February 2014

A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced.  The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and have ‘harmful consequences for patients.’”

This sentiment comes as a result of a report by independent consulting firm Matrix Global Advisors stating “the rule change would needlessly complicate the market and add $4 billion a year to already bloated healthcare costs.”

Alex Brill, lead author of the aforementioned report, states that this increase in cost would come as “‘Higher insurance premiums, self-insurance costs and reserve spending on product liability will likely force generic drug manufacturers to raise prices’” in an interview with the LA Times.  That same LA Times piece also notes that the Matrix report was “sponsored” by none other than the Generic Pharmaceutical Association.

Obviously, the generic pharmaceutical industry wants to keep its costs down, but it is sad that this end seems valued over consumer safety.  As it currently stands, the manufacturers of brand name drugs are required by the FDA to inform the public of newly-discovered hazards related to their medications.  This does not apply to generic drugs manufacturers.

In 2011, the US Supreme Court ruled that “at generic-drug companies don’t share the same level of responsibility as makers of brand-name equivalents to update their warning labels when a new risk comes to light.”  And, in 2013, the Court ruled that because generics manufacturers are simply following manufacturing guidelines from brand-name producers, generics manufacturers cannot be held legally accountable for defective or dangerous products.

LA Times states that in response to this most recent ruling, the FDA has chosen to “empower generic makers to update their warning labels any time new risks become known, rather than wait for federal authorities to require a change.”

The reason that generics manufacturers are opposed to this change is that when label changes weren’t under their purview, companies could sit on data showing a health risk associated with their products without the legal obligation to act.  Now, these companies would be obligated to make timely, effective label changes, which could hurt sales of the drug in question — as it should.

Part I: Destroying Valentine’s Day

Two weeks ago was Valentine’s Day— a holiday that is supposed to be full of romance and heartfelt encounters with those you love. For many lucky people, Valentine’s Day was exactly that this year. Countless couples across the country could be seen on dates, filling restaurants, theaters, and dance-halls to capacity. Recent winter storms inspired hot tubbing rendezvous and even spontaneous trips to various resorts, hotels, and beaches, where an amorous evening awaited.

However, for many women this year, February 14th was a far cry from a joyous occasion. It was like all their other recent days—full of pain, discomfort, and bleeding.  As a result, the holiday seemed only to mock them. These women were in too much pain to enjoy any kind of intimate evening, and too infected to even think about putting on a swimsuit for a night of hot tubbing. For these women, it seemed Valentine’s Day, which was originally named after a martyr, had reverted back to its traditional meaning—a day representing, not romance, but suffering and sacrifice.

The pain that these women are experiencing is due to surgical pelvic mesh devices that were designed, manufactured, marketed, and sold by a variety of companies, including Ethicon Inc. (hereinafter “Ethicon”), a subsidiary of Johnson & Johnson. The devices are pretty much what they sound like—pieces of mesh implanted pelvically in women.  These devices are also referred to as pelvic slings, vaginal slings, and transobturator slings, and are intended to treat stress urinary incontinence and especially pelvic organ prolapse, which can occur in women after birth or surgery. Unfortunately, instead of helping women, some of the devices have only added to the women’s sufferings.

Women who have been injured by these surgical mesh devices have rightfully initiated legal proceedings against Ethicon and other manufacturers of pelvic mesh devices. The multidistrict litigation is still ongoing. The plaintiffs in these actions have mostly complained about two specific product lines: TVT and Prolift. The plaintiffs state that the devices erode internal vaginal tissue, causing bleeding and infection. As if that isn’t enough, plaintiffs are now faced with the cost of surgically removing the devices, or the worse alternative—leaving the devices in and inevitably facing even further injury.

The plaintiffs allege design defects, manufacturing defects, negligence, failure to warn, and breach of express and implied warranties. By now, so many women have been hurt by these faulty products, that literally thousands of additional cases have been joined in the pelvic mesh multidistrict litigation since its initiation.

If you have been injured by any brand of pelvic mesh, including Ethicon, you are welcome to call us for a free consultation. You may be entitled to financial compensation for your pain and suffering and for any medical expenses you incur due to the mesh.

Part II: Destroying Implicating Documents

A lot of us kept diaries or journals when we were teenagers. Now, if your family was anything like mine growing up, you know that keeping a journal is a risky business. After all, a teenager’s journal often proves tempting bait for snooping siblings and concerned parents.

Whenever I was concerned that prying eyes would read something I would prefer to keep private, I would either (1) rip out the particularly incriminating journal entries and destroy them somehow; or (2) hide them somewhere I thought no one would ever look, with the plan to tape them back into my journal later, after the coast was clear. Sometimes when I went with this second option, I hid the journal entries so well that when I genuinely tried to find the pages later, I couldn’t.

Ethicon, the company that sold faulty pelvic mesh devices, recently found itself in a similar, yet much more serious situation.  Due to the vast amount of cases filed against Ethicon, Ethicon’s in-house counsel issued a “Hold Notice” directing employees to preserve all documents pertaining to the TVT and Prolift product lines, as well as other products involved in the ongoing litigation.

Plaintiffs claimed that after the duty to preserve evidence had been triggered, defendant Ethicon lost or destroyed tens of thousands of documents that likely contained information relevant to plaintiffs’ claims. If the missing records are anything like my journal entries, I’m guessing the conveniently missing documents were ones that did not paint Ethicon in a good light.

On February 4th, a federal magistrate judge ruled that Ethicon destroyed or lost documents that should have been preserved in anticipation of litigation involving its pelvic mesh devices. The judge also found that Ethicon’s loss of evidence was negligent, rather than willful or deliberate.

Like my journal entries, whether Ethicon deliberately destroyed the documents, or lost them due to its own negligence, the outcome is the same: The documents are gone. As a result, the judge found that plaintiffs are entitled to monetary sanctions to compensate them for the additional time spent by their counsel piecing together missing custodial files and preparing for depositions of key employees for whom scant information was provided by Ethicon. (In Re: Ethicon, Inc. Pelvic Repair Systems Product Liability Litigation, MDL Docket No. 2327, No. 2:12-md-2327, S.D. W.Va.; See 12/5/13, Page 9).

Further, the federal magistrate judge recommended allowing trial judges to instruct juries to find an adverse inference for missing evidence. Id. An “adverse inference” instruction tells the jury members that they are allowed to assume that the missing documents were in fact harmful to Ethicon’s case.

By destroying, losing, or “losing” documents, Ethicon has shown that it has just as little regard for the plaintiffs’ valuable time, as it does for their injuries. Our law firm, on the other hand, cares a great deal about the pain and inconvenience people have endured due to pelvic mesh. If you have had complications with a pelvic mesh device, we would be honored to work on your behalf, and hope that you will call us for a free consultation.

Over the course of the past several days, Ethicon, a Johnson & Johnson company, has crowed over the fact that it “prevailed” in a lawsuit regarding the pelvic mesh devices it manufactured and promoted. At first glance, the media headlines regarding Ethicon’s recent “triumph” are confusing, and might even make it seem like Ethicon has already won the overall multidistrict litigation. This is far from the truth, so we thought we would set the record straight.

All that has happened is that a federal court has thrown out one woman’s lawsuit. Specifically, on February 18, 2014, Judge Joseph R. Goodwin found that the plaintiff, Carolyn Lewis, failed to show proof of a defective product in her case. As a result, the court granted Ethicon’s motion for directed verdict. See In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.

The lawsuit filed by Carolyn Lewis was the first bellwether trial against Ethicon before Judge Goodwin. “Bellwether” trials are early cases designed to help the parties test how the court and juries may respond to evidence and testimony that is likely to be similar to what is offered in other cases. However, each individual plaintiff has to establish her own case and show that the product caused her injury. The outcome of any bellwether trials are not binding on other cases in the litigation.  (For more on bellwether cases, check out: Vaginal Mesh Cases and Neutered Sheep – What’s the Connection?)

In no way do we minimize the disappointment many feel as a result of the ruling in Ms. Lewis’ case. However, not all is lost for other plaintiffs or potential plaintiffs. The facts of each and every case are different and may therefore have very different outcomes. Prior to this year, at least three other pelvic mesh cases went to trial, including two cases that went before state court juries and one case in federal court. In all three cases, plaintiffs triumphed and received multi-million dollar damage awards from the jury.

With all this said, Ethicon needs to hold off on doing any kind of victory dance. In the grand scheme of things, one motion for a directed verdict in Ethicon’s favor is far from an overall triumph. Ethicon faces months and months of future litigation, as do other manufacturers and promoters of pelvic mesh devices. According to a case list released by the U.S. Judicial Panel on Multidistrict Litigation, Judge Goodwin is currently presiding over 12,992 Ethicon mesh lawsuits, 13,292 AMS mesh lawsuits, 7,617 Boston Scientific mesh lawsuits, 6,172 Bard Avaulta mesh lawsuits, 1,155 Coloplast mesh lawsuits and 152 Cook Medical mesh lawsuits.

We would welcome the opportunity to help any woman injured by Ethicon pelvic mesh.

The alpha-male. It’s a term traditionally used to describe an individual male mammal that is considered to hold the highest social standing in his community. Typically, an animal rises to alpha-male status by exhibiting signs of masculinity, confidence, and aggression to his peers. In acknowledgement of the alpha’s strength and leadership role, other members of the species often act subservient to the alpha, allowing him first dibs on all aspects of life, including food, sleeping places, and even mates.

Last year, the National Geographic channel ran a three-part series entitled, Going Ape, which showed that human males fight to be top-dog in much the same way mammals do in the animal kingdom. See http://natgeotv.com.au/tv/ape-man/episodes.aspx?series=1. The series suggested that men innately try to exhibit signs of masculinity, confidence, and aggression to their peers on a daily basis with the purpose of rising to alpha-male status. Instinctively, the high social standing seems to promise first pick in all of life’s essentials—careers, homes, and mates—to all who achieve it, and is thus vital.

Due to men being as sensitive as they are with regard to reaching, or else maintaining, alpha status, it is no shock that many men would take a diagnosis of low testosterone very seriously. What is shocking, however, is that there are companies who would prey on this anxiety.

Recent lawsuits have been filed involving a prescription drug called, AndroGel, which is manufactured, sold, distributed and promoted by AbbVie Inc. (hereinafter “AbbVie”) and Abbott Laboratories, Inc. (hereinafter, “Abbott”) as a testosterone replacement therapy. Defendants misrepresented that AndroGel is a safe and effective treatment for hypogonadism or “low testosterone,” when in fact the drug causes life threatening events, including strokes and heart-attacks.

The fatal problem began when defendant companies, AbbVie and Abbott, coordinated a massive, aggressive advertising campaign designed to convince men that they suffered from low testosterone—whether they actually did or not. As you can imagine, this sent a massive scare throughout the male universe. After all, it is testosterone that makes men…well, men. A lack of it could mean no-shot at even a beta status, let alone an alpha one.

A recent lawsuit was filed by Mr. Kelly in Illinois against the defendant companies. Mr. Kelly is only one of thousands of men who may have been harmed by AndroGel. His claims against the defendant companies include negligence, failure to warn, breach of implied warranty, breach of express warranty, fraud, and misrepresentation. The complaint states:

“Defendants orchestrated a national disease awareness media blitz that purported to educate male consumers about the signs of low testosterone. The marketing campaign consisted of television advertisements, promotional literature placed in healthcare providers’ offices and distributed to potential AndroGel users, and online media including the unbranded website “IsItLowT.com.” The television advertisements suggest that various symptoms often associated with other conditions may be caused by low testosterone and encourage men to discuss testosterone replacement therapy with their doctors if they experienced any of the “symptoms” of low testosterone. These “symptoms” include listlessness, increased body fat, and moodiness—all general symptoms that are often a result of aging, weight gain, or lifestyle, rather than low testosterone.”

As a result of the massive advertising campaign, hordes of men—most of whom had never been diagnosed with any kind of testosterone deficiency in their lives—flooded in to see their doctors, expressing concern that they suffered from low testosterone.

Tragically, doctors, too, had been bombarded by the defendants’ campaign. Since the FDA had approved AndroGel, the defendant companies convinced primary care physicians that low testosterone levels were widely under-diagnosed, and that conditions associated with normal aging could be caused by low testosterone levels. As a result, thousands of men were indeed prescribed the drug.

Tragically, what the consumers received were not safe drugs, but rather a product which causes life-threatening problems, including strokes and heart attacks.

Our firm is currently taking on new cases involving AndroGel. If you have been hurt by this dangerous product, or if you have lost a loved one due to his use of AndroGel, please don’t hesitate to call us. Additionally, if you are a physician who prescribed AndroGel to a client because you relied on the defendant companies’ promises with regard to AndroGel’s safety, we would be happy to speak with you.

An article published in the January-February, 2014 edition of Female pelvic medicine and reconstructive surgery titled “Pneumomediastinum after robotic sacrocolpopexy.” reviews a case of pneumomediastinum in a woman who underwent robot-assisted surgery for the repair of posthysterectomy prolapse.  The team writes “Pneumomediastinum is a rare but potential complication of laparoscopy that is related to insufflation with carbon dioxide gas and may lead to life-threatening complications.”

This woman was 76 years old, and underwent surgery “without any apparent intraoperative complications.”  Sadly, after surgery, she developed a rapid heartbeat, was short of breath, “and was found to have subcutaneous emphysema and pneumomediastinum.”

The research team (led by NM Crawford) states in its conclusion that “Pelvic surgeons should understand the risks associated with development of pneumomediastinum as well as associated signs and symptoms. In our case, pneumomediastinum likely developed as carbon dioxide tracked from the peritoneum into the mediastinum during prolonged robotic retroperitoneal surgery.” (emphasis added)

As such, these doctors believe “Surgeons should have a low threshold to obtain radiographic tests in the early postoperative period, as close monitoring is essential to manage potentially life-threatening complications such as pneumothorax and cardiac arrest.”

Due to the fact that the manufacturers of many robotic surgery systems have failed to warn users of the elevated risk for complications and longer hospital stay associated with robot-assisted surgery, a number of surgical robot lawsuits have been filed.  If you or a loved one underwent surgery assisted by robot, you too may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of surgical robot lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2012, an article titled “Use of thiazolidinediones and the risk of bladder cancer among people with type 2 diabetes: a meta-analysis.” was published by IN Colmers et al. in Canadian Medical Association Journal investigating the relationship between Actos and bladder cancer.  Thiazolidinediones are a class of diabetes drugs including pioglitazone, the chemical name for the drug Actos.

This article states “Patients with type 2 diabetes have a 40% increased risk of bladder cancer. Thiazolidinediones, especially pioglitazone, may increase the risk,” and as such, the authors “conducted a systematic review and meta-analysis to evaluate the risk of bladder cancer among adults with type 2 diabetes taking thiazolidinediones.”

To perform this study, the team reviewed a number of previously-conducted studies, both randomized controlled studies, and “case-control studies that reported incident bladder cancer among people with type 2 diabetes who ever (v. never) were exposed to pioglitazone (main outcome), rosiglitazone or any thiazolidinedione.”

Using statistical analysis, the team found that thiazolidinedione use was associated with a 15% increased risk of bladder cancer, and that Actos use was associated with a 22% increased risk of bladder cancer.

Due to the fact that the manufacturers of Actos have failed time and again to make clear the risk for bladder cancer, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer, you may be entitled to significant financial compensation for your injuries.  For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

In the December, 2013 edition of European Urology, a team of researchers led by RK Kumar published the results of a study titled “Robot-assisted Partial Nephrectomy in Patients with Baseline Chronic Kidney Disease: A Multi-institutional Propensity Score-Matched Analysis.” that aimed to evaluate the relative safety of robot-assisted nephrectomy, as compared with a traditional approach that surgery.

This study included a total of “1197 consecutive patients who underwent [robot-assisted partial nephrectomy (RPN)] at five academic institutions between 2007 and 2012” and from that group, “A total of 172 patients who underwent RPN with preexisting [chronic kidney disease (CKD)] … were identified. Perioperative results of 121 patients were compared against propensity score-matched controls without CKD”.

After a great deal of analysis, the researchers determined that patients who underwent robot-assisted surgery faced “a higher risk of surgical complications and a longer hospital stay.”  The change in complication rate was not small, either – 21% rate of complications among robot-assisted surgeries, and only about 10% among patients who underwent traditional surgery.

Due to the fact that Da Vinci, the manufacturer of a number of popular robotic surgery systems, has failed to adequately warn users for the risk for an elevated rate of complications and longer hospital stay, a number of Da Vinci surgical robot lawsuits have been filed.  If you or a loved one underwent surgery by surgical robot and faced complications or longer hospital stay, you too may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of surgical robot lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

A recent article published in the January 2014 edition of Obstetrics and Gynecology titled “Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.” lives up to its title and compares the safety and efficacy of robot-assisted to traditional sacrocolpoplexy.

The team, led by JT Anger, writes “Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment” but that “Evidence comparing outcomes and costs is lacking.”  Accordingly, this study made just that comparison.   The patients studied were female, and totalled 78 – thirty-eight traditional surgeries and forty robot-assisted surgeries.

In general, this small study found the procedures to be fairly comparable, but it was found that robot-assisted surgery resulted in longer operating time and patients suffering from higher pain scores one week after surgery.  Further, the cost of robotic surgery was significantly higher than  the traditional laparoscopic procedure.

While the safety and efficacy of robotic surgery is ever increasing, it is important for patients to be fully aware of risk and complication rates associated with this still-novel procedure.  Due to the fact that Da Vinci, the manufacturer of many popular surgical robot systems, has failed time and again to adequately warn users of the risks associated with robotic surgery, a number of Da Vinci Surgical Robot lawsuits have been filed.

If you or a loved one underwent a robotically-assisted surgery and suffered complications or unintended side-effects, you too may be entitled to significant financial compensation from the manufacturer of the device used.  For a free, no-obligation case consultation, contact our team of Da Vinci surgical robots lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2014, an article by AM Coker et al. titled “Outcomes of robotic-assisted transhiatal esophagectomy for esophageal cancer after neoadjuvant chemoradiation.” in Journal of Laparoendoscopic & Advanced Surgical Techniques aimed to “determine if [robotic-assisted transhiatal esophagectomy (RATE)] could be performed safely with good outcomes for esophageal cancer in a more recent series of patients”.

The authors write “This was a retrospective review of patients with adenocarcinoma of the distal esophagus or gastroesophageal junction who underwent RATE between November 2006 and November 2012 at a single tertiary-care hospital.”  In all, the study consisted of 23 patients – 20 men and 3 women.

“Complications included seven strictures, two anastomotic leaks, and two pericardial/pleural effusions requiring drainage. One patient required pyloroplasty 3 months after esophagectomy.” And sadly, “One patient died from pulmonary failure 21 days after surgery (30-day mortality rate of 4%).”

Due to the fact that this procedure is indeed quite complicated, these researchers purport that “RATE can be performed safely with good oncologic outcomes following neoadjuvant chemoradiation in patients with esophageal cancer”.  What is important however, is that patients be informed of the risk for complications associated with any procedure.

Since Da Vinci, the manufacturer of many popular robotic surgery systems, has failed time and again to make the risk rates clear to users, a number of Da Vinci surgical robots lawsuits have been filed.  If you or a loved one underwent robot-assisted surgery and suffered complications, you too may be entitled to significant financial compensation for your injuries.  For a free, no-obligation case consultation, contact our team of surgical robot lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2012, an article by L. Azoulay et al. titled “The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study.” aimed to “determine if the use of pioglitazone is associated with an increased risk of incident bladder cancer in people with type 2 diabetes.”  (“Pioglitazone” is the chemical name for Actos.)

According to this research team, “The cohort consisted of people with type 2 diabetes who were newly treated with oral hypoglycaemic agents between 1 January 1988 and 31 December 2009. All incident cases of bladder cancer occurring during follow-up were identified and matched to up to 20 controls on year of birth, year of cohort entry, sex, and duration of follow-up” and “exposure was defined as ever use of pioglitazone, along with measures of duration and cumulative dosage.”

Overall, the participants in this study included “115,727 new users of oral hypoglycaemic agents, with 470 patients diagnosed as having bladder cancer during follow-up” and, “The 376 cases of bladder cancer that were diagnosed beyond one year of follow-up were matched to 6699 controls.”

This team found that patients ever using Actos resulted in an 83% increased risk for bladder cancer.  And, if patients used Actos for more than two years, the risk for bladder cancer increased to 99% higher than that for non-users.  If patients used more than 28,000mg of Actos in the course of treatment, the risk for bladder cancer was 254% higher than that for non-users.

Sadly, the manufacturer of Actos failed time and again to adequately inform users of the risk for bladder cancer associated with this product, and as a result, a number of Actos lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer as a result, you too may be entitled to significant financial compensation for your undue injury.  For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us