Consumer Advocate Legal Update : Class Action Lawyers & Attorneys : Khorrami Pollard & Abir Law Firm : Mass Torts, Products Liability

What is going on at Johnson & Johnson? The pharmaceutical manufacturer has issued yet another recall. On December 2, CNN reported that the company recalled over 12 million bottles of the antacid Mylanta and more than 84,000 bottles of AlternaGel, a medication for heartburn relief. The recall was due to the fact that alcohol from flavoring agents was not listed on the products’ packaging. Johnson & Johnson officials said it is unlikely that the recalled products will cause either “alcohol absorption or alcohol sensitivity-related adverse events.” The recall was initiated so that the company could add the information to the label.  

This recall comes just weeks after the company recalled millions of packages of Benadryl, Motrin, and Rolaids on November 15.  See this blog post by our very own Roxanna Tabatabaeepour for more information about that recall. In October, Johnson & Johnson recalled several over-the-counter drugs, including Tylenol, Motrin, and Benadryl, due to an “unusual moldy, musty, or mildew-like” odor. The company also issued a recall in late 2009 for certain varieties of Tylenol.  For a more complete list of recent Johnson & Johnson recalls see this blog post. A complete list of the lot numbers affected by the current recall can be found here.   

Would these recalls make you think twice about purchasing Johnson & Johnson products in the future? They certainly raise some serious questions about quality control at the company. But Johnson & Johnson has been making drugs like Tylenol for decades. Is there enough history of quality there to overlook the company’s recent problems? 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Today, Bassett Furniture Industries, Inc. of Bassett Virginia (“Bassett”) voluntarily recalled about 90,000 drop-side cribs after reports of 154 incidents of failed hardware.  The U.S. Consumer Product Safety Commission (“CPSC”) reported that “the cribs’ drop-side rail can malfunction, detach or otherwise fail, causing part of the drop-side to detach from the crib.”  When this happens, a space between the drop-side and crib mattress is created and an “infant or toddler’s body can become entrapped in the space, which can lead to strangulation and/or suffocation.”   

According to the CPSC, a child can also fall out of the crib.  Also due to incorrect or confusing directions,  consumers may unknowingly assemble or install the drop-side or drop-side hardware incorrectly.  Drop-side incidents also occur due to age-related wear and tear.  In fact, in May of this year, the CPSC reported 32 infant and toddler suffocation and strangulation deaths caused by or related to drop-side detachments in cribs made by various manufacturers.  Thus far, there are 18 reported incidents  in which Bassett drop-side cribs malfunctioned or detached from the crib.  In one of the incidents, a child became entrapped between the mattress and the drop-side.  In three of the incidents, children fell out of the cribs.  No injuries were reported.

Below are a few illustrative pictures of drop-side cribs from other manufacturers.  

A baby can strangle in the “V” shape when the top portion of the drop side detaches

When the drop side detaches at the bottom, a baby can fall into the
resulting gap and suffocate between the mattress and the side rail
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On November 17, 2010, the U.S. Food and Drug Administration issued Warning Letters to four makers of caffeinated alcoholic beverages advising them that, following a scientific review by the Agency, the FDA concludes that there is no support for the claim that the addition of caffeine to the identified alcoholic beverages is “generally recognized as safe”. To the contrary, the FDA found that the combination of alcohol and caffeine in these drinks poses a public health concern because the beverages can mask the effects of alcohol leaving the drinker unaware of how intoxicated they are. CNN Reports that critics of the drinks, nicknamed “blackout in a can”, note that the drink producers target young drinkers who may not be aware of the high alcohol volume with a single 23.5 ounce can of Four Loko containing a potent mix of caffeine equal to three cups of coffee and alcohol equal to three cans of beer.  The caffeine makes “wide awake drunks” but wears off quicker than the alcohol leading to blackouts.

According to the FDA’s press release, the drinks affected are: “Four Loko”, “Joose”, “Max” “Core High Gravity HG”, “Core High Gravity HG Orange”, “Lemon Lime Core Spiked”, and “Moonshot”. The FDA views the November 16 announcement of Fusion Projects, LLC, the maker of Four Loko, of its intent to remove caffeine and other stimulants from its drink as a “positive step”. The Warning Letters request that the recipients inform the FDA, in writing, within 15 days of the specific steps that will be taken to remedy the violation and prevent a recurrence. If the FDA is not appeased, it could seize the products or seek an injunction preventing the firms from continuing to produce the products in their current forms. The FDA has also prepared “Questions and Answers” that provides greater information about its findings and actions.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Why would a seemingly innocuous 1994 lawsuit involving a 79 year-old woman who sued the defendant manufacturer for third-degree burns incurred as a result of a defective product have more Google hits than Marbury v. Madison, the landmark decision from the United States Supreme Court establishing the principle of judicial review?  Perhaps if I told you a New Mexico jury awarded Stella Liebeck $2.86 million and the case is better known as the McDonald’s Coffee Lawsuit it will become clear.  Even though the trial court reduced the award to $640,000.00 and the case was resolved through a confidential settlement, Stella Liebeck became the poster-child for frivolous litigation and spawned the tort reform movement.   The case has become the subject of much debate and numerous blogs, both pro and anti tort-reform. 

Fast forward to 1998 when a 76 year-old Manhattan, New York, lady suffers burns to her left leg and foot requiring skin grafts and reconstructive surgery.   Rachel Moltner sued Starbucks because the tea was too hot and Starbucks practice of serving the tea in a double cup – one cup inside the other – was a defective design.  Ms. Moltner alleged she should have been warned the tea could spill and injure her.  The trial court ruled in favor of Starbucks and this past week the 2^nd United States Circuit Court of Appeals upheld the lower court’s dismissal of the lawsuit.  What can we determine from these verdicts?   Does Starbucks hire better lawyers than McDonalds?   Are New Mexico jurors more sympathetic than New York jurors?  Or, has the tort reform debate created an environment where jurors are more skeptical of plaintiff claims?

The answers to the first two questions are of no great importance because the “McDonald’s Coffee Case” was a true anomaly.  The vast majority of these type of lawsuits result in defense verdicts like Starbucks, or are dismissed prior to trial.  What should be of more concern is that many years ago the hysteria over a spilled cup of coffee grew into a movement that impacts the rights today of every citizen that has a legitimate claim.  Large corporations that continue to produce defective products can rest easy knowing that their public relations departments  just received a windfall.  The Starbucks case will be used as an example of how the ‘system’ works and how tort reform is successful.   Your choice of beverage may not impact your life to any great extent, but the type of car you drive, the medical device implanted in your body, and the drugs your doctors prescribe all can have dire consequences.   Access to the courts for every citizen that has a legitimate claim is vital to our society and must be preserved in the face of hysteria.                

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Most of us could not get through the day without our favorite caffeine-laden drink. The long history and widespread use of caffeine make us trust both its safety and effectiveness. For one British man, however, an overdose of pure caffeine was fatal. Pure caffeine, available in a wide range of forms, is widely available online and lightly regulated. The most common use of pure caffeine is as a beverage additive. Energy drinks have been found to contain up to 141mg of caffeine per serving, although the naturally occurring caffeine in a large coffee can be more than double that.  Sodas fall in the range of 20-55mg of caffeine. None of these products warn of the possible side effects of consuming excessive amounts of caffeine. This is not much of a problem for products with relatively low doses of caffeine, such as soft drinks, but the lack of warnings on containers of pure caffeine is disturbing.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Is there a conflict of interest when a doctor testing a medical device manufacturer's products before they are approved by the FDA has received compensation from the manufacturer? Does it depend on the type of payment involved? Senator Charles Grassley wants the FDA to explore this issue. On November 1, Propublica reported that Senator Grassley, R-Iowa, has asked the Food and Drug Administration to outline the circumstances in which such payments could present “too significant a conflict” for a physician to be involved in clinical studies of a medical device. 

Just like drugs, medical devices have to be tested in clinical trials before they are approved by the FDA for use. These studies may be carried out by doctors who have been paid by the company that developed the product for speaking, consulting, or conducting research.  According to a letter he wrote to the FDA, Senator Grassley is concerned that such payments create a conflict of interest for the doctor. His concerns apparently stem from disclosures by medical device manufacturer Medtronic about compensation paid to its consultants and clinical investigators. 

According to the Propublica report, Medtronic reported that it had paid individual physicians consulting payments ranging from $40,000 to $2 million. Other physicians received royalties, while one received Medtronic stock. Medtronic also disclosed information about more than 50 clinical investigators. Nearly all of these investigators received payments from Medtronic, while two of them reported having a “proprietary interest in the product tested and a financial arrangement where the value of compensation could be influenced by the outcome of the study.“ Medtronic insists that it is paying physicians fair market value for their work and that the company is committed to transparency. 

Increased guidance on what exactly constitutes a conflict of interest would seem to be welcome. It certainly seems like it would be hard for a doctor to impartially conduct a study when he knows that the company paying him wants a certain result. And even harder to be impartial when the physician himself benefits from a certain result.

In related Medtronic news, the company’s recall of a tissue stabilizing device has been classified as a Class I recall by the FDA. A recall is classified as Class I when there is a “reasonable probability” that use of the product will “cause serious adverse consequences or death.” 

The company initially recalled the Octopus Nuvo Tissue Stabilizer on September 14, 2010. The device is used to stabilize the heart during cardiac procedures. The recall was due to the potential that a component of the device could fracture during use, causing fragments to fall into the patient’s chest cavity and damage the heart tissue. Prior to the recall, the company received two reports that the device had fractured during use, but neither event resulted in permanent injury or death. Medtronic is working on retrieving the 571 devices that have been distributed to medical facilities worldwide. 

Although it is lucky no one was injured by these malfunctions, some have pointed out that this kind of problem only makes a heart surgeon’s job harder. The last thing a doctor needs during a complex procedure is to worry about his equipment malfunctioning. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Babies. They’re tiny. They’re cute. They’re fragile. They need to be protected. Luckily, the FDA is taking care of it. On October 26, Reuters reported that the Food and Drug Administration recently warned Mead Johnson Nutrition Company that it had violated federal law in its production of several of its Enfamil powdered infant formula products. In a letter to the company, dated October 18, the FDA explained that Mead Johnson had failed to disclose the specifications for a plastic tub and lid which are part of the packaging for the infant formula. The formula is packaged in a pouch, but labeling on the product suggests it can be stored in the plastic tub. Mead Johnson failed to identify the tubs as a food contact source and failed to provide the FDA with an evaluation of the plastic used to make the tubs and lids. According to the letter, this was a violation of the Food, Drug, and Cosmetic Act and federal regulations. 

The Enfamil products identified in the letter include Enfamil Premium Infant, Enfamil Gentlease, and Enfamil A.R. Mead Johnson responded by saying the company recommends keeping the formula in the pouches, but it recognizes consumers may choose to empty the powder into the tub. The label provided instructions on how to do so safely. The company added that the tubs and lids are made with FDA-approved materials and that it was in the process of responding to the FDA. 

This illustrates how careful manufacturers have to be when making disclosures to the FDA, especially when it comes to products related to infants. After all, infants don’t choose what they eat or how to store the food that they are fed. Since they can’t look after themselves, everyone else has to be vigilant about what goes in those tiny tummies.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Botox is most famous for its ability to smooth wrinkles on aging faces. It is also approved to treat eye muscle disorders, neck spasms and excessive underarm sweating. Although the FDA has approved the drug for chronic migraines, studies have failed to show that it works for occasional headaches or occasional migraines.  

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On March 31, 2009, Yamaha Motor Corporation recalled approximately 145,000 off-highway recreational vehicles for repairs due to hundreds of reported injuries and 46 deaths related to several Yamaha Rhino models, including the 450, 660 and 700 model vehicles. According to the Consumer Product Safety Commission, more than two-thirds of the accidents involved rollovers, many of which appear to involve turns at relatively low speeds and on level terrain. Yamaha Rhino ATVs may contain design defects making the vehicle unstable and prone to rollovers.

If you've been involved in an accident involving a Yamaha Rhino ATV, contact us.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Aboutlawsuits.com reported today on the latest developments with the New Jersey Reglan lawsuits.  It looks as though the New Jersey state court system has until May 14 to make their decision on whether or not to consolidate cases from across the state. 

Almost a year ago, the U.S. Judicial Panel on Multidistrict Litigation denied a similar request for consolidation of the federal Reglan litigation, keeping all individual cases across the country as just that, individual cases. 

Will New Jersey start a trend that other states across the country are going to follow?  There seems to be a large amount of Reglan cases across the country, strengthening the possibility of consolidation at some level.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to one expert, the answer might just be yes. That expert is University of Kentucky law professor specializing in product liability, Mary Davis who has been quoted as saying that the litigation mounting against Toyota in the wake of its recent recall of 8.5 million vehicles worldwide, “is bigger than anything I’ve ever seen.”  In light of Davis’ work as a trial attorney in the far-reaching multistate asbestos litigation and her expertise regarding the Ford Explorer recall a decade ago, this statement packs a punch.

On February 9, 2010 the first suit was filed in Covington, Kentucky on behalf of Toyota owners in Kentucky, Ohio, Indiana, and Florida alleging that the company knowingly concealed defective, dangerous accelerator systems on its vehicles in order to protect its sales. The suit further alleges racketeering, mail fraud, and wire fraud, arising from Toyota’s representations that their vehicles were safe, when,  by all appearances, it knew they were not. The Kentucky suit names defendants ranging from Toyota’s giant assembly plant in Georgetown, Kentucky (the automaker’s largest in North America) which was responsible for building the engines and “powertrain” components that are allegedly subject to acceleration problems, to Toyota Motor Credit Corp., and every facet of the corporation in between.

In the less than a month that has elapsed since the filing of the initial Kentucky case, at least 40 more cases have been filed by 22 law firm across 16 different states. On March 25, 2010 there will be a hearing in the U.S. District Court in San Diego regarding consolidation of the cases. An attorney for the Covington Plaintiffs believes that Kentucky has a good chance of hosting the multi-district litigation in light due to Toyota’s largest North American plant being located in Georgetown, Kentucky.

Where the litigation will be consolidated, and exactly how massive it will become remain to be seen, but one thing is clear, the cases that have been filed to date are just the beginning.

Are you the owner of a recalled Toyota or Lexis vehicle? Find out here: http://www.toyota.com/recall/

• Email This
• Print
• Comments
• Trackbacks
• Share Link

This article, "Concerns Over 'Metal on Metal' Hip Implants," from Wednesdays New York Times, highlights the ongoing discussion and alleged danger of using certain hip replacement devices. 

Doctors aren't happy with the performance of many 'metal on metal' devices, and advise caution to other doctors and patents considering these systems.  Some devices have been recalled, and many are being replaced due to continued complications.  Learn more about metal hip implant devices, like the Zimmer Durom Cup.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Coverage on the popular GlaxoSmithKline medicine, Avandia, has recently sparked due to a new Senate report.  Although hundreds of individuals suffer each month from the dangerous side affects associated with the drug, the drug still remains on the market.  A better look at these latest developments can be read in this NY Times article - "Research Ties Diabetes Drug to Heart Woes". 

Shawn Khorrami and James Kenna of KPA have been appointed to the JCCP Steering Committee for Avandia, and will continue to fight on behalf of those injured individuals. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

KPA Moves Forward in Complex Litigation on Behalf of Women with Breast Cancer Linked to Premarin and Prempro

Two multi-million dollar verdicts in Philadelphia last week against pharmaceutical company Wyeth, a division of Pfizer, reinforce that juries are consistently finding the company responsible for breast cancer in women who took its Premarin and Prempro hormone replacement therapy (HRT) drugs.

And just last month, a ruling from the 8th Circuit Court of Appeals confirmed that Wyeth did wrong, and that juries should be permitted to hear this evidence and determine whether the company should be punished.

In the verdicts announced last week, juries awarded Donna Kendall of Decatur, Illinois $6.3 million in compensatory and $28 million in punitive damages, and Connie Barton of Peoria, Illinois $3.7 million in compensatory and $75 million in punitive damages.

Through an ongoing federal multi-district litigation mass tort action, Wyeth still faces lawsuits from more than 10,000 women nationwide who claim that the company’s drugs caused their breast cancer. Of the 12 verdicts announced to date, plaintiffs have been awarded money in 10 of the cases. Every jury that has been permitted to deliberate on punitive damages has returned substantial awards.

To date, winning plaintiffs have been awarded a total of more than $42 million in compensatory and $165 million in punitive damages. In addition, 13 women have settled their HRT claims with Wyeth or Pfizer outside of court.

Shawn Khorrami, founding partner of KPA, is a member of the Plaintiffs’ Steering Committee for the MDL litigation team, and his firm represents around 150 individuals pursuing cases against Wyeth.

A press release on the firm’s involvement with the litigation was released today. For more information on the Barton and Kendall verdicts watch the video below.
 

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

The Supreme Court’s decision in Wyeth v. Levine, 129 S. Ct. 1187 (U.S. 2009), represents a victory for consumer advocates and a change in tide within the preemption debate. On March 4, 2009, the Court found Wyeth, the pharmaceutical giant, liable for the adverse affects of one of its drugs. Phenergan, which is administered intravenously to treat migraine-induced nausea, caused plaintiff Levine to suffer the amputation of her arm after an “IV push” injection of the drug caused irreversible gangrene. Wyeth argued that the Food and Drug Administration’s (“FDA”) regulations preempted Levine’s lawsuit, but the Court disagreed. 

The Court expressly rejected Wyeth’s preemption argument for two reasons: (1) state law claims did not obstruct the FDA’s authority to regulate drug labeling; and (2) the evidence actually suggested that Wyeth had long ignored reports showing the dangers of injecting the drug using the IV push method. In fact, the Court observed that Wyeth could have “analyzed the accumulating data and added a stronger warning about IV push administration of the drug.” The Court also rejected Wyeth’s companion arguments, which spouted the impossibilities of complying with both state law and the FDA’s regulatory scheme and the danger of allowing a “lay jury’s decision about drug labeling” act as a substitute for the “expert judgment of the FDA.”

The Court’s decision was welcomed by consumer advocates who previously feared that pharmaceutical companies like Wyeth would be insulated from liability, especially given the Bush Administration’s expansive view of preemption. Following the Wyeth decision, President Obama made his narrowed view of preemption known when the White House released a memorandum on the subject. On May 20, 2009, President Obama asked heads of agencies and departments to reevaluate their preemption policies, advising them only to issue preemptive statements “if [they are] supported by sufficient legal principles.” President Obama’s memorandum symbolizes a return to traditional federalist ideals, emphasizing the importance of state laws and the ways in which they work in tandem with federal laws to create safeguards for the public. 

In the months following Wyeth, advocates on both sides of the preemption debate have spoken out. Those in favor of preemption call the Wyeth decision “catastrophic” for patients and doctors.   They foresee an insurmountable stall on new drugs entering the market; new drugs that could help combat serious illnesses like cancer and HIV/AIDS. Other analysts are shocked that this medical malpractice case reached the Supreme Court at all, let alone resulted in a lay jury determining the adequacy of a federal agency’s regulatory scheme. Consumer advocates, on the other hand, view the decision as a triumph for the little guy, meaning consumers like Levine. . However, both sides agree on one thing: consumers will test the durability of the Wyeth decision to see just how much liability pharmaceutical companies will bear in the future. 

In any case, Wyeth is not the last time we will see the preemption issue under scrutiny. But, for now, consumer advocates and victims of pharmaceutical drug companies can relish in this victory and rest assured that they have preserved their right to hold pharmaceutical companies accountable in court. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link