Articles Posted in defective products

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Women and children have long used talcum powder as part of their personal hygiene routine as a way to stay fresh and clean after a shower, and as safe way to prevent diaper rash. Products manufactured and distributed by Johnson & Johnson and other talc producers have recently come under scrutiny after the first talcum powder lawsuit alleged that baby powder could place users at a heightened risk for ovarian cancer. Deane Berg, the plaintiff in the lawsuit Berg v. Johnson & Johnson Consumer Companies, Inc., U.S. District Court, District of South Dakota, Case No. 09-4179, is the first to allege that the use of asbestos-free talcum powder can lead to ovarian cancer. Like many women before us, Deane Berg was a faithful user of Johnson’s Baby Powder and Shower-to-Shower products. After 32 years of use, Deane Berg was diagnoses with ovarian cancer in 2006 at the age of 49. The plaintiff in the body powder lawsuit alleges that Johnson & Johnson and other manufacturers not only should have known that their products are potentially cancerous but that they failed to warn consumers of the known dangers. The jury in the Berg v. Johnson & Johnson case found that the defendant failed to warn consumers about the known link between talc powder and female hygiene use creating a heightened risk for ovarian cancer. In failure to warn cases the manufacturer often argues that the injured plaintiff failed to follow the instructions or ignored the warning. Here, the manufacturer of the talc powder instead of warning the public Johnson & Johnson chose to promote the safe female hygienic use with products such as Shower to Shower and Baby Powder.

While new studies have come to light that strongly suggests that talcum powder acts like a carcinogen, these harmful side effects have been well known. The Johnson & Johnson website states the safety of a product in use for over 100 years. Also stating that the U.S. Food & Drug Administration and the National Toxicology Program, which is part of the U.S. Department of Health and Human Services, have concluded in the past that talc is not a carcinogen. However, more recently the American Cancer Society has suggested that while there is not enough data to definitely conclude whether or not talc powder should be considered a carcinogen, it has advised women to consider an alternative product, specifically cornstarch-based cosmetic products instead of their talc alternative. The International Agency for Research Cancer part of the World Health Organization classifies talc that contains asbestos as “carcinogenic to humans” and uses of talc-based body powder especially near the genitals as “possibly carcinogenic to humans.” More information and more studies will be required before the true safety of talc is revealed.
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Eastern District U.S. Judge Cynthia Rufe granted the motion of two health insurers to remand their Avandia pharmaceutical cases to the Philadelphia Common Pleas Court. She ruled that the GlaxoSmithKline removal to federal court had been premature.

Rufe’s decision doesn’t prevent the lawsuits from ever being removed to a consoldated ongoing Avandia Multidistrict litigation in federal court. For now, the complaints are returning to the civil justice division in Philadelphia thanks to a technicality.

Humana Health Plan Inc. and UnitedHealth Group Inc., the plaintiffs in the cases, were seeking remand because the lawsuits were started with the filing of a praecipe to issue writ of summons to take pre-complaint interrogatories, which is basically a pre-litigation tactic that portends litigation. However, the writ isn’t a complaint, per se. In Rufe’s April 17 memorandum, she came down on the side of the health insurers with her decision that removal of both lawsuits to the federal courts was premature.

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As a personal injury attorney, I was intrigued to read about the testimony in the da Vinci robot lawsuit that recently began in California. Allegations have surfaced that Intuitive Surgical Inc. aimed their marketing campaign for the da Vinci robot at less skillful surgeons. In addition to the California trial, the US Food and Drug Administration (FDA) has begun checking into reported problems with the robot’s performance, which include fatalities when the da Vinci robot was used during surgery.

Internal marketing documents named doctors who were regarded as possessing lesser skills when performing minimally invasive procedures, according to Bloomberg (4/18/13). Intuitive’s director of marketing Ryan Rhodes testified that those surgeons were then targeted by the marketing department as the best candidates to purchase the da Vinci robot.

The California lawsuit was brought by Fred Taylor’s widow. Fred died four years after having prostate removal surgery by the da Vinci robot. The lawsuit alleges that the victim died due to surgical errors that were caused because Intuitive did not properly train the surgeon who completed the operation.

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As a Philadelphia injury lawyer, I was interested to see a state Supreme Court decision that makes it a little easier for injured people and their families to win cases involving defective products. In Reott v. Asia Trend et al., the Pennsylvania Supreme Court ruled that if a defendant in a products liability case wants to argue that the plaintiff was highly reckless, the defendant must plead it as an affirmative defense. This puts the burden of proof on the defendant, the court said, rather than on the plaintiff to prove that he or she was not reckless. The plaintiffs in this case were Duane Reott, who was seriously injured while using a tree stand, and his wife, Patty Reott. The defendants argued that Duane Reott was highly reckless in his use of the tree stand, and the jury agreed. On appeal, however, the high court said the defendants didn’t adequately prove that claim.

The tree stands at issue are tree-mounted platforms that allow hunters to sit in trees and watch for deer, so they are installed high above the ground. Duane Reott bought two tree stands through his brother, and used one without incident multiple times. He brought the other one, still new in its box, to another brother’s house to install in a tree there. He climbed 25 feet and cinched the locking strap of the platform around the tree, then bear-hugged the tree and gave a small jump on the platform in order to remove any remaining slack from the strap. Reott had done this “setting the stand” many times without problems, but this time, the strap broke and he fell, crushing a vertebra and breaking his wrist. He and his wife sued four entities involved in manufacturing and selling the stand, alleging a manufacturing defect because the strap was merely glued on, rather than both glued and stitched like a seatbelt.

At trial, the court granted a directed verdict on the issue of the defect itself, but sent the issue of whether the defect caused Reott’s injury to a jury. The defendants argued that Reott was highly reckless in “setting the stand,” however, and the jury agreed. Reott appealed to the Superior Court, saying the defendants should not have been permitted to present evidence of recklessness as a rebuttal because it left him with the sole burden of proof. The Superior Court agreed, saying the evidence should have been presented as an affirmative defense, and ordering a new trial on damages. Defendants appealed.

The Pennsylvania Supreme Court agreed with the Superior Court that recklessness should best be presented as an affirmative defense in product liability cases. It drew a comparison between the established affirmative defense of assumption of risk; the less well-established affirmative defense of product misuse; and the closely related reckless conduct. However, it noted, such a defense could be incorrectly entangled with contributory negligence. Thus, it held that if a defendant wishes to plead highly reckless conduct, it must do so as an affirmative defense. Thus, the burden of proof is in the defendant to show that the recklessness was the sole or superseding cause of the injuries, the court said. It affirmed the Superior Court.

This ruling does not take away a defendant’s ability to argue that a plaintiff was reckless in using a product–but it puts the burden of proof for that assertion on the defendant, where it should be. Putting it on the plaintiff would force the plaintiff to show that he or she was not reckless, and it’s difficult to truly prove a negative. That’s why, as a Philadelphia accident lawyer, I’m pleased by this ruling.
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A confidential settlement has been reached in a Pennsylvania injury case concerning the antipsychotic drug, Risperdal.

The antischizophrenic drug, which faces over 400 lawsuits and product liability claims, allegedly caused a male patient to develop a condition known as gynecomastia. In more simple terms: the boy developed breasts as a result of taking this drug over a six-year period, from 1999 to 2004.

The boy eventually had the breasts surgically removed – he is now an adult – but the damage done both to his body and, presumably, to his social life and emotional development was likely hard to quantify.

Johnson & Johnson reached a settlement in this lawsuit at the last minute. A trial had been set to start on Monday, and plaintiffs were preparing to interrogate Johnson & Johnson’s Chief Executive, Alex Gorsky, who had been the key exec in charge of marketing the antipsychotic when the boy suffered the gynecomastia side effect.

This sad and perplexing case illustrates how drawn-out Philadelphia personal injury battles can become, especially when they involve major accidents and/or lawsuits against large corporations for significant money. Consider that the boy first suffered abnormal breast growth back in 1999 – 13-years ago! – and he has since grown up and become an adult.

In other words, he waited more than half a lifetime for a resolution to his personal injury claim.

He managed to luckily succeed with his case. But not every plaintiff with a compelling story does success. What this tells us is that product liability and personal injury plaintiffs – and their attorneys – need stamina. You may have to push for months or even years for a positive result before you obtain victory. But the difference between a victory and a loss mean a difference of hundreds of thousands of dollars for you and your family, so the battle is well worth it.

Do you need help dealing a Pennsylvania personal injury or product liability lawsuit?
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As a Philadelphia accident lawyer, I handle many cases of auto accidents. In the majority of auto accident cases, one or both drivers caused the crash by negligently failing to pay attention or make good decisions. But every now and then, a case comes along in which the fault lies with the automobile itself, or one of its parts — which means real responsibility for the crash can be assigned to the company that made the defective part. That was the allegation in Bender v. Mazda Motor Corp., a decision from the Eleventh U.S. Circuit Court of Appeals. Peggy Bender of Alabama alleged that a defective airbag in a Miata caused the death of a family member. Mazda attempted to remove the case to federal court on diversity grounds, but the federal court denied the motion and the Eleventh Circuit affirmed. In this ruling, the Eleventh says an intervening decision did not change its mind.

For federal courts to have diversity jurisdiction, the amount of money being asked for must exceed $75,000. In opposing the motion to remove the case, Bender alleged that there was no evidence that the amount in controversy reached that much. In its answer, Mazda cited a similar case, Roe v. Michelin North America, in which the federal court found that even if the amount in controversy was not pleaded in court, it was “clear” and “readily deductible” that it would exceed $75,000. Mazda asked the district court to follow this ruling, or in the alternative, stay the case until an Eleventh Circuit ruling in Roe. The district court denied this and moved the case back to state court. After the Eleventh Circuit’s ruling in Roe, which ultimately stayed in the federal courts, Mazda moved in district court to reconsider in light of the new decision. The district court denied this on the grounds that the case was out of its hands, remanded back to state court. Mazda appealed.

Before the Eleventh Circuit, Mazda argued that under a 1987 Eleventh Circuit case, Ritter v. Smith, the district court should have granted its motion to bring the case back to federal court. Bender counter-argued with another Eleventh Circuit case, 1992’s Harris v. Blue Cross/Blue Shield of Alabama. The Eleventh found Harris most persuasive. That case cited 28 USC sec. 1447, which says in part that orders to remand are not reviewable on appeal or otherwise. In Harris, the Eleventh expressly found that district courts may not review their own remand orders. This trumps the motion to reconsider filed by Mazda, the appeals court found. The appeals court further found that the outcome of Roe did not matter in this case. Even if the remand to state court was legally erroneous, it said, review by the district court or the Eleventh Circuit is still barred by sec. 1447: “The case has been removed to state court, and that is where it will stay.” Thus, it affirmed the district court’s refusal to reconsider.

As a Philadelphia personal injury lawyer, I am familiar with cases in which large, well-funded companies pull out all the legal stops to avoid liability. This is common because large companies generally have the money to fight cases all the way up to federal appeals courts, when necessary. Because facing legal liability can be very expensive in the long run — and because fighting a case in appeals courts is expensive for individual litigants like Bender — it actually does make sense for defendants with a lot of funding to fight small issues to death. This tactic does not give defendants a better argument on the facts, of course — it helps defendants dodge legal liability by removing facts from consideration.
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As a Philadelphia accident lawyer, I was saddened to read about a ruling against a family struggling with a serious brain injury. In Covell v. Bell Sports Inc., David W. and Margaret Covell of Philadelphia sued a helmet manufacturer on behalf of their adult son, David F. Covell. The younger David Covell was riding a bicycle to his job as a schoolteacher when he was hit by a car at the entrance to the school’s parking lot. He suffered such serious brain injuries that he is now disabled and his parents have been appointed as his legal guardians. On his behalf, they sued Bell Sports, the maker of his bicycle helmet, alleging that it was defectively designed and defectively failed to warn users about the risks of a blow from the edge of the helmet.

The appeal turned in part on the instructions given to the jury. Many states use a privately published standard called the Restatement of Torts, a collection of caselaw that states can voluntarily adopt in order to keep current with new decisions. Pennsylvania uses the Second Restatement of Torts, which was published in the 1950s. However, the law on products liability — the cause of action in the Covells’ case — has seen so many changes since then that a Third Restatement of Torts: Products Liability was published in the 1990s. Importantly for this case, the Third Restatement allows manufacturers to defend themselves by arguing that their products meet applicable standards. Pennsylvania has not formally approved the Third Restatement, but the judge in the Covells’ trial instructed the jury according to the Third Restatement.

On appeal, the Covells argued that the judge should not have used the Third Restatement, since it has not been adopted in Pennsylvania, and that federal safety standards for bicycle helmets were in any case inadmissible. The Third Circuit disagreed on both counts. In 2009, the Third decided in Berrier v. Simplicity Manufacturing Inc. that Pennsylvania will eventually apply the Third Restatement, making that the correct standard. It declined to overturn that, dismissing an argument the Pennsylvania Supreme Court’s dismissal of a relevant case means it does not intend to take up the Third Restatement. The Third then addressed the Covells’ other argument, that federal bicycle helmet standards used at trial are not admissible because they are not described in the admissible portions of the Third Restatement. Again, it disagreed, saying that the federal standards described issues like testing and labels that are within the admitted part of the Third Restatement. Thus, it affirmed the district court’s judgment and ended the Covells’ case.

At oral arguments in this case, the Legal Intelligencer reported, Third Circuit judges acknowledged that the situation is not at all settled for Pennsylvanians involved in products liability cases. That’s why, as a Philadelphia injury lawyer, I would be very interested in clear input from the Pennsylvania Supreme Court. The Supreme Court is supposed to adopt or not adopt new standards, but the Third did it in Berrier because the state high court expressly declined to. Thus, it’s possible that the court will ultimately come to the opposite conclusion, which would mean the Covells could have won their case if they had brought it later.
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As a Philadelphia accident lawyer, I was disappointed to see a recent federal appeals court ruling denying an injured man a chance to pursue fair compensation from the company he says is to blame. In Roth v. Noralfco, David Roth sued a chemical supply company for various causes of action claiming it had a duty to design safer acid tank cars. Roth had a job at a York, Penn. paper company that included unloading tanks of sulfuric acid sent by Noralfco by rail. He suffered chemical burns to his face in 2004 when he attempted to unload a tank that was under pressure. The federal trial court granted summary judgment to Noralfco, saying the bulk of the claims are expressly preempted by the federal Hazardous Materials Transportation Uniform Safety Act of 1990, and the Third Circuit affirmed.

The HMTA regulates interstate commerce involving hazardous materials, giving buyers and sellers uniform regulations even between states. A section of the HMTA explicitly says that “Unless authorized by another law of the United States, a law… of a State… that is not substantively the same as a provision of this chapter… is preempted.” It then goes on to list the areas of regulation that are preempted, which include what is a hazardous material, how the materials are packed and labeled, their shipping documents, notice of any spills and their shipping containers. The Third Circuit found that all of Roth’s tort claims fall under the HMTA’s purview, and were thus expressly preempted by the law. It dismissed Roth’s arguments that his job was not “in commerce” and thus the HMTA did not apply, saying unloading is expressly part of the HMTA. Thus, it upheld the trial court’s decision to grant summary judgment to Noralfco.

This decision is disappointing, because it means Roth cannot pursue compensation for what sound like some very serious injuries. In making this ruling, the Third Circuit did not rule on the merits of the case; it simply said there was no case because federal law has taken away the state-law remedy available to him. This leaves Roth and anyone else involved in shipping hazardous materials without recourse if they happen to be injured by dangerous materials like sulfuric acid while they are at work. As a Philadelphia injury lawyer, I believe our society can and should do better for the people who do this kind of dangerous job and rely on supervisors, colleagues or suppliers to stay safe.
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More than one thousand lawsuits have been filed against Philadelphia area company Johnson & Johnson according to reports. These law suits are all filed against the company for its hip replacements. Due to the high number of cases, the FDA’s interest has been peaked.

According to a May 11th report, the US Food and Drug Administration asked Johnson & Johnson as well as 20 other replacement part makers to study whether implants raise the level of metal in patients’ blood to dangerous levels.

The worldwide hip replacement market is a huge one and one that is expected to grow by at least 3.2% this year from 5.28 billion in 2010. Could it, however, be an industry that is putting Philadelphia patients and patients all over the world at risk?

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The U.S. Food and Drug Administration has announced that Terumo Cardiovascular Systems Corporation (TCVS) has finally signed a consent decree of permanent injunction. According to reports, the consent decree was filed in the U.S. District Court for the Eastern District of Michigan and the Department of Justice, Office of Consumer Litigation, and the United States Attorney’s Office.

The consent decree will prohibit the manufacturing, sale, and distributing of two heart-lung bypass systems and other cardiovascular devices to new customers. The decree was filed after an FDA inspection spanning from January through March 2010 that surprisingly uncovered numerous cGMP and MDR violations at the company’s Ann Arbor manufacturing facility.

These violations could cause serious injuries to patients in the Philadelphia Pennsylvania area and across the country. Violations included deficiencies in processes for corrective and preventive action, nonconforming product, complaints, purchasing, process validation, design controls, and adverse event reporting.

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