Rapid Response

MD. lawyer pushes for consolidated suit against medical device-makers

July 27, 2008 8:15 PM - DANNY JACOBS

Daily Record Legal Affairs Writer

The federal lawsuits from across the country all tell a similar tale. An otherwise healthy person, typically between the ages of 20 and 40, undergoes arthroscopic shoulder surgery. Following the successful procedure, a “pain pump” is inserted, a device that injects local anesthetic directly into the shoulder joint.

But in the following months, all of the cartilage in the operated shoulder joint vanishes, leaving bone grinding on bone.

“It’s a lifetime of pain,” said Robert K. Jenner, of Janet, Jenner and Suggs LLC in Pikesville. “We’ve had patients say it hurts just watching TV. Sleeping is impossible.”

Jenner is one of multiple lawyers across the country who, on Thursday, will ask that the more than a dozen federal lawsuits against the medical device-makers and anesthetic innovators be consolidated into one class action. The Judicial Panel on Multidistrict Litigation will hear arguments on the matter in San Francisco. (The five-member panel includes U.S. District Judge J. Frederick Motz of Maryland.)

The panel will issue its ruling on consolidation and, should it agree to consolidate, a venue by the end of September.

Right inside the joint

In medical literature, the vanishing of cartilage is known as chondrolysis. When it occurs in the shoulder joint after arthroscopic surgery, it is known as PAGCL — an ungainly acronym for an even more daunting term, postarthroscopic glenohumeral chondrolysis.

Jenner and other lawyers involved with the PAGCL litigation allege that pain pump manufacturers advised doctors to use the devices directly in the shoulder joint, or intra-articularly, a practice not approved by the U.S. Food and Drug Administration, instead of near the joint. Recently, multiple medical papers have linked intra-articular pain pumps with the onset of chondrolysis.

“No one has tested this for safety and efficacy,” said Michael L. Williams, a Portland, Ore., lawyer who has worked on several class-action pharmaceutical lawsuits and contacted the FDA last year about investigating the issue.

Spokesmen from pain pump manufacturers Stryker Corp. and I-Flow Corp. declined to comment because of the pending litigation. Representatives from DJO Inc. and Breg Inc., two other pain pump manufacturers named in the litigation, did not return calls seeking comment.

Lawyers for Stryker refuted allegations that the company’s pain pumps cause chondrolysis last November in responding to an Oregon lawsuit.

“Stryker specifically denies that the PainPump was unreasonably dangerous and defective when used as directed and designed,” they wrote.

The company also said it could not be held liable because of the “learned intermediary doctrine,” which puts the burden of warning a patient about the dangers of a device on the physician as long as the physician is advised about a device’s potential risk.

DJO, responding to another Oregon lawsuit last December, said the plaintiffs had not established a “causal link” between the pain pumps and their shoulder injuries. The company has issued similar responses in other pain pump lawsuits.

I-Flow, in response to that study and others reporting similar findings, last August issued a bulletin to doctors advising them not to place the company’s catheters in the shoulder joint.

“Although there is no definitive established causal relationship, some literature has shown a possible association between continuous intra-articular infusions (particularly with bupivacaine) and the subsequent development of chondrolysis,” the bulletin stated.

Even so, “we think surgeons are still doing it,” said Williams, the Oregon lawyer.

Williams learned of PAGCL from another Oregon lawyer who was pursuing a case in state court and believed there were similar cases across the country. Williams’ firm, Williams Love O’Leary & Powers P.C., found 35 cases of PAGCL in Oregon, and he estimated there are “thousands” across the United States.

Williams contacted Jenner, whom he has known for 20 years, to help in the consolidation effort because of his firm’s reputation and experience in cases against big pharmaceutical companies, he said. Janet, Jenner and Suggs has won more than $100 million in pharmaceutical product lawsuits, according to its Web site, and Kenneth M. Suggs is a past president of the American Association of Justice, formerly known as the American Trial Lawyers Association.

Williams and Jenner are among a group of lawyers who want the PAGCL cases consolidated and tried in Oregon. Another group is seeking Kentucky as the venue.

Jenner said he has received three inquiries from Maryland residents but no clients yet.

“It was shocking that this condition … was all the sudden occurring in a population of patients where previously chondrolysis was unheard of,” Jenner said.

Younger patients

Chondrolysis affects the articular cartilage in the shoulder, akin to wearing out the tread on a tire, said Dr. Timothy P. Codd, a shoulder and elbow specialist with Orthopaedic Associates P.A. based in Towson. He is not involved in the PAGCL litigation.

The end result of chondrolysis is similar to arthritis, Codd said. But while arthritis shows up gradually, and typically in older patients, chondrolysis occurs quickly and typically in younger patients, he said.

Before evidence linked pain pumps and chondrolysis, the condition was thought to be caused by “unstable shoulders” going through the motions of dislocations and subsequent procedures to correct the problem, infections or shoulder trauma not properly addressed through surgery, Codd said.

The condition is significant because the shoulder has the most motion of any joint in the body and controls where a person’s hand goes, Codd said.

“If you can’t move your hand, it’s a pretty devastating injury,” he said. “You can’t compensate.”

Two of Indianapolis lawyer Liza Doepken’s clients were 16 years old when they had arthroscopic shoulder surgeries. One was a football player injured while wrestling, the other a cheerleader hurt while tumbling. Each had chondrolysis within five months following surgery and lost the use of an arm, said Doepken, an associate with Cohen & Malad LLP, who is working with Williams and Jenner.

“I don’t think anything is more depressing than seeing a football player who needs his mom just to take off his jacket,” she said.

Approximately 500,000 arthroscopic shoulder surgeries are performed each year, according to the American Academy of Orthopaedic Surgeons.

A group of doctors writing in The American Journal of Sports Medicine last year reviewed 177 shoulder surgeries between 2003 and 2005. The group found 12 cases of chondrolysis, a rate it called “startlingly high.”

The dozen cases arose from 30 shoulder stabilization surgeries, of which 19 involved placing a pain pump in the shoulder joint.

More than 100 patients who had the pain pump placed outside the shoulder joint did not suffer from PAGCL, the doctors reported.

The doctors noted all of the patients recovered as expected during the first three months following surgery, including physical therapy. But within the first year after surgery, the PAGCL patients “were seen with complaints of new onset of pain, stiffness, increased pain with motion, and crepitus,” a crackling sound in the shoulder, according to the study.

The average age of a PAGCL patient in the study was 29; the average time of first experiencing PAGCL symptoms was little more than four months after surgery, according to the study.

Anesthetic in common

One common feature in all of the PAGCL patients in the study was the use of bupivacaine as the local anesthetic. Jenner and Williams claim the anesthetic, while relieving pain, destroys shoulder cartilage in the process.

“I think of it as a friendly fire situation,” Williams said.

Bupivacaine is a long-acting form of novocaine used regularly by other doctors, Codd said.

A spokesman for AstraZeneca, which markets generic brand versions of bupivacaine, said the drug has not been approved by the FDA for use in the shoulder joint and that the company has not sought such approval.

“We believe that bupivacaine is safe and effective when used as directed,” said the spokesman, Blair Hains.

Going to the source

Pain pumps were once commonly used following arthroscopic shoulder surgery because the subsequent patient pain is among the most pronounced of all procedures, said Dr. Anand Murthi, chief of elbow and shoulder surgery and an assistant professor of orthopedics at the University of Maryland School of Medicine.

“No matter what oral medication you have, it’s not enough,” he said. “It’s really a nice way to give more numbing medication.”

Doctors would place the pain pump directly in the shoulder joint because it delivered medicine “right to the source,” Murthi said. But between the shoulder’s “ball” and “socket” is a contained space, so the anesthetic has no place to go, he said.

“That’s where you’re bathing the cartilage,” Murthi said.

Murthi has treated several patients with chondrolysis and performed shoulder resurfacing, which he described as “a mini shoulder replacement.” Full shoulder replacements can be done, but may eventually wear out if done for a younger patient.

Murthi added that no orthopedic surgeons he knows have used pain pumps since the studies came out linking them to chondrolysis.

Signature injury

Jenner, Williams and Doepken said chondrolysis cases differ from other class-action medical pharmaceutical lawsuits they have worked on because the symptom is distinct. In lawsuits against the maker of the painkiller Vioxx claiming the drug was responsible for a heart attack or stroke, the challenge was to show causation, Jenner said, by way of an example.

“What makes this case so compelling is we have a signature injury,” Jenner said.

Doepken agreed, calling chondrolysis injuries “fairly clear-cut.”

The effects of chondrolysis are also clear, Doepken added. Her two teenage clients have gone from happy-go-lucky to bitter in demeanor, she said. Another client, a 30-year-old drywall installer, can no longer work and support his family, she said.

“They’re all very similar and they’re all very heartbreaking,” she said of the stories. “How much is your right arm worth?”

For more information about the law firms or about PAGCL, please visit http://www.medlawlegalteam.com/pain-pump-lawsuits.html.

CONTACT:
Janet, Jenner & Suggs, LLC
 Robert K. Jenner, Esquire
 John J. Cord, Esquire
 1829 Reisterstown Road, Suite 320
 Baltimore, Maryland 21208
 1-888-463-3529 (toll free) or 1-410-653-3200
 Or by e-mail at pain-pump@medlawlegalteam.com

The law firm of Janet, Jenner & Suggs, LLC is a nationally recognized law firm dedicated to representing victims of defective medical devices, prescription drugs and medical malpractice. Each of the firm’s principals is named in The Best Lawyers in America® and Super Lawyers®. The firm has offices in Baltimore, Maryland; Columbia, South Carolina; and Asheville, North Carolina, and accepts clients and referrals from patients and attorneys throughout the country.