Articles Posted in Product Defects

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The first Avandia case set for trial against drug manufacturer GlaxoSmithKline (GSK) settled for an undisclosed amount. The pharmaceutical litigation case was brought against GSK after new studies of Avandia revealed that using the drug could increase the risk of heart attacks and strokes.

No details of the settlement or the terms were announced except a statement indicating that the details of the settlement were to remain confidential. And while GSK would not indicate how many plaintiffs were involved in the recent settlement, according to reports by Deutsche Bank, as many as 5,000 claims for damages were reportedly consolidated in this Philadelphia case.

If the alleged number of settled claims is correct, then this could mean that GSK has settled almost half of the pending Avandia claims. Analysts have been evaluating the progress of GSK’s Avandia lawsuits and had originally estimated there to be around 13,000 claims against GSK that would take around $6 billion in total to settle. While GSK has yet to confirm the actual numbers in any of the Avandia cases, according to a recent Reuters’s article by Ben Hirschler, the recent developments indicate that GSK’s final payout would be considerably less. New estimates indicated that the final payout might be close to $1.1 billion instead of the $6.6 billion originally anticipated.

It will be interesting to see whether GSK plans to settle the next set of claims, which is scheduled for an October 2010 trial in Philadelphia. To date it has not settled any of its multi-district litigation claims that are pending in federal court.

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Yesterday the House Committee on Oversight and Government Reform Johnson & Johnson’s Recall of Children’s Tylenol and Other Pediatric Medicines” in order to further investigate McNeil Consumer Healthcare/Johnson & Johnson’s recall of numerous children’s medicines.

Since its April 10, 2010 voluntary recall, Johnson & Johnson has recalled around 136 million bottles of more than 40 different types of popular medicines. A complete list of all the recalled children’s Tylenol products can be found at the company’s website. The list of drugs recalled by McNeil include Infants’ Tylenol, Children’s Tylenol, and Children’s Benadryl, and Children’s Motrin.

The massive recall of children’s Tylenol products was the result of manufacturing defects and poor quality control at McNeil’s manufacturing plants that caused the medications to contain either too much of the active ingredients, inactive ingredients that failed to meet testing standards, or metal specks within the medications.

The House committee’s investigation was set into motion by Chairman Towns and Darrell Issa (R-CA) earlier this month due to the large number of medicines included in the Tylenol recall. McNeil Consumer Healthcare could face a number of repercussions from the Food and Drug Administration (FDA), including seizures of its current products, criminal penalties, and/or additional sanctions.

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Yet another weight loss drug has been accused of posing a safety risk due to its potential causing of liver damage or failure. Yesterday the U.S. Food and Drug Administration (FDA) completed its safety review of the the weight loss drug Orlistat, which has been marketed under the names of Alli and Xenical, in connection with reports of severe liver injury. Alli is manufactured by GlaxoSmithKline (GSK), while Xenical is manufactured by Hoffmann-La Roche (Roche).

These reports of potential liver damage due to a weight loss drug come on the heels of similar reports of liver injury associated with Hydroxycut, which led to a massive recall of the weight loss supplement.

After undergoing an investigation into the safety of Xenical and Alli, the FDA found that Alli and Xenical could in fact cause liver damage in rare cases and therefore has approved the weight loss drugs to stay on the market as long as their labels are changed to include warnings of potential liver damage.

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The U.S. Food and Drug Administration (FDA) announced what could amount to a nationwide recall of children’s Tylenol and dozens of other over-the-counter medicines. The FDA conducted an inspection at a McNeil drug plant in Pennsylvania that has resulted in the recall of more than 40 varieties of liquid pediatric medicines Tylenol, Motrin, Benadryl and Zyrtec. These products may contain metal particles over the limit allowed to meet safety requirements.

Following the discovery that some of the Tylenol products from its plant could contain metal, McNeil initiated a voluntary recall of all products manufactured at that plant. According to McNeil, its April 2010 recall was a precautionary measure and was not based on “adverse medical events”. The McNeil recall included not only Tylenol products, but also other popular children’s medicines, such as children’s Motrin, Zyrtec, and Benadryl products
Tylenol is one of the brands made by a unit of Johnson & Johnson. One of the major distributors of these pediatric liquid products is Perrigo, a company based in Michigan that supplies children medicines to big pharmacy companies like Walgreens and CVS. Perrigo has also received a warning from the FDA that it has committed serious manufacturing errors of its own. Tablets of ibuprofen reportedly contained metal shavings.

Also reported by the FDA are questions of safety and reliability of these products. Other deficiencies in the report included bacterial contamination of raw products, inadequate maintenance of equipment and the fact that no follow up was conducted to investigate 46 consumer complaints as to foreign materials and black or dark particles in the products. Some of the complaints are more than a year old.

Click here for the full list of all the recalled Tylenol products.

For additional information on the timeline of the Tylenol recall, see Parija Kavilanz’s article at CNNMoney.com.

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In the recently-filed Illinois product liability case of Padilla v. Hunter Douglas Window Coverings, Inc., No. 09-cv-1222 (Jan 19, 2010), the Northern District of Illinois Court reviewed the Plaintiff’s Complaint to determine whether the plaintiff’s complaint set out sufficient claims of liability against the three defendants. While the court ultimately decided that there were sufficient claims for potential negligence and liability on behalf of the defendants, if it had ruled that the plaintiff had not established a sufficient claim then the Illinois product liability claim would have been dismissed.

The review of the complaint in this lawsuit was prompted by the defense filing a Motion to Dismiss pursuant to the Federal Rule of Civil Procedure 12(b)(6). Under the Federal Rule 12(b)(6), the Court examines the Complaint to ensure it satisfies the following requirements:

• provides a clear and concise claim showing that the plaintiffs are entitled to receive relief from the defendants and that the defendants had fair notice of the underlying problem;
• a set of facts that are sufficient to support its arguments of liability on behalf of the defendant(s).

The Illinois product liability lawsuit was filed after the plaintiff’s toddler died after becoming entangled in a metal cord at his home’s mini blinds. The complaint was direct towards product’s manufacturer, Hunter Douglas Window Covering, and two industry trade groups involved in reviewing the safety of the mini blinds in question. Defendant WCMA is a window covering industry trade group responsible for the development and implementation of manufacturing standards. Defendant WCSC is a coalition of window covering manufacturers set up to correct the strangulation hazard posed by window coverings, such as those involved in Padilla.

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An Illinois product defect case was reviewed by the Illinois Appellate Court to determine whether the Illinois trial court had erred in granting summary judgment in favor of the defendant transporter company. In Graham v. Bostrom Seating, Inc., et al., No. 5-08-0409, the Illinois Appellate Court evaluated issues of whether the transporting company was involved in the distribution of the defective truck and thereby whether they could be held liable for the Illinois defective product lawsuit.

Graham involves a plaintiff who was injured in an International truck that was equipped with a defective seat. The truck involved in the case was owned by the defendant, Cassens Transport Company. In Graham, the plaintiff alleged that Cassens was liable for the the defective seat under Illinois product liability principles because the company served as a distributor and seller of the truck.

The plaintiff’s liability claims revolved around their claims that Cassens “was in a position to make the truck reasonably safe,” and was “aware at all times . . . of the defects and/or potential for injury arising from the placement of the truck in question into the stream of commerce.” The plaintiff further alleged that Cassens profited directly from the truck’s sale, or by channeling of savings for profits to its affiliated corporations or its board of directors/stockowners.

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An Illinois prescription drug case that originally had been dismissed due to issues of federal preemption, has been reinstated by the 7th Circuit Court of Appeals in Chicago. This case, Mason v. SmithKline Beecham Corp. d/b/a Glaxo SmithKline, No. 08-2265,___F.3d___, 2010 WL 605922 (7th Cir. Feb. 23, 2010) may be the first decision that addresses preemption with respect to prescription drugs.

The original Illinois prescription drug lawsuit was brought by the parents of 23 year-old Tricia Mason after she committed suicide just two days after being started on the prescription drug Paxil. The Illinois prescription drug lawsuit alleged that Paxil increases the risk in suicide in children and young adult, which the manufacturer should have known and therefore had a duty to warn its users.

The lawsuit alleged that GSK violated Illinois law by choosing not to warn Tricia Mason on its label that Paxil increases the risk of suicide for children and young adults. Two years after the decedent’s suicide, Paxil added a label warning of an increased risk of suicide among children taking the drug.

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Toyota recently announced another recall in the long line of Toyota recalls instituted since Toyota’s September 2009 recalls. In the past year around 8 million Toyota vehicles have been recalled and now over 400,000 of their hybrid vehicles, including the high selling Prius, have been recalled.

The unusually large number of recalls due to potential product defects have caught the attention of the top safety officials at the U.S. Department of Transportation. Transportation Secretary Ray LaHood and other top auto safety officials have made requests for information from Toyota since November, but the manufacturer has yet to comply with the requests.

It has been suggested by a senior American Transportation official that executives at Toyota were “dragging things out” and that the U.S. officials have had it with the automaker’s lack of corporation regarding its auto product defects. The official goes on to state that they “were getting excuses [from Toyota] that didn’t make sense anymore.”

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After a long and complicated battle, a major victory for class action and product defect lawsuits was noted in the case of Carideo v. Dell, Inc. In light of new events, the United States District Court Judge found that the computer company’s mandatory arbitration clause and class action ban was “unenforceable”.

Citing product liability claims, Carideo alleged that Dell manufactured and marketed laptops priced between $1,300 and $1,700 that were defectively designed and manufactured. Upon the filing of Carideo, Dell moved to compel arbitration based on its mandatory arbitration clause. Under this clause, the National Arbitration Forum (NAF) was assigned as the arbitrator and class actions were banned. Furthermore, Dell’s forum consumer contract also has a Texas choice of law provision. In June 2007, at Dell’s urging, Texas law was applied to Carideo, which resulted in arbitration being ordered by the court.

However, the following year another case involving similar facts, McKee v. AT&T, the Washington Supreme Court struck down AT&T’s class action ban and held that the phone company’s new choice of law provision was unenforceable. Shortly after the McKee decision, Minnesota’s Attorney General sued NAF, which prompted the company to announce it would no longer be arbitrating consumer disputes. And because NAF was the mandatory arbitrator assigned to all of Dell’s cases, Carideo’s decision was reevaluated by the original judge.

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According to the Chicago Tribune, since 2001 over 1,000 Toyota and Lexus owners have reported that their cars having suddenly accelerated on their own. Sometimes these runaway cars were found after crashing into trees, parked cars, brick walls, and other obstacles. In fact, some of these crashes have resulted in death with as many as 19 deaths directly related to sudden accelerations reported over the last ten years.

To date there have been no less than eight investigations into the sudden accelerations in Toyota and Lexus cars by the National Highway Traffic Safety Administration (NHTSA) over the last seven years. NHTSA investigated the cases from all angles, including whether there was any product defect responsible for the occurrences.

Toyota recalled around 85,000 vehicles in response to two of those inquiries, but the federal agency closed six other cases without finding a defect. Some of those cases closed by federal officials were those in which drivers said they were unable to stop runaway cars even trying to stop by using their brakes. In spite of the NHTSA closing some of these cases, fatal crashes involving Toyota cars have continued to rise.

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