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Philadelphia Injury and Malpractice Attorneys – The Beasley Firm

Dr. Marsha Santangelo Obtains $4.875 Million Verdict For Spinal Surgery Malpractice Client

By The Beasley Firm on April 10, 2015 - No comments

On April 8, 2015, a jury in the Philadelphia Court of Common Pleas awarded $4.875 million to a medical malpractice victim represented by Marsha Santangelo, M.D., Esq., of The Beasley Firm.

The case involved a 50 year old woman who went to Dr. Eric Williams, an orthopedic surgeon at Albert Einstein Medical Center, for an elective spinal surgery including a decompressive laminectomy. A week after the surgery, she called the surgeon’s office to report that she had a fever and that her wound appeared to leak a fluid, both of which are signs of a wound infection. Without consulting the doctor, a staff member at the surgeon’s office told her they could give an appointment the next day, or that she could go to the emergency room. The patient then went to the closest hospital to her home, Underwood-Memorial Hospital in New Jersey, where the emergency room confirmed a wound infection with pus draining from the incision.

The emergency department staff at Underwood contacted Dr. Williams, who agreed to accept transfer of the patient to Albert Einstein Medical Center. Einstein, however, did not have enough beds, and so didn’t accept the transfer, and, according to Dr. Williams, never informed him that they couldn’t do the transfer. At Underwood, the patient continued to get worse, with severe pain in her legs that required intravenuous narcotics. She wasn’t transferred to Einstein until the afternoon the next day.

Incredibly, nearly all of Einstein’s records from those first few hours are missing, but the records that do exist show that the patient still had neurological functioning in her legs and feet. Over the next few hours, virtually nothing was done for the patient: no medication, evaluation, monitoring, or intervention. Six hours after she arrived at Einstein, she was taken to the operating room, but by then it was too late: because her surgical would infection and epidural abscess had gone untreated for so long, she is permanently paralyzed below the waist. Due to her injuries, she is confined to a wheelchair, requires assistance for normal daily living, and can no longer work her job as a Philadelphia school bus driver for handicapped children.

On behalf of the patient, Dr. Santangelo brought malpractice claims against Dr. Williams, against the surgical resident who oversaw the patient when she was transferred to AEMC, and against the hospital itself. Dr. Williams and Einstein denied they were negligent and claimed that the patient was already paralyzed by the time she arrived at Einstein, despite medical records from the transport service indicating that she still had sensation and activity in her legs and feet. Einstein also claimed that the patient’s injuries weren’t caused by the infection (which was later found to be MRSA) but by a “vascular insult” to her spinal cord.

For the trial, Dr. Santangelo obtained reports from seven medical expert witnesses, including:

  1. A former hospital CEO who is board-certified in hospital administration;
  2. A neurointerventional surgeon who is board-certified in radiology and neuroradiology;
  3. A board-certified orthopedic surgeon;
  4. A board-certified neurologist;
  5. A cardiologist who is board-certified in cardiovascular disease and internal medicine;
  6. A board-certified emergency medicine physician; and,
  7. An orthopedic trauma nurse.

After 8 days of trial, the jury unanimously found for The Beasley Firm’s client, finding negligence by the orthopedic surgeon (who was 34% responsible), negligence by the senior orthopedic surgery resident (who was 33% responsible), and negligence by the hospital (which was 33% responsible). The jury found the patient’s damages were $4,875,200.14, broken down as:

  • Past medical expenses $20,180.14
  • Past lost earnings $266,444
  • Past noneconomic damages $750,000
  • Future medical expenses $2,825,566
  • Future lost earning capacity $263,010
  • Future noneconomic damages $750,000

It is unknown at this time whether the defendants intend to appeal, but, if they do, Dr. Santangelo and The Beasley Firm’s two full-time appellate lawyers will be ready.

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Malpractice Insurers Sneak Exception Into Quality Of Care Bill

By Max Kennerly, Esq. on April 1, 2015 - No comments

It is no secret that healthcare costs are out of control. It also should not be a secret that one of the causes of increasing healthcare costs is rampant malpractice throughout the healthcare industry. One study by the Society of Actuaries found that “measureable” medical errors — i.e., the errors that are reported, which are just a fraction of the overall errors every year — directly caused $17.1 billion in avoidable follow-up care. (Another study found that the cost to society of preventable deaths alone was between $735 billion and $980 billion).

 

The smart folks at the Centers for Medicare and Medicaid Services (CMS) came up with one solution back in August 2007: they created a list of preventable errors (many of which are on the so-called “never events” list) and told hospitals and doctors that they would no longer pay for the additional costs associated with those preventable errors. For example, since February 2009, CMS has not paid for any costs arising from “wrong-site surgeries.” Several states and private health insurance companies have followed suit.

 

It’s easy these days to complain about “bureaucrats,” but the truth is that many government agencies are doing good work. The Agency for Healthcare Research and Quality (AHRQ) has produced a wealth of information about medical standards that have reduced costs and saved lives. Recently, a bill was introduced into Congress that would require the government to measure the quality of healthcare provided by physicians, and to rate them accordingly, but, according to The New York Times, the malpractice insurance companies snuck in some sweetheart language:

 

WASHINGTON — A little-noticed provision of a bill passed by the House of Representatives with overwhelming bipartisan support would provide doctors new protections against medical malpractice lawsuits.

 

The bill, which requires the government to measure the quality of care that doctors provide and rate their performance on a scale of zero to 100, protects doctors by stipulating that the quality-of-care standards used in federal health programs — Medicare, Medicaid and the Affordable Care Act — cannot be used in malpractice cases.

 

The provision is nearly identical to legislative language recommended by doctors and their insurance companies. They contend that federal standards and guidelines do not accurately reflect the standard of care and should not be used to show negligence by a doctor or a hospital.

 

To draw an obvious analogy, this is like saying that, when a worker is injured by a contractor that blatantly violated the standards set by the Occupational Safety and Health Administration (OSHA), the worker can’t show the OSHA standards at trial to prove negligence. Of course they can. An OSHA violation isn’t the end-all-be-all of occupational safety, but it is undeniably relevant in determining the standard of care.

 

Over forty years ago, our firm litigated and won the leading case on the “standard of care” in medical malpractice cases in Pennsylvania. As Justice Roberts wrote in his concurring opinion, “The standard of care required of a specialist or general practitioner should be that of a reasonable specialist or general practitioner in similar circumstances practicing medicine in light of present day scientific knowledge.” Incollingo v. Ewing et al., 444 Pa. 263, 299 (1971). This has long been the rule across most of the country. See, e.g., Landeros v. Flood, 551 P. 2d 389, 408 (Cal. 1976)(“we have consistently held that a physician is required to possess and exercise, in both diagnosis and treatment, that reasonable degree of knowledge and skill which is ordinarily possessed and exercised by other members of his profession in similar circumstances.”).

 

Are the standards carefully developed by CMS and AHRQ through years of research, scholarly input, and feedback from the healthcare industry relevant to that question? Of course! If the defendant doctor or their expert witnesses believe otherwise, they’re free to tell the jury how wrong CMS and AHRQ are.

 

Unsurprisingly, this special-interest giveaway is coming from the same legislators who claim they believe in “federalism” and “limited federal government.” If they really believe that, why are they trying to set up a federal law that limits states’ rights to determine what evidence they will or will not admit in their own medical malpractice trials? If a state doesn’t want juries to look to the CMS guidelines, the state legislators and state judges can decide that for themselves.

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FDA Finds Further Proof Diabetes Drugs Cause Pancreatic Cancer

By Max Kennerly, Esq. on December 16, 2014 - No comments

For more than a year now, our firm has been entrenched in litigation against the manufacturers of several “incretin mimetic” diabetes drugs, including Januvia, Janumet, Victoza, Byetta, and Onglyza, which, we allege, cause pancreatic cancer.

No trials have been held, and so much of what has occurred there remains confidential, but two recent developments may fundamentally alter the course of the lawsuits — and may help protect unwary patients from one of the most feared diseases known to man. 

The drug companies still vehemently deny any connection between these drugs and pancreatic cancer. Their drugs mention all kinds of nuisance side effects, like flatulence and burping, but not one has a word about pancreatic cancer. That may be about to change.

First, in a study published in October 2014, one of the FDA’s own labs confirmed that giving a GLP-1 agonist to mice causes precancerous injuries to the pancreas, particularly if the mice eat a high fat, high carbohydrate diet. (“Extended Exenatide Administration Enhances Lipid Metabolism and Exacerbates Pancreatic Injury in Mice on a High Fat, High Carbohydrate Diet.”)

In people with type 2 diabetes, the beta cells in the endocrine pancreas don’t work as well as they should, and the incretin diabetes drugs are supposed to work by making the beta cells in the endocrine pancreas function better. For example, the incretin diabetes drugs could cause more beta cells to proliferate, or could cause them to grow bigger, or live longer. 

Problem is, you can’t pick and choose which cells you make proliferate, and at some point, when cells proliferate too much, they become cancerous. Pancreatic cancer is, in many ways, just too many cells growing, and growing too quickly, in the duct of the pancreas.

Technically, the FDA researchers found injuries to the pancreatic ducts consistent with “focal proliferation of the exocrine pancreas and possibly pre-neoplastic PanIn lesion development.” That is, they saw the drug — specifically, Byetta — causing mice to develop more cells in their exocrine pancreas. Worse, those cells were damaged in a lot of worrying ways, damage that could make them become “PanIn lesions,” which are precancerous.

As the FDA researchers said, they didn’t quite see cancer, their findings were “consistent” with the extremely worrying results reported back in 2013 by a team of researchers that found people treated with Januvia and Byetta had evidence of precancerous changes in their pancreas. (“Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors.”) That’s a pretty big deal, and the FDA researchers said the next step was to look at mice with genetic mutations that made them better mimic pancreatic cancer in humans.

Second, also in October 2014, Health Canada revealed in a communication to physicians that, “[a]s of July 31, 2014, Health Canada received 13 reports of pancreatic cancer suspected of being associated with all incretin-based therapies.” Further, the agency “has initiated an epidemiological study through the Drug Safety and Effectiveness Network (DSEN) to assess the potential association between pancreatic cancer and incretin-based therapies and will continue its ongoing monitoring of this potential safety issue.”

The study covers Nesina (alogliptin)‎, Tradjenta (linagliptin), Onglyza (saxagliptin), Januvia / Janumet (sitagliptin), Byetta (exenatide), and Victoza (liraglutide). 

We’ll see if either action causes some serious change in these products, like perhaps a withdrawal, as Public Citizen has recommended for Victoza, or at least better warnings. Patients have the right — the legal, ethical, and moral rights — to know the risks of the drugs they pay for and put into their bodies.

If you or a loved one developed pancreatic cancer after taking Byetta, Januvia, Janumet, Victoza, or another diabetes drug, please read more about our pancreatic cancer lawsuits.

 

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Heidi Villari Wins $8M Award for Helicopter Crash Victim

By The Beasley Firm on August 15, 2014 - No comments

A Luzerne County Judge awarded $8 Million+ costs for the victim of a helicopter crash caused by a distracted driver in a damages hearing handled by attorney Heidi Villari of The Beasley Firm. The helicopter had been operated for a charity golf event for crippled children. Unfortunately, the helicopter pilot was operating the helicopter 200 ft. above ground at an unsafe speed, and nose-dived simultaneously. This caused a crash to the ground and  plaintiff was partially ejected out of the seat.  He never lost consciousness, and recounted the accident, multiple surgeries and lengthy stays in rehabilitation to the Court.

Joseph Matteo the plaintiff, age 69 at the time of the crash, who was solicited to drop golf balls onto a golf course as a belted passenger suffered from incomplete paraplegia, neurogenic bladder and bowel, nerve pain as a result of the accident. While he could move his legs, stand and walk with a walker, he is not able to walk about freely. Mr. Matteo, who lives alone, testified that his life had become “a living hell” not only because he had become wheelchair-bound but because of the unbearable pain he endures from nerve damage.

Since 1958, The Beasley Firm has fought for the rights of victims of aviation accidents across the country. To date, we have obtained over $2 billion in awards for our clients. If you or a loved one has been injured or suffers from nerve damage and/or spinal injury as as result of an accident, contact us for a free consultation by filling out our online contact form or by phone at (888) 823-5291.

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Another Myth About Premature Labor and Delivery Malpractice

By Max Kennerly, Esq. on July 12, 2014 - 1 comment

I read a lot of medical blogs, including the blog at Emergency Physicians Monthly authored by a pseudonymous ER doctor who goes by the name “WhiteCoat.” WhiteCoat recently complained about a $14.5 million malpractice verdict in favor of a baby born at 24 weeks with severe disabilities. WhiteCoat thinks the case was a “no win” situation in which the doctor would have been blamed either way.

Preterm labor is an issue near and dear to my heart: I’ve represented birth injury victims for years, and my twins were born extremely premature (26 weeks). From what we can tell about the case from the newspaper article, it’s simply malpractice.

The case arises from a birth back in 2003. According to an article at Cleveland.com, the mother went into labor three times during the 22nd and 23rd weeks of her pregnancy, and each time it was stopped with medication* and bedrest, and she was discharged. According to the article:

On April 10, Stewart’s water broke and she was admitted to the hospital at 12:30 p.m. She and her doctor had discussed that she should get another caesarian section [like with her last child].

Although she asked to deliver her baby soon after she was admitted, the nurse and residents on call did not agree, Pantages said.

When Weight, the attending obstetrician,  arrived at 5:30 p.m., she asked to have the baby delivered, but he said monitors showed the baby was healthy.

The baby later showed signs of distress and Stewart had an emergency caesarian section at 9 p.m. Alijah had a massive brain hemorrhage, and evidence showed it occurred after 5:30 p.m., Pantages said.

The child, now 11 years old, still suffers from “cerebral palsy, cognitive delays, visual impairments and other issues that will require lifelong care.”

From those facts alone, I can see three potential avenues for a malpractice case:

  1. The doctors wrongly discharged her previously, and should have kept her in the hospital to monitor the baby’s health and attempt to prevent preterm labor or premature rupture of members (like with the medications above, or with a cerclage, if she was showing signs of cervical insufficiency or cervical funneling).
  2. The doctors failed to timely diagnose the potential for preterm labor and failed to administer steroids (i.e., “antenatal corticosteroids” like betamethasone), which have been produce to reduce the likelihood of premature birth complications.
  3. The doctors failed to recognize fetal distress prior to 9pm, and thus failed to perform an emergency c-section as soon as they should have.

Based on the article, it seems the case focused on #1 and #3, because #2 wasn’t mentioned. Maybe it came up at the trial.

WhiteCoat complains most about the mother’s request for a c-section, arguing that she’s not a doctor, and so her views are irrelevant. Indeed, she’s not a doctor, and thus not the expert on the standard of care. Her lawyers would have their own expert witness to testify about that. But that’s beside the point: the reason that evidence came into the case was to show the jury the whole context, and to respond to the hospital’s arguments about what she would have done if they had offered her a c-section.

Moreover, the bigger picture of the case isn’t about what the mother did, or did not, say. It’s about whether the baby showed signs of fetal distress and the doctors missed it. If so, then a 24 weeker spent up to 9 hours in distress before the c-section was performed, time in which they would have suffered profound — and preventable — injuries.

WhiteCoat is correct that extremely premature babies are at a high risk of numerous disabilities, including cerebral palsy, intraventricular hemorrhage, periventricular leukomalacia, and many of the other complications experienced by the child, but those complications by no means guaranteed. There are plenty of perfectly healthy former 24-week-preemies living full, productive, active, healthy lives, no different from anyone else. Then there are a tragic number of babies born at much later gestations that suffered complications which could have been prevented by better management of the pregnancy (such as to discover low amniotic fluid levels, or growth restriction, or the like), by the administration of steroids, or by an emergent c-section rather than a prolonged delivery.

The question is what those fetal strips showed. If they showed distress, then it was negligent to not perform an emergency c-section. Period. In short, it’s not a “no-win” case for the doctor. If they had properly diagnosed the distress and performed a c-section, the kid would be better off and no one would be liable for anything.

 

* I assume the medication was terbutaline, which was commonly used back then in an effort to stop preterm labor. In 2011, the FDA put out an alert recommending against its use.

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Jim Beasley, Jr. Hired to Investigate Selinsgrove Plane Crash

By The Beasley Firm on June 27, 2014 - No comments

Two Union County men who were injured in an October 4th, 2013 plane crash have hired aviation accident attorney Jim Beasley, Jr. to investigate the incident. Doug Cromley, of Lewisburg, and his uncle Todd Cromley, of Windsor, sustained serious injuries after crashing their single engine Piper-Pacer on takeoff at Penn Valley Airport.

An eyewitness reported seeing the plane’s nose drop when it reached about 125 feet before crashing back on the runway, damaging the wings and fuselage.

A preliminary report released a month after the accident by the NTSB stated that the plane was taking off for the first time since receiving maintenance from Heritage Aviation, who operate at Penn Valley Airport. The full report by the NTSB is expected within the year.

The Beasley Firm has over 50 years of experience investigating and litigating on behalf of pilots or passengers who have been catastrophically injured or killed in aviation accidents. Jim Beasley, the founder of this firm, was also an experienced pilot, who obtained a twenty-nine million dollar verdict against an airplane manufacturer after he proved that a defective airplane part was the cause of a fatal crash. His passion for aeronautics lives on with his son, Jim Beasley, Jr., who flies vintage planes in air shows around the world. Beasley and his team know the inner workings of an airplane and what can go wrong, and have obtained millions of dollars in compensation for their clients.

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The Tracy Morgan Truck Accident Might End Up Saving Lives

By Max Kennerly, Esq. on June 8, 2014 - No comments

Update: Mr. Morgan and two of his traveling companions have filed a complaint against Walmart. Here’s the most important parts:

68. Wal-Mart knew, or should have known, that Mr. Roper was awake for more than 24 consecutive hours immediately before the subject accident on June 7, 2014.

69. Wal-Mart knew or should have known that it was unreasonable for Mr. Roper to commute more than 700 miles from his home in Jonesboro, Georgia to work at a Wal-Mart facility in Smyrna, Delaware, especially immediately before he was to commence a long shift operating a truck that weighed approximately 30–40 tons. Additionally, there were many Wal-Mart distribution facilities closer to Mr. Roper’s home — including at least nine in Georgia alone—which would have significantly reduced Mr. Roper’s commute to work.

70. As a result of Mr. Roper’s fatigue, he fell asleep behind the wheel of his truck while he was driving, failed to slow down for traffic ahead, and resultantly collided with the Limo directly in front of him in which Plaintiffs were passengers.

That’s consistent with what I wrote right after the accident: many of these truck accidents are caused by the company compelling drivers to keep driving even when they haven’t slept enough. These allegations are interesting as well:

71. Further, the Truck being operated by Mr. Roper was state-of-the-art, and equipped with sophisticated collision-avoidance systems all designed to begin automatically braking the truck when it senses slowing down traffic.

72. However, the Truck did not automatically brake before the accident, and thus, Wal-Mart knew or should have known that one of the truck’s most important safety features was compromised.

The truck’s “black box” data recorder should be able to tell us a lot about what really happened in terms of the automatic braking, but I doubt anyone would have access to it yet other than the NTSB, which typically retains it until they have completed their investigation.

Walmart has responded with typical corporate doublespeak, promising to do “the right thing,” at least to the extent the law forces them to do so.

 

Here’s my original post:

 

Yesterday, comedian Tracy Morgan was involved in a horrible accident on the New Jersey Turnpike near Cranbury Township that killed one member of his group, seriously injured another two members, and left Morgan in the ICU.

It seems the group was riding back to New Jersey from Delaware in a passenger bus when traffic slowed — a common occurrence on the turnpike, even at 1am — and a Wal-Mart tractor-trailer failed to notice the slowed traffic, then, at the last second, swerved, but still ended up hitting Morgan’s bus from behind. That sent the bus into other vehicles, and it ended up on its side. (I’ve seen a lot of reports calling it a “limousine” bus, which may be technically true, but it doesn’t seem the vehicle was modified, it was just a normal Mercedes-Benz “Sprinter” passenger van.)

The circumstances of the accident are depressingly commonplace.

Let’s start with the time of the accident: 1am. According to the Insurance Institute for Highway Safety, although the evening rush hours (5pm to 7pm) has the highest total number of fatalities, the hours from midnight to 3am actually have the highest fatal accident rate per number of people on the road.

There are a couple reasons why. First, it’s dark — even with streetlights, it’s darker than in the earlier hours in the night, because businesses tend to be closed and, with fewer cars, there are fewer headlights. I’ve driven that stretch of the NJ Turnpike innumerable times late at night, and it can get really dark, more like a rural highway than the type of driving you would expect between New York City and Philadelphia. The absence of scenery can cause drivers to acclimate to the speed, lulling them into complacency. 70 mph doesn’t feel that fast when all you can see are the road signs ‘slowly’ rolling by.

Second, late into the night, more people are intoxicated, and more people are very intoxicated.

Third, people are just plain tired at that time of day, which causes “drowsy driving” and bursts of “microsleep.” Other than the obvious problems — a drowsy driver is less likely to perceive problems, to react in time, to make the right choice under pressure — there’s also the more subtle problem of how even people who are not at fault in the accident make mistakes. People are are less likely to wear their seatbelt at night, in part because they’re more likely to forget it. (This is part of why it’s good to teach children to put on belts habitually, and to do the same yourself, even just to drive across a parking lot, so that it feels abnormal to be in a car without a belt.)

Then there’s the involvement of the tractor-trailer. A couple years back, the Federal Motor Carrier Safety Administration (FMCSA) and the National Highway Traffic Safety Administration (NHTSA) conducted the Large Truck Crash Causation Study (LTCCS), a collection of data on 1,000 large truck crashes, along with a thorough view of the data for each. Their findings showed that “one-half of the LTCCS crashes involved collisions between a large truck and a passenger vehicle (car, pickup truck, van, or sport utility vehicle),” and, of those crashes, the ten most common associated factors were:

  • Interruption of the traffic flow
  • Unfamiliarity with roadway
  • Inadequate surveillance
  • Driving too fast for conditions
  • Illegal maneuver
  • Inattention
  • Fatigue
  • Illness
  • False assumption of other road user’s actions
  • Distraction by object or person inside the vehicle.

Most of these issues are caused, at bottom, by bad policies in place at trucking companies. Policies that put speed over safety. Policies that encourage — or require — driving more hours than allowed by law, thereby forcing drivers on the road even when they’re fatigued. Policies that put unqualified, incompetent, or untrustworthy drivers behind the wheels of >80,000 lbs vehicles.

All those issues were part of why, last year, the Department of Transportation finally amended the FMCSA had amended the ‘hours of service’ rules to force drivers to get more sleep. (As I wrote about here almost exactly two years ago, given that the hour of service logbooks were already ripe with fraudulent entries, i.e., lying about the number of hours on the road, we desperately needed regulations forcing better compliance, like GPS and satellite tracking.)

In an amazing coincidence, just before the accident,the Senate had discussed rescinding those new rules and forcing the FMCSA to use the old rules. The claim is that the new rules cause congestion during the day; the reality is that manufacturers and retailers have a ton of clout on Capitol Hill, far more clout than safety advocates do.

It is cold-comfort for the victims of any accident to think there is a silver lining to their pain. But here there might really be one. If this accident prevents Congress from taking us back to the old, less safe driving rules of the past, then it will save numerous lives in the future.

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Court Removes Absurd Barrier To Missed Pap Smear / Cervical Cancer Case

By Max Kennerly, Esq. on April 1, 2014 - No comments

When it comes to medical malpractice lawsuits, the deck is often stacked against patients. That’s a hard concept for many people to accept after years of advertising and lobbying by insurance companies and health systems to mislead the public, but, truth is, studies even by medical professionals have shown that the malpractice system, if anything, is too protective of doctors, and too often lets them off the hook for deadly mistakes.

A malpractice case decided last week by the Court of Appeals of Georgia shows just how difficult these cases can be, and how it can take years, and numerous court rulings against the patient, just to get a case in front of a jury.

Cathleen Lavelle had a pap smear in April 2006, which was then sent along to the Laboratory Corporation of America (“LabCorp”) for review. Patients aren’t told this, but, when pap smear biopsies are sent off for review, they are often not reviewed by a doctor but by a “cytotechnologist” reviewing pathology slides from over 100 patients a day. The cytotec isn’t supposed to do the work of the medical pathologist, they’re just supposed to see if there’s anything at all abnormal about the cells on the slide, and, if so, then send the slide to a pathologist for a real review.

The slides from Cathleen’s Pap smear showed abnormalities, but the cytotec missed them and so her developing cervical cancer went undiagnosed. The whole point of a pap smear, of course, is to catch these abnormalities early on and to treat the abnormality before it becomes cancerous, as more than 90% of these cases can be successfully treated if caught early on. If not caught early, however, it can be deadly. Cathleen’s opportunity was lost and her cancer spread. The cancer was eventually diagnosed, but by that point it was too late, it metastasized, and it took her life.

Her husband brought a malpractice lawsuit against her gynecologist and against LabCorp, alleging that they had failed to timely diagnose her abnormalities and then treat her, thereby preventing the development and spread of her cervical cancer. His lawyers then did what good lawyers do: they asked a Professor of Pathology, Oncology, and Gynecology and Obstetrics at Johns Hopkins with experience in cytotechnology and interpreting pap smear slides and who has been publishing about these issues in peer-reviewed journals for years to review the case, to see if those original slides showed signs of cellular abnormalities, and to give her opinion about whether or not the doctor and lab court were negligent.

The medical professor said that the case was a “blatant miss,” that the cytotech should have noticed the abnormalities on the cells, and that a pathologist would have agreed the abnormalities warranted specific follow-up by any gynecologist or family medicine doctor. The medical professor then also said that, even beyond her own “focused review” on the slide itself, two “blinded reviews” were done, in which a cytotech or pathologist looked at the same slides without knowing where they came from and found cell abnormalities.

Sounds reasonable enough, doesn’t it? What more could possibly be asked of a plaintiff in a malpractice lawsuit than to hire one of the top experts in the country to explain, in detail, what went wrong, what should have happened, and how her outcome would have been different if the right thing had been done?

LabCorp, however, challenged the sufficiency of the expert’s testimony, and – incredibly – convinced the trial court to throw out the case against it, without even a jury trial. In short, the court held that the professor of pathology oncology couldn’t be trusted to do a focused review at all (due to ‘hindsight bias’), and that the blinded reviews were done improperly. The judge, of course, had no medical training, experience, or education, at all, and then they’re just supposed to apply the law, and not think they know the medicine.  Nonetheless, the Court felt its interpretation of guidelines provided by the College of American Pathologists and the American Society of Cytopathology was good enough that it could tell a Johns Hopkins professor that her opinion was “unreliable” and that she isn’t even allowed to testify before a jury.

If this sounds, well, crazy, it’s because it is crazy, and yet it happens all the time. Courts are supposed to be mindful of the potential for “junk science” to make its way into the courtroom (as I’ve written before, most of this junk science comes from big corporations or from malpractice insurers trying to avoid paying legitimate claims), but many courts take that “gatekeeper” function way too far, and presume it’s up to them — rather than the experts and a jury — to decide what the science and medicine really show.

Thankfully, last week, the Court of Appeals of Georgia reversed the trial judge’s ruling and sent the case back down, with the expert’s opinion back in evidence. I would say “all’s well that ends well,” but three points need to be made:

  • First, it has been several years since this lawsuit was filed, and the surviving spouse has still not been given their chance to present their case to a jury, and, even now, it will be at least several months before they get the opportunity to do so, so there’s more than a little bit of “justice delayed, is justice denied.”
  • Second, in the Georgia Court of Appeals, four judges agreed to reverse the case, but two judges felt the trial court was right! This shouldn’t be a close question.
  • Third, following up on that last point, this case is just one of many. Throughout the country, everyday malpractice plaintiffs have parts of their cases dismissed, and sometimes the whole case dismissed, because a judge ruled that they knew the science and medicine better than the expert witness asked by the plaintiff to testify in the case.

I hope this ruling is part of a trend, with courts being a little more respective of the role of experts and the jury in our system, but I fear that this is more likely just a successful battle in the middle of a long and difficult war. Congratulations to Frank Ilardi in Atlanta for his hard-won victory, and I wish him and his client the best on their continued pursuit for justice.

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Scott Bennett Elected to the PBA’s House of Delegates

By The Beasley Firm on April 1, 2014 - No comments

Scott-BennettThe Beasley Firm is proud to announce that attorney Scott Bennett has been elected to the PBA’s House of Delegates. Mr. Bennett will represent Philadelphia beginning at the adjournment of the 2014 Annual Meeting in Hershey, PA.

The Pennsylvania Bar Association is a non-profit organization incorporated in 1895, whose missions statement reads:

“to advance the science of jurisprudence; to promote the administration of justice; to see that no one, on account of poverty, is denied his or her legal rights; to secure proper legislation; to encourage a thorough legal education; to uphold the honor and dignity of the Bar; to promote diversity throughout the profession; to cultivate cordial relations among the lawyers of Pennsylvania; and to perpetuate the history of the profession and the memory of its members.”

The House of Delegates is charged with establishing the Association’s policies. The House is divided into 12 zones, comprising different districts in PA. Additional responsibilities include supervising the Board of Governors, Sections and Committees, and any employee or agent of the PBA.

Since 1977, Scott Bennett has been the firm’s go-to lawyer in litigation regarding automobile claims and insurance, and has won many substantial judgements. He has years of experiencing handling auto accident cases involving roadway defects. He has also posted impressive awards for clients in cases involving medical malpractice, product liability, civil rights, and premises liability.

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Can We Prove In Court That Testosterone Gel Causes Heart Attacks and Strokes?

By Max Kennerly, Esq. on February 23, 2014 - No comments

In early February, the media exploded with reports that the FDA was investigating(1) whether low-testosterone therapies like Axiron, Androgel, Testim, and Fortesta might be tied with an increased risk of heart attacks and strokes. Yet, as the FDA said in its safety announcement, “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.” A plaintiff bringing a lawsuit thus can’t run to court and point to the FDA announcement as definitive proof that testosterone therapy caused their (or their husband’s) heart attack or stroke. So evidence can they use to prove or disprove such a causal link? It’s a question I’ve been getting a lot lately, so I thought I’d discuss it here.

The FDA’s investigation is based upon a November 2013 study in the Journal of the American Medical Association(2) and a January 2014 study posted on PLOS ONE(3). The JAMA study found “Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes” like death, myocardial infarction, or stroke, and the PLOS ONE study found “In older men, and in younger men with pre-existing diagnosed heart disease, the risk of [myocardial infarction] following initiation of [testosterone therapy] prescription is substantially increased.”

These results didn’t come entirely out of the blue — for example, a study in 2010 that was supposed to look at the effects of testosterone had to be discontinued when the participants suffered an unusual number of cardiovascular events(4) — but the latest two studies together form the strongest evidence showing a connection between testosterone therapy and cardiovascular events like heart attack and stroke. The situation is not altogether different from Vioxx, the litigation over which also began with a study showing a connection between Vioxx and cardiovascular events. The questions are if, like with Vioxx, future studies will demonstrate that “Low T” therapy causes these conditions and, perhaps, that the drug manufacturer concealed evidence that would have revealed this link sooner.

Let’s back up for a moment. The FDA has approved testosterone therapy to treat a single condition: hypogonadism. The FDA-approved prescribing information describes this as occurring as a result of “testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals,” or “idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.” The FDA did not approve the use of testosterone therapy to treat fatigue, or muscle weakness, or depression, or low libido, or erectile dysfunction, or for “anti-aging” purposes — yet most testosterone therapy prescriptions today are for those conditions, which for most purpose aren’t related to hypogonadism. Some of them are just part of aging.

After about 30 or so, men’s testosterone levels decline as they get older. (A study back in 2012 calculated that athletes’ “peak performance” generally occurred around 26 years old, and that the mean age of world record-setting athletes was 26.1 years.(5)) For some men, this shift can be sublime or even exciting*, but, for most of us, the shift comes too quickly or with severe side effects, and let’s face it: most of us would be more than happy to find the fountain of youth.

That’s where the drug companies saw a chance to make a buck. Although testosterone therapy is only approved to treat hypogonadism (or to be even more specific, hypoandrogenism), doctors are allowed to prescribe virtually any medication for virtually any purpose. There’s nothing wrong with that — doctors and patients need to have room to make their own medical decisions — but the drug companies routinely exploit that situation by engaging “off label” marketing, in which they try to convince doctors to prescribe patients medications for unapproved conditions, or to convince patients (by way of relentless television, Internet, and magazine advertisements) to lobby their doctors for the medication. Off label marketing is illegal, and pharmaceutical companies have paid the federal government billions in penalties for doing it, but they keep doing it anyway, concealing it when they can and then, if they’re caught, writing off the penalties as a cost of business. There’s too much money to be made.

The “Low T” companies have engaged in that sort of off-label marketing in spades, like the website “Is It Low T?”, for the purpose of encouraging men to wrongly believe that a variety of ailments are really the symptoms of low testosterone, and that the ordinary effects of aging can be safely treated with testosterone therapy. E.g., the website asks visitors if they are “sad” or “grumpy,” if they have “a lack of energy,” and if they aren’t as good at sports as they used to be — something that is to of course be expected as a person ages, particularly into their 60s and beyond.

All of that marketing (Abbott Laboratories spends over $80 million annually marketing AndroGel) worked: testosterone therapies are a $4 billion market, well over the size it should be based on the prevalence of the condition the medication was designed to treat. A review of prescribing information on low testosterone therapy found that one third of men on testosterone therapy were diagnosed with “fatigue,” and that one quarter of men on testosterone therapy did not even have their testosterone levels tested before they received a prescription(6).

Now, let’s move to the mixed question of science and law that I used for the title of this post: can we prove in court that testosterone gel causes heart attacks and strokes?

Ideally, we would prove (or disprove) such a causal link with a randomized controlled trial, putting one group of men on testosterone therapy and another on a placebo and then watching for heart attacks and strokes. But we need to be realistic: such a trial would be extraordinarily difficult to construct correctly given the huge number of factors at work, and it might even be dangerous to complete the trial. In many prior examples, like with Vioxx, clinical trials looking for potentially fatal conditions had to be stopped as soon as the initial evidence of a risk became apparent, because it would be unethical to knowingly expose patients to a risky medication.

So let’s start with what we already have. The JAMA study and the PLOS ONE studies are both observational studies, not randomized controlled trials. Medical researchers looked at a bunch of data they already had on patients, performed statistical analysis with the hope of removing any “confounding variables” — e.g., you have to make sure you’re not accidentally comparing heart attacks among obese smokers in their 80s and normal weight non-smokers in their 60s — and then saw the worrying conclusions that have prompted all this attention. These observational studies are a great way to learn about complex medical issues that defy easy analysis; a prominent, and perhaps foreshadowing, example was the Women’s Health Initiative, which identified the potentially fatal risk posed by women’s hormone therapy treatment, particularly as women got older.(7)

As the Executive Editor of Harvard Health notes, “neither was the type of study that can prove cause and effect. They can only show associations, or links. That means there’s no smoking gun here that testosterone therapy is harmful. But the studies do suggest caution.”(8) I disagree. Both as a matter of science and as a matter of law, although observational studies primarily show associations, observational studies can also be enough to show that a drug causes a particular disease — if they are done properly. As the Federal Judicial Center’s Reference Manual on Scientific Evidence says(9):

[O]bservational studies can be very useful. For example, there is strong observational evidence that smoking causes lung cancer. Generally, observational studies provide good evidence in the following circumstances:

• The association is seen in studies with different designs, on different kinds of subjects, and done by different research groups. That reduces the chance that the association is due to a defect in one type of study, a peculiarity in one group of subjects, or the idiosyncrasies of one research group.

• The association holds when effects of confounding variables are taken into account by appropriate methods, for example, comparing smaller groups that are relatively homogeneous with respect to the confounders.

• There is a plausible explanation for the effect of the independent variable; alternative explanations in terms of confounding should be less plausible than the proposed causal link.

In other words, well-done observational studies can be good enough, as long as they’ve approached the subject from different angles, have accounted for other possibilities, and have suggested “a plausible explanation” for the effect.

The JAMA and PLOS ONE studies have already been criticized, but, frankly, the criticisms I’ve seen are just plain wrong, to the point of being irresponsible. Over at Huffington Post, an OB/GYN who sells hormone therapy argues that the studies are “essentially meaningless,” because they didn’t assess testosterone levels “to tell if a patient is a proper candidate for therapy and if they are tolerating the therapy well.”(10) There’s no reason to believe those results would be different, but, the biggest issue is that she missed the point of the study: the point wasn’t to see if a narrow class of “proper” patients were at risk, but whether all patients on testosterone were at risk. Part of the problem with testosterone therapy is that it’s overprescribed, and artificially limiting a study of its risks would be tantamount to willful blindness to the real problem.

That said, the second factor — “effects of confounding variables” — is likely going to be the biggest issue in the testosterone therapy litigation. Heart attacks and strokes aren’t like, say, mesothelioma, which can only be caused by asbestos exposure. As they get older, men are at an increased risk of both, particularly after age 65. Observational studies have shown that there are nine major factors that increase the risk of heart attack in both men and women (11):

  • HDL to LDL cholesterol ratio;
  • current smoking;
  • former smoking;
  • hypertension;
  • diabetes;
  • abdominal obesity;
  • psychosocial (e.g., (depression, locus of control, global stress, financial stress, and life events including marital separation, job loss, family conflict);
  • physical inactivity;
  • very low alcohol intake;
  • high risk diet

If a man had any of those factors, then the drug companies will jump on it and claim that it’s impossible to prove the testosterone therapy increased his risk of suffering a heart attack or stroke.

To which I say: rubbish. We’ve seen those sorts of attacks before by drug companies as a way to avoid responsibility, but this isn’t the place to start explaining how we intend to do that in the litigation, beyond saying those issues are better left for cross-examination at trial. There’s no “smoking gun” here but there’s enough smoke to know there’s a fire, which is why we’re actively pursuing these cases. A company can’t just sit back and reap billions off a false wonder drug while being silent about its potential to kill its users.

 

 

REFERENCES:

(1) “FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products,” an FDA Drug Safety Announcement.

(2) “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels” at JAMA Network.

(3) “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” at PLOS ONE.

(4) “Adverse Events Associated with Testosterone Administration” available at PubMed.

(5) “Exponential growth combined with exponential decline explains lifetime performance evolution in individual and human species” at Springer.

(6) “Trends in Androgen Prescribing in the United States, 2001 to 2011” at JAMA Network.

(7) “The Last Word On Hormone Therapy From the Women’s Health Initiative” at NPR Health News.

(8) “New study adds caution to testosterone therapy for “low T”” at Harvard Health.

(9) Federal Judicial Center’s Reference Manual on Scientific Evidence, at fjc.gov.

(10) “Testosterone Therapy Does Not Cause Heart Attacks” at Huffington Post.

(11) “Risk factors for myocardial infarction in women and men: insights from the INTERHEART study” at European Heart Journal.

* Anyone despairing of getting older should read “My Dear Son” and “The Joy of Old Age.”

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