March 06, 2007
Congressional Panel Examines Off-Label Use of Drugs and Medical Devices
Article in the Wall Street Journal -- Congressional Panel to Study Off-Label Use of Stents, Drugs, by Keith J. Winstein. Here's an excerpt:
A congressional committee is looking into the "off label" use of drugs and heart stents, examining the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration.
Boston Scientific Corp. and Johnson & Johnson's Cordis unit, the only makers of drug-coated stents sold in the U.S., were asked to submit marketing materials and clinical data to the House Committee on Oversight and Government Reform on Wednesday. About 60% of drug-coated stents, which prop open clogged arteries, are used off-label. For example, manufacturers haven't rigorously tested their stents in patients who have had heart attacks, but stents are commonly given to such patients. Doctors are allowed to prescribe stents to off-label patients, but manufacturers can't encourage off-label use.
The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.
February 24, 2007
Stent Risks May Result in Return to Heart Bypass Surgery
Article in the New York Times -- In the Stent Era, Heart Bypasses Get a New Look, by Barnaby J. Feder. Here's an excerpt:
After more than a decade-long decline, is heart bypass surgery poised for a comeback?
Some doctors say it may be time to give bypass operations a second look. They include even some cardiologists who specialize in the far more popular alternative — using stents to keep coronary arteries open.
No one is predicting a sudden surge back to bypass, which is still a far more invasive and initially riskier way to treat plaque-clogged heart arteries, a condition that afflicts millions of Americans.
But in light of new safety concerns over the long-term risks of stents, as well as accumulating data indicating that the sickest heart patients may live longer if they receive bypass surgery instead, some well-known stent specialists say the pendulum may have swung too far away from bypass surgery.
February 13, 2007
Defibrillator Lawsuits Increase
The number of lawsuits against Medtronic concerning allegedly defective defibrillators has increased significantly, according to this Bloomberg story in the Seattle Post-Intelligencer -- Medtronic Defibrillator Suits Double:
The number of heart patients suing Medtronic Inc. over faulty defibrillators more than doubled in the past two months, raising the company's risk of getting hit with damage awards.
Through Monday, about 1,670 patients had filed 943 suits in U.S. courts related to the 2005 recall of 87,000 implanted electronic devices that protect against sudden cardiac death, said Hunter Shkolnik, a trial lawyer helping to manage the cases. In December, the number was 417 lawsuits.
February 06, 2007
Federal Agency Reviewing Coverage for Drug-Coated Cardiac Stents
Article in the Wall Street Journal -- Agency Reviews Stent Coverage, by Keith Winstein:
The agency that controls Medicare and Medicaid payments is considering restricting its coverage of drug-coated cardiac stents because of safety concerns.
Drug-coated stents, which prop open clogged arteries and slowly release a chemical to keep them from closing up again, have recently come under fire because of fears that they increase the risk of blood clots over the bare-metal stents that they have largely replaced. Some studies suggest that the clotting is especially apparent when the coated variety is used "off label" in high-risk patients -- often diabetics and those who have had heart attacks -- even though the Food and Drug Administration hasn't approved the devices for use in these patients.
Now, the Centers for Medicare & Medicaid Services, or CMS, says it is considering reopening its decision about how broadly to cover the stents. An agency spokesman said such a process, known as a National Coverage Determination, could result in restricting coverage of the stents to FDA-approved uses, keeping coverage the same, or something in between.
November 22, 2006
Chicago Tribune Editorial on Silicone Breast Implants
Editorial in the Chicago Tribune -- A reversal on breast implants:
It took nearly 15 years, but last week, the Food and Drug Administration essentially admitted that it made a mistake when it outlawed silicone breast implants on grounds of safety, deciding to repeal the ban at last.
It's a good day for women who would like access to these devices for reconstructive or cosmetic purposes, and a good day for anyone who thinks individuals should be free to assess risks and make their own choices. But it comes a decade and a half too late for women who were deprived of a largely safe option because of fears that now turn out to be mostly groundless.
Back in the early 1990s, panic-mongers sounded alarms about all the horrors awaiting any woman getting silicone implants--cancer, connective tissue disorders, chronic fatigue and more. Even though more than a million women had them, and even though the great majority expressed satisfaction, the FDA under Commissioner David Kessler ordered them off the market. The only exception was for women getting them for reconstruction after cancer surgery, and then only in rigidly controlled, FDA-approved clinical trials. He acted against the unanimous recommendation of his agency's own expert panel.
L.A. Times on Growth in Silicone Breast Implants
Article in the Los Angeles Times -- Breast implant makers, plastic surgeons expect boost from silicone, by Daniel Costello:
Plastic surgeons and the two dominant Southern California-based makers of silicone breast implants are gearing up for what they expect will be a boom in sales of the devices. The only question: How big of a windfall can they expect?
More than 290,000 women had breast augmentation surgery in the U.S. last year, most with the saltwater-filled versions that have been legal for years. With last week's Food and Drug Administration approval of silicone implants — generally considered to have a more natural look and feel — many in the industry believe a large percentage of women could quickly switch. In countries where both products are sold, silicone implants make up nearly 90% of the market.
Some doctors also predict that overall growth in breast augmentations could accelerate, as women waiting for approval of silicone implants visit their doctors and others with saline implants consider replacing them.
November 20, 2006
NY Sun Editorial on Mass Torts
Today's NY Sun editorializes on the FDA's recent decision to permit cosmetic use of silicone gel breast implants. The editorial -- Now They Tell Us -- links breast implants to asbestos and Vioxx, suggesting that the entire mass tort litigation system is out of whack:
The Food and Drug Administration recently lifted its 14-year ban on the use of silicone breast implants for cosmetic purposes, saying that even though the devices are unlikely to last a lifetime — surgeons will need to warn patients of the likelihood of future surgeries — there is no scientific evidence that leaking silicone implants cause cancer or other serious illnesses. So where does Dow Corning go to get its $3.2 billion back?
That's the amount the erstwhile silicone implant manufacturer paid out from the jaws of bankruptcy court in 1998 to settle 170,000 lawsuits filed over its supposedly faulty implants. ...
Indeed, silicone implants join asbestos and Vioxx in the pantheon of products that have been the subject of some of the most irrational litigation in history. Women whose silicone implants had ruptured and leaked couldn't actually prove that their implants had caused the illnesses they were suffering. The majority of today's asbestos plaintiffs can't prove they're suffering any illness at all. And Vioxx's alleged victims can't point to any actual proof that the arthritis drug's cardiac risk is greater than that posed by over-the-counter painkillers. Yet overeager lawyers were happy to sue, and the courts have been only too happy to oblige. Trial lawyers are currently trying to eviscerate Merck, Vioxx's manufacturer.
Merck has elected to fight each Vioxx suit individually, and that strategy seems to be working, but it's hard to fault Dow Corning or asbestos manufacturers for settling the suits against them instead of taking them to trial. The FDA's latest announcement does, however, highlight the broader dangers of leaving the out-of-control liability system unreformed. With the benefit of hindsight it is even clearer than it was before that the only crime Dow Corning committed was selling what was then a perfectly legal product that turns out to be safe. For that transgression, the company was allowed to be eaten alive by the trial bar. Dow Corning managed to survive. Others haven't been so lucky. Congress needs to decide how many more companies will suffer Dow Corning's fate before lawmakers deliver much needed legal reforms.
It's hard to argue with the editorial's 20-20 hindsight on the breast implant litigation, but I question whether it's fair to throw asbestos and Vioxx into the same bucket. The wisdom of "much needed legal reforms" depends on what legal reforms you're talking about, which depends mightily on what problem you're trying to address.
The breast implant litigation is the most egregious example of liability in the face of strong scientific evidence casting doubt on general causation. The scientific community largely rejected the claim that silicone gel breast implants caused autoimmune disease or other systemic disorders. Bendectin and Agent Orange come to mind as other major mass torts where plaintiffs' general causation case was questionable, but neither of those reached the scale of the breast implant litigation. It's worth remembering that the settlement class action in the breast implants case came after Judge Sam Pointer, overseeing the MDL, appointed a National Science Panel to report on whether breast implants caused the alleged harms. Without the court-appointed scientific experts, the defendants' exposure surely would have been larger. Even so, there's power in the editorial's rhetorical question: "So where does Dow Corning go to get its $3.2 million back?" The problem of litigation outpacing science is a serious issue in mass torts. But the editorial gets sloppy, I think, in suggesting that the lessons of the breast implant litigation extend to mass torts generally, rather than to the particular problems of scientific evidence and general causation.
The editorial points out that much recent asbestos litigation involves uninjured plaintiffs (and could have added that the claims are against third-tier defendants rather than against the major producers of asbestos-containing products, all of whom were bankrupted by the litigation). But the problems of exposure-only plaintiffs, latent disease, and substitute defendants differ from the problems of scientific evidence and general causation. The legal reforms to address the former set of problems (e.g., pleural registries, tort law on exposure-only claims and medical monitoring, and reforms of joint-and-several liability) differ dramatically from reforms to address the latter (e.g., court-appointed experts, jury reforms, phased trials, and preemption defenses).
It's too early to judge the Vioxx litigation, but at this point it seems that the most difficult problems there involve individual causation rather than general causation. If that's correct, then again, there's a huge difference in how the legal system ought to respond. In the absence of general causation, a defendant should face zero liability. When there's proof of general causation and a basis for liability, but individual causation remains difficult to establish, then liability serves the policies of deterrence and disgorgement, and the real problems are allocation and the extent to which tort compensation must be individualized.
In other words, to criticize the breast implant litigation is easy. To lump it with asbestos and Vioxx, and to demand "much needed legal reforms" as if it were obvious what those reforms should be, is a lot harder.
October 25, 2006
NJ Mass Tort Designation for Ortho Evra
On October 10, New Jersey centralized its state court litigation over Johnson & Johnson's Ortho Evra birth control patch. Plaintiffs allege that the contraceptive increases the risk of blood clots. Here's the Notice to the Bar and the accompanying announcement:
On October 11, 2006, the Supreme Court designated all litigation, pending and future, involving the Ortho Evra Birth Control Patch as a mass tort and assigned it for coordinated, statewide handling in Middlesex County by the Honorable Bryan D. Garruto. This litigation involves claims against the manufacturer and others of this pharmaceutical for damages allegedly caused by its use.
This statewide centralization comes well after the federal MDL transfer. On March 1, 2006, the Judicial Panel on Multidistrict Litigation transferred all federal court Ortho-Evra cases to Judge David Katz in N.D. Ohio.
October 18, 2006
Study: Neck Stents Present Stroke Risk
Article in the Washington Post -- Study: Neck Stents Present Stroke Risk, by Mike Stobbe of the Associated Press:
An experimental treatment used to clear clogged neck arteries carries a higher-than-expected
risk of stroke and death, according to a study that was stopped early for safety reasons.
The study compared the use of stents _ small tubes that prop open blood vessels _ with a
common surgical procedure for cleaning out blockages in the carotid artery. Deaths and
strokes were more than twice as common in patients treated with stents, the researchers found.
The findings conflict with influential earlier research, which found stents to be safer.
October 13, 2006
FDA Review Sought Of Data on Implants: Risks Possibly Minimized, Group Says
Interesting article in today's Washington Post -- FDA Review Sought Of Data on Implants: Risks Possibly Minimized, Group Says, by David Brown:
A consumer activist organization yesterday asked the Food and Drug Administration
to investigate what it considers a possibly criminal attempt to suppress information
about the risks of the new generation of silicone breast implants.
In a letter to the FDA's administrator, Public Citizen said it learned of test results --
some new, some reinterpreted -- from a scientist at implant maker Mentor Corp. who
says he could not persuade his bosses to forward the data to the regulatory agency.
The scientist had worked for 15 years for Mentor, which is based in Santa Barbara,
Calif. He was let go earlier this year in a company reorganization, although he thinks
his protests to superiors were part of the reason.
September 15, 2006
Guidant Settles Device Suit
Article in today's New York Times -- Guidant Settles Device Suit, by Bloomberg News:
The Guidant Corporation, the maker of implanted heart devices, settled a fraud suit
over its recalled defibrillator for an undisclosed amount, a plaintiffs’ lawyer said
The trial in the civil suit brought by two plaintiffs, Beatrice O. Hinojosa and Louis E.
Motal, was scheduled to begin Monday in Corpus Christi, Tex. The plaintiffs claimed
the company failed to warn them that their implanted heart devices might fail.