< TortsProf Blog: Legislation, Reforms, & Political News

May 14, 2008

FDA Asks Congress for Money

As the New York Times reports, the FDA has asked Congress for an "immediate infusion of $275 million to ensure that imported foods, drugs and medical devices are safe."

Last week, Senator Herb Kohl, Democrat of Wisconsin, who is chairman of the Senate appropriations subcommittee with jurisdiction over the F.D.A., sponsored a measure that would provide the F.D.A. an additional $275 million this year as part of an emergency supplemental appropriations bill largely intended to finance the war in Iraq.

The supplemental bill may be the only way to provide additional financing to the F.D.A., since appropriations bills for next year are likely to stall.

Mr. Kohl’s measure mirrors [FDA Chief] Dr. von Eschenbach’s letter to Mr. Specter. Both call for $125 million to finance food safety activities; $100 million for medical product and drug safety activities; $40 million for modernizing F.D.A.’s science and work force; and $10 million to upgrade agency facilities and laboratories.

- SBS

May 14, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

May 13, 2008

Apartheid Suit Continues

As MSNBC (via AP) reports, the United States Supreme Court upheld a Second Circuit decision allowing an Alien Tort Claims Act suit to proceed against various banks and corporations based on their alleged "aiding and abetting" of the apartheid system in South Africa by providing loans and goods.   The Supreme Court did not reach the merits of the appeal, but rather was forced to affirm when four Justices recused:

Chief Justice John Roberts and Justices Samuel Alito, Stephen Breyer and Anthony Kennedy provided no explanation for their decision not to take part in the case.

But those justices have ties to Bank of America Corp., Bristol-Myers Squibb Co., Colgate-Palmolive Co., Credit Suisse, Exxon Mobil Corp., Hewlett-Packard Co., IBM and Nestle SA, among nearly three dozen companies that asked the high court to step in.

Kennedy does not hold stock in any affected company, but his son, Gregory, is a managing director at Credit Suisse. Kennedy sat out a case last term involving the investment bank.

The case returns to the lower courts for further proceedings.  In a two-part series on Findlaw, Tony Sebok analyzed the Second Circuit's decision and argued that the win may prove to be a "pyrrhic victory" for the plaintiffs. (Prior posts here and here).

- SBS

May 13, 2008 in Current Affairs, Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

May 12, 2008

Preemption Legislation Hearing Scheduled

I don't see this up on the Oversight Committee's website yet, but just received this by e-mail:

Should FDA Drug and Medical Device Regulation Bar State Liability Claims?
Committee on Oversight and Government Reform
Wednesday, May 14, 2008, 10:00 AM at 2154 Rayburn House Office Building
http://www.oversight.house.gov/

Witnesses: Actor Dennis Quaid and his wife Kimberly, parents of newborn twins, Thomas Boone Quaid and Zoe Grace Quaid, who were victims of a heparin overdose; William Maisel, director of the Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston; Aaron Kesselheim of the Harvard Medical School's Division of Pharmacoepidemiology; David Kessler, professor of pediatrics and epidemiology and biostatistics at the School of Medicine, University of California, San Francisco; David Vladeck, professor of law at the Georgetown University Law Center; Gregory Curfman, editor of the New England Journal of Medicine; Christine Ruther, president and chief engineer for C&R Engineering, Inc.; and Utah State Representative David Clark (R) of the National Conference of State Legislatures.

--BC

May 12, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

May 05, 2008

Study on Texas Liability Modifications

Texans for Lawsuit Reform commissioned a study on the effects of the various reforms in that state over the past couple of decades.  That study (PDF of report, article in The Monitor) concludes that "the reforms [since 1995] have resulted in nearly $113 billion in additional annual spending, almost 500,000 new jobs and $2.6 billion a year in increased state budget resources."  The study was done by the Perryman Group, a Waco economics group that does economic and policy analysis.

--BC

May 5, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

April 30, 2008

Second Circuit Weighs In on NYC Menu-Calorie-Regulation

As noted yesterday, a federal district judge has upheld the NYC regulation requiring chain restaurants to post calorie information.   The United States Court of Appeals for the Second Circuit has now lifted a stay, allowing the law to go into effect.  The city, however, has agreed to delay issuing any fines under the new law until July 18th.   As WNBC reports, yesterday's oral argument on the stay might have foretold at least one Judge's position on the merits:

In arguments earlier Tuesday, [Restaurant Association lawyer Kent] Yalowitz said restaurants believe federal laws pre-empted local efforts to try to regulate how restaurants describe the contents of their food. He said the First Amendment rights of restaurants protected them as well.

Judge Rosemary Pooler noted that cigarette packages contain health warnings. "If we were to adopt your view, no warnings would ever appear on anything," she said.   

- SBS

April 30, 2008 in Current Affairs, Legislation, Reforms, & Political News, Products Liability | Permalink | Comments (0) | TrackBack

April 29, 2008

Would You Like to Supersize?

On April 16th, U.S. District Judge Richard J. Holwell upheld New York City's revised Regulation 81.50, which require restaurants to post calorie information on menus.  As previously reported, Judge Holwell struck down the original regulation last September.  The original regulations only applied to restaurants that already had voluntarily disclosed nutrition information to their customers.  Judge Holwell concluded that the original regs were preempted by the federal Nutrition Labeling and Education Act of 1990 because the NLEA regulated voluntary disclosure of nutrition information by restaurants.   

In his latest opinion, however, Judge Holwell found that the revised regulation "is not preempted by NLEA because that statute explicitly leaves to state and local governments the power to impose mandatory nutrition labeling by restaurants."    Judge Holwell also rejected a First Amendment challenge by the Restaurant Association.  The New York Law Journal (via law.com) has a full report on the decision. 

The new regulations took effect on Monday, April 21st, and only apply to chain restaurants with at least 15 outlets across the country.  WNBC reports that the Health Department will not start fining restaurants until June 1st. 

- SBS

April 29, 2008 in Current Affairs, Legislation, Reforms, & Political News, Products Liability | Permalink | Comments (0) | TrackBack

Utah AG Calls for Punitive Damages Cap

On Monday, Utah Attorney General Mark Shurtleff stated that he is open to a cap on punitive damages awards. 

To help improve the state's legal climate, Shurtleff said caps on punitive damage awards would, among other things, help prevent physicians from being driven from Utah by skyrocketing medical malpractice premiums, as has happened in Nevada.

"A lot of times those punitive damages awards are outrageous, and the cumulative effect, particularly when it comes to medical malpractice litigation, can create a situation like they have in Nevada," Shurtleff said.

Doctors are just leaving the Silver State because they can't afford their insurance premiums anymore, "and a big part of that is because of these horrific damage awards that are being awarded in some of these cases," he said.

Via Legal Newsline.

- SBS

April 29, 2008 in Damages, Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

April 28, 2008

Obama & Liability Reforms

On his much-hyped Fox News appearance, Barack Obama cited his support of tort reform (presumably CAFA) as evidence of independence.  Point of Law is underwhelmed.

--BC

April 28, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

April 26, 2008

Med Mal Reform in Tennessee

Both houses of the Tennessee General Assembly have passed a medical malpractice reform bill; it is now in the hands of Governor Phil Bredeson.  The Memphis Business Journal states:

The bill will require attorneys to file a certificate of good faith to reduce the number of medical malpractice claims that end in no payment to the plaintiff. The bill will require that medical providers are notified 60 days before a medical malpractice lawsuit is filed. The plaintiff's attorney would need to get certification from a qualified medical expert that there is good cause to pursue a claim against defendants. Also, attorneys who fail to comply with certification rules will be penalized. The bill does not provide for any limits on non-economic damages.

--CJR

April 26, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (1) | TrackBack

April 23, 2008

Lawsuit Climate 2008

The Institute for Legal Reform has released its annual ranking of the civil litigation systems in the fifty states.   The top five states, in order, are Delaware, Nebraska, Maine, Indiana and Utah.  The bottom five, also in order, are West Virginia, Louisiana, Mississippi, Alabama and Illinois.  The full report is available here [pdf].

- SBS

April 23, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

GAO Report on FDA: Recent Initiatives Have Potential But Weaknesses Remain

In a report [pdf] released yesterday, the Government Accounting Office concluded that "[r]ecent FDA initiatives--some of which have been implemented and others proposed--could strengthen FDA's foreign drug inspection program, but these initiatives do not fully address the weaknesses that GAO previously identified."  For example,

[In November 2007], GAO testified that gaps in information weaken FDA's processes for prioritizing the inspection of foreign establishments that pose the greatest risk to public health. While FDA recently expressed interest in obtaining useful information from foreign regulatory bodies that could help it prioritize foreign establishments for inspections, the agency has faced difficulties fully utilizing these arrangements in the past. For example, FDA had difficulties in determining whether the scope of other countries' inspection reports met its needs and these reports were not always readily available in English.

- SBS 

April 23, 2008 in Current Affairs, Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

April 22, 2008

FDA Traces Tainted Heparin In 11 Countries to China

The New York Times reports that the FDA has identified 12 Chinese companies that supplied contaminated heparin (an anti-coagulant) to 11 countries, including the United States.  In addition, "federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States."

- SBS

April 22, 2008 in Legislation, Reforms, & Political News, Products Liability | Permalink | Comments (0) | TrackBack

April 18, 2008

PA: Med Mal Claims Remain Lower Post-Reform

In 2003, Pennsylvania, via both the Pennsylvania Supreme Court and the legislature, instituted several medical malpractice reforms.  The court prohibited venue shopping and required lawyers to file a certificate of merit for their cases.  The legislature created a fund to subsidize malpractice insurance.  Since those reforms, claims have dropped significantly.  There were 2,903 claims in 2002, as compared with only 1,693 in 2006 and 1,617 in 2007.  The Pittsburgh Business Times has the story.

--CJR

April 18, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (1) | TrackBack

April 15, 2008

Senate Hearing on FDA's 2009 Budget

The Senate Appropriations Committee is holding a hearing today on the FDA's fiscal year 2009 budget.  As Business Week (via AP) reports,

FDA's advisers recommended boosting the agency's budget by $375 million in the next fiscal year, and the Senate recently passed a resolution supporting such an increase. The White House proposed a $54 million increase in its budget.

Democratic Sen. Herb Kohl, who chairs the subcommittee that sets FDA's budget, is expected to question whether the agency's plan to hire 200 additional safety inspectors is enough.

In related news, the FDA has linked certain brands of recalled puffed rice and puffed wheat cereal to salmonella outbreaks in thirteen states.

- SBS

April 15, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (1) | TrackBack

April 14, 2008

Virginia Weighs Upping Caps on State Liability

In reaction to the Virginia Tech shootings, the Washington Post reports, several Virginia legislators are considering increasing the cap on state damages, which has been set at $100,000 since 1993.  The state has reached an agreement in principle to settle the potential litigation for a total of $11 million, and any change to the caps would not apply to the VT victims' families' lawsuits.

--BC

April 14, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

April 10, 2008

Liability Changes Maybe Alive Again in Oklahoma, Only Not Probably for Very Long

Last year, Oklahoma's governor vetoed legislation that would have changed various things in that state's tort system -- capping noneconomic damages at $300K, requiring clear and convincing evidence of intentional conduct or gross negligence for punitive damages, etc.  There's more about the veto in this post.

Well, it's back.  And presumably it has the same fate; it seems at least plausible that this being an election year has just a little to do with its reintroduction.

--BC

April 10, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 31, 2008

Scalia Is Not Fond of the Press Reporting on Preemption

Eric Posner, on the new Slate law blog, has more on Scalia's criticism of press coverage, finding that, indeed, some coverage of the Riegel preemption ruling suggested that the Court just decided it liked the FDA, and that tort suits were thus preempted -- rather than engaging in a textual analysis, etc.  Of course, as Posner points out, how one does that textual analysis is often (always?) affected by one's other inclinations, so some of the discussion (particularly that of the NYT's editorial) is not as unfair as Scalia suggests.

--BC

March 31, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 26, 2008

Is the FDA Tougher Than Its European Counterpart?

Today's Wall Street Journal includes an interesting article by Jeanne Whalen comparing the FDA's approval process for new drug applications with the European process:

It is unclear whether getting FDA approval has become tougher than getting approval from its European Union counterpart in London, the European Medicines Agency, known as the EMEA. Current data on the speed of approvals in the regions aren't available. In a study comparing the FDA and EMEA from 2000 to 2005, Tufts University researchers found that mean approval times were similar at the agencies -- about 15.7 months -- but that there was "considerably more variability" in FDA approval times.

Some industry executives theorize that the FDA faces more public and political pressure when considering approvals. 

- SBS

March 26, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 25, 2008

Hillary on Tort Reform

MedPage Today reports on a conversation with Neera Tanden, the chief policy director for Senator Hillary Clinton's presidential campaign.   The interview included Senator Clinton's position on tort reform:

On tort reform, Clinton and Obama see practically eye to eye. Before they became presidential candidates, the two senators co-authored an article in the New England Journal of Medicine and co-sponsored legislation to fund programs for the disclosure of medical errors and compensation to patients. The bill would have created an office of public safety. Physicians would be given some protection from liability under a system that encourages greater disclosure.

Like Obama, Clinton strongly opposes caps on awards for pain and suffering. "There are instances where injured patients would be disadvantaged by a cap," said Tanden. "Malpractice premiums have gotten out of control and Hillary is focusing on reforming the insurance system so that physicians won't have to pay as much."

McCain, who has voted in favor of caps, says tort reform is a top priority. He favors eliminating liability for physicians who follow clinical guidelines and adhere to patient safety protocols.

- SBS

March 25, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 21, 2008

Washington AG Decries Costs of Tort Law

On Wednesday, the Attorney General of Washington, Rob McKenna(R), faulted tort law for siphoning away scarce government resources.  He cited the lack of boundaries on claims and Washington's continued use of joint-and-several liability.  He also compared Washington's annual tort payments with those of neighboring states (allegedly ten-times as much as Idaho and six-times as much as Oregon).  McKenna did not advocate a return to sovereign immunity, but called for limits.  He also said he would not propose tort reform again (he last did so in 2006) until it had a reasonable chance of passage.  The Washington State Trial Lawyers disputed McKenna's characterization of Washington as overly-friendly to liability. The group noted that Washington is one of only two or three states that allows no wrongful death suit by anyone on behalf of a person who reaches the age of majority and has no children, thus allowing a complete avoidance of responsibility for the death.  In addition, Washington is one of the few states that has no punitive damages.  The full story is here.

--CJR

March 21, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 20, 2008

Tort Reform Dead Again in Hawaii

After passing the Health Committee, the Hawaiian tort reform bill moved to the House floor, where the House agreed by voice vote to send the bill back to committee.   The Honolulu Advertiser has more.  State KHNL reports that Rep. Josh Green (D-6th)  plans to bring tort reform up again next session.

- SBS

March 20, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 19, 2008

Katrina Victims Sue FEMA

Hurricane Katrina victims have added the Federal Emergency Management Agency to their suit against the manufacturers of trailers provided to the victims for emergency housing following the hurricane.   The suit alleges that the trailers contained hazardous fumes that caused the nearly 100 plaintiffs to become ill.  As the Houston Chronicle (via AP) reports,

Many trailer occupants have blamed their illnesses on formaldehyde, a common preservative found in building materials. Formaldehyde can cause respiratory problems and has been classified as a carcinogen by the International Agency for Research on Cancer.

The plaintiffs accuse trailer makers of using shoddy materials and construction methods in a rush to fill FEMA's unprecedented demand for emergency housing after Katrina laid waste to tens of Gulf Coast homes in August 2005.

Recent government tests on hundreds of FEMA trailers and mobile homes in Louisiana and Mississippi found formaldehyde levels that were, on average, about five times higher than what people are exposed to in most modern homes.

Plaintiffs seek certification as a class action. 

- SBS

March 19, 2008 in Legislation, Reforms, & Political News, MDLs and Class Actions, Products Liability | Permalink | Comments (0) | TrackBack

March 18, 2008

Update: Tort Reform Alive Again in Hawaii

We've been following the on-again, off-again tort reform efforts in Hawaii for the past month or so.   As Chris recently mentioned, the original bill died in the judiciary committee at the end of February.

Now, it appears back "on again."   A revised version of the bill has passed the health committee, KHNL reports.  But the win may be short-lived as the bill now goes back to the judiciary committee.

At the same time, a resolution was offered in the House asking the Legislative Service Bureau "to study the effects of medical tort reform on access to health care and to submit a report of its findings to the Legislature no later than twenty days prior to the convening of the Regular Session of 2009."

- SBS

March 18, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 16, 2008

Med Mal: Torts v. Contracts

Jennifer Arlen (NYU) has posted to SSRN a new paper, "Contracting over Malpractice Liability," discussing the recent trend towards advocating for a contractual resolution of medical malpractice rather than a tort one.  The abstract:

Proponents of contractual liability assert that contracting is superior to malpractice because patients will select the rules that maximize their welfare so long as contracting is voluntary and the parties correctly estimate the costs and benefits of imposing liability. This article analyzes the claim that patients have optimal incentives to contract into liability when they are informed about the consequences of liability. It shows that contractual liability is inefficient, even when patients are informed, because contracting itself is not an optimal mechanism for imposing liability because patients derive less benefit from imposing liability by contract than they could obtain from liability imposed by the state by fiat. Specifically, this article examines the two plausibly-efficient forms of contractual liability: individual negotiable contractual liability and MCO contractual liability. It shows that neither provides patients with sufficient benefits to induce optimal contracting over liability.

Patients engaged in individual negotiated contracting with medical providers at the point of service do not have optimal incentives either to adopt malpractice liability reforms or contract around reforms adopted by the state because malpractice liability is designed to confer collective, multi-period, benefits on patients - in the form of investments in safety that benefit many patients collectively both now and in the future. Patients do not derive the full benefit of the collective, multi-period investments produced by malpractice liability when required to impose it through individual contracts. Accordingly, even when contracting is informed and voluntary, patients can be harmed by the introduction of contractual liability because it provides incentives for them to reject liability even when they would be better off were liability imposed by the state. By contrast, collective non-negotiable contracting between patients and Managed Care Organizations) does not face as serious a collective goods problem. But this form of contracting is inefficient because it is distorted by adverse selection. MCOs will charge patients more for liability than is optimal because patients' demand for liability provides a signal of their expected demand for expensive medical services since liability confers the greatest expected benefits on patients likely to need hospital care. Accordingly, contractual liability will not induce even informed patients to impose liability whenever they would be better off were it imposed. Thus, we cannot be confident that states could better serve patients by allowing contracting over liability than they could by adopting effective reforms to malpractice liability and leaving it within the control of the tort system.

--BC

March 16, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (1) | TrackBack

March 14, 2008

Tort Reform Update: Colorado

The bill to raise the noneconomic damages cap (from $300,000 to approximately $460,000) in medical malpractice cases has been stalled, at least temporarily.  A House committee delayed the bill on Wednesday after doctors issued dire warnings about physician shortages and increased health care costs.  The story is here.

--CJR

March 14, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 12, 2008

Downer Cows in the Meat Supply

The president of the meat company that the Humane Society caught abusing cattle had a rough day in Congress, as the WSJ law blog reports. Remarkably, he claimed not to have seen the video that got rather a lot of attention. To paraphrase Marge in Fargo, not so sure I agree with your witness prep work there.

--BC

March 12, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 11, 2008

Georgia Supreme Court Upholds Expert Witness Part of 2005 Tort Reform Law

In Mason v. Home Depot [pdf], the Georgia Supreme Court on Monday upheld the expert witness section (Section 7) of Georgia's 2005 tort reform law. Under this provision, expert witnesses in civil cases are subject to more stringent requirements than experts in criminal cases.  The Masons had argued that the civil expert witness provision violated the Equal Protection and Due Process Clauses.  The Georgia Supreme Court, however, rejected both arguments and upheld the constitutionality of the statute.

- SBS

March 11, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 08, 2008

Medical Malpractice, Tort Reform, and Insurance Reserves

A side-effect of Colorado's debate about raising the cap for noneconomic damages in med mal cases is a dispute over the size of the reserve of COPIC, the largest malpractice insurer in the state.  The Denver Business Journal has the details.

--CJR

March 8, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 06, 2008

NEJM on Device Safety

Launching from the problems with Medtronic's implantable defibrillators, William Maisel (Beth Israel Deaconess Medical Center, Boston) advocates for increased consumer protection provisions in the medical device context.

--BC

March 6, 2008 in Legislation, Reforms, & Political News, Products Liability | Permalink | Comments (0) | TrackBack

March 05, 2008

Senate Debates Toy Safety Bill

Yesterday, the Senate began debate on S.2663, a bill to overhaul the Consumer Product Safety Commission and increase toy safety.   The bill is a response to the numerous toy recalls from last summer.   

As the Chicago Tribune reports,

The House bill would tighten lead standards, mandate new toy safety testing and boost the CPSC's annual budget to $100 million by 2011, an increase of more than 50 percent from 2007.

The Senate version would give the agency more money and would go further in other ways. It would require even stricter toy testing, mandating industry standards that are now voluntary. It would extend whistle-blower protections to any company or government employees who expose unsafe products.

It calls for the creation of a new publicly searchable database of product safety information and complaints. It would set stricter lead standards and would give states more power to enforce product safety laws.

A Senate vote on the bill is expected this week.   The Senate version will then need to be reconciled with the bill passed by the House last year.

- SBS

 

March 5, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

March 01, 2008

Tort Reform Update: CO, HI, WY

Several significant tort reform actions in the states from the last day or two:

CO:  The full senate passed a bill increasing the cap on noneconomic damages in medical malpractice cases.  The story is here.

HI:  A bill that would have capped noneconomic damages at $500,000 for high risk medical specialties died because the judiciary committee chair would not hear it.  The story is here.

WY:  A bill is under review by a state senate committee that would restrict the medical malpractice loss of chance doctrine to cases where the chance of survival was less than 50%, but greater than 25%.  The vote is expected next week.  The story is here.

--CJR

March 1, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

February 26, 2008

Dallas Cowboy Part of Suit Challenging Texas Caps

Ron Springs, a former Dallas Cowboy football player, is one of eleven named plaintiffs in a suit challenging Texas's 2003 damage caps, reports the AP via the NYT. Springs's suit alleges medical malpractice during surgery to remove a cyst that resulted in brain damage.

--BC

February 26, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

February 25, 2008

Nader on Tort Reform

With Ralph Nader's announcement yesterday that he is again running for president, I thought it might be a good time to link to a 1995 column he wrote on tort reform for Legal Times, reproduced on the 'Lectric Law Library (still proudly sporting a 1995-era web design). You can also check out the Google cache of his 2004 statement on the issue; his new site does not appear to have anything on the subject as yet.

--BC

February 25, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

February 21, 2008

Updated: After Riegel

The Drug & Device Law Blog has a looking-forward post about what happens post-Riegel -- and, by implication, what happens after the rest of the preemption trilogy if, as seems at least possible, much state tort litigation related to FDA-approved drugs is preempted.

The question, as they accurately note, comes down to whether the mostly-regulatory, mostly-not-litigation approach to pharma safety can work. (Or at least whether it can work as well as the litigation-intensive system existing now.) I expect many (including me) would feel much more comfortable about a broad preemption in a world where the FDA didn't confuse factories with similar names and the like. Indeed, that's an example the D&D folks mention as "not cutting it." But that's not the world we have. Perhaps in light of the new world of preemption, FDA funding will get increased and expectations raised. We'll see.

If it does turn out to be a catastrophe, of course, Congress has the power to explicitly reject preemption, express, implied, and otherwise.

The post is worth a read. I think they've accurately captured what their clients need now to do in order to show that preemption is not a mistake.

Update: Eric Turkewitz discusses the post and links to more.

--BC

(As usual, I have done consulting to pharma clients. I realize that it's actually been a while since I've had any of that work, but I still note it in case it's of interest.)

February 21, 2008 in Legislation, Reforms, & Political News, Products Liability | Permalink | Comments (1) | TrackBack

February 20, 2008

Breaking: Riegel is Out, 7-1 for Preemption

The opinion is here [PDF]. Scalia wrote the majority opinion; Ginsburg dissented. There's some concurring in part going on too by Stevens. The opinion concludes that state common law claims based on medical devices that received premarket approval are preempted by federal law.

Update: The Drug & Device blog has a post on it; it's the first semi-in-depth post I've seen so far, at least in my usual rotation.

--BC

February 20, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

February 17, 2008

CPSC Overhaul Agreement In Sight

So reports the Washington Post. The compromise measure would more than double the beleaguered agency's budget and add some additional powers. Consumers' groups appear generally supportive (with a significant dissent from Public Citizen), while the National Association of Manufacturers was critical, contending that the new bill would not improve safety but instead merely increase litigation.

--BC

February 17, 2008 in Legislation, Reforms, & Political News, Products Liability | Permalink | Comments (0) | TrackBack

February 06, 2008

AMA: Punitives Caps Increase Access to Care

The American Medical Association (which, to say the least, has a dog in the liability fight) concludes that caps on punitive damages improves access to care:

The American Medical Association said yesterday its new analysis of independent research proves that capping punitive damages in medical malpractice cases both reduces doctors' malpractice insurance premiums and increases the number of physicians available to care for patients.

The AMA's press release is here, and the report itself is here [PDF].

--BC

February 6, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

Hawaii Considers Tort Reform Bill

The Hawaii House Consumer Protection Committee holds hearings today on HB 1992, a bill that would cap non-economic damages in medical malpractice actions at $250,000, and also require that economic damages be allocated based upon proportionate percentages of negligence.  The Honolulu Star Bulletin reports on the Hawaii Medical Association's support of the bill. 

- SBS

February 6, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

January 28, 2008

WNEC Hosting Hearing on Physician Availability

I just received this from our Institute on Legislative and Governmental Affairs:

The Law School’s Institute for Legislative and Governmental Affairs
cordially invites you to attend a hearing of the Commission on Public Health
Access in Sleith Hall Auditorium on January 30, 2008, from 1:00 – 5:00 p.m.
The 14-member Commission is charged with the investigation and study of the
accessibility and quality of doctors who specialize in obstetric,
gynecological, and neurosurgical care of women in western Massachusetts.

“Western Massachusetts is losing physicians within these specialties
at an alarming rate. It is a public health nightmare waiting to happen if
women do not have access to quality doctors and specialists,” said Senator
Gale D. Candaras (L’82) (First Hampden and Hampshire District). 

Senator Candaras introduced the legislation that created the
Commission as part of the 2008 Fiscal Year budget.  “Establishing the
commission was at the top of my list of legislative priorities in
conversations with Senate President Therese Murray and Senator Steven
Panagiotakas, the Chair of Ways & Means.  I thank them both for being so
very receptive and willing to take action on this growing problem,” Senator
Candaras noted.

The Sleith Hall hearing is open to the public. Persons wishing to
testify are asked to provide ten copies of their testimony to the
Commission. Individuals or parties interested in offering testimony but
unable to attend may submit written testimony to the Commission for
consideration. For further information, please call the Department of Public
Health at 617-624-6000 or Senator Candaras’ Office at 413-599-4785.

The 14 Commission members are: John Auerbach, Commissioner, MA
Department of Public Health; Nancy Audesse, Executive Director of the Board
of Registration in Medicine; Nonnie Burnes, Commissioner, MA Department of
Insurance; Dr. Roger Snow (designee), Commissioner of MassHealth; Dr.
Herbert Kantor, physician, Dr. Stephen Metz, physician, and Dr. Sherry
Taylor, physican, appointed by the President of the Massachusetts Medical
Society; Senator Gale Candaras and Senator Benjamin Downing, appointed by
the President of the Senate; Dr. James Wang, appointed by the Minority
Leader of the Senate; Representative Stephen Kulik, Representative Daniel
Bosley, and Dr. Susan Yates,  appointed by the Speaker of the House of
Representatives; and Representative Mary S. Rogeness, appointed by the
Minority Leader of the House of Representatives.

--BC

January 28, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

January 26, 2008

Challenge to West Virginia Med Mal Reform

On Thursday, I posted about two states, Ohio and Texas, that passed significant medical malpractice reforms in 2003.  Another state that did so was West Virginia.  This week, the West Virginia Supreme Court heard arguments in a case challenging one of those reforms, the "certificate of merit" requirement in malpractice cases.  The plaintiff claims the requirement is an undue burden; physicians will not sign the certificate because of an association with the defendant or they will charge exorbitant fees to do so.  The plaintiff claimed the fee was "upwards of" $40,000.

The facts of this case are somewhat bizarre, and may make it difficult to focus on the underlying issues.  The plaintiff himself is a physician, he was not represented by counsel for most of the litigation, and plaintiff's claims include a battery allegation in which he was held down by defendant's assistants and had a stent removed (despite his repeated demands to stop the procedure).  The story is here.

--CJR

January 26, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

January 24, 2008

Medical Malpractice Claims Decrease in Ohio

As part of a series of Ohio reforms, the Insurance Department was required to compile data on medical malpractice claims.  The initial report was issued last year, making this the first year a comparison could be conducted.  In 2005, there were 5,051 med mal claims filed in the state.  In 2006, only 4,006 claims were filed, a decrease of approximately 20%.

The Insurance Department attributed the decrease to changes made by lawmakers five years ago.  Those changes included caps for pain-and-suffering, and attempts to restrict "frivolous" claims against doctors.  The story is here

Because Texas seems to have had an influx of physicians following relatively similar tort reforms in 2003, I was curious whether Ohio had been likewise affected.  The State Medical Board of Ohio has licensing statistics on its website, but only through 2005.  I don't see any evidence that the reforms had a significant effect on licensing, but I didn't run statistical tests on the figures.  Will more data show bigger changes?  Will the Ohio Supreme Court's blessing of the tort reforms convince other doctors to come?  Or is there something that separates Texas from Ohio?  The weather?  The lack of a state income tax?

--CJR

January 24, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (2) | TrackBack

January 23, 2008

Edwards on Clinton on Trial Lawyers

I'm on the John Edwards mailing list, having given a small contribution.  Today, I got this:

Dear William,

Throughout this campaign, John Edwards has spoken with pride of his life as a lawyer, providing a voice for those who would otherwise be voiceless in our justice system.

But in Monday night's presidential debate, Hillary Clinton shared a different viewpoint. To her, trial lawyers are no more than another Washington special interest, focused only on selfishly influencing the outcome of this year's election.

For her, the individual contributions made by attorneys to John's campaign equate to the hundreds of thousands of dollars she has received from lobbyists and public action committees. John has never taken a dime from special interests or PACs -- and Hillary Clinton is wrong to make the comparison.

I was proud of the way in which John came back forcefully and spoke passionately of the difference lawyers make every day for American families who have been victimized by negligent acts of large companies.

Take a look at the debate exchange on trial lawyers between John Edwards and Hillary Clinton for yourself.

Click here to see the video clip

You decide for yourself who truly understands the legal community and the importance of lawyers: Hillary Clinton or John Edwards?

Please support John as he campaigns across America to provide a voice for those who have no voice, speaking out with no fear or favor.

Sincerely,

--David Bonior
  National Campaign Manager, John Edwards for President
  January 23, 2008

--BC

January 23, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

Calorie Counting in New York City

The New York Times reports that New York City once again is going to require restaurants to post calorie content on menu boards.   The Board of Health revised the regulations following a decision last September by U.S. District Judge Richard J. Holwell striking down the original regs.   (In an interesting note given the buzz on preemption these days, Judge Holwell found that the original regs were preempted by the federal Nutrition Labeling and Education Act of 1990). 

Under the revised regs, "any chain that operates at least 15 outlets nationwide would have to display calorie content on their menu boards, menus or food tags — essentially wherever the restaurant lists the information that customers use to make their choices."   The regulations are scheduled to take effect March 31st, but the New York State Restaurant Association is considering a lawsuit.

- SBS

January 23, 2008 in Current Affairs, Legislation, Reforms, & Political News, Products Liability | Permalink | Comments (0) | TrackBack

January 17, 2008

Vladeck on Regulatory Preemption

The ACS blog has a post (with video) and an issue brief [PDF] from David Vladeck (Georgetown) relating to regulatory preemption.  He focuses less on the wisdom (or lack of wisdom) of preemption and more on the means by which agencies are announcing their views on preemption:

The concern here is not with agencies expressing their position on the preemptive effect
of their regulatory actions.  That is unobjectionable, and, in many instances, unavoidable.  What is objectionable is that agencies are making substantive preemption determinations in a way that is neither transparent nor democratic, and are doing so because the Administration has determined that insulating big business from tort litigation is right as a matter of federal policy. Invariably, in making these pro-preemption determinations, the agency is repudiating long-standing agency policy to the contrary.

--BC

January 17, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

January 16, 2008

FDA Approves Food From Cloned Animals

As reported by the New York Times, the FDA has concluded that food from cloned animals is safe to eat.  The Agriculture Department, however, has asked farmers to continue withholding foods from cloned animals from the market, "saying the department wanted time to allay concerns among retailers and overseas trading partners."

“We are very cognizant we have a global environment as it pertains to movement of agricultural products,” said Bruce I. Knight, under secretary of agriculture for marketing and regulatory programs. He said it was his goal to have the transition last months, not years.

- SBS 

January 16, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack

NJ Governor Vetoes Changes To Wrongful Death Statute

The New Jersey Law Journal (via law.com) reports that New Jersey Governor Jon Corzine vetoed the bill passed by the Assembly last week to expand the state's wrongful death statute.  As posted earlier, the bill would have allowed claims for emotional harm.   (Under the present statute, damages are recoverable only for pecuniary loss).  Governor Corzine explained his veto: 

"[U]nlimited damages … could have a significant impact on state and local budgets, since government entities are not infrequently named as defendants in wrongful death suits, and there are similar concerns as the State undertakes efforts to attract and grow businesses here."

"Unfortunately, I do not believe that this bill in its current form strikes a fair balance that would avoid using a strict monetary valuation of a person’s life while also addressing the adverse effect of allowing unlimited and unpredictable damages."

He urged the Legislature to consider alternatives "granting more flexibility for courts to reduce excessive non-pecuniary damage awards and defining non-pecuniary damages less expansively."

- SBS 

January 16, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (1) | TrackBack

January 09, 2008

NJ Assembly Allows Emotional Harm In Wrongful Death Actions

NJ.com (via the NJ Star Ledger) reports that the New Jersey Assembly has passed an amendment to the state's wrongful death statute allowing claims for emotional harm.   Under the present statute, damages are recoverable only for pecuniary loss.  A copy of the bill is available here

- SBS

January 9, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (1) | TrackBack

January 06, 2008

Edwards Focuses (Even More) on Plaintiffs

Former Sen. John Edwards is making what he terms victims of corporate greed a more central part of his campaign.  He is now being joined on the trail by family members of a girl who died after her insurer refused to pay for a liver transplant (the insurance company denies that its decision caused her death), by the a man who, lacking health insurance, lived with a cleft palate for half a century, and by one of his former clients, whose daughter was seriously injured in a swimming pool.  (What appears to be a pretty thorough discussion of the last case is available here.)

--BC

(I gave Edwards some money in 2004 and have given him a little again this year.  My support for him is generally speaking based on non-Torts-related issues, if it matters.)

January 6, 2008 in Legislation, Reforms, & Political News | Permalink | Comments (0) | TrackBack