Products Liability

Jeeps Recalled for Potential Fuel Tank Rupture Risks

June 21, 2013 | Lebowitz & Mzhen

Chrysler Group recently announced a recall affecting nearly 1.56 million 1993-1998 Jeep Grand Cherokee and 2002-2007 Jeep Liberty SUVs.

However, the company allegedly only reluctantly agreed to to the final recall after nearly 1.1 million 1999-2004 Grand Cherokees were excluded from NHTSA’s original recall request for 2.7 million vehicles. According to Chrysler, the government was incorrect in its original analysis regarding which vehicles were affected.

The recall is reportedly due to an issue with the fuel tank, which can rupture and lead to an explosion and or fire in the event of a rear end collision.

The recall excludes 1999-2004 Grand Cherokees, which are of a different design than the earlier models that NHTSA had initially suggested would be subject to the recall. However, concerned customers can contact their local jeep dealership for information regarding the safety of their vehicle.

The most publicized cases of issues with the Jeeps occurred when rear end collisions resulted in fires which caused death. In those cases, the Jeeps were either stopped or driving at a slow speed, and were hit from the rear by vehicles traveling at highway speeds.

While detailed information was not readily apparent, the conclusion was that the safety issue comes down to the hitch. Apparently the sturdy structure of a trailer hitch fastened into the vehicle’s rear frame helps to absorb some force from a rear crash. As part of the recall, Jeep will inspect and in some cases install rear hitches for the affected vehicles.

Skechers Faces Lawsuits Alleging “Shape-Ups” Caused Severe Knee Injuries

May 15, 2013 | Lebowitz & Mzhen

An announcement was made recently, regarding the filing of several different lawsuits against Skechers on behalf of individuals from four different states, who have suffered meniscus injuries allegedly caused by the defective design of Shape-Ups toning shoes. The plaintiff consumers reside in Maryland, Mississippi, West Virginia and Wisconsin.

According to the lawsuit, the plaintiffs were injured when the rocking bottom of the shoe suddenly caused them to fall, resulting in a torn meniscus. A torn meniscus is a painful knee injury, which involves damage to the cartilage in between the thigh bone and the shin bone (the meniscus). While physical therapy can sometimes help, surgery is often needed in order to adequately fix the injury.

This is not the first time Skechers has faced scrutiny for its Shape-Ups. The shoes were marketed toward consumers for having various health benefits, including allegedly increasing muscle tone simply by wearing them. According to documents filed by the plaintiffs, an independent study on the shoes found no evidence of increased intensity of exercise, increased burning of calories, or increased muscle strength or tone from wearing them.

Therefore, in 2012 Skechers was ordered by the Federal Trade Commission to pay $40 million for its misleading advertising campaigns. This order included a court determination that Skechers failed to warn consumers about potential risks associated with these shoes, and that the company had not performed adequate safety testing.

U.S. Supreme Court to Rule on Liability of Generic Drug Manufacturers

April 9, 2013 | Lebowitz & Mzhen

The U.S. Supreme Court is set to make a ruling on a very important pharmaceutical case this term. At issue is whether a generic drug manufacturer can face a lawsuit for their inability to warn consumers of potentially dangerous side effects.

The case at issue involves the drug manufacturer Mutual Pharmaceutical Co., which has appealed a jury award of $21 million in a case where the plaintiff took a generic NSAID drug made by the company for shoulder pain as prescribed by her doctor, and instead suffered incredibly serious complications. The verdict was affirmed at both the trial and appeal levels.

In this case, three weeks after the woman took the drug at issue, she developed a rare and severe reaction, which caused her skin to peel off, leaving her with burn-like lesions over two-thirds of her body. She spent some of the nearly two months during which she was in a hospital burn unit in a medically induced coma, and has had to undergo 13 eye surgeries.

The reaction, which is considered to have been a severe form of Stevens-Johnson Syndrome, caused the woman to suffer permanent near-blindness, scarred lungs and a constricted esophagus, making it difficult to swallow. She originally sued the manufacturer under state law in 2008 for alleged design defects. Following a 14 day trial, the jury awarded her $21 million for her injuries and suffering.

The appeal centers on the applicability of two prior court rulings, particularly PLIVA v. Mensing, which held that generic drugmakers cannot be sued for failing to warn about certain health risks due to the fact that federal law requires generic drugs to carry the same warning label as their brand name equivalents. Therefore, it remains unclear whether the court will choose to distinguish this case in that it does not solely claim a failure to warn, but also argues a design defect, which again may potentially be excludable under prior case law.

Ford Announces Nationwide Recall of Certain Freestar and Mercury Monterey Models

March 28, 2013 | Lebowitz & Mzhen

Earlier this month, Ford announced the recall of several of its Freestar and Mercury Monterey Vehicles. Owners of either of these types of vehicles should check any records they have relevant to their vehicles, and contact the dealer if necessary in order to determine if your vehicle is affected by this recall.

Vehicles subject to this recall meet all of the following criteria:

have a manufacture date falling within the period of March 24, 2003 through November 7, 2006
are equipped with a third row seat
originally sold in, or are now registered in the following states: CO, DE, IL, IN, IA, ME, MD, MA, MI, MN, MO, NH, NJ, NY, OH, PA, RI, VT, WV, WI, and Washington D.C.

The recall has been initiated due to a potential defect in the stowable seat in the third row. The anchor mechanism that is mounted to the rear wheel wells can suffer from corrosion, leading to structural degradation. Thus, as a result of the corrosion, the third row seat may not latch properly into its seating position. This is potentially dangerous, because a rear end collision could cause great personal injury to a person sitting in an unlatched seat.

Ford has said that it will notify owners and that dealers will install replacement third row seat latch striker mounting brackets, which will hopefully rectify the problem.

Class Action over Alleged Shuddering of Ford F150s

February 20, 2013 | Lebowitz & Mzhen

A class action lawsuit was filed today against Ford Motor Company, alleging that the company’s Ford F150 trucks contain a dangerous safety defect which causes the trucks to shudder or shake violently, and even stall when the driver attempts to accelerate.

The complaint, filed on behalf of at least 20 owners, arises out of frightening situations in which the trucks stall suddenly as the drivers were attempting to change lanes or pass, while driving in dense freeway traffic. It is scary to imagine attempting to navigate dense traffic and having your truck or car’s engine suddenly cut off completely. It’s not immediately clear whether this stalling occurred only at slower speeds, or if it also occurred while drivers were driving at full freeway speeds.

One theory is that the problem is caused by moisture moving into the engine as the drivers attempt to accelerate,causing the vehicle to shudder. In some severe cases, it is alleged, the F150’s computer system senses the change in the engine, and thus forces the vehicle into a so called “limp mode” in order to prevent incurring engine damage. It is believed the problem may lie within the Charge Air Cooler (CAC) system, which regulates cooling and temperature in the engine.

The suit further claims that Ford has been aware of the issue, and not only failed to address the issue, but may have even gone so far as to warn dealers of the potential defects in an internal document, stating that the vehicles may, “stumble and/or misfire on hard acceleration after an extended drive at highway speeds during high humid or damp conditions.”

Court Dismisses Putative Class Action Alleging Defective Tires, in Part for Failing to Allege Injuries or Damages

February 6, 2013 | Lebowitz & Mzhen

A New Jersey federal court dismissed a putative class action against an automobile manufacturer and a tire manufacturer for failing to state claims for which the court could grant relief, ruling separately on motions to dismiss brought by both defendants. Greene v. BMW of North America, et al, No. 2:11-04220 (D.N.J., Nov. 28, 2012). The lawsuit asserted causes of action for breaches of warranty related to allegedly defective tires, although the plaintiff did not allege any personal injury or property damage. While this case involved alleged violations of consumer rights laws, it is similar to some products liability claims alleging damages caused by a dangerous or defective product.

The plaintiff, David Greene, leased a BMW automobile that was equipped with Potenza Run Flat Tires, a product of the tire manufacturer Bridgestone. Greene alleged that he noticed a bubble in the side of the left-rear tire less than six months into the lease, followed by two bubbles in the right-front tire over the next twelve months. He claimed that the bubbles made operation of the car “distractingly loud,” “[un]controlled,” and “dangerous.” Slip opinion on BMW’s motion to dismiss (BMW opinion) at 5, slip opinion on Bridgestone’s motion to dismiss (Bridgestone opinion) at 7. When the mileage on the car reached 13,800, he sought advice regarding the condition of the tires. He claimed that multiple representatives of BMW dealerships informed him that this type of tire often developed bubbles before the vehicle hit 14,000 miles. They also allegedly told him that he should replace the tires immediately. Greene requested the dealership from which he leased the BMW to provide replacement tires, but claims that they refused. He then purchased the same model of tire online.

Federal Government Reports on Improvements to Approval Process for Medical Devices

January 22, 2013 | Lebowitz & Mzhen

The Center for Devices and Radiological Health (CDRH) issued a report in November 2012 on improvements to its review and approval procedures for new medical devices. As part of the U.S. Food and Drug Administration (FDA), the CDRH is responsible for medical device safety and quality. The FDA defines “medical devices” as any device designed to either diagnose or treat disease or other conditions, or to alter or affect a bodily structure or function. They may range in complexity from Class I devices, such as dental floss, to Class III devices like pacemakers. The CDRH’s recent report builds on a plan the agency developed in 2011 to streamline and improve the premarket review and approval of medical devices.

Section 510(k) of the Food, Drug, and Cosmetic Act (FD&C Act) requires any person or business who intends to market a medical device designed for human use within the U.S. to submit a Premarket Notification, commonly known as a “510(k),” to the CDRH. The purpose of the 510(k) requirement is to allow the CDRH an opportunity to review the device and confirm that it is at least as safe as similar devices already on the market. Certain Class III medical devices that are entirely new, or otherwise not similar to any other device on the market, must submit to a Premarket Approval (PMA) process, which is more comprehensive because of the lack of existing safety data.

According to the CDRH’s report, entitled “Improvements in Device Review Data,” the agency’s premarket review and approval efficiency declined between 2001 and 2010. This was largely due to budget constraints, high staff turnover, limited training resources, and high workload. A lack of federal funding accounted for much of these issues, but the ever-increasing sophistication of medical devices compounded the problem, according to the CDRH, making it even harder for the agency to keep up with the incoming documentation. The effect of this decrease in efficiency was a significant increase in the time required for approval of new medical devices, along with the possibility of older, less effective or less safe devices remaining in use, posing a possible threat to patient safety.

Federal Judge Permits Company Disputing CPSC Complaint Data to Remain Anonymous

December 14, 2012 | Lebowitz & Mzhen

In October, a federal judge permitted a company known only as “Company Doe” to remain anonymous in a lawsuit against the U.S. Consumer Product Safety Commission (CPSC). The anonymous company argued that the CPSC’s report with consumer complaint data was “baseless” and would cause “irreparable harm to [the company’s] reputation and financial well-being.” While that is certainly a valid concern, a Washington, DC products liability attorney would likely be more concerned with the extent to which such secrecy places the public at risk of encountering the dangerous product.

The CPSC is the federal agency tasked with protecting the public from “unreasonable risks of injury or death” from consumer products within its jurisdiction. Children’s toys, automobiles, and consumer appliances all fall within the purview of the agency’s power to regulate. The CPSC is perhaps most known for issuing announcements regarding product recalls.

In this lawsuit, Company Doe sued the CPSC, asking the court to stop the federal agency from publishing a report on its public searchable database, SaferProducts.gov. Presumably, the report is related to a consumer product Company Doe produces or produced.

Consumer advocacy groups have opposed Company Doe’s requested injunction, citing the First Amendment of the U.S. Constitution and the public interest in understanding why the report should remain undisclosed. They argue that the CPSC database is a critical tool for informing consumers about potentially dangerous products, and the exclusion of one product from the database by an anonymous company could undermine that purpose.

By law, the CPSC must post consumer complaints within 20 business days of receiving them, but it must first notify the product manufacturers to give them an opportunity to respond. Complaints that are shown to be materially inaccurate are corrected or removed.

Each year, thousands of consumer products are manufactured, sold, and then recalled for being defective. A product may be defective three ways. A design defect is a flaw in the way the product was conceptualized. In this case, every single instance of the product is defective, and a recall would affect every product sold. A manufacturing defect is a flaw in the production of the product, and these defective products deviate in some way from the intended product. Products recalled due to a manufacturing defect are often only a subset of the products sold, such as those manufactured and sold in a certain facility, or during a specific time frame. Finally, products may be defective if the manufacturer fails to warn consumers and potential users about foreseeable dangers of using the product, such as detachable blades or dangers of choking.

Energy Drink Maker Faces Lawsuits and Congressional Scrutiny After Multiple Reports of Deaths

December 7, 2012 | Lebowitz & Mzhen

Living Essentials, LLC, the Michigan-based manufacturer of the drink marketed as 5-Hour Energy, currently faces lawsuits around the country blaming the drink’s high caffeine content for multiple injuries and deaths, or alleging that the company makes false statements regarding the drink’s contents or benefits. A nonprofit health organization recently accused the company of misquoting its executive director in an advertisement. The U.S. Food and Drug Administration (FDA) has named the drink in multiple reports based on consumer complaints, including thirteen fatalities, and two U.S. senators have requested to meet with the FDA regarding concerns about regulation of the beverage.

At least ninety-two FDA reports have mentioned 5-Hour Energy since 2004. Thirty-three of those reports involved hospitalizations, and thirteen involved deaths. Common caffeine-containing beverages like Coca-Cola have strict limits on their caffeine content set by the FDA, but “energy drinks” like 5-Hour Energy, Monster, and others are often labeled as “dietary supplements” rather than beverages. While a 12-ounce beverage like Coca-Cola might have an upper limit of 71 milligrams of caffeine, or roughly six milligrams per ounce, a dietary supplement does not face the same regulations. A single serving of 5-Hour Energy, sold in sixty milliliter (approx. two ounce) containers, may contain 207 milligrams of caffeine. The FDA has announced its intention to review its policies on labeling and warnings for drinks with such high caffeine content.

The company has also dealt with complaints from a non-profit science group, the Center for Science in the Public Interest (CSPI). The group accused Living Essentials of running a misleading advertisement online, which implies that the group’s executive director endorses the product’s safety. According to the CSPI, the advertisement includes a quote from the director saying that a fatal overdose is unlikely based solely on caffeine. The company suspended the advertisement in response to the group’s criticism.

Several lawsuits pending around the country are challenging the safety of 5-Hour Energy, either as a result of injury or death, or based on allegedly false or misleading statements regarding the beverage’s ingredients. A Tennessee lawsuit, Hassell v. Innovation Ventures, et al, alleges that consumption of 5-Hour Energy caused the death of the plaintiff’s husband by cardiac arrhythmia in 2009. The plaintiff asserted causes of action for negligence and products liability, but nonsuited the case without prejudice in November 2011.

Washington DC Court Reviews Venue and Personal Jurisdiction in a Case Alleging a Defective Medical Device: Marshall v. I-Flow, LLC

October 22, 2012 | Lebowitz & Mzhen

A medical device manufacturer moved for dismissal of a lawsuit, Marshall v. I-Flow, LLC, in a Washington DC court, arguing that the court lacked personal jurisdiction over it or, alternatively, that the venue was not proper. The plaintiff had undergone surgery in upstate New York and alleged injuries caused by the defendant’s device. The court found that it had personal jurisdiction and that venue was proper, but it exercised its authority to transfer the case to New York for purposes of convenience.

The plaintiff, Jennifer L. Marshall, had surgery on her shoulder in 2006 in Syracuse, New York. Marshall was and remains a resident of Ithaca. After the surgery, her doctor implanted a “pain pump” manufactured by the defendant, I-Flow, LLC, in her shoulder joint. The pump delivered a steady stream of painkillers directly to the joint. Marshall alleges that the pump caused extensive damage to the cartilage in the joint, eventually requiring further surgery in Rochester in 2011. As of the date of the court ruling in 2012, Marshall had received a recommendation for “total shoulder replacement.”
Marshall filed suit against I-Flow, a Delaware company based in California, in the U.S. District Court for the District of Columbia in 2012. The lawsuit asserted various causes of action for negligence, product liability, and failure to warn. I-Flow filed a motion asking the court to dismiss the case for lack of personal jurisdiction, or to transfer it to the Northern District of New York.