Product Liability Suit Against Bayer, Others to Proceed

A judge from the District of New Jersey denied Bayer Corporation et al.’s motion to dismiss a product liability case alleging gadolinium-based contrast agents (GBCAs) caused the plaintiff’s Gadolinium Deposition Disease (GDD).  Bayer and co-defendants opposed the original complaint, but plaintiff Kimberly Gremo responded by filing an amended complaint.

GBCAs are a Federal Drug Administration (FDA) approved type of drug that are administered intravenously by medical professionals to enhance the quality of magnetic resonance imaging (MRI).  The amended complaint noted “[t]oday, Gadolinium-based Contrast Agents (GBCAs) are the most widely used contrast agents in MR imaging.”

The plaintiff is suing not only Bayer, but also General Electric Company (GE), Mallinckrodt, Inc., Guerbert LLC, and Amerisource Bergen Corporation (Amerisource) for their respective GBCAs. In the amended complaint the plaintiff alleged that from 2007 to 2016, she was exposed to three types of “GBCAs: Magnevist (Bayer), Omniscan (GE), and OptiMARK (Mallinckrodt, Guerbert, and Amerisource).”  The alleged symptoms and health affects suffered as a result of receiving the GBCAs are: “skin issues including rashes, dermatitis, burning, hyperpigmentation, rough patches, loss of elasticity, peeling and callus like buildup; teeth issues including darkened teeth and spots, cracking, and sensitivity; neurological issues including brain fog and memory loss; pain including hip, back, bone and joint; neuropathy; fatigue; muscle aches and fasciculation; and loss of smell.”  Gremo is seeking compensatory damages for all past, present and future damages, including pain and suffering, emotional distress and all health and medical care costs.

District Judge Noel L. Hillman wrote the opinion, in which he allowed all of plaintiffs’ claims to proceed to discovery.

The court noted, to prove a failure to warn claim, the 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.”  Initially, though, the plaintiff has to show the defendants had a duty to warn.  The defendants argued that the impossibility pre-emption doctrine “requires the dismissal” of this claim.  The court responded that at this stage in litigation, the defendants can only point to the contents of the complaint.  Additionally, the court pointed out the Supreme Court said the pre-emption doctrine is “a demanding defense” that requires “clear evidence” with the burden on the defendants, rather than a pleading requirement for the plaintiff.

The second count alleged a defective design, which requires a plaintiff to prove “either that the product’s risks outweighed its utility or that the product could have been designed in an alternative manner so as to minimize or eliminate the risk of harm.”  The court noted there are seven factors, but the most meaningful is that the plaintiff can prove there was a reasonable alternative design.  The defendants argued federal law preempts this claim because they cannot create alternative designs of their GBCAs, but the court held at this stage the court must take all of the plaintiff’s allegations as true, and the plaintiff’s claim that defendants can create “a safer redesign of Defendants’ GBCAs.”

The court also rejected defendants’ arguments to dismiss the breach of warranty claim, the request punitive damages, and their statute of limitation arguments.

Gremo is being represented by The Braslow Law Firm.  Bayer is being represented by McCarter & English; GE is being represented by Traflet & Fabian; Mallinckrodt is being represented by Shook, Hardy & Bacon; and Guebert is being represented by Morgan, Lewis & Bockius.