defense failed here again. The Court also denied Defendants’ motion as to Plaintiff’s other claims. (Id. at 28.)

KBA celebrates its client victory and tips its hat to partner Derek Braslow 

We are happy Plaintiff’s case gets to continue at this stage. Derek is passionate about his clients. This is a great victory for his legal team!