Future trials in the coming year will be against other manufactures of pelvic mesh devices including American Medical Systems and Boston Scientific. Cases against some of the smaller manufacturers like Coloplast, Caldera and Tyco/Coviden will probably not go forward until after a first round of trials involving Ethicon, Bard, AMS and Boston Scientific. Our firm is still pursuing claims against these smaller manufacturers. We have multiple cases filed in state court in Minnesota. Some of the device names of the smaller manufacturers include: Tyco’s IVS Tunneler, Coloplast’s Aris Sling, MPathy Restorelle and Novasilk and Caldera’s T-Sling and Desara.

As is now obvious, these devices are extremely dangerous and can lead to a lifetime of pain. In 2011 an FDA warning was released saying these products should be classified as high risk, and “with the exposure to greater risk comes no evidence of greater clinical benefit such as improved quality of life.” The question now becomes whether the manufacturers were aware or should have been aware of these risks at the time they marketed these products to women and their physicians.

It is troubling, however, that these associated risks were not properly described in these drugs’ warning labels until last month when the FDA finally ordered Bayer to change the warnings on its labels. In a Bayer Pharmaceuticals statement to the press, it acknowledged these increased risked and agreed to update its label for drospirenone-containing contraceptives. It took nearly six years for this label change, and countless women have suffered needlessly with blood clots as a result.

If you or a loved one has experienced problems resulting from the prescription of Yaz and Beyaz, please contact Pogust Braslow & Millrood for a free consultation to make sure that your rights are protected.

Dr. James R. Roberts, director of emergency medicine at Mercy Philadelphia Hospital and Mercy Fitzgerald Hospital, is seeing an increasing number of incidents of ACE inhibitor related angioedema and is calling for a black box warning on the product labeling. Angioedema is a recognized side effect, and at least one other doctor has petitioned the FDA (in 2002) for a black box mandate. The FDA rejected that request.

According to Dr. Roberts' recently published letter in the American Journal of Cardiology, "The incidence and potential for [complications] is not appreciated by the public, or by many physicians."

Dr. Roberts' observations appear to be backed up by recent data showing roughly a doubling in hospitalizations for swelling due to ACE inhibitors from 2000 to 2009. And the data appear to show an even heightened risk for African-American patients.

The recent rise in reports of increased bleeding events in patients taking Pradaxa has been particularly troubling. This is especially true since there are safer alternatives currently on the market for patients. Because of these reports, the FDA released a safety alert in December 2011, warning that bleeding events were occurring more often than expected.

Recently, Boehringer stated that prior to taking Pradaxa; patients should have their kidneys monitored in order to rule out the possibility of overdosing. If a patient’s kidneys are not functioning adequately, too much Pradaxa may stay in the bloodstream and increase the risk of internal bleeding. Patients taking Pradaxa must be familiar with the signs of internal bleeding so that medical attention can be sought immediately.

Significantly, the elderly and patients with kidney conditions face a greater risk of suffering serious uncontrollable bleeding, even from minor falls. And there is no cure to the internal bleeding caused by Pradaxa, as there is for another drug in this class like Warfarin.

If you or someone you know has suffered as a result of taking Pradaxa, please contact Pogust Braslow & Millrood. Just fill out this form, click here to send us an email or call us at (610) 941-4204.

Plavix is often prescribed in combination with aspirin, and a study done in the New England Journal of Medicine found that taking Plavix with aspirin was “not significantly more effective” than taking aspirin alone in lowering the risk of a heart attack or stroke. In addition, this combination is more deadly than aspirin alone as it results in increased bleeding risks. While Plavix was initially thought to lower bleeding risks compared to other anti-platelet drugs, a study in the Archives of Internal Medicine showed an increased risk of both minor and major bleeding incidents, similar to that experienced in patients prescribed warfarin.

This information has been available to physicians for several years, and physicians continue to prescribe the billion dollar drug Plavix, when aspirin may do the job just as well, with less risk and at a cheaper price.

A study done in 2011 further supported the FDA’s recall of these devices saying the Journey devices led to “"unacceptable” results. Compared to other knee implants the Smith and Nephew-Journey base plates are not considered a worthy alternative to other knee implants and 39 percent of surgery results are thought to have a “poor” result.

If you or a loved one has experienced problems resulting from a Smith and Nephew Journey knee replacement, please contact Pogust Braslow & Millrood for a free consultation to make sure that your rights are protected.

What’s even more alarming is that the makers of the Ortho Evra Patch, Johnson & Johnson, might have actually had knowledge of these increased risked as far back as 2005. One investigation revealed Johnson & Johnson knew about the higher risks and chose to ignore those warnings. With the new information regarding the possible side effects from using the Ortho Evra Patch it is no wonder sales of the patch have decreased in the last 5 years. The patch might be an easy solution for your birth control needs, but it is a solution with potential life threatening risks.

Last July, a study found a significant increase in deaths, injuries and malfunctions associated with these products, and an advisory panel recommendation sought to reclassify this mesh as high-risk.

Now, the FDA has ordered 35 manufacturers of mesh devices to conduct three years of trials to determine their safeness and effectiveness. Because vaginal mesh is a permanent implant and the complete removal of mesh might not always be feasible, the FDA released a statement asking surgeons to “carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.”

Vaginal Mesh complications are not rare, and there is a lack of evidence showing mesh is more beneficial than non-mesh procedures. These are alarming side effects that should have been tested years ago, but were not because of the FDA’s 510k process or accelerated review program. Devices approved under this expedited review process are permitted to skip the clinical trial testing phase because these devices are similar to those already on the market (which had been tested).

Unfortunately, it is too little, too late for women everywhere, who are suffering and undergoing multiple surgeries to try and repair this problem.

If you or someone you know has suffered serious complications and additional surgery as a result of a transvaginal mesh or sling medical device, please contact Pogust Braslow & Millrood. Just fill out this form, click here to send us an email or call us at (610) 941-4204.

In Barton, the sole defendant was Wyeth Pharmaceuticals, and the trial was “reverse-bifurcated,” with the jury considering medical causation and compensatory damages in Phase I, liability in Phase II, and punitive damages in Phase III. After Phase I, the jury found that E+P was a cause of Ms. Barton’s breast cancer and awarded $3.7 million in compensatory damages. After Phase II, the jury found that Wyeth had failed to study and failed to warn about the breast cancer risk and that its conduct in ignoring the risk was outrageous and reprehensible. The jury then awarded $75 million in punitive damages in Phase III.

In Kendall, the plaintiff brought suit against both Wyeth and Pharmacia & Upjohn, making the same claim: that E+P caused her breast cancer and that Wyeth and P&U failed to study and warn about the risk. After a five-week trial, with PBM attorney Tobi Millrood serving as lead trial counsel for the plaintiff, the jury awarded Mrs. Kendall $6.3 million in compensatory damages and $28 million in punitive damages – $16 million assessed against Wyeth and $12 million against Upjohn.

In both cases, the drug companies sought J.N.O.V. (judgment non obstante veredicto) – that is, dismissal of the verdicts – on a variety of grounds. Although both trial judges refused to undo the verdicts, they reduced the punitive awards significantly. The trial judge in Barton cut the punitive damages award from $75 million to $5.6 million, and the trial judge in Kendall cut the award from $28 million to just $1 million. In both cases, all of the parties sought appeals to the Pennsylvania Superior Court. Wyeth and Upjohn claimed that the verdicts should be thrown out altogether, raising a number of arguments, including challenges to the admission of certain evidence and the viability of certain expert testimony. Ms. Barton and Mrs. Kendall each appealed only one issue: whether the trial judge in each case was correct in reducing the punitive damages awards. The cases proceeding separately on appeal, with separate briefing, although the same Superior Court panel heard consolidated oral argument on the cases.

In separate opinions, issued earlier this week, the Superior Court panel denied all of the drug companies’ challenges to the verdicts. The Superior Court was resolute in rejecting the drug companies’ arguments that their conduct was not punishable at all. In Barton, the court explained:

Wyeth contends that there was insufficient evidence for the jury to find willful and wanton misconduct. We disagree.

* * *

The jury considered Wyeth’s “revolution” in marketing a drug that it knew was not sufficiently tested. The jury heard of Wyeth’s manipulation of medical literature and its effect on the medical standard of care. The jury pondered over Wyeth’s numerous decisions to ignore studies, extinguish dissenting science, and thumb its nose at the FDA. Finally, the jury saw evidence that Wyeth promoted the drug for extensive, non-authorized, wholly fabricated, and even detrimental off-label uses.

Barton, Slip Op. at *28. Similarly, in Kendall, the court echoed its condemnation of Wyeth’s conduct and also discussed co-defendant Upjohn at length:

Upjohn argues that the jury could not impose punitive damages for failing to discover an unknown risk. However, the record reflects that Upjohn was willfully ignorant of the increased risk of breast cancer from long-term use of Provera in conjunction with exogenous estrogen. As Kendall argues, there were numerous “red flags,” not least of which was the Degge Group’s review and explicit recommendation for further study, which Upjohn consciously ignored. Indeed, there was evidence of a possibility of increased risk as early as the 1960s. Yet, inexplicably, Upjohn did not conduct any studies to evaluate a breast cancer risk despite the ability to do so. … This was sufficient for the jury to find that Upjohn was grossly negligent and acted with wanton disregard for users of its products including Kendall. Upjohn’s disingenuous claim that it was unaware of any increased risk does not shield it from liability.

Kendall v. Wyeth, Slip Op. at *15.

But the Superior Court went further than simply affirming the jury verdicts. In both cases, the appellate court reinstated some measure of the punitive damages awards that had been previously reduced. In Kendall, the court reinstated the entirety of the jury’s $28 million punitive damages award, while in Barton, the court reinstated the punitive award to $7.49 million. Explaining its rationale for the divergent punitive damages awards and why they are not inconsistent under the circumstances, the Barton court clarified:

We recognize that in a similar case argued before the same panel, Kendall v. Wyeth, et al., we reinstated a punitive award with a ratio of 4.44:1, or more than four times compensatory damages. In that case, we concluded that the trial court abused its discretion in granting the defendants’ motion for remittitur and reducing the amount of punitive damages to only $1 million, measured against compensatory damages of $6.3 million. We emphasized in Kendall that while perhaps close to the line, single-digit multipliers, particularly in the 4:1 range, can usually survive constitutional scrutiny. … In Kendall, we found that the jury’s original punitive damages award of $28 million did not offend federal due process guarantees. It should also be noted that the plaintiff in that case suffered unusually devastating physical and emotional injuries, including a double mastectomy, serious complications from reconstructive surgery, and a 75% chance of recurrence. Indeed, had the trial court in this case elected, in its discretion, to remit damages in an amount greater than a 2:1 ratio, we would have no hesitancy in affirming that judgment; however, we discern no inherent inconsistency between the case sub judice and Kendall, where the jury’s initial award of $75 million in punitive damages here was plainly excessive.

Barton v. Wyeth, Slip op. at *45, n.5.

The Superior Court has relinquished jurisdiction, but the drug companies retain the right to seek reconsideration and seek further appellate review.

In August 2011, Public Citizen filed a petition with the FDA to put Black Box Warnings on all PPIs to warn doctors and patients alike of the dangerous side effects and safer alternatives. The dangerous side effects that should be included in the Black Box include the following:

1. Rebound Acid Hypersecretion Risk – there is currently no warning regarding the dependence or addictiveness of these drugs after taking them for as little as four weeks;
2. Fracture Risk – long term and multiple daily dose has been linked to increased risk of osteoporosis-related fractures of the spine, hip and wrist fracture;
3. Infection Risk – increased risk of community-acquired pneumonia and C-difficile-caused diarrhea; and
4. Severe Magnesium Deficiency – can increase the likelihood of fatal heart rhythm disruptions.

First, regarding the addiction of PPIs, The American Journal of Gastroenterology reported the results of its PPI clinical trial, which which confirmed an earlier study in Gastroenterology - concluding that these types of medications actually induce the very symptoms they are used to treat. In other words, many of the people taking these medications to treat heartburn-related symptoms, end up with worse heartburn if they attempt to stop taking the medications. These studies finally provide an answer as to why so many people have been taking these medications for so many years and are resigned to taking them for the rest of their lives.

Physicians who prescribed these medications in the 1990s and over the course of the last ten years were never warned of the risk of addiction or withdrawal symptoms. Now, millions of patients cannot stop taking these drugs.

With respect to the risk of fractures, in 2010, the FDA announced that required strengthened warnings concerning the possible increased risk of fractures of the hip, wrist, and spine with the use of PPIs. The strengthened warnings will be required for both prescription proton pump inhibitors and over-the-counter (OTC) versions.

Third, regarding infections, a JAMA study found that hospital patients who are given certain heartburn drugs like Prilosec, Nexium, and Prevacid are at higher risk for pneumonia than those who are not given these medications. In fact, the study determined that there was a 30% increased risk for pneumonia among hospital patients taking these types of medications, called proton-pump inhibitors (PPIs).

The drugs are often recommended for intensive-care patients to prevent stress ulcers. However, in recent years they have been given, often unnecessarily, to a large percentage of inpatients largely because they are widely considered to be safe drugs. Experts estimate that over 50% of all inpatients now receive acid-suppressive drugs during a hospital stay, and half of those patients are receiving the medication for the very first time.

The overprescription of these drugs in the hospital setting is staggering because this is not the first time that these medications have been linked to pneumonia. In fact, a study reported in 2004 found an association between community-acquired pneumonia (in non-hospitalized people) and acid-suppressing meds. Therefore, it is unsurprising that a link has now been found with hospital-acquired pneumonia.

However, despite these studies, the FDA-approved labels for Nexium, Prilosec, and Prevacid remain void of any warnings about the increased risk of pneumonia. In fact, Prevacid's label is the only one that even states that a single case of pneumonia was ever reported by a patient taking the drug.

Despite the lack of information provided by the drug manufacturers, the causal relationship can still be explained. Although stomach acid is negatively viewed since it causes heartburn, acid reflux symptoms, and other painful conditions, its presence is also necessary to digest food and to act as a first defense against viruses, bacteria, and other harmful organisms entering your body through your mouth. Therefore, heartburn drugs by reducing stomach acid, are also reducing one of the body’s defense mechanisms against the germs causing pneumonia.

Finally, we can now add low magnesium levels to the growing list of side effects caused by Proton Pump Inhibitors (PPIs), like Nexium, Prilosec, Prevacid and Protonix. While PPIs do an incredible job of controlling chronic acid reflux, many researchers now believe that they may also increase your risk of contracting pneumonia, developing bone fractures, and increasing your risk of a heart attack if taken with a drug like Plavix. It seems as if every couple months, a new warning is issued by the FDA concerning these products.

While low magnesium levels, called "hypomagnesemia," may not seem like a serious condition, it can lead to muscle spasm, irregular heartbeat and convulsions or seizures. The FDA is recommending that doctors monitor patients' magnesium levels for those taking PPIs for longer than one year. Furthermore, the FDA has advised that magnesium supplements may not be helpful in many cases, and PPI treatment should be stopped entirely.

What may be the most disturbing part of all of this is that studies have shown that these drugs actually induce the symptoms they were prescribed to treat. In other words, some patients who have low magnesium levels caused by PPIs, who cannot be helped by magnesium supplements, may not be able to stop taking these drugs because stopping would induce even worse heartburn symptoms.

PPIs like Prilosec and Nexium were never intended to be taken for long periods of time for minor symptoms. Black Box Warnings should be mandatory for these drugs. They can be addictive and cause a host of serious side effects. Physicians and patiens alike need to be warned that there are safer alternatives to PPIs, especially at the beginning of treatment. Only a Black Box warning can adequately disclose the real risks of these drugs. The FDA should not allow another generation of patients to become dependent on these medications and be put at risk for serious infections, bone fractures and heart rhythm abnormalities.

It has not yet been determined? Perhaps the FDA should first decide how long a drug should be used for and then approve it.

Over the past year, hundreds of lawsuits have been filed alleging that the osteoporosis drug Fosamax caused femur fractures. These lawsuits have been consolidated in New Jersey federal court. Fosamax lawsuits claiming the drug caused osteonecrosis of the jaw have been consolidated for several years in a federal court in New York.

Bisphosphonates are sold under the names Actonel, Aredia, Bonefos, Boniva, Fosamax, Didronel, Reclast, Skelid and Zometa. Most people are familiar with these drugs as osteoporosis treatments for postmenopausal women; however, they are also approved for a variety of other indications, including other bone diseases such as Paget's disease.

It was in October 2010 that the FDA warned about the risk of two rare types of thigh fractures associated with drugs like Fosamax. These fractures are very uncommon and possibly account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, the FDA said in its alert that these unusual femur fractures have been predominantly reported in patients taking bisphosphonates. According to the FDA, these atypical fractures may be related to long-term term use of these drugs.

So we now believe that these drugs cause rare leg fractures and jaw death, but we’re not exactly sure how long we should ingest them. And we’re not exactly sure how long the risk remains after we stop taking these drugs. Doctors and patients alike really need to weigh what the true the benefits of these drugs are against the very real and serious risks of taking them.