New Study Suggests Plavix May Increase the Risk of Heart Attack or Stroke

By Craig S. Hilliard on Posted in Defective Drugs

Plavix®, marketed by Bristol-Myers Squibb and Sanofi Pharmaceuticals, is the second most commonly prescribed drug on the U.S. market to prevent heart attacks and stroke.  The medication, known as a “clopidogrel,” is a blood thinner that belongs to a category of drugs called antiplatelets.  The drug works to prevent blood clots.

 A recent study by the Neurological Disorders and Stroke (NINDS) concludes that Plavix® offers no further benefits than other competing antiplatelet medications and may actually increase the risk of suffering a heart attack or stroke.  Previous studies have discussed the harm of this common combination of Plavix® and aspirin.

As we have previously reported, Plavix® litigation continues to proceed in New Jersey State and Federal courts.   If you feel you have experienced any side-effects from taking Plavix®, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Plavix® manufacturers.

Pradaxa Manufacturer Ordered to Produce Employee Records

By Kevin M. Hart on Posted in Defective Drugs, Pradaxa®

As we have previously reported, the use of Pradaxa has been linked to serious injury.  There are nearly 600 cases currently pending in federal court.  The lawsuits allege that Pradaxa, manufactured by Boehringer Ingelheim, Inc., has resulted in devastating and sometimes fatal outcomes.  Pradaxa is a blood thinner that was marketed to replace warfarin, a commonly used anticoagulant.  Unfortunately, there is no readily-available antidote for the internal bleeding that can sometimes occur in patients treated with Pradaxa.

Plaintiffs’ counsel in the Multi District Litigation (MDL) pending in Chicago, Illinois has successfully argued for the production of certain Boehringer Ingelheim’s employee personnel records.  The recent Court Order directs the company to disclose employee reviews and bonuses related to Pradaxa for company witnesses that played a role in the development, approval or marketing of the drug.

The devastating consequences of Pradaxa use will likely continue. If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.

An Ounce of Prevention: Benefits of a Medication Review

By H. Matthew Taylor on Posted in Uncategorized

In 1735, Benjamin Franklin famously declared “An ounce of prevention is worth a pound of cure.” Franklin delivered that message to persuade a group of stubborn Philadelphians to create a full-time fire department that could serve the city and effectively manage a potentially devastating fire.  The idea that a modest preventative step could result in the realization of a meaningful future benefit is comforting and something every individual wishes to achieve.  It is especially true in the context of an individual’s personal health.  Everyone wants to live a long, pain free life, uncomplicated by the scourge of old age.  Sadly, this is not reality.

To better realize that goal of good health you might wish to consider consulting a physician or health care provider for a “medication review.” A medication review is a proactive measure that allows a person to evaluate their prescription drug regimen in a comprehensive fashion.  The reviewer can consider how an individual medication or multiple medications are affecting your health.   This review considers both the individual and more global effects of the medications.

It is an unavoidable truth that prescription medication is necessary and often desirable to help treat or control a given health issue.  However, equally true is the fact that complications may arise—sometimes resulting in devastating or even fatal consequences.  Many times the unsuspecting individual does not know that a medication is causing their problem.   Every person owes it to themselves to become educated on the drugs entering their body.  This is one area where a small investment in time can yield substantial benefit.

If you uncover any unsettling or troubling information during the medication review, you have served yourself well in two respects. First, and most importantly, you have a chance of fixing the problem and removing the medication from your prescription regimen.  Second, you can decide whether you wish to pursue legal recourse against the manufacturer of the harmful medication. Litigation may be a viable alternative or a practical necessity but it is best to be proactive and informed.

Pradaxa Lawsuits Move Closer to Trial

By Martin P. Schrama on Posted in Defective Drugs, Pradaxa®

As we have previously reported, the use of Pradaxa has been linked to serious injury.  There are nearly 600 lawsuits pending in federal court.  The Multi District Litigation (MDL), centralized in a Chicago federal court, continues to move forward.  The next Status Conference in the Pradaxa litigation has been schedule for the middle of May.

Trials are currently scheduled for August 2014 through February 2015.  The court presiding over the Pradaxa litigation continues to take an active role in the prompt and efficient resolution of the cases.

The devastating consequences of Pradaxa use will likely continue. If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.

Stryker ShapeMatch Recall and FDA WarningStryker ShapeMatch Recall and FDA Warning

By Stefanie Colella-Walsh on Posted in Medical Devices

Stryker Corporation has recalled its ShapeMatch Cutting Guides due to manufacturing concerns with the device.   The ShapeMatch is intended to be used as a patient specific surgical instrumentation to assist in the positioning of total knee replacement components and is used to guide the marking of bone before cutting.

Stryker has acknowledged that the guides may have been manufactured outside of the planning ranges specified in a 2011 clearance issued by the Food and Drug Administration (FDA).  The FDA has reviewed the recall and decided to issue a “Class I” label, reserved for only the products with the most serious safety concerns.

Patients who have had knee replacement surgery where the ShapeMatch guide was used, are asked to contact their surgeon, contact Stryker at 1-888-STRYKER or submit a report directly to the FDA via its online MedWatch system.

The United States Department of Justice is Concerned with Plavix®

By Craig S. Hilliard on Posted in Defective Drugs

The United States Department of Justice (“DOJ”) is concerned that the dangers of Plavix® were not properly identified by its manufacturers Sanofi-Aventis and Bristol-Myers Squibb.  The DOJ is concerned that the manufacturers failed to disclose certain information in hopes of misleading consumers about the safety of the drug.  Studies show that certain individuals have a difficult time metabolizing Plavix®.  The DOJ was troubled with the warning and “is investigating disclosures to the FDA regarding the variability of response to Plavix” according to Sanofi. This is not the first time Sanofi and Bristol-Myers have been questioned about their Plavix® disclosures.  The FDA inquired into the drug’s safety back in 2003.   A warning was added to the box to flag the differences in Plavix®,effectiveness back in 2010.

If you feel you have experienced any side-effects from taking Plavix®, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Plavix® manufacturers.

New Study Correlates Elevated Cobalt Levels with Hip Device Failure

By Kevin M. Hart on Posted in DePuy ASR®, DePuy Pinnacle®, Medical Devices

A recent study published in the British Medical Journal Open suggests that elevated blood metal ion concentrations may be associated with early failure of metal on metal devices.  The study reveals that the presence of elevated cobalt blood levels is correlated with an increased risk of failure in the DePuy ASR device.

The study reveals that male patients with 10 mcg/L cobalt had nearly a 22 percent higher risk of failure with the DePuy ASR device.  The failure rate was significantly higher in females, climbing to 43 percent risk with identical cobalt levels. Currently, the FDA recommends against routine blood metal ion testing in patients with no symptoms.  This study asks the FDA to revisit that recommendation.   The hope is that patients with elevated cobalt levels can receive physician treatment early and determine whether revision surgery is necessary.

If you have had a hip replacement, which used the DePuy ASR or DePuy Pinnacle devices, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufacturers.

DePuy ASR Hip Replacement Signs of Trouble

By H. Matthew Taylor on Posted in DePuy ASR®, DePuy Pinnacle®

As we previously reported, DePuy has recalled its ASR hip replacement device.  There are thousands of cases pending across the country related to the ASR device.  This blog provides some of the warning signs that your ASR device has failed.  This list is not comprehensive and should not be substituted for the judgment of your physician or medical provider.  If you have had a DePuy ASR hip implant, it is recommended that you contact your medical provider immediately.  Some of the reported signs that your device has failed or is otherwise defective include:

  1. The inability to squat to the full range you should be able to post-surgery or post-therapy;
  2. Pain or continued pain in the hip, leg, lower back or groin area after the appropriate healing time has passed;
  3. The feeling that something is loose or not fully connected in your hip area;
  4. An audible “click” or “popping” sound in the hip area; and
  5. The inability to fully move or a limitation on your normal range of motion.

Again, this list of symptoms or observations is not exhaustive.  It is strongly recommended that you contact your medical provider to discuss your DePuy ASR device.

If you have had a hip replacement, which used the DePuy ASR or DePuy Pinnacle devices, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufacturers.

First New Jersey Nuvaring Trial to Begin in June 2013

By Stefanie Colella-Walsh on Posted in Defective Drugs, NuvaRing®

As we have discussed in previous posts, studies have shown that the hormones contained in the birth control product NuvaRing® have been linked to various forms of severe side-effects including: heart attack, stroke, deep vein thrombosis (also known as DVT or blood clots), internal organ damage, myocardial infarction and pulmonary embolism.

At a Case Management Conference on April 16, 2013, Judge Brian Martinotti, who is overseeing all New Jersey state Nuvaring® cases, confirmed that the first trial is still scheduled to begin on June 17, 2013 in Bergen County, New Jersey. If the trial proceeds as scheduled, it will be the first Nuvaring® case to go to trial in the U.S. The outcome will likely impact the thousands of lawsuits pending throughout the country. Currently, there are 20 Nuvaring® cases being prepared for trial in New Jersey, which are considered representative of the hundreds of cases filed in New Jersey.

If you, or someone you know, has experienced adverse effects as a result of using Nuvaring®, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the manufacturer of Nuvaring®.

Pradaxa Linked to Increased Risk of Viral Infections

By Craig S. Hilliard on Posted in Defective Drugs, Pradaxa®

A study by the University of North Carolina found that Pradaxa may increase the risk of some viral infections, such as flu and myocarditis, and infection of the heart.  The study also affirms that the blood thinner blocks key components of the human blood clotting system.

Pradaxa works by inhibiting thrombin, the body’s central coagulation activator of the blood clotting system.  By blocking the thrombin activity, the drug disturbs the “protease cascade of molecular events that normally occurs during coagulation.”  The new study shows that, although clot formation is reduced, an unintended consequence may emerge. The study reported that “blocking thrombin reduces the innate immune response to viral infection.”  This research will be published in the March 2013 issue of the Journal of Clinical Investigation.

The devastating consequences of Pradaxa use will likely continue. If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.