Articles Posted in Product Liability

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Aimee L. Flynn, from Pennsylvania, has filed a lawsuit over NuvaRing. Flynn suffered a stroke that was allegedly caused by the popular birth control ring.

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The complaint was filed in the U.S. District Court for the District of New Jersey on February 3. Flynn used the Nuva Ring contraceptive from October 2008 through February 2010.

The lawsuit names Merck & Co., Organon Pharmaceuticals, Akzo Nobel NV and Schering-Plough Corporation as defendants. Organon is a subsidiary of Shering-Plough, which was purchased by Merck.

Flynn’s lawsuit accuses the defendants of strict liability, breach of warranty, negligence and fraud. She is seeking both compensatory damages for her injuries and punitive damages.

NuvaRing releases a combination of etonogestrel and ethinyl estradiol through a small ring that is inserted into the vagina once a month.

In 2011, the FDA published a birth control study that found that the NuvaRing raised the risk of blood clots by 56% when compared to older birth control pills.

Women who used the NuvaRing were at increased risk of deep vein thrombosis (DVT), pulmonary embolism and arterial thrombotic events such as heart attacks and strokes.

A growing number of women have filed a NuvaRing lawsuit in courts throughout the United States. All of the complaints involves similar allegations that the manufacturer failed to adequately warn about the risk of blood clots from NuvaRing side effects.

In the U.S. federal court system, all NuvaRing injury cases has been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized in the U.S. District Court for the Eastern District of Missouri.

Flynn’s claim is likely to be transferred to that court to be included in the MDL.

Parties are scheduled to review a plan for starting potential NuvaRing settlement discussions at a hearing on February 28.

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Dr Shezad Malik Law Firm is investigating NuvaRing Lawsuit Claims due to side effects that may include blood clots, Deep Vein Thrombosis, Pulmonary Embolism, Heart Attacks, Strokes, and Wrongful Death.

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Read our latest filed NuvaRing lawsuit here. We have many more NuvaRing lawsuits in the preparation phase for filing.

Dr Shezad Malik law firm is a national law firm focused on fighting for the rights of serious personal injury victims. We are announcing the launch of an investigation into alleged NuvaRing side effects.

We are evaluating the following alleged NuvaRing Injuries:

Blood Clots,
Deep Vein Thrombosis (DVT),
Pulmonary Embolism,
Heart Attack or Myocardial Infarction,
Strokes,
Cerebral Thrombosis,
Retinal Thrombosis,
Cerebral Hemorrhage,
Wrongful Death

There is still time for young women who may have been injured by NuvaRing side effects, or their families, to file their own lawsuits against Merck and Organon.

To discuss a potential lawsuit claim, please contact us at 1-888-210-9693 or visit our website.

What is NuvaRing?

NuvaRing is a hormonal contraceptive device that releases a combination of etonogestrel, a synthetic generation progestin, and the estrogen, ethinyl estradiol.

NuvaRing is a small flexible ring that is designed to be inserted into the vagina once a month. It is kept in place for three weeks, and prevents pregnancy by releasing controlled amounts of those hormones into the bloodstream.

NuvaRing is marketed by Merck & Co.’s Organon subsidiary, NuvaRing was introduced to the U.S. marketplace in 2001.

Etonogestrel is a form of desogestrel, a third-generation progestin. In February 2007, the consumer advocacy group Public Citizen petitioned the U.S. Food & Drug Administration (FDA) to ban oral birth control pills that contain desogestrel, citing studies which indicated they could double the risk of blood clots compared to second generation oral contraceptives.

In 2007, the consumer advocacy group Public Citizen asked the FDA to ban oral contraceptives that contained forms of desogestral because this dangerous progestin has been implicated in a higher risk of strokes, blood clots and other cardiovascular problems.

NuvaRing releases approximately 120 micrograms of etonogestral – an active desogestral metabolite – per day, a relatively high dose of this dangerous hormone. The NuvaRing injury lawyers at our firm believe this high dose of etonogestral is responsible for the high number of cardiac side effects reports associated with NuvaRing.

NuvaRing Lawsuits.

In August 2008, the Judicial Panel on Multidistrict Litigation (JPML) ordered all federally filed NuvaRing lawsuits to be consolidated in a multidistrict litigation and transferred to Judge Rodney W. Sippel of the U.S. District Court, Eastern District of Missouri.

The lawsuits allege that Merck & Co. and Organon failed to adequately warn patients and their doctors about the potential for NuvaRing blood clots, deep vein thrombosis, pulmonary embolism, heart attacks, strokes and sudden death because of the device.

File Your Lawsuit Now

There is still time for young women who may have been injured by NuvaRing, or their families, to file their own lawsuits against Merck and Organon. To discuss a potential claim, please contact us at 1-888-210-9693 or visit our website.

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Federal regulators in the United States had serious safety concerns about one variation of a recalled DePuy hip implant. Johnson & Johnson nevertheless went ahead and sold thousands of the devices in Europe, before later acknowledging that all versions of the ASR hip implant may be prone to early failure.

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According to a recent New York Times investigation, the FDA rejected the DePuy ASR Hip Resurfacing System after a detailed review of its safety profile raised concerns.

DePuy Orthopaedics, a division of Johnson & Johnson, was able to market the device in Europe without the concerns of U.S. regulators being relayed to their European counterparts.

Although the ASR Hip Resurfacing System was rejected by the FDA, DePuy was able to gain permission to market a variation of the device in the United States, known as the DePuy ASR XL Acetabular Hip System.

That variation of the implant was approved under the FDA’s controversial 510(k) fast-track approval process, which only requires that a device be substantially equivalent to one that has already been approved.

DePuy argued that the ASR implant was similar to their previously approved DePuy Pinnacle metal-on-metal hip replacement.

FDA officials say that the ASR Hip Resurfacing System had more rigorous requirements because resurfacing was a fairly new technique at the time.

Both devices were metal-on-metal hip implant systems, which have since been linked to a number of safety concerns.

In August 2010, Johnson & Johnson recalled all variations of the DePuy ASR hip implant after acknowledging that the devices may be prone to fail within a few years of surgery. By the time of the recall, more than 93,000 of the two hip systems were implanted in people worldwide.

As it turns out, the resurfacing variation that the FDA rejected may have been the safer of the two systems.

Since the recall, a growing tsunami of lawsuits over the DePuy ASR hip have been filed against Johnson & Johnson in state and federal courts throughout the United States.

So far, about 3,500 DePuy ASR metal hip recipients have filed a lawsuit against the company.

Johnson & Johnson also faces over 900 DePuy Pinnacle hip lawsuits filed by individuals who have experienced problems with the older metal-on-metal hip replacement, which was used to gain approval for the ASR hip implant under the FDA’s 510(k) process.

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A new medical study suggests that side effects of Pradaxa, a new blood thinner, may increase the risk of bleeding events even more than warfarin, the drug it was designed to replace.

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Kansas researchers tested the use of Pradaxa during radiofrequency ablation of atrial fibrillation and discovered more than double the number of bleeding problems with Pradaxa, when compared to those seen when warfarin was used.

In a study was published in the Journal of the American College of Cardiology.

Pradaxa (dabigatran) is under increased scrutiny from federal health regulators. A large number of post-marketing reports involving severe bleeding events and deaths are reported with Pradaxa.

Pradaxa was introduced by Boehringer Ingelheim in October 2010, as an alternative to Coumadin (warfarin) for prevention of strokes among patients with atrial fibrillation.

The drug was heavily marketed as superior to warfarin, because it is easier to use and requires less monitoring. When serious bleeding events do occur, warfarin can be quickly counteracted by doses of Vitamin K or fresh frozen plasma infusions. There is no such quick fix for bleeding with Pradaxa.

According to a report by the Institute for Safe Medication Practices in January 2012, more episodes of hemorrhages with Pradaxa were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group.

At least 505 episodes involving Pradaxa bleeding were reported, compared to 176 cases reported with warfarin, which was second on the list.

A number of patients throughout the United States who have experienced severe bleeding problems are considering a potential Pradaxa lawsuit against Boehringer Ingelheim for failing to adequately research their medication or warn about the risk of internal bleeding.

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New Jersey state court lawsuits over Accutane and generic versions have been consolidated as a mass tort in Atlantic County before Judge Carol Higbee, and the number of complaints filed in the state has more than doubled over the last year.

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There are now more than 7,000 Accutane lawsuits pending in New Jersey state court. These complaints allege that the makers of the acne medication failed to adequately warn about the risk of serious and debilitating bowel problems.

All of the complaints involve similar allegations that the acne drug had inadequate warnings and that side effects of Accutane may increase risk of severe inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis.

The drug maker Roche, discontinued Accutane in June 2009, due to the increasing costs associated with the litigation over Accutane, but a number of generic versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

Several Accutane trials have already occurred in New Jersey state court, with a number of multi-million dollar verdicts being returned for damages caused by Accutane.

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The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal Wright Conserve hip replacement lawsuits be transferred to one judge for coordinated pre-trial proceedings as part of an MDL, or multidistrict litigation.

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The U.S. JPML centralized the Wright Conserve hip litigation before U.S. District Judge William S. Duffey, Jr. in the U.S. District Court for the Northern District of Georgia.

The complaints allege that Wright Medical Technology manufactured a defective metal-on-metal hip implant, known as the Conserve Plus, and failed to warn patients about the potential risk that the device may fail within a few years of surgery.

According to plaintiffs, the Conserve acetabular cup has a tendency to loosen and fail as metal particles are shed into the body from the metal parts rubbing against each other.

The FDA approved the Wright metal-on-metal hip replacement system under their controversial 510(k) approval system. More than 200 adverse event reports have been submitted by patients or physicians, which likely only represents a fraction of the total number of problems with Wright hip replacements.

The Wright Conserve hip system is a metal-on-metal design. And consists of cast cobalt chromium molybdenum cup that provides the connection for the cobalt chromium molybdenum femoral head.

The metal femoral head rotates within the metal monoblock Conserve Cup, which does not have a liner, resulting in the release of metal particles that can cause metal toxicity in the blood, soft tissue and bone.

According to the complaints, this can result in metallosis, tissue necrosis, pseudotumors and other problems.

Furthermore, a number of patients have filed complaints over problems with the Wright Profemur hip replacement. These involves a femoral stem that may be prone to fracture, break, degrade and ultimately fail, according to allegations raised in a number of other lawsuits.

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A new medical study has found that the anti-clotting drug Xarelto could have less of a risk of causing a stroke than older blood thinners, but the drug appears to share of the same risks as Pradaxa.

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The study, which was funded by Johnson & Johnson, the manufacturers of the new medication Xarelto. According to researchers, users of Xarelto were one-third less likely to experience brain bleeding than patients given warfarin, (Coumadin), when the drug was prescribed for the treatment of atrial fibrillation.

But, Xarelto, like Pradaxa, belongs to a new class of blood thinners that require less monitoring, but may cause severe bleeding problems that are more difficult to treat.

Pradaxa (dabigatran) is a blood thinner that was introduced in October 2010, as an alternative to warfarin for prevention of strokes among patients with atrial fibrillation. The medication has been heavily promoted by the manufacturer, Boehringer Ingelheim.

If severe bleeding problems do occur with warfarin, they can be treated by an injection of Vitamin K, fresh frozen plasma, and blood transfusions. There is no easy fix for bleeding problems with Pradaxa, and similar medications like Xarelto.

In December, the FDA announced that it was launching a safety investigation into reports of severe bleeding events with Pradaxa, after a shocking number of deaths and severe injuries were submitted to the agency’s adverse event reporting system during the first year Pradaxa was on the market.

Experts are alarmed about the safety of the drug, and some researchers have recently questioned the validity of the drug’s pre-approval clinical trials, saying that they were so flawed that the FDA should have never approved Pradaxa for the market.

The Institute of Safe Medication Practices (ISMP) reported that the FDA received hundreds of complaints about Pradaxa problems just weeks after it was released, related to bleeding events in elderly patients.

A number of individuals throughout the United States are now considering a potential Pradaxa lawsuit against Boehringer Ingelheim after suffering problems like internal bleeding, hemorrhages, heart attacks, strokes and sudden death.

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The U.S. Judicial Panel on Multidistrict Litigation has decided to create three new multidistrict litigations (MDLs) for all vaginal mesh lawsuits.

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These lawsuits involve products manufactured by American Medical Systems, Inc. (AMS), Boston Scientific Corp. and Ethicon, Inc. The new MDLs will be centralized in the Southern District of West Virginia, where litigation over Bard Avaulta mesh systems is already consolidated.

According to an order issued this week, all four vaginal mesh MDLs will be assigned to Chief Judge Joseph R. Goodwin.

Recently, a growing number of lawsuits over problems with vaginal mesh and bladder sling products have been filed against manufacturers of the medical devices, which are used transvaginally to treat pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

The complaints allege that design defects with the mesh products can cause women to experience painful and debilitating complications, such as infection and erosion of the mesh through the vagina.

The FDA has issued warnings about an increasing number of adverse event reports associated with the products. In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

There are currently about 84 AMS vaginal mesh lawsuits pending in 19 federal district courts throughout the United States; 23 Boston Scientific pelvic mesh lawsuits pending in 14 different district courts; and 37 Ethicon or Gynecare mesh lawsuits pending in 22 different district courts.

All of these cases will be transferred to the Southern District of West Virginia, where Judge Goodwin will preside over pretrial proceedings. Judge Goodwin was assigned to the three new MDLs, as he already presides over more than 330 Bard Avaulta mesh lawsuits that have been transferred to his court since that MDL was formed in October 2010.

Each of the vaginal mesh MDLs will be kept separate, because they involve different manufacturers. Putting all of the litigation before one judge will help reduce scheduling conflicts, eliminate conflicting pre-trial rulings and serve the convenience of the witnesses, the parties and the courts.

Read more here and visit my website for further information.

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According to medical experts, a medical study underway is expected to reveal that side effects of metal-on-metal hip replacements can cause genetic damage, which could lead to an increased risk of cancer.

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According to the U.K.’s Telegraph newspaper, a study to be presented next month at the British Hip Society conference will include findings that suggest the metal particles released by the grinding of metal-on-metal hip replacements could cause chromosomal changes, which may lead to kidney cancer and bladder cancer.

The findings are the latest nails in the coffin over the safety of the once-popular hip implant designs. These hips have been the subject of massive recalls and product liability lawsuits filed by individuals who allege that they are subject to failure within a few years after surgery.

The most likely cause of the genetic damage is metal debris made up of cobalt and chromium, which is released into the body when metal hip implant parts grind against each other. The particles have been linked to tissue damage, tumors, high metal ion blood counts and metal blood poisoning, known as metallosis.

DePuy Orthopaedics, a division of Johnson & Johnson, already faces a massive number of metal hip implant lawsuits. In August 2010, a DePuy ASR metal hip implant recall affected 93,000 implants worldwide and about 40,000 sold in the United States.

Approximately 3,500, of those victims who received the implant in the U.S. have already filed a DePuy ASR hip lawsuit. As more hip implants fail over time, the number of people filing product liability claims against manufacturers is bound to increase.

Recent data from the National Joint Registry for England and Wales indicates that nearly a third of patients will experience problems within six years and other estimates suggest that as many as half of all individuals who received the recalled hip system may eventually experience loosening or failure of their implant.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and what the potential side effects of metallosis are.

Read more here and visit my website for further information.

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The litigants in the federal NuvaRing litigation are scheduled to meet with the Court to discuss a plan to settle the lawsuits filed by women who allege that they suffered serious blood clot injuries from side effects of NuvaRing birth control.

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All NuvaRing lawsuits filed in federal district courts are consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Rodney W. Sippel in the U.S. District Court for the Eastern District of Missouri.

NuvaRing is a ring birth control device that releases a combination of etonogestrel and ethinyl estradiol and is inserted into the vagina once a month.

The complaints all involve similar allegations that Merck and their Organon Pharmaceuticals subsidiary failed to properly research the birth control ring or adequately warn about the risk of blood clots from NuvaRing.

Plaintiffs claim that they have suffered injuries after taking NuvaRing birth control, including deep vein thrombosis (DVT), pulmonary embolism, heart attacks and strokes.

Following a status conference last week, the Court issued an Order that directed the parties to be prepared to discuss a preliminary plan for alternative dispute resolution at hearing set for February 28.

In January the Court ordered the attorneys to submit proposed plans for alternative dispute resolution, which would be designed to assist the parties in negotiating a potential NuvaRing settlement agreement.

While attorneys for the plaintiffs submitted a plan that calls for the appointment of a special master to oversee the negotiations, attorneys for Merck and Organon have suggested that it is premature to consider such efforts.

The parties are currently preparing a handful of lawsuits, known as “bellwether” cases, for early trial dates. The cases are designed to help the parties gauge how juries are likely to respond to certain evidence that will be introduced throughout other cases in the litigation. In complex pharmaceutical litigation, the results of such trials often factor heavily into settlement negotiations.

Read more here and visit my website for further information.