Articles Posted in Product Liability

The Indiana Court of Appeals recently considered Bayer’s motion to dismiss the claims of more than 30 women who had suffered complications alleged to have been caused by Bayer’s Essure medical device. Bayer’s challenge was two-fold: (1) that the complaint itself was deficient and (2) that the claims were preempted by federal law, and thus did not belong in an Indiana court.

Indiana follows a liberal notice-pleading standard when it comes to legal complaints. All that is required is to put the defendant on notice of potential liability and the potential harms and losses arising out of the liability.

The women alleged manufacturing defects in the Essure device such as “the central axis was not fully adhered to the spring which can cause the [device] to fracture/break apart.” This, Bayer argued, was not good enough. The women alleged a variety of symptoms following the implantation of the Essure device including menorrhagia, extreme fatigue, abdominal pain, back pain, joint pain, and various skin rashes.” Again, Bayer claimed the women had failed to tie these injuries to any alleged defect.

The Indiana Supreme Court recently held in Brewer v. PACCAR, Inc. that a component part manufacturer (PACCAR) may have a duty to offer or install necessary safety features under Indiana’s Product Liability Act (IPLA). Because issues of fact existed as to whether the safety features were offered and necessary to make the final product safe, the Court reversed the trial court’s finding that PACCAR owed no duty, as a matter of law, to install safety features that the injury party alleged were necessary.

The IPLA subjects a manufacturer of “a product or a component part of a product,” I.C. § 34-6-2-77, to liability for physical harm caused by a manufacturer placing “into the stream of commerce any product in a defective condition unreasonably dangerous to any user or consumer,” I.C. § 34-20-2-1. A product is defective under the IPLA if it is defectively designed, if it has a manufacturing flaw, or if it lacks adequate warnings about dangers associated with its use.

Rickey Brewer was a construction foreman killed when a semi driver backed up a semi with an integrated PACCAR glider kit, did not see Rickey, and pinned him against a trailer, killing him.  His widow and his estate asserted an IPLA claim against PACCAR. The claim asserted PACCAR’s glider kit was defectively designed because it lacked certain safety features to reduce the danger inherent in its forty-foot blind spot. (If you drive a vehicle with a rear camera and sensors, you can probably attest to the peace of mind and safety such devices add to our everyday life). Here, because a design-defect claim is based in negligence, Brewer would need to be able to prove at trial that (1) PACCAR owed a duty to Rickey; (2) PACCAR breached that duty; and (3) the breach proximately caused an injury to Rickey. The only element at issue in the case was duty—whether PACCAR lacked a duty, as a matter of law, to install certain safety features.

Yes, according to the Indiana Supreme Court decision in Myers v. Crouse-Hinds Div. of Cooper Indus., Inc., 53 N.E.3d 1160 (Ind. 2016). In this case, the Court consolidated three appeals involving the constitutionality of the Indiana Product Liability Act statute of repose as applied to plaintiffs who had suffered mesothelioma-related illnesses and in one case death.

What is mesothelioma? Mesothelioma is a rare type of cancer that often develops years after exposure to asbestos, which is a naturally occurring mineral used in a variety of products manufactured for various industries and still found in many old buildings where it has not been removed through abatement. Mesothelioma can take different forms in tissues lining certain of the body’s organs or cavities including pleural mesothelioma (mesothelioma occurring in the pleura aka lining of the lung), peritoneal mesothelioma (mesothelioma occurring in the peritoneum aka lining of the abdominal cavity), and pericardial (mesothelioma occurring in the pericardium aka lining of the heart).

Turning to the decision in Myers, the Court examined Indiana’s Product Liability Act as applied to cases of the mesothelioma-inflicted plaintiffs. Chapter 3 of the Indiana Product Liability Act sets forth the statute of limitations for product liability actions in Indiana. Section 1 of Chapter 3 applies to product liability actions generally and includes a two-year statute of limitations and a ten-year statute of repose. Section 2 of Chapter 3 applies to asbestos-related actions and also includes a two-year statute of limitations. However, Section 2, unlike Section 1, does not include a ten-year statute of repose.

The Indiana Supreme Court recently held in Campbell Hausfeld/Scott Fetzer Co. v. Johnson that product misuse, like the defenses of incurred risk and product alteration, operates as a complete defense to bar recovery in product liability cases. While misuse is normally a question of fact for the jury, under this opinion, misuse can be established as a matter of law, for which summary judgment can be granted, when the undisputed facts show the plaintiff misused the product in an unforeseeable manner in direct contravention of the product’s warnings and instructions, and that such misuse caused the harm and could not have been reasonably expected by the seller.

The Plaintiff was seriously injured in this case when he used a grinder designed by the Defendant in an attempt to cut around a truck’s headlight opening to substitute larger headlights. The Defendant’s warnings and instructions directed users to wear safety glasses, to avoid attaching a cut-off disc without a safety guard in place, and to avoid using a cut-off disc with an RPM rating below the minimum of 25,000 RPM. The evidence established that the Plaintiff did not follow these warnings and instructions and the Indiana Supreme Court found that, despite any product defect, had the Plaintiff used a guard and safety glasses, he would not have been injured.

An injury claim arising out of the use of a product falls under the Indiana Products Liability Act (IPLA).  Under the IPLA, a product-liability plaintiff must show that a product was in an unreasonably dangerous defective condition and that the product caused the plaintiff’s injuries. Plaintiffs can establish that a product was defective because of a manufacturing flaw, a defective design, or a failure to warn of dangers while using the product. Strict liability claims under the IPLA are limited to manufacturing defect claims, while claims based upon design defects or inadequate warnings or instructions are determined under negligence principles. While comparative fault principles still apply under the IPLA, the IPLA provides three non-exclusive defenses—incurred risk, product alteration, and product misuse— which based upon this opinion, all now operate as complete defenses, if proven, despite any product defects.

Our lawyers are currently investigating the FDA’s recall of Valsartan in an effort to determine whether a sufficient medico-legal basis will exist to file Valsartan lawsuits for those impacted.  At this point, it is difficult to ascertain whether those who have taken Valsartan products contaminated with NDMA may have been adversely affected by taking the contaminated drug.  The viability of such claims will depend in large part on how long the medication was taken, from whom the medication was sourced, who manufactured the medication, what dose of the medication was taken, and the amount of contaminant contained in the medication.  A Valsartan lawsuit attorney can investigate the facts necessary to form a basis for possible Valsartan litigation.  First and foremost, though, is the need for those taking a contaminated Valsartan medication to consult their physician to determine if they have been taking a contaminated Valsartan product to determine whether a different medication may be indicated.  According to the FDA, Valsartan users should not stop taking the medication until completing a physician consultation.

The biggest concern for Valsartan users appears to be an elevated risk of cancer, although other concerns are possible organ damage or tumors.  Nonetheless, and importantly, at this time, the FDA is warning those taking Valsartan do not stop taking the medication unless and until you have consulted with your prescribing physician.  It is also important to note that not all Valsartan medication was contaminated with NDMA. The FDA has published a list of the recalled and non-recalled medications, which can be found here.  Valsartan lawsuit lawyers will continue to monitor the information being developed by the FDA and companies participating in Valsartan recalls.

According to the FDA, taking the highest Valsartan does (320 mg) from the recalled batches daily for the full four years may increase the risk of cancer to the point one additional case of cancer occurs in the lifetimes of a hypothetical group of 8000 such Valsartan takers.  This may seem like a relatively insignificant risk compared to the risks of developing cancer published by the American Cancer Society.  However, this is additional risk and one additional case of this terrible disease is one too many and may very well warrant a Valsartan law firm to file a product liability or failure to warn lawsuit supported by admissible scientific and epidemiological evidence.

There is a misconception among some that if a product is destroyed during a fire, that it will be too difficult to prove the product had a defect because no specific mechanism can be pinpointed as the cause and origin of the fire.  However, in spite of manufacturing defendants’ attempts to take advantage of a potential legal Catch-22, Indiana law allows a manufacturing defect in a product to be proven through circumstantial evidence and a process of elimination.  This was explained by a federal court applying Indiana law in Gaskin v. Sharp Electronics.

In Gaskin, the plaintiffs claimed that a 19-inch Sharp television caught fire in Ms. Gaskin’s elderly mother’s room, causing her death.  They alleged that Sharp was strictly liable for placing an unreasonably dangerous and defective product–the television–into the stream of commerce.  Sharp filed a motion for summary judgment claiming the plaintiffs were unable to show a defect in the television after their engineering expert was excluded by the court as unreliable.

The plaintiffs responded to the manufacturer’s motion with evidence from a fire investigator who noted that based on his burn pattern analysis and other evidence examined, the fire originated to the north of the television stand.  And, circuit wiring in the room was examined and eliminated as the cause of the fire.  Although a definitive cause could not be determined,  the investigator opined that the fire had burned upward and outward from the television stand.  He conceded he didn’t know the first thing about televisions, but the television was the only ignition source among many he examined that could not be eliminated.

The world’s largest crop chemicals company–Switzerland-based Syngenta–is facing a wave of lawsuits arising out of the sale and marketing of a genetically modified (GMO) first generation corn seed called Agrisure Viptera with a corn trait known as MIR162. The claimants are a variety of individuals and businesses seeking damages and other relief in 20 states.

Viptera was genetically altered to contain a protein (MIR162) that kills corn-eating bugs. It was approved by the USDA in 2010 and Syngenta began selling it to U.S. farmers in 2011. China refuses to buy genetically modified crops it hasn’t tested and had not approved Viptera when Syngenta began selling it. In April 2012, Syngenta’s CEO released a statement suggesting import approval from China was imminent. The import approval, however, was not granted until approximately 20 months later in December 2014. In the interim, in November 2013, China began rejecting U.S. corn shipments on account of genetic modifications in varieties found in the shipments that had yet to be approved by China.

The lawsuits say that China rejected more than 131 million bushels of corn during the time the corn was not approved for import. As a result, corn prices decreased. Losses to the corn industry are estimated at between $1 billion and $3 billion. A federal lawsuit filed in Iowa alleges that “Knowing that contamination of Viptera corn with the rest of the U.S. Corn supply was inevitable, Syngenta nevertheless gambled U.S. farmers’ livelihood on approval of Viptera by the major corn-importing countries.”

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