There was an article in today's NYT about a woman who used a Medtronic pump but didn't have a safety feature set - see below. The article seems to imply that this is Medtronic's fault, which seems absurd. Anyone who gets a pump is responsible for knowing how it works and how it operates. Although doctors and nurses can help with that, in my view, it's part of the burden of being diabetic to figure out how to best take care of yourself. It's well-documented how having diabetes is so like walking a tightrope - ironically too much careful care can prompt serious hypoglycemia. For the Seattle Times to imply that it is Medtronic's fault that the woman slipped into a hypoglycemic coma is wrong - if more people are successful at sueing companies for behavior that went wrong that is ultimately their own responsibility, then pretty soon we'll have companies deem it not worth it to even make these devices. Similarly, is it the doctor's or nurse's fault? I don't think so. They can't foresee every problem - that's why the patients have instruction manuals. The companies do have a responsibility to make sure the manual is clear and understandable but beyond that, I think patients can take responsibility for their own care - they need t, no one else will, and resorting to suing seems going far too far ....
Your Courts, Their Secrets
Woman's coma leads to secrecy, silence
By Ken Armstrong and Justin Mayo
Sylvia Lane, a diabetic, lay in her apartment bed in Lynnwood, comatose and alone, her blood and brain in desperate need of sugar.
But the medical device she'd just received instead kept pumping insulin into her body, pumping and pumping, starving her brain and making it more unlikely she would ever wake up.
Lane was 17 weeks pregnant. Her husband was on an aircraft carrier, halfway round the world. Relatives were calling but getting no answer.
The pump, about the size of a cellphone, had a safety feature designed to stop the insulin flow in emergencies like this. But the feature wasn't on. The pump had been shipped to Lane with the option turned off, and the device's instructional video devoted only 15 seconds to it, saying nothing about why the feature should be used.
Ultimately, Lane suffered severe and permanent brain damage. Her family sued Medtronic Inc. — the parent company of the pump's manufacturer — alleging the pump was unsafe. Medtronic had already sold 150,000 insulin pumps in the United States.
A "defective" product — but what product?
Four years ago, a lawsuit alleged that a medical device was unsafe and that the University of Washington Medical Center had committed malpractice. But the whole file was sealed. Under a public-disclosure request, The Seattle Times got a copy of the complaint from the UW — but almost every meaningful detail was blacked out, including the name of the medical device.
What happened to Sylvia Lane could have yielded insight into the pump's design and instructions, alerting patients and health-care providers to the importance of this safety feature, originally called a "Deadman's Switch."
But when Medtronic settled the lawsuit three years ago, the entire court file was improperly sealed, hiding every allegation and discovery behind an electronic password.
What's more, Medtronic failed to disclose Lane's injury to the federal government, which uses such reports to spot problems with medical devices and to protect the public.
Lawsuits and regulatory reports allow patterns to emerge and warnings to sound. Here, there was merely secrecy and silence.
The Seattle Times got this file opened three months ago as part of a continuing investigation of improperly sealed court records.
Lane's family also sued the state of Washington, alleging the University of Washington Medical Center committed medical malpractice while instructing Sylvia on the pump's use. The state settled, using taxpayer dollars. But the UW, despite being asked for all its records a year ago, has yet to reveal the amount.
The following account relies on the court file. The lawyer for Lane's family said he cannot comment, nor can the family, because the parties agreed to confidentiality as a condition of settlement. Medtronic also declined comment, citing the settlement agreement and Lane's privacy.
A pump that mimics the pancreas
Michael Lane and Sylvia got married in 1989, then moved about as his Navy career dictated. In 1995, they were living in Naples, Italy. That's when Sylvia learned she had type 1 diabetes.
Her pancreas didn't work. It wasn't producing the insulin she needed.
Glossary
Diabetes: A disease in which the body cannot properly convert sugar, starches and other food into energy. An estimated 20.8 million adults and children in the United States are diabetic. Long-term complications include heart disease, blindness, kidney damage and amputations. There are three major types: type 1, type 2 and gestational diabetes.
Insulin: Insulin is a hormone normally produced by the pancreas that helps convert sugar from food into energy the body uses. The pancreas releases more insulin when blood sugar goes up, and less as blood sugar drops.
Type 1 diabetes: People with type 1 diabetes have a pancreas that doesn't produce insulin. To survive, type 1 diabetics must get insulin from daily injections or an insulin pump. An estimated 5 percent to 10 percent of Americans diagnosed with diabetes are type 1.
Hypoglycemia: Hypoglycemia is a condition in which blood sugar is too low. If untreated, it may lead to unconsciousness, coma or death. Diabetics that become hypoglycemic need to eat or drink something to raise their blood sugar.
Source: American Diabetes Association
Insulin, a hormone, counteracts rising blood sugar. When blood sugar goes up, a healthy pancreas releases more insulin. When blood sugar goes down — during sleep, for example — insulin production decreases. The pancreas acts as a regulator, keeping blood sugar from going too high or low, either of which can mean sickness or death.
Sylvia now needed to inject herself with insulin, using a syringe.
The couple moved to Washington in 2000. In August of that year, Sylvia, then 34, learned she was pregnant. Soon after, Michael, a lieutenant, left for duty in the Persian Gulf.
Sylvia lived alone in their Lynnwood apartment.
Because her blood sugar wasn't under control, Sylvia went to the UW's Diabetes in Pregnancy clinic. A doctor there prescribed an insulin pump. Sylvia's insurance helped her buy a pump, a model 508, for about $5,100. The pump arrived in October 2000.
Insulin pumps came onto the market in the 1980s. Today's models weigh just a few ounces and can hold a several-day supply of insulin. A thin tube runs from the pump, worn on a belt or in a pouch under clothes, into the user's stomach. Mimicking a pancreas, the pump steadily releases small amounts of insulin. It can also be programmed to release larger doses — to anticipate a meal, for instance.
Pumps help minimize the highs and lows, reducing diabetes' long-term effects, such as kidney failure, limb loss and blindness.
But pumps also carry risk. If someone's blood sugar drops too much, he can go into a hypoglycemic coma. Hypoglycemia demands sugar, not insulin. But the pump doesn't know that. It keeps pumping insulin — and the user, unconscious, can't turn it off.
MiniMed, the maker of Sylvia's pump, recognized this danger early on. It created a safety feature in the late 1980s that would stop the insulin flow if the user didn't press a button for a set number of hours. Company documents initially called it a "Deadman's Switch." It later became known as the "Auto-Off."
Medtronic, a multibillion-dollar company based in Minnesota, acquired MiniMed in 2001. This took place a year after Sylvia received her pump and a year before her family filed suit.
When Sylvia's pump arrived, the Auto-Off was deactivated. That's how the company ships all its pumps, to this day.
Sylvia's pump came with an instructional video. The video, 48 minutes long, devoted only 15 seconds to the Auto-Off, and that came more than a half-hour into the tape. "A safety feature which can be helpful for every pump user," the video called it. But the video didn't say why anyone might want the pump to stop pumping. It didn't say how the feature could save users from harm.
Medtronic Inc.
Headquarters: Minneapolis, Minn.
Employees: 37,000 worldwide
Annual sales: $11.3 billion
Products include: Implantable pacemakers and defibrillators for the heart; insulin pumps; stents for vascular diseases; devices to treat spinal pain
That video would become emblematic of this question:
Insulin pumps help diabetics. The 508 appears to be a good pump. The Auto-Off appears to be a smart feature. But how can it be a safety feature if many people don't know why they need it?
17 calls — and no answer
On Oct. 25, 2000, a Wednesday, Sylvia met with Emily Holing, a diabetes educator at the UW clinic. Holing hooked up Sylvia's pump and showed her how to use it.
This same afternoon, Holing documented two episodes of hypoglycemia for Sylvia, 15 minutes apart. Each time Sylvia needed to drink orange juice.
Holing didn't activate the Auto-Off on Sylvia's pump. She understood the feature, Holing said later, but didn't think Sylvia should use it. "I don't want the insulin interrupted during pregnancy," Holing said in a deposition. She advised Sylvia to use a "buddy system," with a friend or relative making regular checks on her.
Sylvia had pizza that evening, then drove home. She wouldn't be heard from for three days.
Friends and family tried calling Sylvia on Thursday, Friday and Saturday, leaving 17 messages. Sylvia's twin sister lived three hours away. On Saturday she traveled to Sylvia's and, with another relative, went inside. They found Sylvia on her bed, unconscious, lying in vomit. Her insulin pump was attached and running.
Sylvia was in a hypoglycemic coma. Paramedics injected her with sugar water and transported her to the hospital.
She gradually emerged from the coma but suffered permanent and severe brain damage. Memory, comprehension, reading, writing, walking, problem solving, judgment — all were impaired. Sylvia could speak only in combinations of two or three words, such as, "I'm fine." Medical experts said they expected little improvement. She would need round-the-clock care for the rest of her life.
Doctors terminated Sylvia's pregnancy Nov. 11, at 20 weeks, fearing the unborn child had suffered serious injury.
10 deaths — with few details
In May 2002, Michael Lane filed suit in King County Superior Court, on his and Sylvia's behalf.
The lawsuit named two sets of defendants.
Medtronic, the lawsuit alleged, violated Washington's product-liability law: The pump's warnings were insufficient and its design unsafe. The Auto-Off should be automatic, not an option, the lawsuit alleged. Had the feature been activated and the insulin cut off, Sylvia could have emerged from her coma and sought help before suffering brain damage, the lawsuit contended.
The lawsuit also accused the UW Medical Center of medical malpractice, saying Holing failed to advise Sylvia adequately on the pump's use and risks.
Christopher Otorowski, a Bainbridge Island lawyer, represented Michael Lane.
A year into the suit, Otorowski cited 15 reports filed with the U.S. Food and Drug Administration (FDA) for a nine-month period ending in March 2003. Although light on detail, the reports disclosed 10 deaths and five injuries suffered by people using Medtronic's insulin pumps.
The reports, Otorowski said, constituted "a trend or pattern of deaths." He said Medtronic should divulge more information about each case. The company, he wrote, was concealing information about the pump's risks "from the public, the medical community and the government."
Before approving a new medical device, the FDA requires clinical studies or testing for safety and effectiveness. But MiniMed had bypassed that step by saying the devices were "substantially equivalent" to a generic infusion pump used for medical fluids, Otorowski said. That general-purpose pump was approved before 1976.
The company made and sold insulin pumps "without anything more than a rubber stamp," Otorowski wrote.
Medtronic defended its pumps in general and the safety option in particular. The Auto-Off "is not some mysterious and nefarious device that dooms unsuspecting pump users to hypoglycemic comas," wrote Douglas Hofmann, a lawyer representing the company.
Medtronic said the role played by Holing, the UW diabetes educator, should free the company from any claims of liability. How could Medtronic be blamed for shipping the pump with the safety feature off, the company argued, when Holing had decided Sylvia shouldn't use it anyway?
The company also said the law does not require it to warn users about risks. The pump is available only by prescription, Medtronic said, so the company's duty is to ensure that health-care providers prescribing the pump understand its features. And in this case, Medtronic said, Holing understood the safety option and chose not to activate it.
Medtronic tested Sylvia's pump afterward and determined that it "performed flawlessly," Hofmann said. The company called any demand for a redesign "manifestly irresponsible."
Medtronic also challenged the relevance and reliability of the 15 reports to the FDA. The reports said little or nothing about the Auto-Off feature. Plus, none of the reports concluded that a pump had caused a death or injury, Medtronic said.
Motions that become moot
As the October 2003 trial date approached, Otorowski demanded more and more information from Medtronic. He wanted records of other lawsuits; customer complaints; details of adverse-event reports to the FDA; documents on the government-approval process.
Medtronic and Otorowski sparred over what documents the company would have to produce. Ultimately, the judge would have to decide.
In August 2003, the UW settled the claim against it. But the university has yet to disclose what it paid, even though that figure is a public record.
The same month, just before a hearing to determine if there was enough evidence to warrant trial, Medtronic and Michael Lane also settled. The judge had not yet ruled on Otorowski's demands for additional records — so those motions became moot.
Together, Lane, Medtronic and the UW asked for the entire file to be sealed. They said they wanted to keep private Sylvia's medical information and Medtronic's proprietary records; to protect the Lanes from financial predators; and to honor the parties' settlement agreement, which required that the amount remain confidential.
The joint sealing request also made one other argument — a perplexing one, given Otorowski's prior reference to the pump's "insidious danger."
"It is unlikely that the sealing of this court file would be of interest to any other individuals," the request said. "This is a unique case involving the claims of a single individual."
In October 2003, Judge Richard Jones sealed the file.
This year The Times challenged that order. Just because the parties want their settlement a secret is no grounds to seal an entire file, the newspaper argued. And where legitimate privacy concerns exist, limited parts of documents can be blacked out.
Jones opened the file back up.
"Tip of the iceberg"
Manufacturers must file reports with the FDA when they become aware that a medical device has malfunctioned or may have contributed to a death or serious injury.
The key word is "or." That's the word used in federal regulations: malfunction or injury.
In the Lane lawsuit, Medtronic acknowledged that it did not report Sylvia's injury to the FDA. A Medtronic director wrote in court documents that the company makes a report "if a malfunction is identified and it meets" reporting requirements.
He used the word "and."
"By making this convenient word substitution, the defendant has created an imaginary loophole," Otorowski wrote. Medtronic's interpretation requires a malfunction — in effect, erasing injury as grounds for reporting, he argued. Lane's lawsuit didn't claim malfunction. It alleged that Sylvia suffered severe brain damage because of a flawed design and insufficient warnings.
Otorowski said Medtronic's reporting practices were "deceptive" and put the company's "credibility squarely at issue."
One of Lane's experts, William Damaska, once directed the FDA's Division of Compliance Operations. The FDA uses "adverse-event" reports to issue recalls, safety alerts and labeling changes, Damaska wrote. Doctors use them to make choices about treatment and medical devices.
Sylvia's injury "clearly" met the reporting criteria, Damaska wrote. Medtronic's failure to alert the FDA, he said, suggested that "what is reported is only the tip of the iceberg."
Medtronic said any suggestion that it had not reported other events was "entirely speculative."
Nationally, other lawsuits have also accused Medtronic of reporting lapses. Medtronic, a Fortune 500 company with annual sales of $11 billion, makes all kinds of medical devices. Other lawsuits have alleged that Medtronic failed to make timely warnings to the public and physicians about problems with implantable heart defibrillators and with the tubing on insulin pumps.
In addition, the company agreed last summer to pay a $40 million fine to settle civil allegations that it provided kickbacks to doctors, to encourage them to use its spinal products. The kickbacks included sham consulting and royalty agreements, as well as lavish trips, the U.S. Justice Department said.
Which device? The words are blacked out
Some lawsuits allege a broad threat. But sealing the file can make it nearly impossible to figure out what happened.
When The Times began this investigation, it identified 420 sealed civil suits in King County. The names of the parties were available, but little else.
The Medtronic case stood out. The company sells pacemakers, defibrillators, insulin pumps, heart-valve products. Did the lawsuit claim some device was defective? And if so, which one?
Because the UW — a public entity — was also a defendant, The Times asked for its records from the lawsuit. A sealing order applies to the courts; it does not suspend open-records laws for other public entities.
In January the university turned over the complaint, a document that lays out the allegations. This provided a first glimpse inside the court file. But the university — citing patient privacy — had blacked out just about every meaningful detail in it.
The complaint said some medical device was unsafe. Which device? That information was marked out.
The newspaper contacted Medtronic. In February, a spokesman said the company couldn't comment on the lawsuit because the file was sealed. But his e-mail added:
"Medtronic and the entire medical technology industry follow strict guidelines and regulations stipulated by the FDA regarding product development, safety, effectiveness and quality. We take those guidelines and regulations very seriously, and must — by law — report any incidents that could potentially harm our patients. Medtronic would not intentionally hide information that could potentially jeopardize patient safety by sealing a court file."
Lawmakers do an about-face
The Washington Legislature passed two laws in 1993 to prevent secrecy in product-liability cases.
One barred parties from entering confidentiality agreements that concealed a public hazard. The other kept judges from signing orders that hid such dangers.
But in 1994, lawmakers did an about-face. The former law was repealed, and the latter, diluted.
Gone was the rousing endorsement of the public's right to know about hazards. The new law said the public has two interests: knowing about threats to safety — and making sure that businesses can keep trade secrets. A judge must balance the two before approving secrecy.
The new law has rarely, if ever, been used. A search of published appellate opinions failed to turn up even one case where it has been applied.
But the law still allowed an outsider to challenge a confidentiality agreement as contrary to the public interest. And that's what The Times is doing.
The newspaper has asked a judge to void the confidentiality agreement between Medtronic and Michael Lane. Doing so might free the parties to discuss the case and reveal how much Medtronic paid.
The newspaper's motion is still pending.
Ken Armstrong: 206-464-3730 or karmstrong@seattletimes.com; Justin Mayo: 206-464-3669 or jmayo@seattletimes.com
Copyright © 2006 The Seattle Times Company
