H.R. 1346 Archives - Shopfloor

Never Letting a Good Deed (Device) Go Unpunished (Unregulated)

By | Briefly Legal, General, Innovation, Regulations, Taxation | One Comment

In a Forbes magazine column, “K Street Capers,” Brian Wingfield reviews some of the lower-profile issues on which business associations lobby, such as the unintended consequences of Iran sanctions, foreign-made plastic flowers and mixed-martial arts.

And lithium batteries. We wrote yesterday how the new health care law taxes one of U.S. industry’s great success stories, medical devices, forcing manufacturers to cut jobs and investment. (“Never Letting a Good Deed (Device) Go Unpunished (Untaxed).”) Federal regulators are also working to make it more expensive and difficult for the industry to operate in the United States.

Batteries. Makers of lithium ion batteries and medical-device producers are fuming about a proposed Department of Transportation rule they claim will drive up the distribution costs to power cellphones, e-readers, pacemakers and insulin pumps by $8.5 billion during the next decade. The regulation would classify all lithium batteries as hazardous materials when transported by cargo plane–requiring special storage easily accessed by pilots in case of fire–and forcing manufacturers to get safety certifications for battery design. A pending transportation bill sponsored by House Transportation Committee Chairman Jim Oberstar (D–Minn.) would impose similar restrictions.

Meanwhile, the trial lawyer lobby is still trying to stimulate more speculative lawsuits against device makers, pushing the Medical Device Safety Act, which would replace consistent federal safety standards under the FDA with a more exploitable regulatory regime under 50 state court systems. (The bills are S. 540, originally introduced by Sen. Edward Kennedy.)

Too many federal officials claim to support U.S. manufacturers but then enact laws and regulations that disadvantage the same manufacturers in global competition. In the case of medical device manufacturers, they have to be wondering, “What’s next?”

Medical Malpractice Reform, the Administration’s Signals

By | Briefly Legal, Health Care | No Comments

Below we linked to stories about the White House holding out the possibility of medical malpractice reform as an element of a broader government restructuring of health care.

A serious offer to win more acceptance from the medical profession and business? Or just positioning, talking points to move the debate forward even as the public recognizes that the costs of “reform” are staggering?

Well, here’s one way to tell. This Thursday, the House Energy and Commerce Committee, Health Subcommittee, holds a hearing, “‘Medical Devices: Are Current Regulations Doing Enough For Patients?‘”

As an industry, medical device manufacturers rank as a priority target for trial lawyers: The companies do make money and for all the lives the devices save, nothing is perfect. We exist in a world of risk. The one-in-a-million malfunction can, in isolation, produce a compelling story of individual suffering that leads a jury to hand out a huge award.

The hearing Thursday figures to be a follow-up to the subcommittee’s session in May on H.R. 1346, the Medical Device Safety Act. (We blogged about the hearing here, here and here.) The goal of the bill is to end legal protections gained by the device manufacturers when their products win FDA regulatory approval. The bill would end this federal preemption and allow litigation ins state courts, in effect creating a 50-state regulatory regime — costly and capricious.  As the Washington Times editorialized, “This bill would kill innovation.” More lawyers and their clients would win gigantic awards, but medical advances would be hampered and health care costs would increase.

So here’s at least one way to judge the Obama Administration’s seriousness about tort reform as an element of broader health care legislation: If an Administration official testifies at the hearing in opposition to H.R. 1346, that’s a good sign the White House regards tort reform something other than a mere talking point, raised and then abandoned as a negotiating tactic.

UPDATE (noon): Wall Street Journal Law Blog, “Will Obama Buck Dems on Medical Liability?“:

But to deliver a deal with doctors, Obama would probably have to defy senior members of his party in both houses of Congress. Many Dems oppose putting limits on medical lawsuits because they believe it is ineffective and unfair to patients. Senator Harry Reid of Nevada, the Democratic leader, has, for instance, called “the whole premise” of a presumed medical-malpractice crisis “unfounded.”

And any effort to restrict patients’ legal rights to sue will face tough opposition from the American Association for Justice, perhaps not surprisingly. Linda Lipsen, the association’s chief lobbyist, said practice guidelines were established by unregulated medical societies and “should not be conclusive” in a court of law.

UPDATE (1:15 p.m.): President Obama tells the AMA:

I want to be honest with you. I’m not advocating caps on malpractice awards (murmurs, laughter) which I personally believe can be unfair to people who have been wrongfully harmed. But I personally I think we need to explore a range of ideas about how to put patients’ safety first, how to let doctors focus on practicing medicine, how to encourage a broader use of evidence-based guidelines.

Full sound clip of the President’s remarks on tort reform. It’s 1 minute 50.

Preemption and Medical Devices: Saving Lives

By | Briefly Legal, Health Care, Regulations | No Comments

One of the witnesses at the House Energy and Commerce subcommittee hearings on medical devices and federal preemption (see earliers posts) was a woman whose pacemaker had malfunctioned, causing her great distress, surgery and continued medical problems. In a similar fashion, Diana Levine became the public image of the preemption issue as it relates to labeling of medicines; a musician, she had lost her arm after an anti-nausea medication was improperly administered intraveneously.

The ones damaged have compelling stories, used by advocates (and trial lawyers) to promote a cause. We should certainly listen to them. But how about those saved? As the columnist Michael Kinsley noted in his testimony yesterday, “Lawsuits focus on the victim of some medical product. By their nature, they undervalue the benefit that same product has brought to other users, or even to the victim herself.”

So we note with appreciation this news release from AdvaMed, the Advanced Medical Technology Association, which organized remarks in Washington by a group of patients who had benefitted from medical devices. From “Patients Call for Continued FDA Preemption Authority“:

“Without my medical device, I would not be here today,” said Laura Doud of Arlington, Virginia, who received life-saving implantation of cardiac resynchronization therapy with defibrillation in 2004 after suffering almost fatal viral cardiomyopathy. “If the proposed legislation were passed, would the lawsuits facing inventors and manufacturers prevent devices like mine or future medical innovations from ever making it to patients like me?

And then there’s Olivia Vervaeke, a senior from Detroit, Michigan, graduating this week from the University of Notre Dame, born with a congenital heart defect that severely worsened in high school. Olivia required an implantable cardioverter defibrillator (ICD) in 2005.

“This device saved my life,” said Olivia Vervaeke, who is graduating from college on Sunday, May 17 but took a break from wrapping up her final days at Notre Dame to come to Washington to tell her story. “I can run five miles a day now; I could never do that before.”

The news release includes testimonials from other people helped by medical devices, and although they did not testify at the committee, their experiences need to be heard. Replacing a consistent, predictable and expert-based FDA regulatory system for medical devices with 50 different state systems determined by juries would discourage the innovation that helped save these people’s lives.

On Medical Devices, FTC Regulator is Claiming Policy Wisdom

By | Briefly Legal, General, Health Care, Regulations | No Comments

We’ve been watching the hearing by the House Energy and Commerce Subcommittee on Health on H.R. 1346, the Medical Device Safety Act.

The first witness was David Vladeck, listed and introduced as J.D, Professor of Law, Georgetown University Law Center. He testified, vehemently, against federal preemption, criticizing the Supreme Court ruling in Riegel v. Medtronic.

Vladeck’s views don’t surprise us; he’s a hard-core advocate of expanded regulation, regards business as nemesis, and made a career out of suing people. Before coming to Georgetown, he was with Public Citizen Litigation Group for decades.

Thing is, Vladeck was announced on April 14 as the new director of the Bureau of Consumer Protection in the Federal Trade Commission. (FTC news release, Washington Post article.)

Even if he hasn’t started work at the FTC yet [see UPDATE below], do we really want our regulators — and the FTC is a regulatory agency — commenting on policy matters? You have a regulator declaring he holds little respect for the Supreme Court’s opinion on preemption and that members of Congress who believe in FDA preemption are wrong and ill-informed. That’s an improper role for a regulator.

In addition, the FTC has a large regulatory portfolio involving health care competition. While not the regulatory agency in charge of medical devices, the FTC has dealt with the industry. Won’t Vladeck’s appearance and testimony give people in the health care industry grounds to suspect they won’t get a fair shake?

All in all, a strange and imprudent appearance before the committee.

UPDATE: According to the Federal Leadership Directory (the Yellow Book):

Director David C. Vladeck

Career Senior Executive Service (SES) Appointment

Note: David C. Vladeck has been appointed Director of the Bureau of Consumer Protection, with an effective date still to be announced. More information will be provided as it becomes available.

The Medical Device Litigation Act, a Hearing

By | Briefly Legal, Health Care, Regulations | One Comment

Balanced story in today’s Cleveland Plain Dealer on a House committee hearing scheduled this afternoon on H.R. 1346, the Medical Device Safety Act. This is the bill that would end what’s called “preemption,” the federal liability protection for FDA-approved medical devices, opening the gates wide for product liability suits in state courts.

The bill comes in response to the Supreme Court’s ruling in Riegel v. Medtronic, and has long been a priority of the trial lawyers at the American Association for Justice.

The Plain Dealer’s headline represents the pro-lawsuit arguments, “Patients injured by faulty medical devices want laws to hold manufacturers accountable,” and the story leads with the claims of the injured party. Still, the Plain Dealer provides space for manufacturers and others to comment on innovation-stifling effects of the legislation.

“This bill does not in any way improve patient safety,” said Steris spokesman Stephen Norton. “It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits, and ultimately result in higher health-care costs for all Americans.”

And from Medtronic spokesman Rob Clark:

“When you regulate through litigation, which is the recipe the Medical Device Safety Act is aimed at, it places decisions in the hands of a 12-person jury that’s only looking at one particular patient, and one particular situation and not evaluating the safety and efficacy and risk benefit of that device for everyone,” Clark said.

Washington Post columnist Michael Kinsley, who is testifying at today’s House Energy and Commerce subcommittee hearing, made that important point last year when commenting on the high-profile preemption case, Wyeth v. Levine.

The flaws of litigation as a method of making important government decisions are well rehearsed. It is ungodly expensive: The lawyers typically cost more than even the most worthy plaintiff ever gets. It is arbitrary: The same issues get litigated again and again, usually with a different result each time. Most people who suffer never sue and get nothing. While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement. And because trials occur only when a risk has gone wrong, they inevitably overemphasize the risk and undervalue the benefit.

The Subcommitte on Health holding the hearing is chaired by Rep. Frank Pallone (D-NJ), sponsor of the bill, so the agenda is clear enough. We trust that agenda allows space for the argument that undermining preemption will create a chaotic, expensive and capricious regulatory system ruled not by medical experts and the disinterested FDA but by juries in the 50 different states. And that’s a regulatory regime that does not serve the public.

For more on the hearing, see our post at Point of Law.com, “Medical Device Safety Act hearing, the PR angle.” It’s an interesting witness list.