Articles Posted in Products Liability

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The circumstances surrounding a product liability penalty announced this week by the Consumer Product Safety Commission go a long way toward explaining why both government oversight and the remedies offered by our courts are so important when defective or dangerous products find their way to market.

According to the Sacramento Bee, and an announcement on the agency’s website, the Consumer Product Safety Commission “has reached a settlement with E&B Giftware LLC of Yonkers, N.Y., resolving CPSC staff allegations that E&B failed to report a defect with its fitness balls.” The agency reports that the company has been hit with a $550,000 civil penalty as a result of its failure to act promptly on legitimate product safety issues.

A statement published on the CPSC website notes that E&B sold three million fitness balls between 2000 and 2009, despite, over that period, “47 reports of the fitness balls unexpectedly bursting when overinflated by consumers, resulting in injuries, including a fracture and bruises.” The agency notes that the balls were recalled by the company in 2009, but that more recent investigations have shown that the manufacturer was aware of some of the potential problems for a significant period of time prior to agreeing to the recall.

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The federal government’s Food and Drug Administration announced recently that Beaverton-based King International has agreed to recall its ShoulderFlex Massager. The Oregon product recall was ordered after evidence emerged that ShoulderFlex use can lead to serious injuries or even a product liability-related Oregon wrongful death.

“One death and one near-strangulation have been reported after a necklace and piece of clothing became caught in a rotating component of the device. In other cases the FDA says people’s hair became caught in the ShoulderFlex,” Portland television station KATU reports.

The station notes that all 12,000 of the massagers the company has sold nationwide since 2003 are being recalled. It adds that efforts to obtain a comment from the Beaverton-based company were unsuccessful.

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A recent column in the Capitol Hill newspaper Roll Call highlights a potentially serious attack on patients rights here in Oregon and elsewhere, one that has received relatively little notice in the months since the new Congress convened.

The focus of the piece is HR 5. Formally titled the Help Efficient, Accessible, Low-Cost, Timely Healthcare Act (i.e. the “HEALTH Act”), it is billed as a centerpiece of Republican efforts to repeal and replace the health care reform act passed by President Barack Obama and the Democrats last year. According to the federal government’s legislative bill-tracking service, Thomas.gov, the bill is co-sponsored by about half of all the Republicans in the House. Among Oregon’s congressional delegation only Rep. Greg Walden, whose district covers much of rural eastern and central Oregon, is a co-sponsor.

The official summary says that the bill “sets conditions for lawsuits arising from health care liability claims.” In particular, it establishes a three-year statute of limitations for most health-care related injuries. In addition, the bill “limits noneconomic damages to $250,000 (and) makes each party liable only for the amount of damages directly proportional to such party’s percentage of responsibility.” It also forbids the awarding of punitive damages “in the case of products approved, cleared or licensed” by the federal Food and Drug Administration (FDA).

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Earlier this week Notre Dame University wrapped-up its investigation of an accident last October in which a 20-year-old student was killed when the mobile lift from which he was filming football practice toppled over amidst high winds. In a news conference the school’s president announced, in effect, that because everyone involved was partly to blame for Declan Sullivan’s death no one in particular was actually responsible, according to an account by sports columnist Mike McGovern.

The idea that universal blame for this tragedy means no one is individually responsible is disturbing – especially since, in many respects, it clashes with the findings of Indiana’s Occupational Health and Safety Administration. That organization fined the university for a list of workplace safety violations related to the accident. According to McGovern: “Notre Dame was cited for failure to properly train the students, failure to have the lift serviced and inspected as required, failure to have an operator’s manual on the lift and failure to have warning labels displayed.” IOHSA has levied over $77,000 in fines for these violations, which the university is contesting.

At a more basic level, however, someone made the decision to send Sullivan up an unsafe lift “in known adverse conditions.” Someone decided that videotaping football practice overrode legitimate concerns about a student’s safety.

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The US Supreme Court heard arguments this week in a case that raises important issues about personal privacy, patients relationships with their doctors and what some see as corporate America’s right to see people’s personal data because doing so may aid their marketing efforts.

According to the Burlington Free Press, the case turns on “a Vermont law that restricts the use of doctors’ prescription records for marketing purposes.” Pharmaceutical companies have challenged the law, arguing that they need to know which doctors are prescribing generic as opposed to brand-name drugs so that they can target their marketing to doctors who, they feel, should opt for generic medicines less often. The Free Press reports that 35 states, the District of Columbia, the US Justice Department and “organizations representing more than 100,000 physicians” back the law, while “numerous business and research groups, including the US Chamber of Commerce” oppose it. The measure went into effect last year. A Federal District judge upheld it, but was reversed by the 2nd US Circuit Court of Appeals.

From a patients’ perspective challenges to this law raise several potentially disturbing issues. As patients we presume our conversations with out doctors are private. It is unclear from the court arguments whether personally identifiable information is being shared with drug companies. Also, should patients have some right to know whether their doctor’s prescribing decisions were effected by a marketing hard-sell from drug manufacturers? Considering the number of scandals in recent years surrounding medical marketing these are very legitimate questions for patients to ask.

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On March 30 a case was argued before the US Supreme Court that has the potential to impact the use of nearly every generic prescription drug sold in America. The court heard oral arguments in a case involving generic drug manufacturers and their contention that they should be held to less strict labeling laws – and receive greater immunity from lawsuits – than the manufacturers of brand-name medications. This case has clear, significant implications for personal injury and medical malpractice law here in Oregon. The court’s final decision, expected in the late spring or early summer, will bear close scrutiny

According to a detailed account of the case on the website of the American Association for Justice, generic drug makers are arguing that a federal law requiring them to use the same labels as their brand-name rivals prohibits them from strengthening warnings to consumers and also, in effect, prohibits consumers injured by generic drugs from suing the manufacturers over labeling issues. They are making this claim, AAJ notes, despite a court brief filed by one of the congressmen who write the law saying that his, and Congress’, intent was nothing like what the drug makers claim.

At issue is a piece of legislation known as “Hatch-Waxman” that requires “a generic label to match that of its associated brand-name drug.” Lawyers for the plaintiffs, two women injured by a generic prescription drug for stomach conditions, described the case as turning on the manufacturers’ belief that “in the face of considerable information that the warnings on their products were inadequate” generic drug manufacturers did nothing to protect consumers, and feel they should suffer no consequences for that decision. The case is especially important since, as AAJ reports, “70 percent of all prescriptions in the United States are filled with generic drugs and that, of the drugs that have both a generic and a brand-name available, more than 90 percent of the prescriptions are filled with generics.”

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Senator Tom Udall (D-New Mexico) is making headlines this week as the man leading efforts by Senate Democrats to reform rules governing filibusters. As the New Year begins he also, however, is emerging as the congressional point person for a very different issue: traumatic brain injuries, specifically those sustained while playing football.

According to The New York Times, Udall is calling on the Federal Trade Commission to “investigate what he called “misleading safety claims and deceptive practices” among helmet manufacturers and refurbishers.”

As I noted in this post last fall, safety standards for football helmets have not changed meaningfully since the early 1970s. The Times article notes that Udall “took specific aim at Riddell, the official helmet manufacturer of the N.F.L., for its prominent claim that its popular Revolution models decrease concussion risk by 31 percent.” Udall contends that the testing standards used to evaluate helmets – along with much of the advertising based on those tests – are misleading. A spokesman for the company told the Times that Riddell welcomes the scrutiny, but hopes other helmet manufacturers will be subjected to it as well.

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A ruling late last month by a California judge could hold significant long-term benefits for Oregon accident victims. The judge struck a blow for openness and, in so doing, may make it a bit easier for accident victims across the country to obtain justice when they face off against large corporations.

According to the Los Angeles Times, the judge ruled that Toyota “cannot keep secret the terms of a settlement it made with the family of four people killed in a Lexus accident outside San Diego last year.” The paper reports that the 2009 accident was attributed to “sudden acceleration” by the vehicle. This is, in fact, the accident that touched off the multiple vehicle recalls that caused Toyota so many headaches last year.

Interestingly, both Toyota and the victims’ families had asked that details of their settlement be sealed, arguing that public disclosure could taint any subsequent legal proceedings. The judge rejected that claim, writing that “in this case, the right to know overpowers the concerns raised by the plaintiffs and the defendants.” A Toyota spokesman described the carmaker as “disappointed” in the ruling, but did not say whether the company will appeal, according to the newspaper.

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Back in August I wrote about the dangers posed to children by ATVs, and the effort in Massachusetts to cut the number of deaths and injuries to young riders through a new law banning ATV use by kids 14 and younger. Now we have even more evidence of the need for such laws, and the need for accountability among ATV manufacturers.

According to a recent article in the trade publication The Safety Record, a new study conducted by Johns Hopkins University’s Center for Injury Research and Policy looks at ATV-related hospitalizations and injuries to children between 1997 and 2006. The study found a huge spike in both categories among children during that time period. The numbers are particularly noteworthy because, as The Safety Record notes, it was during this time that a 10-year consent agreement between the Consumer Product Safety Commission and ATV manufacturers expired. Under that agreement, reached in 1988, the manufacturers offered “free training for riders, warning labels, a public education campaign and a ban on three-wheeled ATVs,” the publication notes. Once the agreement expired some manufacturers continued to honor it voluntarily, but others did not.

During the 1997-2006 period, the study found, ATV-related injuries to children (defined as 17 years old or younger) increased by 150 percent overall. Some sub-groups showed even more alarming jumps: notably 15-17 year old boys, among whom injuries increased by 260 percent. “All-Terrain vehicles are inherently dangerous to children,” the report quotes Dr. Stephen Bowman, a Johns Hopkins professor and the study’s lead author, saying.

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The New York Times reported last week that Massachusetts has reached a settlement with the Stryker Corporation in a lawsuit alleging that the hip and knee manufacturer “marketed items without regulatory approval and misled health care providers about the use of its products.” The case focused specifically on Stryker’s OP-1 implant and OP-1 putty, according to the Times.

The $1.35 million settlement with Stryker’s biotech unit consists of a $325,000 civil penalty and $875,000 in funds to combat illegal marketing by other health-care related companies. The remainder is taken up by “legal fees and investigative costs.”

After the Massachusetts attorney general announced the settlement the company issued a statement emphasizing that under the terms of the agreement it has admitted no liability. It is hard, however, not to miss the product liability issues this may raise for Stryker in other states. Clearly, any Oregon patient suffering from the symptoms that were raised in the Massachusetts case would be well advised to consult with a Portland medical malpractice lawyer to consider best way to proceed.

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