Archives for August 2011

From the News Desk

The news has been a little busier this week, most notably with an announcement that HHS awarded $137 million to states to boost prevention and public health. Elsewhere:

The Big Business of Devices

In an analysis of federal data, conducted and reported on by The New York Times, the Food and Drug Administration has received more than 5,000 reports since January of 2011 about several widely used hip replacement devices using metal-on-metal joints.  The number of reports the agency received surpassed the total amount about those devices in the previous four years combined.  All-metal replacement hips are on a trajectory to become the the largest medical implant problem since Medtronic recalled a widely used heart device component in 2007.

The report also noted that one of the most problematic hip replacement devices, the ASR, or Articular Surface Replacement, and was recalled last year by Johnson & Johnson accounted for 75 percent of the complaints.  While the increase in reports may be attributed to an increased awareness among the public and FDA because of the recall, the situation brought to light the FDA’s difficulties in relying upon device manufacturers to self-police.

Not surprisingly, in May of this year the FDA ordered postmarket surveillance studies be conducted by the manufacturers of the hip systems distributed in the U.S. to better understand possible adverse events associated with metal debris from metal-on-metal hip systems.  In the case of all metal implants, both the ball and socket of the artificial joint are made of metal.  When those two parts rub together during normal wear and tear, minuscule particles of metal can shed and be released into surrounding tissue and even into the bloodstream.  A valid concern of these patients is whether long-term exposure to the devices’ toxic metals can lead to health issues, localized as severe damage to tissue, including necrosis, infection and allergic reactions, and systemic as renal problems and cancer.  Even amid concerns about certain models of artificial hips, most patients have no problems.

The unconventional FDA action was partly driven by consumer complaints that the metal bearings, which should last up to 15 years, were exhibiting early failures.  Although the order was unprecedented, the problem with the FDA’s review is that thousands of patients already have had the replacement systems implanted and unfortunately too late to be of much good for those in pain.  As discussed earlier this month, the mounting pressures on the agency support the notion that the medical device approval process has notable flaws. 

Regardless of whether the device manufacturers or FDA is at fault, whether it is a consequence of hyper-aggressive marketing by the device companies to sway physicians to use their products or lack of oversight by the FDA, patients stand to lose the most.  More than 800,000 joint replacement procedures are done in the United States every year, according to the American Academy of Orthopaedic Surgeons.  Knee replacements are the most common, followed by hips.  With this sheer number of joint replacement surgeries performed annually, it is surprising that the government still does not have a national joint registry in place. 

Countries such as the United Kingdom, Australia, and Sweden have national joint registries, which monitor the performances of these types of devices.  The national joint registry is used to gather a patient’s basic information, hospital and surgeon information, the procedure and device used, as well as note if a patient has a revision surgery. The registries can used to identify a device that is defective or malfunctioning and is not working on par with other comparable devices.

The ASR system that was used extensively prior to its recall may have benefited from a U.S. joint registry to inform physicians and their patients of possible complications.  For instance, Australian surgeons had access to information in their national joint registry regarding the higher rates of revision surgery for the ASR system in 2007, leading to Australian physicians reluctance to use the device in hip replacement surgeries.  This played a role in the eventual withdrawal of the device from the Australian market in 2009 – in advance of the general recall here in the U.S. in 2010.

U.S. physicians do not have a national government-affiliated registry to reference regarding how well a certain device is performing.  There are various enterprises associated with hospital networks, but the dearth of information on a national scale is pronounced.  Additionally, in the current environment, the FDA typically relies upon companies to provide the agency with safety reports on their products.  In turn, the hip replacement safety issues support the idea that at times there is a basic difficulty with letting industry – and one can choose whichever industry one wants – be self-policing.  For instance, a medical journal alleged that Medtronic downplayed the risks of its spinal repair protein and failed to disclose millions of dollars in payments to the authors who wrote the initial studies of the product.  The spinal repair protein accounted for 85 percent, or $750 million, of Medtronic’s total spinal repair business, which is its second largest.

Medical devices are big business. Caveat emptor.

Health Care Reform Law Heads Toward Supreme Court

No other piece of legislation signed into law by President Barack Obama has sparked more controversy than the Patient Protection and Affordable Care Act of 2010 (known as  “ObamaCare” to its critics) (P.L. 111-148).  After months of debate and controversy, the President signed the comprehensive health reform measure into law on March 23, 2010.  Dozens of lawsuits were promptly filed across the country contesting the bill’s constitutionality. In each of the suits, the main issue has focused on whether the “individual insurance mandate” provision that requires every American adult either to obtain health insurance or to pay a penalty for failing to do so is a violation of the Constitution’s Commerce Clause.  The lower federal courts have split on the matter, setting up a battle in the nation’s highest court.

Individual Mandate

Generally, opponents of the law contend that the individual mandate provision is unconstitutional as exceeding the scope of Congress’s powers. Supporters maintain that it falls within Congress’s authority to regulate commerce among the states and as an exercise of congressional power to tax and spend for the general welfare.  Every judge who has ruled on the issue has recognized that Congress has never previously imposed a comparably sweeping mandate under the Commerce Clause, and that the Supreme Court has never ruled on the issue of whether Congress has a general power to regulate “inactivity.”

Most recently, the Eleventh Circuit Court on August 12 struck down the individual mandate provision.  Writing for the majority of the court in Florida v HHS, Chief Judge Joel F. Dubina said Congress could do many things under the commerce clause, but one thing it could not do was “mandate that individuals enter into contracts with private insurance companies for the purchase of an expensive product from the time they are born until the time they die….The federal government’s assertion of power, under the Commerce Clause, to issue an economic mandate for Americans to purchase insurance from a private company for the entire duration of their lives is unprecedented, lacks cognizable limits, and imperils our federalist structure.”

 The Court, however, did not strike down the entire law, as a federal judge in Florida had done earlier, because the Circuit Court found that the insurance mandate could be scrapped without nullifying all of the sweeping law.  This was the second federal appeals court ruling on the constitutionality of the insurance mandate, and it conflicted directly with the first — by the Sixth Circuit (Thomas More Law Center, et al v Obama). The Sixth Circuit upheld the law, holding that the individual mandate “falls within Congress’s power to regulate activities that substantially affect interstate commerce.”

Keeping Score

 Twenty six federal lawsuits have been filed seeking to overturn the Act. To date, two district courts have found that the individual mandate exceeds Congress’s power under the Commerce Clause, and three district courts have upheld the mandate.  Two circuit courts have split.  More courts are expected to weigh in in the next few months.

Looking Ahead

The battle over the constitutionality of the Obama administration’s health reform law is almost certainly headed for the Supreme Court.  How the Court will rule is anyone’s guess, but a deeply divided Court would not be surprising, given the ideological gap that exists on the extent of the government’s reach raised by these lawsuits.  If the federal government prevails, Congress is likely to have an unlimited power to impose mandates of any kind.  If the plaintiffs win, the Court will have reaffirmed the importance of constitutional limits on federal power.

 The Supreme Court is likely to decide by January whether it will weigh in on the controversial case in the Spring, meaning that a ruling could come before the November 2012 election.  The stakes couldn’t be higher for the Justices, for lawmakers, for President Obama, and for the voters.

Ban on Political Contributions from Medicaid Providers Upheld

The constitutionality of an Ohio statute prohibiting Medicaid providers or owners of Medicaid providers from making contributions to candidates to the office of Attorney General or county prosecutor in Ohio, was recently upheld in the decision of Lavin v. Husted.  Medicaid providers challenged the  state law as an unconstitutional limit on their First amendment right to free speech.

 A state law must meet two requirements for a ban on political contributions to not be considered an unconstitutional limitation on free speech:

  • (1) the law must be closely drawn to advance a sufficiently important state interest, and
  •  (2) the law must be a marginal restriction of free speech that does not preclude or ban a majority of other types of free speech.

The United States District Court for the Eastern Division of the Northern District of Ohio determined that the Ohio law met both of these requirements.

Marginal and closely drawn

While the Ohio statute places a ban on contributions from Medicaid providers or owners of Medicaid providers to these particular type of candidates, it does not (1) prevent Medicaid providers or their owners from making contributions to political action committees or political parties that support these candidates; (2) place a limit on a family member or employees of a Medicaid provider or owner from contributing to a candidate; nor (3) infringe upon a Medicaid provider’s ability to make symbolic expression of support or prevent any provider or owner from participating in any other First Amendment activity in support of a candidate for these offices. For these reasons the statute places only a marginal restriction on the free speech protections of the First Amendment and it meets the requirements for limiting contributions established by the U.S. Supreme Court in Buckley v. Valeo, 424 U.S. 1 (1976).

Also in Buckley , the Supreme Court determined that limitations on political contributions did not violate the First Amendment’s protection of free speech if the limitation was closely drawn to advance a sufficiently important state interest. The district court found that the Ohio Secretary of State presented sufficient evidence regarding Medicaid fraud in Ohio, and the role of county prosecutors and the Attorney General in combating that fraud, to justify limiting campaign contributions under this closely drawn principle. Banning political contributions to these elected officials was one way to prevent the corruption, or the appearance of corruption, in the prosecution of Medicaid fraud.

Overbreadth argument

The Medicaid providers also argued that the state law would prohibit political contributions from an individual owning just one stock of large chain stores that fills Medicaid prescriptions, as they would be considered an owner of a Medicaid provider. Even though the providers  did not have standing to make this argument, as none of them were stockholders in these stores, they relied on the overbreadth doctrine which permits litigants to challenge a statute not because their own rights of free expression are violated, but on the basis that the statute’s very existence may cause others not before the court to refrain from constitutionally protected speech. The district court found that since this case does not involve pure speech, but rather, a form of expression that (1) can be limited due to its marginal restriction and (2) is closely drawn to further a sufficiently important government interest, the alleged overbreadth is not substantial enough to justify invalidating the state statute.