Philadelphia Injury and Malpractice Attorneys – The Beasley Firm

Three months ago, I posted an article on my Litigation & Trial blog titled, “Player Piano” Robotic Surgeries Put Women’s Lives At Risk, discussing the Da Vinci surgical robot, which is marketed as a safer alternative to other types of hysterectomies. By my count, there are now more than 4,500 complaints about the Da Vinci surgical robot in the FDA’s MAUDE (“Manufacturer and User Facility Device Experience”) Database — 50 or so of them involving the death of the patient — and 30 lawsuits against the manufacturer, Intuitive Surgical, Inc.

Since my post, there have been three main developments. First, the FDA is taking a closer look at worrisome number of patient, doctor, and hospital complaints about the machine. Second, the media is taking a closer look at the real risks of using the robot. Third, the company finally admitted a problem, though they don’t admit nearly enough, and they aren’t taking any real steps to make it safer.

The first two developments are great news, though we’re not holding our breath that anything will come of them. The FDA is often way too late to address problems with medical devices, like how they were years behind on the DePuy and Stryker metal-on-metal hip implant debacles, and how they still haven’t recognizes the scope of the vaginal mesh erosion epidemic. Both products are shockingly still on the market, despite having injured hundreds of thousands of patients.

The Da Vinci Robot Has A History Of Causing Burns, Tears, And Perforations

Focusing on the third point, the company recently admitted in a letter to users that certain batches of “EndoWrist Monopolar Curved Scissors” (the electronic scalpel used with the robot) might develop tiny cracks that can allow electricity to escape from the device, burning patient’s organs. Unsurprisingly, they don’t admit anyone was actually injured by it: “our analysis shows only one complaint of injury associated with [one of the broken electronics couples], however, laboratory testing did not detect any energy leakage from this instrument.” We know better — the Da Vinci robot routinely burns patients.

A few months ago, an investment advisory firm, Citron Research, scoured the MAUDE database for details on the Da Vinci robot and found numerous extraordinary reports of inexplicable perforation, tearing, and burn injuries. Doctors reported the device, for example:

• “sparked through the intact protective sheath … vessel injury”
• “caused a spark … onto the right external iliac artery”
• “It was reported that during a da Vinci’s prostatectomy procedure, while the surgeon was performing pedicle dissection, arcing from the mcs tip cover accessory installed on the monopolar curved scissors instrument occurred causing unintentional burning”
• “It was reported that after a da Vinci pulmonary wedge resection procedure was completed, a burn was observed at one of the port sites when the cannula accessory was removed from the instrument arm. The burnt skin was excised, however, the patient was burnt all the way through the tissue”

We’ve heard that from our clients and from reports from doctors. One general surgeon told me that the majority of Da Vinci injuries weren’t really perforation injuries — as in, the robot accidentally cutting tissue or organs it shouldn’t have — but rather monopolar cautery injuries, or rather an injury caused by the use of electric current to cut the patient’s tissue.

The Causes Of Robotic Surgery Burns: The Robot’s Improper Technique While Using Electrosurgery, And The Robot’s Poorly Insulated Surgical Instruments

And that’s one of the key problems with the robot: the injuries it causes have less to do with the way in which the robot was operated than with the inherent design of the robot. All surgery is dangerous. While electrosurgery has benefits over the use of the traditional scalpel (the heat and electricity cauterize the wound as they cuts, thereby preventing bleeding), it also has numerous risks. These are risks that surgeons train over the course of years to reduce. The Da Vinci robot, no matter how sophisticated it may seem, simply doesn’t have the ability to mitigate those risks through advanced technique.

The tragic part is that patient’s aren’t trading some risks for other benefits: the Da Vinci robotic surgery hasn’t been proven to be any safer or more effective than any other form of laparoscopic surgery, a/k/a minimally invasive surgery. The benefits of the robotic surgery extolled by Intuitive Surgical are usually just the same benefits of traditional laparoscopic surgery, in which the patient is cut as little as possible, and the surgeon tools are then manipulated inside their body. The use of laparoscopy for hysterectomies has been growing for a generation now, and its benefits are frequently extolled in medical journals. The same goes for all of the major procedures the Da Vinci is marketed for, like radical prostatectomy, colectomy, cystectomy, nephrectomy, myomectomy, endometriosis resection, sacrocolpopexy, and gastric bypass — none of these procedures benefit any more from the use of the robot as compared to an experienced surgeon using a laparoscopic approach.

The Da Vinci Robot Is A Triumph Of Aggressive Marketing, Not Medical Research

So how did this happen? Based on the research patients’ lawyers have done, most of the lawsuits include verbatim these allegations:

Defendant has promoted its device as (a) safe, and (b) safer than other comparative methods of surgery including, in the case of hysterectomies, laparoscopy, vaginal surgery and open surgery.

Defendant utilizes prominent websites aimed at consumers, seeking to create demand for the use of its robotic device by patients who consult surgeons.

Defendant sold it device through a calculated program of intimidation and market management, forcing hospitals and physicians to purchase it in order to appear to be competitive, and creating a fear in their minds that if they did not have this technology they would lose business to competitors.

Defendant reinforced its calculated program, as stated in the preceding paragraph, by placing, on its website for potential patients, names of certain physicians who had performed 20 surgeries with the device.

Plaintiff’s lawyers like me have been on top of that for a while, and it was nice to see the editors of the Journal of the American Medical Association agree, with their editorial arguing that “Consumer advertising of expensive devices should be subjected to the same scrutiny as that of new and expensive medications.”

As the plaintiffs also allege:

The use of defendant’s robotic device in surgery presents substantial risks of complications and injuries, including de-vascularization of the vaginal cuff impeding healing, partial thermal injury burns to bowel, post-surgical abscesses, tears, dehiscences, bleeding, hematomas, sepsis, and fistulas.

More specifically, defendant’s robotic device can cause damage to the bowel, blood vessels, arteries, ureters, bladder and vaginal cuff.

Indeed. All of this is why, two weeks after my blog post went up, the President of the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement noting “the outcome of any surgery is directly associated with the surgeon’s skill,” and urging patients “to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.” Maybe robots are taking over increasingly sophisticated jobs — but this is one job they’re not ready to do, not by a long shot.

Attorneys Representing Da Vinci Robot Surgery Victims

Since 1958, The Beasley Firm has fought for injured patients and consumers, obtaining over $2 billion in awards for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one were injured in a robotic surgery, contact our lawyers for a free and confidential consultation by by calling the firm at (888) 651-9530 or by calling attorney Max Kennerly’s office directly at (215) 931-2634. 

Extra Strength Tylenol, one of the most aggressively-marketed consumer products in the country, has been making news again lately. The media focus has been on how researchers built on previous findings that “acetaminophen reduced neural responses to social rejection in brain regions previously associated with distress caused by social pain” and found that Tylenol can reduce existential unease and cause people to be less morally judgmental. It is an undeniably powerful drug.

But the bigger news from a patient safety standpoint has been the creation of “multidistrict litigation” against McNeil Pharmaceuticals. The order means that the bulk of Tylenol injury lawsuits while be handed, at least for pretrial purposes, here in the federal court in Philadelphia, a couple blocks from our office.  A year and a half ago, I wrote a post about how courts were lagging behind the science on acetaminophen, and it seems that the tide is changing on that.

The Long History Of Tylenol Liver Failure Lawsuits

The risk of acute liver failure when using Tylenol certainly isn’t new, and even Tylenol lawsuits aren’t new. As just one example, more than twenty years ago Antonio Benedi, a regular wine-drinker (but by no means an alcoholic) “had been taking Extra-Strength Tylenol in normal, over-the-counter doses since February 5, 1993 for flu-like aches,” when, five days later, he “was admitted to the hospital on February 10, 1993 in a coma and near death due to liver and kidney failure.” Benedi v. McNeil-PPC, Inc., 66 F.3d 1378 (4th. Cir. 1995).

The hospital’s pathologist examined Benedi’s damaged liver and concluded that the injury was characteristic of acetaminophen toxicity. In the lawsuit that followed, Benedi’s lawyers proved that even “therapeutic” doses of Tylenol — i.e., doses within the limits given on the label — could cause acetaminophen hepatotoxicity and acute liver failure when combined with ordinary amounts of alcohol. The Tylenol warning label was subsequently updated to warn about alcohol use while taking acetaminophen.

The Continued And Commonplace Danger Of Tylenol Liver Injuries

Since then, not much has changed even while acetaminophen liver injuries continue to mount. Researchers know “acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States,” and that the incidence of Tylenol-induced acute liver failure is on the rise. Some estimates by the American Association of Poison Control Centers suggest more than 50,000 emergency department visits every year related to acetaminophen.

There were two inadequate changes over the past decade. In 2005, the over-the-counter Tylenol label was modestly updated to warn that “severe liver damage may occur if more than 4,000mg of acetaminophen is taken.” In 2011, Tylenol changed the label on its Extra Strength Tylenol formulation (the 500mg pills) to impose a maximum of 6 caplets every 24 hours, or 3 grams a day.

Neither of these changes really get to two biggest problems: many routine medical conditions increase Tylenol toxicity and Tylenol has no safety margin for its use.

Even Taking The Recommended Dose Of Tylenol Can Cause Acetaminophen Related Hepatotoxicity, Acute Liver Failure, Or Death

Starting with the first problem, McNeil Laboratories and Johnson & Johnson are simply wrong that a patient has to take more than 4 g of Tylenol to run the risk of acute liver failure or death. Way back in 1987, researchers confirmed the metabolic process by which, when mice weren’t fed as much, their livers didn’t produce as much glutathione, and the liver had much greater difficulty clearing acetaminophen. It’s easy to see that and think, well, how often do people really “fast” — as in, go without any food at all — and take a significant amount of Tylenol?

But “fasting” in this context doesn’t mean abstaining from food entirely, and, more to the point, think about when people consistently take the maximum dose of Tylenol – for example, when they are sick with a cold or the flu, or when they are recovering from surgery, times when people don’t tend to eat much. Last time you had the flu, even if you could keep food down, you weren’t hungry, so you didn’t eat much, but your fever kept going up and you felt aches and pains throughout your body, and so you took Tylenol as often as the label said you could. They even market it for this purpose, like “Tylenol Cold & Flu Severe.”

Bad idea. That’s where the “increased hepatotoxicity” comes in. In just a few days, you can go from “having a flu” to “in the hospital with ‘Acetaminophen related hepatotoxicity,” to the liver transplant list — or worse. It’s scary, and it happens to consumers all the time. Indeed, the problem might be even worse than we think: as researchers noted two years ago, “the cause of liver injury in 14% of patients with acute liver failure remains unknown.” Their data lead them to conclude there was a “high prevalence of unrecognized or uncertain acetaminophen toxicity among subjects with indeterminate acute liver failure.”

If you have any other condition that affects the liver, or if you’re anything other than a perfectly healthy adult, then the risks are even worse. Consider this 2001 article from the American Academy of Pediatrics, which lists “Conditions and Situations That May Increase the Risk of Acetaminophen Toxicity” including Diabetes mellitus, Obesity, Chronic undernutrition, Prolonged fasting, Family history of hepatotoxic reaction, and Concomitant viral infection.

Consumers Don’t Realize The Potentially Fatal Consequences Of Going Even Slightly Over The Recommended Tylenol Dose

Moving to the second problem, there’s no denying that, even in perfectly healthy patients, at some dosage Tylenol is likely cause acute liver failure. The question are: what is that level, and how often do people cross it? Many studies have found, for example, “that there is a narrow therapeutic margin and that consistent use of as little as 7.5 g/day may be hazardous.” The phrase, “narrow therapeutic margin,” is a euphemism for “the recommended dose brings you awfully close to permanent injury and potentially death.” Other studies have found the number could be much lower, so that consumers who frequently take just a little bit more Tylenol than recommended — the so-called “staggered overdose” — are at far greater danger of liver injuries, and some slight tipping point like a flu or some alcohol use can push them over the edge.

We’re all familiar with cases of people attempting suicide by overdosing on Tylenol, but that’s not the whole story: there are literally hundreds of published medical studies describing unintentional overdoses on Tylenol, typically referred to as “therapeutic misadventures.” How does this happen? I have one guess: patients don’t know just how dangerous acetaminophen can be. Although that warning references “liver damage,” it doesn’t convey the two most serious potential side effects: acute liver failure and death. As the Washington Post noted in a long article earlier this week about Medicare, one of the biggest contributors to health problems today is “non-compliance” with medications. The consequences of just a few days of “non-compliance” or a “therapeutic misadventure” with Tylenol, however, are far worse than with any other over-the-counter pill — but consumers don’t know that.

Put simply, there are no other over-the-counter drugs with such a narrow window that, if you merely take an extra four or five pills, you could die, and yet Tylenol is labeled and advertised not just as being like everything else, but as being safer than other drugs.

Where The Tylenol Lawsuits Go From Here

As noted above, Tylenol litigation isn’t new, but the creation of the multi-district litigation (“MDL,” which is different from a class action) really changes things. Over 50,000 people go to the emergency room with these injuries every year, but Johnson & Johnson and McNeil aren’t going to do anything. They sell over $1 billion a year of Tylenol. (Read more about their branding initiatives over the past fifty years here). The FDA isn’t going to do anything, either.

These days, there’s only one way unsafe drugs are ever pulled from the market or given better warnings: when the company is held accountable to its victims, it makes less of a profit, and so moves on to something else. The creation of the multidistrict litigation is important because it will help gather together these hundreds, potentially thousands, of cases, allowing them to have strength in numbers, and preventing the company from spending literally millions of dollars fighting each one of them to try and dissuade other plaintiffs and their lawyers from bringing individual lawsuits.

We see the same tragic situation several times a year: a patient, often a young person in their twenties or thirties, goes to their primary care physician with the signs and symptoms of “GERD,” or gastroesophageal reflux disease. They have persistent heartburn that seems to resist antacids, giving them pain in their throat and chest, maybe even a dry cough or trouble swallowing. Their doctor prescribes a proton-pump inhibitor — maybe Nexium, or Prevacid, or Prilosec — and then sends them on their way with instructions for them to follow-up in a couple weeks. 

The heartburn drug works a little bit, but doesn’t resolve the problem entirely. The patient goes back to the doctor two or three months later, and the doctor tells them to keep taking the pill, and reminds them to quit smoking, quit drinking alcohol, or get more sleep, or improve their diet. The patient starts just living with the pain and discomfort, and adding a couple antacids before and after their meals, too, and asking their family physician what to do. The doctor tells them they should avoid overeating, shouldn’t go to bed with a full stomach, shouldn’t eat onions or drink caffeine, and should raise their pillow. All the usual stuff.

After many more months, maybe more than a year, much more worrying symptoms appear — nausea, severe fatigue, blood in the stool, or throwing up blood. That’s when the patient starts to get worried, and then either gets their doctor to finally order some follow-up diagnostic tests (often just blood work, or maybe a colonoscopy) or ends up in the Emergency Room wondering what’s going on. Those other doctors, the ones at the imaging facility or in the emergency department at the hospital, tell the patient what’s happening: cancer. The next day the patient gets a CT Scan or an MRI, and one of two things are confirmed: stomach cancer or esophageal cancer. And it’s often inoperable by that point.

There’s a little secret buried deep in the “prescribing information” given to physicians with those proton-pump inhibitors, information they’re supposed to know but often don’t: those drugs aren’t meant to be used if you have signs of a serious condition, and they aren’t supposed to be used for more than a couple weeks at a time.

Here’s the approved usage on Nexium’s FDA label:

Healing of Erosive Esophagitis

NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered. …

Symptomatic Gastroesophageal Reflux Disease

NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.

And here’s the approved usage on Prilosec’s warning label:

1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients) …

The efficacy of PRILOSEC used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

And Prevacid’s label:

1.7 Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD.

Short-Term Treatment of Erosive Esophagitis

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.

For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered.

Notice the key term there: “short-term treatment.” Doctors are supposed to prescribe the medications for 4–8 weeks, evaluate how well they’re working, and then prescribe them for at most another 8 weeks. Nobody is supposed to be on any of these proton pump inhibitors for more than four months at the very most, and then only while a doctor is evaluating them. (H2 receptor antagonists like Zantac are even shorter: the warning label for Zantac says to see a doctor if “you need to take this product for more than 14 days.”)

Why? For the same reasons the medications tell you not to use them “if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.” It could be sign of gastric or esophageal cancer, or of Barrett’s esophagus, which is tied closely with esophageal adenocarcinoma, a particular lethal cancer. Like with all cancers and precancerous tumors, the sooner a patient can be diagnosed and treated, the better, but that diagnosis requires an endoscopy be done of the throat and stomach. 

For years, there has been frustratingly been debate in the medical community over when a doctor should tell a patient with signs of GERD to undergo upper endoscopy. Three different physician associations had completely different guidelines, all of which were bad and which shockingly discouraged doctors from recommending an endoscopy to patients:

• The American Society of Gastrointestinal Endoscopy recommends that screening upper endoscopy be considered “in selected patients with chronic, longstanding GERD.” GERD several times a week, or GERD for more than five years, or nocturnal reflux symptoms were risk factors.

• The American Gastroenterological Association guidelines recommend against screening the general population with GERD for Barrett esophagus and esophageal adenocarcinoma but say that it should be considered in patients with GERD who have several risk factors associated with esophageal adenocarcinoma, like age, hiatal hernia, elevated body mass index, and intra-abdominal distribution of fat.

• The American College of Gastroenterology guidelines note that “screening for Barrett’s esophagus in the general population cannot be recommended at this time. The use of screening in selective populations at higher risk remains to be established, and therefore should be individualized.”

This advice was awful, and it cost lives. Frankly, it’s hard not to think that the guidelines were written that way to excuse negligent physicians who failed to properly order tests. Thankfully, back in December 2012, the Clinical Guidelines Committee of the American College of Physicians published in the Annals of Internal Medicine new proposed guidelines that are far, far better than the guidelines from the other organization:

Best Practice Advice 1: Upper endoscopy is indicated in men and women with heartburn and alarm symptoms (dysphagia, bleeding, anemia, weight loss, and recurrent vomiting).

Best Practice Advice 2: Upper endoscopy is indicated in men and women with:

•  Typical GERD symptoms that persist despite a therapeutic trial of 4 to 8 weeks of twice-daily proton-pump inhibitor therapy.
•  Severe erosive esophagitis after a 2-month course of proton-pump inhibitor therapy to assess healing and rule out Barrett esophagus. Recurrent endoscopy after this follow-up examination is not indicated in the absence of Barrett esophagus.
•  History of esophageal stricture who have recurrent symptoms of dysphagia. 

Best Practice Advice 3: Upper endoscopy may be indicated:

•  In men older than 50 years with chronic GERD symptoms (symptoms for more than 5 years) and additional risk factors (nocturnal reflux symptoms, hiatal hernia, elevated body mass index, tobacco use, and intra-abdominal distribution of fat) to detect esophageal adenocarcinoma and Barrett esophagus.
•  For surveillance evaluation in men and women with a history of Barrett esophagus. In men and women with Barrett esophagus and no dysplasia, surveillance examinations should occur at intervals no more frequently than 3 to 5 years. More frequent intervals are indicated in patients with Barrett esophagus and dysplasia.

(If you don’t want to read the journal article, Medscape has a summary here.) The first two examples of “best practice advice” are the most common issues we see in our work on behalf of malpractice victims. Either a doctor ignored an “alarm symptom” like blood in the vomit or stool or weight loss, or the doctor kept a patient on prescribed heartburn medication for too long even while GERD symptoms persisted.

It’s our hope that these new guidelines, published in as widely-read journal as the Annals of Internal Medicine, will help educate family physicians, primary care physicians, and other about the warning signs of cancer that can be masked by GERD treatments. The unfortunate truth, however, is that negligent treatment persists among doctors long after the standard of care moves forward, and so we expect to continue to see these tragic cases for years to come.

All across the major cities in America, the violent crime rate shot up dramatically beginning in the 1960s, from 150 violent crimes per 100,000 people in 1960 to a peak of 750 violent crimes per 100,000 people in 1990 — a shocking four-fold increase. Then, after 1990, violent crime started falling, to under 450 as of 2009, and it’s still falling. 

Why? Sociologists and economists have come up with a number of answers, ranging from “broken windows” to the economy to the rise of crack cocaine, and none of those explanations have held up under scrutiny. The explanations make sense, but the data simply doesn’t fit. As Kevin Drum at Mother Jones detailed recently, though “Experts often suggest that crime resembles an epidemic. But what kind?”

Thinking of an epidemic, researchers often use as a rule of thumb, “If it travels along major transportation routes its microbial. If it spreads out like a fan, its an arthropod. If its everywhere, all at once, its a molecule.” As Drum asks rhetorically, “What molecule could be responsible for a steep and sudden decline in violent crime? Well, here’s one possibility: Pb(CH2CH3)4.”

That’s tetraethyllead, the lead that was used in gasoline. Although we all think of childhood lead exposure resulting from paint — more on that in a minute — the primary cause of lead exposure since World War II was really leaded gasoline. “Lead emissions from tailpipes rose steadily from the early ’40s through the early ’70s, nearly quadrupling over that period.” As other researchers have concluded, “if you add a lag time of 23 years, lead emissions from automobiles explain 90 percent of the variation in violent crime in America. Toddlers who ingested high levels of lead in the ’40s and ’50s really were more likely to become violent criminals in the ’60s, ’70s, and ’80s.”

It sounds crazy, but there’s ample evidence of it, from specific lead levels that can still be tested in urban neighborhoods, particularly the poorest neighborhoods, to indisputable medical evidence that there is no safe level of lead exposure. It is always toxic in every amount. Once a kid is exposed to a contaminated source, like paint, it will affect their brain, reducing IQ and, perhaps even more importantly as it relates to crime, injuring the prefrontal cortex, thereby hindering impulse control and reasoning abilities. Thankfully, lead in gasoline has been slowly reduced since 1972, and finally banned in 1996.

But let’s get back to paint. PBS recently posted an excellent story on the dedicated efforts by Herbert Needleman, a child psychiatrist, to discover and to expose the dangers of lead contamination in paints, particularly the paints used on walls in homes. Unfortunately, as PBS notes, although lead paint has been banned since 1978, “more than 38 million homes in the United States contain deteriorating lead painted walls. Landlords refuse to abate these homes because it costs so much money; the renting parents have neither the funds nor access to safer housing elsewhere.” The CDC has estimated that over 300,000 children under the age of five have high enough levels of lead in their blood to be diagnosed with lead poisoning.

Pennsylvania has a serious lead poisoning problems. As Nan Feyler, chief of staff for the Philadelphia Department of Public Health, wrote in an editorial:

At the newer level recently adopted by the CDC – 5 micrograms per deciliter of blood, down from 10 – roughly 13,000 more Pennsylvania children, an increase of 400 percent, would have been considered lead-poisoned in 2011, according to statistics for counties and selected cities compiled for the state Department of Health’s Childhood Lead Surveillance Program’s annual report. That’s a total of 4,900 children in Philadelphia, 85 in Bucks County, 188 in Chester County, 580 in Delaware County, and 466 in Montgomery County.

Despite the federal and state bans on lead paint, the only thing that’s made a difference in those past forty years has been the lawsuits filed against landlords, contractors, and paint companies that failed to follow the law, thereby exposing children to dangerous levels of lead. To its enormous credit, Philadelphia took action to compel better inspections and remediation of lead, with a prevention program and a law that went into force last December. Despite loud complaints from landlords too cheap to have their own properties checked for lead, in Philadelphia now:

The law states that upon turnover, before renting any house or apartment built before 1978, to new tenants with children aged 6 years and younger, the landlord must:

• certify the property is lead safe or lead free

• provide the tenant with a copy of a lead safe or lead free certificate, along with other required information

• provide the Department of Public Health with a copy of the lead safe or lead free certificate, signed by the tenant 

Will all the landlords comply? Almost certainly not, and I don’t doubt that cut-rate contractors and inspectors will falsely “certify” properties that they are free from lead when they are certainly not. But it is a step in the right direction and, in time, we’ll get the lead out of Philadelphia — and cut the crime rate even further.

For fifty years, The Beasley Firm has stood up for injured people and their families, including children injured by lead contaminated products and paints. If your landlord or the seller of your home didn’t properly check for lead, or if you have any doubts, get your property inspected and ask your child’s pediatrician to order a blood test for lead. If your child has been diagnosed with lead poisoning, call us for a free, confidential consultation.

Merely a week ago I wrote about what an $11.1 million jury verdict in a vaginal mesh lawsuit in New Jersey meant for other women with those meshes and involved in the nationwide litigation. Yesterday came big news in another litigation we are heavily invested in: the DePuy ASR hip implant recall. A jury in Los Angeles awarded over $8 million to a Loren “Bill” Kransky and his wife for injuries arising from his recalled DePuy ASR XL hip implant. (Reuters article, Bloomberg article.) Over $300,000 was for his medical expenses, and the rest was for pain and suffering.

It was obviously a big win, but the big question for us, our clients, and the other thousands of patients with recalled DePuy hip implants is: what does it mean for the other cases?

Initially, it doesn’t mean anything. Bill Kransky and his wife now have a verdict against Johnson & Johnson and DePuy and a couple related companies. The defendants will inevitably file post-trial motions arguing that the judge made erroneous rulings during the trial and that the jury made factual findings that could not rationally be supported by the evidence. These are all standard legal procedures, and they will almost inevitably result in an appeal, which will take months, potentially a year or more. Meanwhile, the thousands of DePuy lawsuits filed in the federal multidistrict litigation will continue moving forward.

That said, the verdict and the evidence developed at trial do create indirect benefits for other patients who received the recalled ASR XL hip and who have filed (or will file) claims, by showing how seriously juries take these injuries, and how upset they are with Johnson & Johnson / DePuy’s cavalier attitude towards safety.

That said, let’s start with a couple important distinctions in the Kransky case.

1. The case was in California state court, not the Ohio federal court where the bulk of the DePuy ASR cases are being litigated. (The DePuy Pinnacle cases are in Texas federal court.)
2. The reason this case went to trial before so many others was due to a special provision in California law allowing plaintiffs with severe health problems to accelerate their cases. Kransky has diabetes, cancer, kidney disease, heart disease, vascular disease, and other problems.
3. As mentioned above, Kransky has many problems that most DePuy recall patients don’t. For example, while large numbers of DePuy recall patients had high chromium and cobalt levels, and had to endure a painstaking revision surgery (plus weeks of recovery), few patients were unable to properly rehabilitate from a stroke like Kransky.
4. The trial judge in the case was, at least in my opinion, was more friendly to the plaintiffs than many other courts would be. For example, the judge precluded Johnson & Johnson / DePuy Orthopedics from relying upon the FDA’s nominal clearance of the implants through its 510(k) process. (I completely agree with the trial judge — I’m just saying that many other judges in the future may not.)

But perhaps the biggest distinction relates to the preparation of the defendants. While we, as plaintiffs’ lawyers, have known for some time how strong the evidence was against the company, the company hasn’t known how our theories and strategies would pan out at trial. Now they’ve seen one trial, put together by multiple teams from the multiple coordinated litigations. The defendants are spending literally millions of dollars on attorneys just to learn from these trials, and they will do so.

As one of the many law firms heavily invested in the nationwide transvaginal mesh and bladder sling litigation, we pay close attention to any legal developments that might help our clients, and this week a New Jersey jury ordered Johnson and Johnson and its subsidiary Ethicon to pay $3.35 million in compensation and $7.76 million in punitive damages to Linda Gross, a South Dakota nurse who had Gynecare Prolift implanted to treat pelvic organ prolapse. The mesh failed, eroded through her vaginal wall, and thereafter she has had so many complications that she has already had 18 revision and repair surgeries — and may need more in the future.

It was obviously a big win, but the big question for us, our clients, and the other thousands of women with complications from their vaginal mesh and bladder slings is: what does it mean for the other cases?

Initially, it doesn’t mean anything. Linda Gross alone now has a verdict against Johnson & Johnson and Ethicon (and a couple related companies). The defendants will inevitably file post-trial motions arguing that the judge made erroneous rulings during the trial and that the jury made factual findings that could not rationally be supported by the evidence. These are all standard legal procedures, and they will almost inevitably result in an appeal to the New Jersey Appellate Division, and that appeal will take months, potentially a year or more. Meanwhile, the thousands of mesh lawsuits filed in the federal multidistrict litigation will continue moving forward, as will the hundreds of mesh lawsuits filed in the consolidated New Jersey state court litigation — and the companies show no signs of offering reasonable settlements any time soon. (That’s okay, that’s what we expect at this stage.)

Although the $11.1 million verdict doesn’t do anything directly to help other mesh patients, the verdict and the evidence developed at trial do create indirect benefits for other mesh patients who have suffered complications and who have filed (or will file) claims.

First, the jury verdict shows how seriously jurors take the injuries suffered by women with complications from the mesh or sling.

Whenever you have prescription drug or medical device litigation of this size, the courts set up “bellwether” trials to assess factors such as how juries respond to the plaintiff’s damages. Here, the damages our clients are suffering are intensely personal, intimate, and psychologically challenging. In contrast to many of the prescription drug or medication cases, in which the dangerous drug gave patients a life-threatening condition like heart attacks (which is what happened with the improper Fresenius dialysis solution) or cancer (right now, we have other cases in which Actos gave patients bladder cancer and Januvia gave patients pancreatic cancer), the implanted vaginal mesh complications do not threaten women’s lives, but they rob women of their personal dignity and their intimacy with their partners. For example, women with erosion complications are often subjected to permanent incontinence and pain during intercourse so great that they cannot even attempt intimacy with their partners anymore.

We knew that juries would understand the extraordinary pain and emotional trauma that mesh erosion complications caused, and have deeply the affected women’s lives – many of our clients are in the midst of a separation or divorce in part because of their complications and the toll it took on their marriages – but we did not know what type of an award that would translate into. In a previous trial in California, a jury awarded $5.5 million in compensation to Christine Scott and her husband for their damages caused by a failing CR Bard Avaulta Plus implant, but we, as lawyers, were unsure what to make of that verdict. The Scott case was unusual for a variety of reasons, not least the fact that it included both a product liability claim against the mesh manufacturer and a medical malpractice claim against the implanting doctor, a rarity for these cases.

In contrast, the Gross case involved solely a product liability claim against the mesh manufacturer, as well as damages more specific to mesh failure (rather than mesh failure coupled with malpractice) and so the Gross case, at least in my mind, provided a better window into how juries will calculate the damages in most of the mesh lawsuits. As hoped, juries understand the significance of these damages, and are willing to provide compensation in accord with those damages, even against a household name like Johnson & Johnson.

Second, the evidence developed at trial shows the lax attitude towards patient safety held by Johnson & Johnson and its subsidiary Ethicon.

The big consortium of plaintiffs lawyers have conducted extensive discovery, including literally thousands of hours of testimony and millions of dollars in expenses, but, even in cases as simple as a car running a red light, you never really know what is going to happen at trial until you have the case there. In the Gross trial, a number of the more important employees and officers and Ethicon were called to testify, including:

• Ethicon’s product development manager for the Prolift surgical kit
• Ethicon’s medical director
• Ethicon’s principal scientist involved in Prolift’s development
• Ethicon’s senior project manager
• the supposed principal investigator of the Ethicon Registry (who testified he did not know that was his job at the time!)

In the end, the plaintiffs were able to confirm under oath many startling facts, including the fact that the clinical expert report for the Prolift mesh was largely a cut and paste job from the Gynemesh PS clinical expert report comes years earlier. Ethicon further admitted that, despite the device design safety assessment and the failure mode effects analyses, both of which are standard industry tools for ensuring that only safe medical devices are marketed, Ethicon knew when it first launched the Prolift that it had a high rate of erosion, causing problems like pain during intercourse and abdominal pain, but they launched the product anyway – even while their internal documents show that the company was looking for improved products that would be much safer.

In many ways, the most interesting evidence developed at trial related to a highly technical issue: the size of the pores in the mesh. As a rough generalization, it has been well known for decades that the pore size of an implanted mesh makes a big difference in the safety of the mesh. If the pores on an implanted mesh are too small, e.g., if it is “microporous,” then bacteria will be able to enter into the mesh but white blood cells won’t be able to, leading to terrible consequences, like the recurrent infections and uterine tract infections that many of our clients experience. The pore sizes also affect the tendency of the mesh to cause erosion of the vaginal wall; if the pore sizes are too small, then the tissue around the mesh will have an adverse reaction, causing severe inflammation.

At trial, the employees at Ethicon responsible for the development and safety testing of the mesh admitted that, while they believed the Prolift mesh was “macroporous,” they never performed any safety testing whatsoever to assess whether the pores in the mesh would collapse under pressure and become too small once implanted in an actual patient — which is exactly what has been happening to many of the women implanted with these mesh and sling kits. At trial, the plaintiffs called a professor of electrical engineering who specializes in the measurement of materials performance to talk about how, when put under strain, the mesh would retract and the pores would close up.

We, as lawyers pursuing these cases, knew all of that before the trial, but the trial confirmed the defendants don’t really have a good answer for any of those allegations. At one point, Ethicon tried to qualify one of their own researchers as an expert witness, but the court refused to let them do so, because they were trying to do it by surprise. Normally, parties have to disclose all of their expert witnesses before trial, and the expert witness has to produce a report explaining in detail what he was going to testify about, so that the other side can prepare. Seems Johnson & Johnson and Ethicon were trying to pull a fast one and were stopped by the judge.

All in all, there is reason to celebrate with the verdict, as the indirect benefits of the verdict are significant. The verdict, however, certainly does not end of litigation, which will still require many more months, and many more trials, but it does show that we are on the right path.

The problems of vinyl chloride are well known. Nearly two years ago, I wrote a long post about a court shockingly dismissing expert testimony about the dangers of the chemical. Let’s be clear when it comes to vinyl chloride: every Material Safety Data Sheet (MSDS) lists it as a carcinogen. The International Agency for Research on Cancer, National Toxicology Program, and the Occupational Safety and Health Administration (OSHA) all list vinyl chloride as a carcinogen. The Centers for Disease Control and Prevention puts vinyl chloride at #4 on its priority list of hazardous substances, just below mercury and just above polychlorinated biphenyls.

So when 180,000 pounds of vinyl chloride spilled in the Paulsboro area when a Conrail train derailed, it was big news for the people there. The biggest problem with vinyl chloride is liver cancer: it may be years before a person exposed to vinyl chloride develops liver cancer, not least because the vinyl chloride remains in the adjacent groundwater in the Mantua Creek watershed in Gloucester County, where it can be slowly consumed by residents without their knowledge.

Similarly, there’s nothing new about railroad companies trying to pull a fast one to avoid their legal responsibilities. Just last week, I wrote about Norfolk Southern going through extraordinary lengths to try to hide a surveillance video shot from one of their trains that hit a delivery truck. So the ABC 6 Action News report late yesterday was no surprise:

As Conrail started to clean up the chemical spill, rumors about cash payouts started spreading.

“It sounds kind of strange that they are going to give everybody $500 to be quiet, I guess,” Ward said.

Like dozens of other residents we observed, Ward went to the Family Assistance Center to file a claim and listened as a Conrail representative promised him cash to sign papers.

“By signing this release you are forever barred from bringing a lawsuit or any claim against any of the companies or individuals listed on the release for any reason,” a Conrail representative can be heard saying in an undercover video.

As ABC notes, “The contract releases the company of any liability for the incident including unknown injuries spanning from brain damage, dementia, cancer, and even death.” $500 bucks for your liver cancer. Fair deal? Of course not, no one would take that, so they start lying to people:

A concerned resident agreed to take our hidden camera inside to document the process on tape.

“Giving up the right to be a part of the class action lawsuit means that you’re giving up the potential to receive more money than your offered settlement payment,” the representative said.

They were offered various amounts of money.

“The railroad is offering you $650,” the representative told the resident.

Those affected were told they could sign the papers now or they could risk losing a chance at money in the future.

“If I sign this and I was to get cancer, what would happen?” the resident said.

“Well, first of all they would have to prove it was caused by the derailment, and how are they going to prove that?” the representative said.

We should call this what it is: lying. Conrail knows vinyl chloride causes liver cancer, and they know toxic spill lawyers can prove it. How would we lawyers prove that? The same way we prove all other environmental contamination cases: through science.

According to the Agency for Toxic Substances & Disease Registry (“ATSDR”), exposure to vinyl chloride can cause liver cancer, brain cancer, lung cancer, cancers of the blood, and damage to sperm and testes; and exposure to 1,4-dioxane can cause liver and kidney diseases and cancer. We don’t have to go far to find studies showing a link, consider this study from 2010 published in Occupational & Environmental Medicine, concluding “occupational exposure to vinyl chloride monomer … may increase the risk of liver cancer and leukaemia. When [vinyl chloride monomer] exposure was controlled at worksites, mortality from these cancers returned to background levels.” 

The litigation over the Paulsboro spill has only just begun. New Jersey, thankfully, is one of the few states that permits a “medical monitoring” tort. The Supreme Court of New Jersey’s decision in Ayers v. Twp. of Jackson, 106 N.J. 557, 525 A.2d 287 (1987), held that:

[T]he cost of medical surveillance is a compensable item of damages where the proofs demonstrate, through reliable expert testimony predicated upon the significance and extent of exposure to chemicals, the toxicity of the chemicals, the seriousness of the diseases for which individuals are at risk, the relative increase in the chance of onset of disease in those exposed, and the value of early diagnosis, that such surveillance to monitor the effect of exposure to toxic chemicals is reasonable and necessary.

(That case involved chemicals including “acetone; benzene; chlorobenzene; chloroform; dichlorofluoromethane; ethylbenzene; methylene chloride; methyl isobutyl ketone; 1,1,2,2-tetrachloroethane; tetrahydrofuran; 1,1,1-trichloroethane; and trichloroethylene” leeching from a landfill into the Cohansey Aquifer.)

$500 wouldn’t even cover the first couple of visits available under a successful medical monitoring lawsuit, much less a life cut short by liver cancer.

But to me the real shame isn’t that Conrail is trying to get people to sign these releases — did we expect anything more? — but that courts generally enforce these “agreements” without question.

A $63 million verdict awarded by a jury earlier this week in Maine shows the lengths to which drug companies will go to make a profit.

It’s well known that NSAID pain relievers like Motrin (ibuprofen) can cause Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis; the life-threatening complication is well-known in the medical literature, and there have been successful lawsuit against Johnson & Johnson and its consumer drug subsidiary, McNeil Consumer & Speciality Pharmaceuticals, the maker of Motrin and children’s Motrin, in the past. (I wrote about one such lawsuit here in Philadelphia two years ago.)

There’s also nothing new about the difficulty in holding pharmaceutical companies liable for the catastrophic side effects of their medications. The United States Supreme Court has taken a very hostile approach to drug injury lawsuits; while lawyers can raise a number of legal claims, like negligence and strict liability, in the end all of the lawsuits have to be proven the same way, i.e., by proving that the prescribing information or warning label did not adequately disclose the actual risks of the drug. If it’s a prescription drug, the injured patient has to prove the doctor would not have prescribed it (that’s called the “learned intermediary doctrine,” and it’s a terribly unfair rule). If it’s an over-the-counter drug, the patient has to prove they would not have taken it had they known.

In practice, that means that drug manufacturers can usually escape responsibility for any of the harm they cause as long as they stick a warning somewhere on the label, in tiny print, that a horrific complication like Stevens-Johnson Syndrome might happen. That means for Johnson & Johnson and McNeil that, if they wanted to stop facing these Stevens-Johnson / Toxic Epidermal Necrolysislawsuits, all they need to do is update the label of Motrin and Children’s Motion to better warn consumers about the risks of taking the medicine, and to instruct them, in big bold letters, to stop taking Motrin immediately if they develop any sort of rash or hives.

Samantha Reckis would have had a different life if her parents had been warned. I have young children, and I know how easy it is to get into the routine of treating your child with Tylenol or Motrin for every illness the child has, and to give more of the medicine – so long as you have not given in the past four hours – if the child continues to be sick. After all, when the kids were babies, that’s usually the best thing to do, because it’s the only thing that can keep the baby’s temperature down, and thus let the baby rest and get over the virus on their own.

The problem for NSAIDs is that, once a child or even adult has started to develop any signs of Stevens-Johnson Syndrome, giving more is — almost literally — adding fuel to the fire, any additional medication will turn what would have been a really awful experience into a lifetime of agonizing injuries, like the ones that Samantha suffered, including blindness, burns over most of her body, and such injuries to her internal organs that she had to be put into a medical coma.

Now that Johnson & Johnson has faced more than $125 million in jury awards against them for failing to warn about the rare but horrific complications of Motrin, why don’t they just change the label already? The answer, I think, is obvious: it is more profitable for them to pay tens of millions of dollars in jury awards, and millions of dollars in defense attorneys fees, then it is for them to update the label and thus potentially reduce sales. And that is a terrible, tragic shame.

The headline started with the phrase “$109 Million Personal-Injury Award,” but two phrases from the article better summed up what really happened: “Mommy is on fire,” and “the power line that had killed her had collapsed in the family’s yard twice before, [but] no serious attempt was made to find out why the line failed.”

The Philadelphia Inquirer’s article on the recent verdict in the Goretzka v. West Penn Power Co. electrocution case  is concise yet thorough, portraying the extraordinary lawsuit in an even-handed manner. The $109 million verdict has two components.

$48 million of the award was for compensatory damages, split between the “wrongful death” claim for her husband and her two little girls, and the “survival claim” representing the compensation she would have recovered had she lived. (More about that divide in this post on wrongful death damages.) The number is certainly at the top end of compensatory damages verdicts, but it is not surprising. Lawyers who have worked on a number of catastrophic injury and wrongful death cases spend a lot of time talking with physicians who provide expert testimony about the pain caused by various injuries, and few disagree that the two most painful experiences a person can suffer are electric shock and significant burns. Ms. Goretzka had both: 20 minutes of severe electrocution that caused her burns over 85% of her body, followed by three days in agony at the hospital. The article doesn’t say what she died from specifically, but under the circumstances, I assume infection, as burn victims tend to die from infection.

She suffered thus suffered pain almost beyond comprehension. The thought of it reminded me of the words of George Wilson, a Scottish chemist who had his foot amputated in 1843, before use of anesthesia:

During the operation, in spite of the pain it occasioned, my senses were preternaturally acute. I watched all that the surgeons did with a fascinated intensity. Of the agony it occasioned, I will say nothing. Suffering so great as I underwent cannot be expressed in words, and thus fortunately cannot be recalled. The particular pangs are now forgotten; but the black whirlwind of emotion, the horror of great darkness, and the sense of desertion by God and man, bordering close upon despair, which swept through my mind and overwhelmed my heart, I can never forget, however gladly I would do so.

$61 million of the award was for punitive damages, the subject of the article. That figure was reached through a surprisingly generous calculation: the jurors took one quarter of the company’s retained earnings after dividends and expenses, and awarded that.

(The article also reveals that, just prior to trial, the parties agreed to settle the lawsuit for $50 million and a commitment for the company to fix improperly installed electrical wires across Western Pennsylvania, but the company backed out the next day.)

But the article bothered me nonetheless, because it could leave a mistaken impression with readers. This case was, by any interpretation, extraordinary, and the presence of punitive damages was extraordinary as well. Punitive damages are one of the great bogeymen of tort reformers, who repeatedly point to verdicts like this and then claim that they are commonplace and destroying American business. Nothing could be further from the truth: punitive damages are barely even presented to the jury, even more rarely reported, even more rarely sustained on appeal, and even more rarely actually collected against the defendants.

A 2005 study by the Bureau of Justice Statistics noted that, in the mere 3% of civil cases that were resolved by a trial, punitive damages were awarded in fewer than 1% of typical tort cases, like negligence, product liability, and malpractice cases. (If intentional torts — like criminal assaults — are included, the figure rises to 3% of tort cases.) The study looked at Allegheny County specifically, and found that punitive damages were only even sought in 3% of civil cases, including intentional torts and fraud claims. Even when those criminal cases are included, the median punitive damages verdicts were still only $64,000.

That’s certainly my experience, as most of my cases don’t even involve punitive damages. But even in the big punitive damages case, the verdicts don’t necessarily translate into actual money paid. A few years ago I was co-counsel in a wrongful death trial in Philadelphia that resulted in a large verdict, including a $15 million punitives damages component. When all was said and done, after all of the appeals and bankruptcies, we collected not one penny of those punitive damages, and the defendant is still out there, doing business as usual, hurting people just the same.

So while I applaude the Inquirer from bringing attention to the awful facts of this case — and thus showing to the public how justified they were — I do wish they would have put more into explaining how rare punitive damages are.

The news here in Philadelphia has been filled with reports about the bus accident in Boston, in which more than three dozen high school students (who had just finished touring Harvard University through the “Destined for a Dream Foundation” in Bristol Borough) were injured when the charter bus they were riding foolishly rammed into a low overpass. It seems like a classic distracted driving case, as the driver was allegedly checking his GPS right before the crash. There will of course be numerous accident claims filed, and rightly so: many of the passengers were significantly injured, and the whole point of negligence law is to make negligent parties responsible to the people they hurt.

There’s a tendency for outside observers to look at these types of situations involving obviously preventable traffic accidents and consider the inevitable lawsuits to be a “slam dunk” — the lawyer files the lawsuit and the insurance company pays, right? Truth is, it’s not that simple, and there’s a lot of work to do.

First, even assuming there’s ample insurance coverage for everyone (more on that in a moment), the insurance company will hire its own lawyers, and send the medical records and bills to its own adjusters, and will try to minimize the value of the claim. It’s one thing to prove someone broke their wrist in a bus accident: you just show the Emergency Department record from the hospital diagnosing the break and treating it, plus the follow-up visits. It’s quite another thing to show, for example, “soft tissue” injuries, though they can be just as painful — and sometimes even more disabling. Similarly, neurological and psychological injuries are notoriously difficult to prove in court, and insurance adjusters know it, so they try not to pay for them at all.

Second, it is extremely unlikely the bus company has adequate insurance to cover all the claims. Many bus companies have insurance policies of one million dollars or less, rarely enough to cover three dozen or more people with significant injuries. The obvious solution would be to demand the company pay out of its own pockets, but, apart from a handful of national carriers, bus companies rarely have significant assets, and the moment an accident like this happens, the company goes bankrupt and all of their funds are rapidly dissipated. (You don’t have that problem suing NJ Transit, for example.)

So, the initial challenge for the passengers’ lawyers is to look for other potential defendants beyond the bus company. Remember that awful “Chinatown bus” crash back in March of 2011? Unsurprisingly, the company had minimal assets (the company was barely operating) and minimal insurance, and so the passengers’ lawyers have been pursuing Mohegan Sun casino, alleging it contributed to the accident by failing to provide sleeping quarters for drivers.

Third, once multiple claims are filed and additional defendants are added, the lawsuits become far harder to pursue from a procedural standpoint. All it takes to stop the cases is for one defendant (or insurance) company to file bankruptcy, which automatically “stays” all cases pending the outcome of the bankruptcy. In major bus accidents, it’s not surprising for these many procedural issues to require hundreds or thousands more hours from lawyers, and to delay the cases for years.