Supreme Court Ruling Favors Medical Device Firms

Professor Elizabeth Malloy over at the Health Law Professors Blog sums up my reaction to the recent Supreme Court on medical devices manufacturers being shielded from liability:

"The New York Times reports on the Supreme Court's decision in which the Justices ruled "that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury." The Times reports,

The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.

In 1996, a balloon catheter burst and severely injured Charles R. Riegel while he was undergoing an angioplasty. Mr. Riegel and his wife, Donna, sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.

But a federal district court and the United States Court of Appeals for the Second Circuit, in Manhattan, dismissed the Riegels’s suit on the ground that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. (The case of Riegel v. Medtronic was tried in federal court because the plaintiffs and defendant were based in different states.)

The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”

But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.

In 1996, when there was a different lineup of justices, the Supreme Court ruled that medical devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At the time, the federal government took that position.

But in 2004, the Bush administration reversed the government’s position and began to take the side of manufacturers. In the Medtronic case, the administration argued that there would be “serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits” if juries could second-guess the agency.

Justice Ruth Bader Ginsburg was the lone dissenter on Wednesday, asserting that the majority had adopted an unnecessary “constriction of state authority.” Justice Ginsburg said she did not believe that Congress had intended to bring about “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”

But, will the Supreme Court have the last word on this topic . . . we discover that perhaps not -

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Representative Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

Senator Edward M. Kennedy of Massachusetts, the chairman of the Senate Health, Education, Labor and Pensions Committee, agreed, saying: “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”

If I had a better feeling about how the people running our government, I probably wouldn't be upset by this decision but it doesn't appear that everyone is playing on a level field. With all the stories in the news about recalls for tainted products and food, I am a bit concerned about the regulators being influenced too greatly by those they are supposed to be regulating."


I couldn't have said myself, Elizabeth -- thank you for posting this.

News: Kansas Court Blocks Records Request

The Kansas Supreme Court has temporarily ruled on an appeal filed by Dr. George Tiller's attorneys, blocking the grand jury from obtaining semi-redacted medical records of patients that had late-term abortions.

Tiller's attorneys had asked that the court squash the subpoenas and disband the jury, primarily citing serious concerns about patients' privacy, and the power and reach of the Kansas grand jury system. The Center for Reproductive Rights of New York has filed a second petition with the court, also asking that the case be dismissed on behalf of the patients affected by the records subpoena, again citing patient privacy laws and expectations of medical privacy.

The spokeswoman for Kansas For Life, one of the groups behind the grand jury formation, has said that the ruling is extremely disappointing and that

there is no way to determine if the reasons for these late abortions were done within the narrow legal criteria without looking at the records themselves. His lawyers say they are worried about women's privacy. They are worried about protecting Dr. Tiller.

Those presiding over the grand jury have until February 11 to file their objections with the Kansas Supreme Court, who then plan on issuing a ruling by the end of February.
-Kelly

Kansas Abortion Provider Ordered to Turn Over Medical Records

What do you consider identifying personal data in your medical records? It's not a trick question, but a genuine one based on the ruling, earlier this week, that a Kansas abortion provider must turn over 2,000 patient records - the records of all women who have had late term (21 weeks or later) abortions in the past five years.

In Kansas, citizens have a right, based on an obscure 19th century law, to convene grand juries when they feel the government isn't enforcing a law. As far as I can trace back, the two citizen subpoena's are based on two separate laws that Kansas for Life feels are not being enforced, and that these records are necessary to prove it. The first law requires reporting sexual abuse in minors (and they argue that 11 and 12 year old's are receiving late term abortions without the 'abuse' being reported), while the second prohibits late term abortions unless they are medically necessary.

In other words, it's a wide dragnet to investigate abortion in Kansas.

Now, to be clear, I'm not basing this conclusion on who is behind the subpoena, or even the stated goals of the prosecuting attorneys. I'm basing it on the argument that they are looking for signs of abuse, or medical necessity - in health records that are supposedly going to be redacted of name, age, and identifying medical history.

If you take away name, age, and identifying medical history - exactly what do you have left, that allows the investigation of either of these laws that Kansas for Life says are not being enforced?

Further indications that this is a wide dragnet hidden behind other laws is the fact that they also want the records of any woman who was 22 or more weeks pregnant who came in and even consulted about an abortion, even if she didn't have one. Where's the necessary information here in enforcing laws? I can't see one - and the request is construed broadly enough that it sounds as if even mentioning abortion (even to say "well, I know it's an option because the fetus has XYZ problem, tell me more about it... mm, I don't think that's for me, but thanks") is enough to flag your record.

So the question then becomes - can you truly redact medical records that will remove personal and identifying information, and still leave meaningful data that will tell them what they want to know about abortions in Kansas? Your medical history is a map across your body, building a record that's unique to each individual. Every scar I have leads the way to a story, every surgery, every break and set of bone, every time my lungs decide to stop working. Every medication taken is a marker along the path, all of which will build to create a single individual.

Yes, in theory Tiller, the abortion provider, will be passing these files to another doctor and attorney to independently review and redact. But I remove identifying data from papers all the time, and I know how easy it is to miss just a single word that clearly flags who the person is. Attempting to redact 2,000 medical records in 68 days? The magnitude of error possible is staggering.

As of yesterday, Tiller's attorneys have filed an appeal to the Kansas Supreme Court, and refused to hand over any files until after the Supreme Court makes their ruling.

-Kelly