Product Liability

Published on: December 17, 2015

Delaware Court Reduces Transvaginal Mesh Product Liability Claim Verdict from $25 Million to $10 Million

There have been thousands of lawsuits brought in recent years against the manufacturers of transvaginal mesh (TVM) products, which have been identified as causing severe, painful, and often permanent injuries. Multiple medical device manufacturers have developed and marketed these devices, which are designed to treat pelvic organ prolapse and stress urinary incontinence. What the patients soon realized, however, is that the device caused severe internal damage, intense pain, and other related injuries.

To recover damages against a medical device manufacturer, the plaintiff must show that the defendant’s device bears an unreasonably dangerous design or that the device possesses a defect that occurred during the manufacturing process that renders the device unreasonably dangerous. The overwhelming majority of plaintiffs bringing claims against TVM manufacturers claim that the devices are unreasonably dangerous.

Once the U.S. Food and Drug Administration started receiving complaints about the health effects of these devices, it launched an investigation into multiple brands of TVM products, issuing warning letters to some and ordering others to perform post-market studies on the TVM products’ safety.

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Published on: December 15, 2015

Jury Awards $11 Million to Bellweather Plaintiff In Wright Medical Defective Hip Implant Litigation

By Moll Law Group

One of the first bellweather trials in the Wright Medical metallic hip implant litigation went to trial earlier this month, and the jury returned a verdict of $1 million in compensatory damages and $10 million in punitive damages. A bellweather trial is part of a multi-district litigation (MDL). Like a lead plaintiff in a class action lawsuit, the bellweather plaintiff’s claim is used to test the legitimacy of the plaintiffs’ claims and to help the parties get some picture of what common issues of law, fact, and damages might look like for the other claimants in the MDL.

In a product liability action, the plaintiff needs to prove that the defendant’s product was defective. This can be done in two ways: by showing that the product bears an unreasonably dangerous design, or by showing that the particular device that the plaintiff received suffered a manufacturing defect that rendered the product unreasonably dangerous.

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Published on: December 12, 2015

Boston Scientific Issues Class I Recall for Chariot Guided Sheath Medical Device

By Moll Law Group

Earlier this month, medical device manufacturer Boston Scientific announced that it has initiated a voluntary recall of its Chariot Guiding Sheath devices (CGS). The CGS devices were designed and manufactured to be used in peripheral vascular procedures. The U.S. Food and Drug Administration, which is responsible for overseeing the approval and safety of medical devices, among other things, has labeled the recall a Class I, the highest and most serious level of recall that the agency issues. The agency’s website defines a Class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

According to the recall, Boston Scientific has received reports that at least 14 of the CGS devices experienced shaft separation issues and other related issues that created complications in patients who were implanted with the CGS device. According to its statement announcing the recall, separation of the shaft can lead to life-threatening injuries like embolisms, blood flow obstruction, and emergency surgery to remove the device or its fragments.

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Published on: December 9, 2015

FDA Approves First Genetically Engineered Animal for Human Consumption

By Moll Law Group

The U.S. Food and Drug Administration (FDA) made major headlines this week when it granted approval for the first genetically engineered animal intended for human consumption. Dubbed AquAvantage salmon, the fish are designed to reach harvest maturity much faster than their non-genetically modified counterparts.

The approval has many consumers leery of genetically modified foods concerned because the FDA did not require the maker of the salmon, AquaBounty, to label the fish as genetically modified. Instead, the fish can be marketed and sold under the name “Atlantic Salmon.” FDA approval for genetically modified foods involves a determination of whether the altered food item in question is materially different from its non-genetically altered counterparts.

Stated differently, the FDA does not require a genetically modified food to be labeled as such unless the genetically engineered food is found to materially differ from its non-genetically engineered counterpart.

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Published on: December 2, 2015

Federal Court Remands Case to State Court for Failure to Prove Amount in Controversy Under CAFA

By Moll Law Group

In a recent case filed in the Northern District of California, Gyorke-Takatri v. Nestle USA, Inc., the court concluded that a party to a class action case who seeks removal to a federal court must offer sufficient admissible evidence to show that there is an adequate jurisdictional basis for removal. The underlying case involved a plaintiff’s allegations about the defendant’s Gerber Graduates Puffs product, which bears a label depicting a variety of fruit and vegetables. The plaintiffs sought to represent a class of in-state consumers who claim that these images were misleading by leading consumers to believe the products were healthier than they actually are. Ultimately, based on its conclusion, the Northern District of California granted the plaintiff’s motion to remand.

In their motion for remand, the plaintiffs alleged that the defendant failed to meet its burden, which required it to show by a preponderance of the evidence that the amount in controversy in the case exceeded five million dollars. This requirement is part of the federal Class Action Fairness Act (“CAFA”), 28 U.S.C. 1332(d). In order to prove that the amount in controversy requirement under CAFA has been satisfied, the party must show that the total amount of damages sought in the lawsuit, exclusive of attorneys’ fees, costs, and interest, exceeds five million dollars.

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Published on: November 24, 2015

Investigative Report Reveals Arbitration Clauses are Interfering with Consumer Rights

By Moll Law Group

A recent investigative report from the New York Times suggests that many contracts that consumers sign on a regular basis include severe and harsh provisions that effectively abolish the consumers’ rights to combat unfair and deceptive business practices. Most of these contracts are lengthy, complex, and difficult to understand, discouraging consumers from digging too deeply into the provisions and the impact of what they may be signing. Cell phone contracts are one of the most common examples of this type of contract, but they can also come with certain product purchases or even medical services.

The article discusses some specific examples involving credit card contracts, which impose an arbitration requirement on the signing party. Arbitration is a process that supplants the traditional judicial system and right to a jury. In an arbitration, the parties meet with a single, agreed upon arbitrator who is often a former lawyer or judge. The arbitrator’s decision is binding on the parties, and the parties are virtually precluded from bringing an action in court. In many cases, these arbitration requirement provisions will also specify the venue where the arbitration must take place, the set of arbitration rules that will apply, and who will be responsible for the cost of the arbitration.

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Published on: November 12, 2015

NHTSA Fines Defective Airbag Manufacturer Takata $200 Million

By Moll Law Group

The National Highway and Traffic Safety Administration (“NHTSA”) has released a statement indicating that it has fined Japanese airbag manufacturer Takata $200 million for mishandling the recall of its airbag inflators, which have been linked to at least seven deaths of Americans. On May 19, 2015, the United States Department of Transportation (“DOT”) issued a statement indicating that Takata had identified a number of defects in some of its airbag inflators. According to reports, the affected inflators were constructed with a propellant that is subject to degrading over time, leading to ruptures that can cause serious injury or even death.

On June 5, 2015, the NHTSA initiated a formal administrative proceeding against Takata, referred to as the Coordinated Remedy Program Proceeding. The purpose of this action was to determine whether the NHTSA should implement an accelerated remedy approach to addressing the millions of defective Takata airbag products contained in American vehicles. The NHTSA has the authority to require vehicle manufacturers to accelerate repairs on recalled vehicles pursuant to the TREAD Act, passed in 2000. The acceleration can only be ordered when the agency determines that there will be a risk of serious injury or death if the remedy process is not accelerated.

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Published on: November 9, 2015

California Court Dismisses Class Action Alleging Use of Term “Handcrafted” Was Misleading

By Moll Law Group

Earlier this month, a California federal court dismissed a class action lawsuit seeking to recover damages from the makers of Jim Bean, claiming that the company violated state consumer protection laws by labeling some of its whiskey and bourbon products as “handcrafted.” Dating back to the 1820s, bourbon is a type of whiskey. The term bourbon reached pervasive usage during the 1870s. Today, the Kentucky Distillers’ Association reports that roughly 95 percent of the world’s supply of bourbon is produced in Kentucky.

In Welk v. Beam Suntory Import Co., the plaintiffs’ complaint asserted claims under California’s consumer protection laws, including the False Advertising Law (FAL) and the Unfair Competition Law (UCL). In response to the complaint, the defendant filed a motion to dismiss, claiming that under the state’s safe harbor doctrine, the company is insulated from state law claims due to its compliance with federal labeling laws. The company also alleged that the plaintiffs failed to state a claim because the plaintiffs did not allege any facts showing that a reasonable consumer would find the label misleading. Also, the defendant contended that the economic loss doctrine prevented the plaintiffs from pursuing the claim for negligent misrepresentation.

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Published on: November 6, 2015

Colorado Court Considers First Cannabis Product Liability Lawsuit

By Moll Law Group

While a number of states are moving to legalize the use of cannabis, manufacturers of products containing marijuana may not be entirely clear when it comes to understanding how product liability rules will apply to them. In the recent case of Flores v. LivWell, Inc., two marijuana consumers sued the defendant, claiming that a fungicide known as Eagle 20, a petroleum-based product, was used during the marijuana growing process. The plaintiffs sought to certify a class action against the Colorado-based defendant, one of the largest producers of cannabis in the state.

The plaintiffs alleged specifically that the company used Eagle 20 without adequately warning consumers of the potential side effects and dangers associated with the insecticide. According to their complaint, however, neither of the two plaintiffs alleged that they became ill or experienced any of the potential side effects after ingesting cannabis products they purchased from the defendant.

Eagle 20 is a controversial substance, especially when it comes to cannabis cultivation. The product is used to kill pests and mites that destroy crops. One of the main ingredients in the product is Myclobutanil, which breaks down into hydrogen cyanide–a poison–when subjected to heat. The product is permitted for use in vegetation that will not ultimately be inhaled. As a result, the Colorado Department of Agriculture has banned the use of Eagle 20 for tobacco crops because the end use for tobacco and similar plants is inhalation.

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Published on: October 26, 2015

Eleventh Circuit Upholds Denial of Class Action in Diet Drug Lawsuit

By Moll Law Group

Earlier this year, the Eleventh Circuit Court of Appeals upheld a lower court’s dismissal of a proposed class action based on the plaintiffs’ failure to meet a number of the four required elements of class certification.

In Karhu v. Vital Pharm, Inc., the defendant manufactured and marketed a dietary supplement intended to help users lose weight. The defendant marketed the product for this purpose. The plaintiffs’ class action lawsuit alleged that the product did not in fact aid with weight loss as the defendant claimed. The plaintiffs sought to certify a class of product users nationwide.

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