Nineteen new cases filed against Pfizer for birth defects caused by Zoloft

August 11, 2012, by JONES WARD PLC

Wayne Circuit Court in West Virginia saw nineteen new cases filed last month on behalf of families and children who were harmed by Zoloft. Each suit alleges that the plaintiff mothers took Zoloft as prescribed by a treating doctor while pregnant. The lawsuits are based on congenital defects such as heart defects, newborn pulmonary hypertension, and related conditions.

Zoloft is the trade name for sertraline hydrochloride. (Another trade name is Lustral.) Zoloft was introduced to the market in 1991, and is prescribed to treat major depression in adults. In 2007, it became the most prescribed antidepressant for adults.

The use of Zoloft during the first trimester of pregnancy is associated with abdominal problems, rectal development problems, limb reduction, and congenital heart defects. While these risks are small and occurrences are rare, they have still given rise to potential claims on behalf of the children suffering from these defects.

Corey Ann Finn of Jones Ward PLC represents families and individuals who have been harmed by defective drugs. If you wish to speak with her about your case, please send her an email at corey@jonesward.com or give her a call.

Malfunctioning Riata cardiac leads associated with patient deaths

August 11, 2012, by JONES WARD PLC

A recent study indicates a need to watch recalled Riata and Riata ST cardiac leads. The study suggests that these products have higher electrical failure rates. Riata and Riata ST were recalled in December 2011 following a medical device advisory that was issued by St. Jude Medical.

The survival rate for Riata ST leads was 97.5% for five years which is significantly lower than that of other cardiac leads which are generally above 99.0 %. Sprint Fidelis leads, which were previously recalled, have the lowest survival rate after five years at 89.6%.

Also troubling was that only 60% of the failures of Riata ST presented with noise the time of lead failure, a safety backup for leads.

The problem with Riata leads appears to be that the conduct wires inside the lead can erode through the silicone insulation, causing electrical abnormalities, lead malfunctions, and possibly even high-voltage shorts. This defect has been linked to as many as 22 patient deaths.

Corey Ann Finn of Jones Ward PLC represents individuals who have been harmed by defective and recalled products. If you wish to discuss your potential claims with her, please send her an email at corey@jonesward.com.

Another pelvic mesh case: Elevate Prolapse Repair System

August 11, 2012, by JONES WARD PLC

An Ohio woman has filed a case against Endo Pharmaceuticals and American Medical Systems (AMS) for injuries she sustained from the surgical implantation of an Elevate Prolapse Repair System. The case has been filed in the U.S District Court in Philadelphia.

This system was designed to treat pelvic organ prolapse, a condition that can occur in women following multiple childbirths.

AMS advertises the system as "a Total Transvaginal Approach to Prolapse Repair Requiring Just a Single Incision." The product website boasts minimal tissue trauma and shorter recovery periods.

The lawsuit alleges that the plaintiff has experienced unspecified pain, suffering and permanent injury since undergoing the surgery implanting the mesh device. Transvaginal surgical mesh devices have been associated with severe complications and in rare occasions have been linked with death.

Generally, the case against these manufacturers has been based on a lack of FDA oversight and a lack of premarketing testing.

Corey Ann Finn of Jones Ward PLC has experience with cases involving transvaginal mesh products. If you wish to discuss your potential claims that may arise from the surgical implantation of transvaginal mesh, please send her an email at corey@jonesward.com.

1.3 Million Dishwashers Recalled Over Fire Hazard

August 9, 2012, by JONES WARD PLC

GE and Hotpoint in conjunction with the Consumer Product Safety Commission announced the voluntary recall today of machines sold from March 2006 to August 2009. The machines ranged in price from $350 to $850. GE has said that the recall is the result of at least 15 reports of problems with the dishwasher heating elements, seven of which caused fire beyond the unit itself. Three of these fires have caused extensive property damage although there have been no reports of personal injury to date.

GE is offering to provide owners with free repair. Owners have been cautioned to stop using the units at once until they can be serviced and even to turn off the fuse or circuit breaker that the unit is on.

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Cornett Decision New Jersey

August 9, 2012, by JONES WARD PLC

A8810CornettvJohnsonJohnson.pdf

Impossibility Preemption Brief

August 5, 2012, by JONES WARD PLC

2012.07.09 DN 102 Plaintiff's Opp Generic Premption.pdf

Kenmore Dehumidifiers Recalled

August 2, 2012, by JONES WARD PLC

Sears recently issued a recall for approximately 795,000 Kenmore Dehumidifiers. According to reports, the dehumidifiers can overheat, smoke and catch on fire. The risk of fire and burn hazards to consumers prompted the recall. Sears has received 107 reported incidents with more than $7 million in property damage. At least three consumers suffered smoke inhalation injuries.

The recall involved 35-, 50- and 70-pint Kenmore Dehumidifiers manufactured between 2003 and 2005. The dehumidifiers are made of white plastic and come with front-loading water buckets. Consumers can identify the recalled dehumidifiers by model number, which is located on the right side of the interior of the unit once the bucket is removed. The recalled dehumidifiers have the following model numbers:

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The recalled dehumidifiers were sold exclusively at Sears and Kmart stores nationwide from 2003 to 2009. To avoid injury to person or property, consumers should immediately turn off and unplug the dehumidifiers.

If you have any questions, contact attorney Terrance Massey at JONES WARD PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

Club Car Golf and Transport Vehicles Recalled

July 23, 2012, by JONES WARD PLC

Club Car LLC has issued a recall for various sizes, models and colors of its 2012 gas-powered golf and transport vehicles. According to the U.S. Consumer Product Safety Commission, the fuel hose can separate from the fuel tank, which poses a fire hazard. A list of the recalled models and serial numbers is below.

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If you have any questions, contact attorney Terrance Massey at Jones Ward PLC. He can be reached by phone at 502-882-6000 or by email at tj@jonesward.com.

Escape fire danger!--New Ford vehicles subject to two recalls

July 21, 2012, by JONES WARD PLC

Ford Motor Company announced on Thursday that owners of new Escapes with 1.6 liter engines should immediately stop driving the vehicles and schedule them for pickup by the dealer. Drivers were instructed not to drive the vehicles because it was discovered that fuel lines are subject to breaking, which may cause fire. Ford has said the faulty fuel lines were the result of work done by a contractor and not Ford, although Ford has not named the company. Ford has assured the public that the defect is not related to the manufacturing process, which takes place here in Louisville.

It is clear from Ford's response to the problem that it could be very dangerous to drivers. Ford has offered for its dealers to pick up the Escapes and give drivers loaner vehicles while the problem is fixed. The recall covers more than 11,500 vehicles although only 4,800 of them have been sold to date. The recall follows three known fires in the vehicles: two in vehicles that were en route to dealers and one while a customer was driving the vehicle. No injuries have been reported.

This is the second recall of the newly-redesigned vehicle, both of which were announced this week. On Monday, Ford announced a recall that affects 10,000 Escapes. The car maker said that carpet padding would interfere with braking (remember Toyota made similar claims in the early days of the sudden unintended acceleration cases?)

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Bayer to Pay $15 Million for Settlement of Aspirin Marketing Suit

July 16, 2012, by JONES WARD PLC

In the case of Goldberg v. Bayer Healthcare LLC, based on New York, the claims include that Bayer AG--a leading producer of aspirin and other over-the-counter medications--mismarketed some of its aspirin products that were actually mixed with supplements. The company recently agreed to a $15 million settlement to resolve the matter.

The case began in 2008 when consumers brought suit alleging its Bayer Women's Low Dose Aspirin + Calcium product and Bayer Aspirin with Heart Advantage contained the supplement phytosterols. According to the United States Food & Drug Administration (FDA), the aspirin mixtures were "unapproved new drugs" that had not gone through the FDA process to receive approval and therefore, were being sold illegally.

This tactic is one we've seen before: many products are able to escape FDA regulation by being labeled "supplements", despite the fact that technically, they should go through the FDA approval process. And unfortunately, it often isn't until the products come onto the FDA radar that anything is revealed about their true nature.

With over-the-counter drugs, the FDA doesn't typically require approval so long as the products conform to pre-approved formulas.

Bayer's settlement includes settlement for all United States consumers who purchased the products within a specified timeframe that has yet to be determined.

The defective product lawyers at JONES WARD are dedicated to bringing you the most up-to-date news as it comes out. It is too often that hidden, unapproved substances are contained in the products we use every day. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or layne@jonesward.com.

June 2012 Drug Label Changes

July 16, 2012, by JONES WARD PLC

In June, thirty-five medical products underwent label revisions, with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

The following drugs had modifications to the boxed warnings, contraindications and/or warnings sections:

  • Avodart (dutasteride) 

  • Bepreve (bepotastine besilate) 1.5% ophthalmic 

  • CellCept (mycophenolate mofetil) 

  • CellCept (mycophenolate mofetil hydrochloride) 

  • Estraderm (estradiol) transdermal
  • Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride) 

  • Incivek (telaprevir) 

  • Jalyn (dutasteride and tamsulosin HCL) 

  • Methergine (methylergonovine maleate) 

  • Myfortic (mycophenolic acid) 

  • Noxafil (posaconazole) 

  • Prezista (darunavir) 

  • Prinivil (lisinopril) tablets and
  • Prinzide (lisinopril/hydrochlorothiazide)

  • Privigen Immune Globulin Intravenous (Human) 10%
  • Stelara (ustekinumab)
  • Strattera (atomoxetine hydrochloride) 

  • Sustiva (efavirenz) 

  • Vesicare (solifenacin succinate)

  • Zithromax (azithromycin)

The attorneys of Jones Ward PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you have any questions about one of the above prescription drugs or any other type of product, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

J&J Pledges to Improve Corporate Oversight of its Drug Production & Marketing

July 15, 2012, by JONES WARD PLC

Johnson & Johnson revealed last week that it intends on providing more corporate oversight of its drug manufacturing and marketing practices. J&J made these promises to resolve investor lawsuits claiming J&J executives ignored bad and harmful practices.

Specifically, the company has agreed to create a board-level group to ensure its subsidiaries' compliance with federal regulations. The company has also agreed to adopt a revised risk management policy.

These measures will be part of J&J's settlement of claims filed against J&J executives in federal court in New Jersey. Included in the allegations against J&J are claims that it mis-marketed its antipsychotic drug, Risperdal.

J&J allegedly is in talks for a $2.2 billion settlement to resolve claims against it regarding Risperdal and other drugs. Concern over Risperdal marketing began in 2004. The allegations include J&J's marketing of the drug for off-label, unapproved uses. J&J recently disclosed in August that it agreed to a settlement for a misdemeanor criminal charge relating to Risperdal marketing.

The investor suit began in 2010 when investors brought derivative claims against directors alleging they ignored "red flags" of the company's marketing and production practices for Risperdal and other drugs, which led to recalls. Although derivative suits are based on financial losses, rather than injuries, they too shed light on the bad conduct that drug companies continuously engage in for profit. Reports estimate over 40 of J&J's products were recalled in 2010 because of contamination and incorrect labeling.

According to shareholder's, J&J's decentralized corporate setup allows its subsidiaries (often manufacturing plants) to operate without oversight from corporate headquarters. This allows violations to go unnoticed. Thus, one of the changes the company has agreed to make involves a committee of "independent directors" who will produce an annual report to shareholders indicating the company's regulatory compliance.

As more information surfaces, we will be sure to update you. Corporate accountability is certainly a step in the right direction, but the fact it's only occurring because of a wave of lawsuits is troubling. The dangerous drug lawyers at JONES WARD handle a variety of defective drug cases. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or layne@jonesward.com.

Stryker Recalls Two Devices used with Hip Implants

July 15, 2012, by JONES WARD PLC

The United States Food & Drug Administration (FDA) recently reported that Stryker Orthopaedics has voluntarily recalled two types of devices used in conjunction with artificial hips in hip replacement surgeries.

The recalls comes after reports of at least 45 adverse events reported by patients who have the implants. According to these reports, the devices cause pain and tissue swelling at the site of implantation. The two brands subject to the recall are Rejuvenate and ABG II modular-neck systems, which attach to artificial hips. Stryker revealed they would remove the devices from the market and cease production.

Stryker advises that although pain and swelling is rare, patients who experience pain and/or swelling at the local joint site should contact their surgeons. Stryker representatives state they intend to work with the medical community to better understand the problems and to evaluate the adverse event data. Patients who received the two devices should contact their surgeons.

As more information surfaces, we will be sure to update you. The defective device lawyers at JONES WARD handle a variety of dangerous medical device cases. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or layne@jonesward.com.

New study links Propecia to long-term sexual dysfunction

July 15, 2012, by JONES WARD PLC

Popular male pattern baldness drug Propecia is linked to long-term sexual dysfunction in a new study. It was published in the Journal of Sexual Medicine. The study included 54 men who had sexual problems at least three months after they stopped using Propecia. 89 percent of the men had sexual problems that were severe enough to be considered "sexual dysfunction." Researchers on the project are concerned that the findings may indicated that Propecia may cause permanent damage to sexual health of its users.

While this new study was relatively small, TIME recently reported that 96 percent of men who took Propecia and ten stopped continued to have sexual side effects more than a year later. The recent study is small, however, and based on self-reporting. Researchers noted that only 3% of men will have this kind of side effect from the medicine.

Earlier this year, the FDA required the maker of Propecia to add a warning to its product that it may cause sexual side effects. Those taking Propecia or considering taking the drug are encouraged to talk with their doctors about this side effect.

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Old Navy announces recall of Toddler Girl Aqua Socks

July 15, 2012, by JONES WARD PLC

In conjunction with the U.S. Consumer Product Safety Commission, Old Navy has announced a recall of its Old Navy Toddler Girl Aqua Socks. Approximately 34,000 have been sold in the U.S. and Canada since February of this year.

The recall is due to the aqua socks not having sufficient traction. This creates a slipping hazard on surfaces such as hardwood and tile. So far, two customers have reported falls with minor injuries.

Old Navy Shoes.jpg

Consumers are asked to return the product to any Old Navy store for a full refund.

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