Segal McCambridge Legal Blog

Posted By:
June 25, 2012

University of Pennsylvania surgeon makes headway against a rare lung cancer


From Philly.com
Penn surgeon makes headway against a rare lung cancer
June 24, 2012|By Marie McCullough, Inquirer Staff Writer

During a grueling operation early last year, when the intractable five-pound tumor seemed to mock his skills, thoracic surgeon Joseph S. Friedberg felt buoyed by what he and his scrub-suited crew had already achieved.

The University of Pennsylvania team battles pleural mesothelioma, a rare, ferocious, incurable type of lung cancer.

Typically, patients die within a year of diagnosis. Yet more than two years after treatment at Penn, 27 out of 38 patients – 71 percent – were still alive, including four who had marked five years. These were advanced-stage cases, ostensibly hopeless, and they were defying the odds.

Friedberg, who was about to submit a study on those results for publication, knew there would be skepticism. The number of patients was small. And the treatment was almost as formidable as the disease. He spent up to 14 hours stripping out the cancer while preserving the patient’s lung; then residual malignant cells were zapped with laser light therapy.

He was disappointed, but not surprised, when the Annals of Thoracic Surgery demurred at publishing the study. “The reviewers said the follow-up time was too short and we were overestimating” the projected survival time, he recalled.

The only way to address that concern was to let more time elapse.

Last month, with a fuller picture, the journal published the results, which are impressive.

This story is about those results, and how the 25 members of Penn’s pleural and mesothelioma program are making remarkable progress against a dreadful disease.

It’s also about the heartbreaking inadequacy of that progress.

“I don’t particularly consider it a victory,” said Friedberg, co-director of the program. ” ‘Good’ for me would be 10 years. Every time these patients’ cancer recurs, it kills me.”

Caused by asbestos
Pleural mesothelioma is caused by exposure to asbestos, a once-ubiquitous building material. Decades after exposure, renegade cells arise in the mesothelium, a cellophane-thin membrane that lines the chest cavity, lungs, heart, and diaphragm.

By the time the classic symptom of breathlessness shows up, the cancer usually has a stranglehold, invading all surfaces and organs in the cavity.

Conventional treatments – chemotherapy, radiation, and surgery – have dismal outcomes. In the pivotal study of the only chemotherapy specifically approved for mesothelioma, 60 percent of patients did not respond. For the rest, it extended median survival just 13 weeks, to 12.1 months.

Mesothelioma has become a big specialty for liability lawyers, but with 3,000 new cases a year in the United States, it is hardly a hot research field.

Nonetheless, for more than two decades, Penn scientists have been doggedly pursuing innovations. They are combining conventional treatments with gene therapy, T-cell therapy, and the laser technology, called photodynamic therapy.

Patients come thousands of miles to Penn after exploring their options – or lack thereof.

William J. McQueen, 63, an ear-nose-and-throat doctor from San Antonio, Texas, is one of them. Because his cancer encased one lung – the typical pattern – and because he was in good overall health, specialists at several top hospitals recommended an “extrapleural pneumonectomy.”

The harrowing surgery involves removing the lung, the lining of the chest, the heart’s sac, and the diaphragm muscle, which controls breathing, then reconstructing certain tissues with high-tech fabric.

Up to 10 percent of pneumonectomy patients die of complications. The rest die of the cancer, which invariably comes roaring back, typically within months.

McQueen asked about preserving his lung but was told that would depend on the extent of his cancer – something that would be assessed on the operating table.

“I got the impression they would not take the time to strip the tumor out,” he said. “They’d go in and take the lung out. That’s what most surgeons do.”

Sparing the lung
That’s what Friedberg used to do.

Theoretically, taking the lung left minimal cancer for conventional therapies to mop up, thus lowering the chance of relapse. In reality, he could see it didn’t work. It was like uprooting a garden to get rid of weeds, only to have the weeds grow back worse than ever.

In the late 1990s, Friedberg teamed with Penn radiation oncologist Stephen Hahn, an expert in photodynamic therapy, to try it for mesothelioma.

It requires injecting the patient with a drug, a photosensitizer, that makes cancer cells ultra-sensitive to visible light. When the drug is exposed to red light, it sets off a chemical reaction that destroys the cells, damages blood vessels that feed the tumor, and activates the immune system.

The cell-killing effect only works near the surface, because red light penetrates only half an inch or less.
Regulators have approved photodynamic therapy for several cancers, but evidence that it works for mesothelioma is mixed. In the most rigorous study, published in 1997, it did not improve survival or time to recurrence.

But surgeons in that study were allowed to leave a thin layer of tumor – too much, Friedberg speculated, for the laser light to reliably penetrate.

Still, he knew that even if he cut out every speck of detectable tumor, preserving the lung would leave behind more microscopic disease than removing the organ would. So beginning in 2004, the team performed a modified pneumonectomy – removing the lung but preserving the heart sac and the diaphragm – followed by the light therapy

Then came a patient in her 80s. Taking her lung would be too risky, agreed the physicians – Friedberg, Hahn, Daniel Sterman, Keith Cengel, and Steven Albelda.

To their shock, she was back on the golf course not many months after Friedberg preserved her lung. So he preserved the next patient’s lung. And the next. With perseverance and ingenuity, he found he could save the lung no matter the extent of the tumor.

By 2008, it was clear the lung-sparing strategy was superior. The 14 patients whose lungs were removed had a median survival of only 8.4 months. But most of the 14 who kept their lungs were alive after more than two years – at least twice as long as other studies had reported for such advanced disease.

Though those with two lungs were physically better able to cope with a relapse, Friedberg believed the light therapy was playing a big role, somehow priming the immune system to keep resurgent cancer under control. “The cancer comes back more like a house cat than a tiger,” he said.

To try to prove it, the team decided to treat 24 more patients – 38 in all.

On April 19, 2011, Bill McQueen was rolled into the operating suite, a three-ring medical circus of physicians, nurses, anesthetists, laser physicists, and technicians.

Some of the photosensitizer, given intravenously two days in advance, had migrated into his healthy cells, as expected. To protect them from burning, the team covered the operating room lamps with protective filters, sewed blue surgical towels to the edges of his skin incision, and clipped the oxygen monitor to a different finger every 15 minutes. Even the tiny red light in that device could activate the sensitizer and burn his nail bed.

Friedberg spent 111/2 hours cutting out the cancer. Though it had not penetrated into the airways of the lung – it typically does not – it formed a thick, reddish rind around the organ, and mottled the chest cavity with nodules and plaques.

The volume of McQueen’s cancer, about a pint, was comparatively small. Some patients have a quart or two.

But Friedberg also had to remove a rib, two nerves, parts of the diaphragm and heart sac, and lymph nodes.

The thing that best prepared him for the arduous marathons, said the lanky 53-year-old, was being on the crew team at Penn.

“You just keep going no matter how much it hurts or how tired you are. You just have to make the commitment that you’re not going to fail [patients] that way.”

After the cancer was out, Friedberg sewed seven light detectors in strategic locations in McQueen’s chest cavity. These were connected to a computerized “dosimetry” system, enabling real-time calculations of the laser light dosage. Too little and the chemical reaction would not kill the cancer. Too much and a vital organ could be perforated, causing a fatal hemorrhage.

Next, radiation oncologist Keith Cengel took over, looking a bit sinister in black goggles and protective garb.

He poured a warmed liquid containing fat particles into McQueen’s chest while moving a fiber-optic laser around the cavity. The fat particles reflected the light, dispersing it into the recesses of the chest – and creating an eerie red glow that made McQueen’s torso seem like a magic cauldron.

Despite the care and precision, McQueen had complications. Lymphatic fluid leaked from a thoracic duct, requiring eight more hours of surgery the next day. A small stroke temporarily impaired his vision.

“But I came through it,” he said.

Indeed, within four weeks, he was playing the tourist, wandering Reading Terminal Market with his wife, Karen.

A windfall of days
In the harsh calculus of cancer, “median survival” – the point at which half the patients are still alive – is a crucial number.

The median survival for the 38 patients Friedberg’s team treated from 2004 through 2010 was 31.7 months – more than 21/2 years – even though the cancer came back in a median time of 9.6 months.

That’s a windfall of birthdays, holidays, time with loved ones.

The researchers still can’t say for sure why the treatment combination failed to delay the return of cancer, yet made it “less imminently lethal.”

Friedman points to the well-documented immune effects of photodynamic therapy. Debris from dead cancer cells signals the immune system to send scavenger cells to clean up the mess.

He believes that may act like a vaccine, preparing the immune system to strike when cancer reappears, thus curbing the explosive growth usually seen when mesothelial cancer recurs. The cancer, he says, becomes “more indolent.”

Photodynamic therapy pioneer Harvey Pass is not convinced. The New York University thoracic oncologist led several mesothelioma studies that found light therapy didn’t help.

“There may be an immune effect, but I don’t know about a more indolent form,” Pass said. “But I think Joe has the right idea. I think we ought to be saving lungs on these people. The patients are in better shape, and they can get more therapy” to fight relapses.

McQueen is now waging that fight with chemotherapy and, in a few months, radiation. He needs narcotics to manage his pain.

But he recently went hunting with his daughter, and he and his wife will soon fly cross-country for a wedding. “I’m going to do the best I can for as long as I can,” he said.

That could be the Penn team’s mantra. Researchers are now working to parse the immune effects at a molecular level, to find better photosensitizers, and to develop minimally invasive ways to deliver the laser light energy.

“I’d be happy to turn this into a chronic disease, like diabetes,” Friedberg said. “My goal for my career is to make it truly better for these patients. That’s what I want to do with the rest of my life.”


Posted By:
June 7, 2012

Pennsylvania Supreme Court shoots down ‘any-exposure’ asbestos theory


From LegalNewsLine.com and its May 24, 2012 edition

Pa. SC shoots down ‘any-exposure’ asbestos theory

BY JESSICA M. KARMASEK

PITTSBURGH (Legal Newsline) – The Pennsylvania Supreme Court on Wednesday rejected the “any-fiber” theory of asbestos causation.

The Court, in its 53-page ruling, sided with Allegheny County Common Pleas Court Judge Robert J. Colville.

“In the present case, Judge Colville was right to be circumspect about the scientific methodology underlying the any-exposure opinion,” the state’s high court said.

“Simply put, one cannot simultaneously maintain that a single fiber among millions is substantially causative, while also conceding that a disease is dose responsive.”

The lawsuit underlying the appeal was selected as a test case for the admissibility of expert opinion evidence to the effect that “each and every fiber” of inhaled asbestos is a substantial contributing factor to any asbestos-related disease, including mesothelioma, a type of cancer.

In February 2005, plaintiff Charles Simikian filed a product liability action against defendants Allied Signal Inc. and Ford Motor Company, and others, alleging that his exposure to asbestos-containing friction products, such as brake linings, caused his mesothelioma.

Simikian had worked for 44 years as an automotive mechanic.

After Simikian’s death, his wife, Diana Betz, was substituted as the plaintiff.

The lawsuit was among a number of similar ones pending in the common pleas court.

Allied and Ford anticipated that the plaintiffs would rely on expert opinion that each and every exposure to asbestos — no matter how small — contributes substantially to the development of asbestos-related diseases.

This opinion often is referred to as the “any-exposure,” “any-breath” or “any-fiber” theory of legal causation.

Seeking to preclude such opinion testimony, the defendants filed global motions challenging its admissibility under the litmus of general acceptance in the relevant scientific community applicable to novel scientific evidence.

They referenced a litany of techniques used for various purposes in science, arguing that none of these — alone or in combination — supports the any-exposure theory.

More specifically, the defendants contended that the methodology underlying the any-exposure theory is “novel” and “scientifically invalid.”

Thus, they urged that the theory be deemed inadmissible at all trials of asbestos cases against them.

In its May 2006 ruling, the common pleas court — while it did not discount that a single fiber may possibly increase the risk of developing a disease — did not accept that an unquantified increase in risk could serve as proof that a defendant’s product was a substantial cause of a plaintiff’s or decedent’s disease.

In an April 2010 ruling, the state’s Superior Court ruled otherwise.

The majority regarded Colville’s review of the mechanics of Dr. John C. Maddox’s methodology, and the judge’s decision not to address the epidemiological studies, as “inapt.”

Maddox, a pathologist, was brought in by the plaintiffs as their primary causation expert.

The intermediate court also concluded that Colville had abused his discretion in ruling for the defendants.

According to the majority, the judge’s approach violated the tenet that judges are to be guided by the scientists in assessing the reliability of a scientific method, not the reverse.

As a result, the superior court sided with the plaintiffs.

Allied and Ford appealed to the state’s high court. A number of business groups and organizations, including the U.S. Chamber of Commerce, filed amicus briefs on their behalf.

Legal Newsline is owned by the U.S. Chamber Institute for Legal Reform.

Allied and Ford argued that the superior court “simply ignored” the extensive evidence, as well as the “strong logic” supporting Colville’s ruling, and “improperly substituted” its judgment for his.

On appeal, they maintained that the any-exposure opinion remains a hypothesis, or assumption.

In a 6-0 ruling, the state’s high court agreed.

“Colville spent considerable time listening to the attorneys’ arguments but was unable to discern a coherent methodology supporting the notion that every single fiber from among, potentially, millions is substantially causative of disease. Moreover, he appreciated the considerable tension between the any-exposure opinion and the axiom (manifested in myriad ways both in science and daily human experience) that the dose makes the poison,” Justice Thomas G. Saylor wrote.

“Contrary to the perspective of the superior court majority, Judge Colville was not misguided in his desire to probe how Dr. Maddox could simultaneously maintain that mesothelioma is dose-responsive and that each and every fiber among millions is substantially causative.”

Saylor continued, “Given both the controversial nature of the any-exposure opinion and its potency in asbestos litigation, Judge Colville pursued the sensible course of permitting evidentiary development so that he could make an informed assessment.”

The Court disagreed that the defendants could not address Maddox’s methodology through the testimony of risk assessors, toxicologists and epidemiologists.

“Dr. Maddox identified himself as a community hospital pathologist ‘try[ing] to present the medical literature as I understand it.’ He did not indicate, however, that his opinion was based on a particular clinical diagnosis; indeed, he expressed no familiarity whatsoever with Mr. Simikian’s individual circumstances,” Saylor wrote.

“Instead, Dr. Maddox offered a broad-scale opinion on causation applicable to anyone inhaling a single asbestos fiber above background exposure levels. In doing so, he took it upon himself to address (and discount) the range of the scientific literature, including pertinent epidemiological studies.”

The Court said Maddox’s any-exposure opinion was not “couched” in terms of a methodology or standard peculiar to the field of pathology.

“Indeed, the pathologist acknowledged that the rendition of a broad and generally applicable opinion concerning specific causation was outside the range of his usual professional activities,” Saylor wrote.

While the superior court was correct that Colville did not “embellish” his opinion with specific citations to the record, the judge’s findings and conclusions are “amply supported,” the Court said.

The Court reversed the superior court order and remanded the case “for consideration of whether there were remaining, preserved issues on appeal which were obviated by the intermediate court’s approach to the common pleas court’s ruling.”

Justice Joan Orie Melvin — who has since been suspended from the Court in the wake of charges that she allegedly used her staff to perform campaign work — did not participate in the decision.

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.


Posted By:
January 13, 2011

Philadelphia asbestos verdict reduced by settlements received from asbestos bankruptcy trusts


From Legal Newsline

A Philadelphia judge says the current system of recovery for plaintiffs with asbestos claims can help them recover more than a jury determines they deserve.

Common Pleas Judge Stephen Levin expressed that viewpoint in a Dec. 22 opinion that reduced the amount a jury ordered Honeywell International pay to the family of a deceased brake mechanic. The $492,000 verdict was reduced by nearly $150,000 to reflect settlements the plaintiffs made with asbestos bankruptcy trusts.

Several dozen companies named in asbestos lawsuits have gone bankrupt, and trusts have been established to pay out asbestos claims.

According to Levin, it is possible for plaintiffs to recover from trusts without defendants in their civil lawsuits ever knowing.

“This has led to the potential of double recovery, as there has only been haphazard reporting, if at all by plaintiffs of funds received from bankruptcy trusts, despite recoveries also received at trial,” Levin wrote.

In Philadelphia’s Complex Litigation Center, asbestos trials contain two phases. The first asks the jury to determine the amount of damages the plaintiff is owed, and the second determines if the defendant is liable for those damages.

Levin wrote that bankrupt companies may not be placed on the verdict sheet, like settling defendants are. Bankruptcy trusts have more than $30 billion in assets.

“(T)he total recovery available to many plaintiffs exceeds the damage amount set by the jury during Phase I asbestos trials,” he wrote.

“Here, the releases allow Honeywell, which was found liable at trial, to pursue contribution, but the trust releases stipulate that the plaintiffs hold the trusts harmless and indemnify them from liability.”

Levin wrote that it would be a waste of time and resources for Honeywell to seek contribution from the trusts for an entire verdict because it would require the plaintiffs to return the trusts’ funds so they could be given to Honeywell.

So Levin reduced the jury award.

“Moreover, such a procedure could further delay compensation for the plaintiffs,” he wrote.

Plaintiffs attorneys wrote that no evidence was presented at trial as to asbestos exposure caused by the bankrupt companies.

“Plaintiffs cannot now come before this court and argue that there was no evidence of exposure to asbestos from said manufacturers’ products presented at trial in order to effect a double recovery,” he wrote. “Plaintiffs applied to the bankruptcy trusts based on the fundamental contention that they were liable for Plaintiffs’ decedent’s mesothelioma.”

Bankruptcy law prevents the introduction of evidence against bankrupt manufacturers in civil trials.

So-called “double-dipping” from civil lawsuits and bankruptcy trusts has been a hot topic. In West Virginia last year, a judge’s case management order ensured defendants receive proper credit when plaintiffs are paid by trusts.

The order was a product of negotiations related to legislation. That legislation was reintroduced this week for West Virginia’s new session.

The article can be found here


Posted By:
December 14, 2010

Texas, Baltimore and New York City firms will have cases on 2011 Philadelphia asbestos docket


From LegalNewsline.com

PHILADELPHIA (Legal Newsline) – Local law firms seem to make up the majority of Philadelphia’s asbestos docket at the Complex Litigation Center, but some regional and national firms also have a presence in the city.

A list of all trials scheduled for 2011 shows only 10 different law firms will be trying cases in Philadelphia, where a process called “reverse bifurcation” is used. A jury decides damages in the first phase of the trial, and then determines if the defendant is liable in the second part.

Among the big-name law firms who have trials scheduled next year are the Law Offices of Peter Angelos, Baron & Budd and Weitz & Luxenberg.

Forty-three trials are set to take place. In Philadelphia, plaintiffs are grouped for trial by their law firm and their alleged illnesses.

“It’s usually pretty much the same attorneys,” said Stanley Thompson, executive director of the CLC. “It’s the same players.”

As of Oct. 3, there were 631 active asbestos cases at the CLC, which was designed to solve a backlog of more than 7,000 cases. Thompson says the amount of lawsuits filed by these attorneys stays steady at 200-250 every year.

The full LegalNewsline.com article can be found here

The Southeast Texas Record article can be found here


Posted By:
September 10, 2010

Third Circuit affirms summary judgment under preemption theory in asbestos case


On September 9th, the Third Circuit issued an opinion which a district court grant of summary judgment to defendants Viad Corporation and Railroad Friction Product Corporation, finding that the plaintiffs' claims were all preempted by the Locomotive Inspection Act, 49 U.S.C. ยง 20701, et seq. ("LIA").

Plaintiff’s counsel at oral argument was Robert E. Paul.

A copy of the Third Circuit opinion is here