When New York Attorney General Eliot Spitzer settled two days ago with wholesale drug giant Cardinal Health regarding its trading of drugs with the secondary market, he published what I think is a devastating indictment of the company and how it risked the lives of consumers across the country. Why did Cardinal do this? Fom the AG's press release is this:

The investigation determined that Cardinal purchased drugs from certain alternate source vendors, despite risks associated with buying from those vendors, to take advantage of higher available profit margins. Cardinal also sold pharmaceuticals to certain customers even in the face of evidence that those customers may have been illegally diverting the drugs outside their intended channels of distribution. (emphasis added)

For those new to the story, this is my post from yesterday on the announcement. While the press release was covered in the newspapers, most (all?) overlooked the specific findings that the AG's office made regarding Cardinal's sins. What follows are some of those findings, which give the very distinct appearance to me that Cardinal was being deceptive and/or turning a blind eye to the problem of counterfeits at the time. While problems have now been rectified, it doesn't excuse the conduct that occurred when it happened.

In reading the AG's comments below, I noted that when Cardinal employees discuss the risk-benefit issues involved when dealing with the secondary market and suspect medications, they apparently refer to their own risk -- as opposed to the risk of patients who may need to take the life saving medications that they are busy trading around.

7. One employee in 2002 wrote an e-mail discussing a newspaper article on a spate of recent counterfeit drug cases. The article quoted one commentator's view that criminals are bright, rational people "doing the risk-benefit analysis," and shifting their activities to diverting and counterfeiting prescription drugs. The Cardinal employee wrote, apparently referring to that observation regarding counterfeiters,, "The article mentioned the risk reward ratio of price to penalty when caught." He concluded: "We obviously need to earn money in this area, but have to manage risk."

...

9. At times, Cardinal purchased from sources despite indications that the vendors may have been unsuitable. For example, in January 2004, one employee examined the pedigrees that Cardinal was receiving, and noted suspicious sources in the chain of custody -- in his words -- firms "which could be bad." The employee asked that a plan be put together to review those entities. A Cardinal compliance employee indicated that he had already verified that those entities were licensed as wholesalers. That verification was one appropriate step but insufficient. It does not appear that there was any further response to the request for review, nor that the suspect vendors were excluded. The Investigation has shown that some of the entities the employee identified were, as he suspected, engaging in diversion....

10. In March 2004, Cardinal realized that it possessed an anabolic steroid product that customers might perceive as high-risk, although in fact there was no specific evidence of any product integrity issues. It sought to avoid such customer concerns by transferring this product from its trading company, which was known for buying from [alternate source vendors], to its "divisions," which customers perceived as selling pharmaceuticals purchased from manufacturers. A Cardinal employee sent an e-mail to the head of the Trading Company, noting a substantial inventory in "an anabolic steroid that is on the restricted list due to potential counterfeit. There is plenty of room to pass our inventory to the divisions. What are your thoughts on moving this product to the divisions?' The reply e-mail instructed simply: "Go ahead and move it."

11. Cardinal repeatedly sold pharmaceuticals to customers that it knew or should have known were diverting pharmaceuticals. Prior to March 2005, Cardinal made numerous sales of pharmaceuticals to a Nevada company which purported to be a "closed-door" pharmacy that served only nursing homes. In a routine pattern, the Nevada company placed two orders at the same time. One was for products likely to be needed by its stated patient population of nursing home residents, typically in quantities of ones or twos, as would be expected for its needs. The other was for much higher quantities and included products unlikely to be needed by the nursing home residents. Despite this pattern, Cardinal continued to fill the company's dual orders as described above. Investigation has shown that the company dispensed the products on the small-quantity orders to nursing home residents, and it transferred the products on the large-quantity orders to an affiliated wholesaler for resale on the Secondary Market....

12. Similarly, starting in January 2003, Cardinal was alerted that its customers in the Carrington network of closed-door pharmacies were diverting drugs. One warning came from a Cardinal sales representative who reported visiting the Carrington pharmacies and finding the doors locked, an "Administrative Assistant" on site but no pharmacist, about thirty large boxes awaiting pickup by UPS and delivery to a wholesaler in Kentucky, and purchase orders from a Florida wholesaler with directions to ship to the Kentucky wholesaler. One of the Administrative Assistants explained in detail the process by which the closed-door pharmacy received drugs and sold them to the wholesalers. Cardinal took steps to determine whether the Carrington pharmacies were engaged in diversion, but continued its sales, though at a reduced level, until September 2003. The steps taken by Cardinal, such as seeking assurances from Carrington executives and accepting those assurances, were, in light of other evidence known to Cardinal, inadequate. In December 2003, Cardinal finally severed its business relationship with Carrington after learning from law enforcement that Carrington was under criminal investigation...

13. Cardinal also sold pharmaceuticals to wholesalers who were at the same time on Cardinal's excluded vendor list -- in other words, wholesalers that Cardinal itself deemed sufficiently high-risk that it adopted the policy of never buying product that had passed through their hands. The Trading Company president noted as to one wholesaler in June 2003 that "several things that have happened in the past are making us feel we need to very closely examine our buying" from the wholesaler, while simultaneously noting that "we are fine" with selling to that same wholesaler. In another example from December 2003, the president reported that "we now have been asked by compliance" to add a certain wholesaler to the excluded vendor list, but "We can still sell to them."

14. Cardinal made "third party" returns to manufacturers on behalf of other wholesalers regardless of where the wholesaler had purchased the product. As a former Cardinal employee testified: "[I]t wasn't worth our while to research whether we had [originally] sold it to the alternate source or to this third party or not." Such practices can support the Diversion Market by giving unscrupulous customers an incentive to divert drugs and then "return" them for full credit....

One can only hope that the folks responsible have long since been fired. If not, then I think top management must have been complicit in the conduct.

Labels: counterfeit drugs, Eliot Spitzer

Cardinal Health, one of the "Big Three" of the drug wholesaling business, has settled New York's investigation against it for $11M and agreed to reforms of its business practices. Cardinal is ranked 19th on the Fortune 500 list of America's largest corporations.

The underlying problem dealt with the company's purchase and sale of drugs out of the "secondary market," instead of buying them directly from manufacturers. This gray market in drugs involved some 6,000+ wholesalers as of 2005 when New York's investigation began, and before changes started to sweep through the industry. Many of those changes I had previously documented on my Counterfeit Drug Resource Page.

The existence of so many secondary wholesalers -- who are licensed by a hodgepodge of regulations that vary from state to state -- led some to buy and sell pharmaceuticals without knowing exactly where they had been and who had owned them in the past. This opened a gaping hole for counterfeit medications to leak into the legitimate drug supply system. The purchase of such mystery medicines was widely condemned and led to changes by major wholesalers in 2005.

From the press release out of the office of New York Attorney General Eliot Spitzer:

Secondary market trading is not illegal on its face, but can create opportunities for the introduction of unreliable drugs, including counterfeits, into the marketplace. In recent years, there has been an increase in the number of cases of counterfeit drugs in the American supply chain. Secondary market trading also can create an opportunity for companies to divert drugs from their intended distribution channels. Diversion into the secondary market, often to take improper advantage of manufacturer discounts, can begin a series of trades from wholesaler to wholesaler that makes it difficult to trace the origin of a drug and impossible to ascertain its authenticity.

The investigation determined that Cardinal purchased drugs from certain alternate source vendors, despite risks associated with buying from those vendors, to take advantage of higher available profit margins. Cardinal also sold pharmaceuticals to certain customers even in the face of evidence that those customers may have been illegally diverting the drugs outside their intended channels of distribution.

A review of the AG's findings, which does not seem to appear in newspaper accounts of this settlement, represents in my view a devastating indictment of the conduct of Cardinal Health, which appeared to act in a reckless disregard for the safety of consumers. This will be the subject of a follow-up post.

As per the AG's office, Cardinal will pay $3 million to New York State, $7 million to a non-profit health research corporation called Health Research, and $1 million to the attorney general's office to cover costs of the investigation. But wait... there's much more...it appears it isn't just about money but about forcing better business practices:

In addition to adopting the Wholesaler Safe Product Practices, Cardinal has agreed that in the regular course of its business it will:

-- Buy pharmaceuticals directly from manufacturers and not on the secondary market from alternate source vendors;
-- Sell pharmaceuticals only to wholesalers who have certified their compliance with the Wholesaler Safe Product Practices, and have agreed to allow audits of those certifications;
-- Adopt "know your customer" provisions and monitor for customer diversion; and
-- Hire an external auditor to conduct periodic reviews of its compliance with the settlement.

As I wrote on November 27th, I was one of the people the attorney general had dropped a subpoena on, for the records I had obtained and created in my own investigation regarding the counterfeit drugs taken by a Long Island teenager, Tim Fagan, after he had undergone an emergency liver transplant. It's nice to see the investigation has paid dividends for New Yorkers, not just in financial recovery, but in a safer pharmaceutical supply chain.

Labels: counterfeit drugs, Eliot Spitzer, Tim Fagan's Law

In an unusual personal injury case out of New Jersey, an appeals court rules on whether a stable can be held liable for negligence in assigning a "green" horse to a rider. The 5 1/2 year old horse had been broken to saddle just a few months earlier:

A horse farm owner who fails to carefully match a rider with a mount can be held liable if the rider is thrown, despite a New Jersey statute that generally affords immunity to equine facilities, an appeals court ruled last week.

In a case of first impression, the judges said giving a guest rider a green horse with a propensity to lurch could constitute conduct for which the Equine Activities Act...gives no protection.

The appeals court partially reversed summary judgment and remanded the case...for trial on the issue of negligent assignment.

The suit was lodged by Barbara Stoffels, who in April 2003 e-mailed a reply to an advertisement by Barbara Cammeyer, owner of Freehold, N.J.'s Harmony Hill Farm, inviting the public to ride for free to give her horses exercise. Stoffels, then 62, retired and arthritic, said she had 30 years of riding experience.

...After a half hour of riding without incident, Stoffels was attempting to turn left around a stump at the bottom of a ravine when the horse suddenly bucked three times, causing her to fall off and suffer injuries that required surgery.

Stoffels' suit charged that Cammeyer was negligent by providing her an untrained horse, not advising the horse was green and failing to inquire adequately about her riding experience in order to choose a suitable mount.

...

Appellate Judges Mary Catherine Cuff, Jose Fuentes and Carmen Messano agreed with the motion judge that Cammeyer was justified in believing that Stoffels was not a novice rider and affirmed dismissal of the claim Cammeyer failed to take experience into account.

However, the panel found issues on which a jury could find liability. For one, Cammeyer was not completely forthcoming about the training history of Glory, even after Stoffels expressed concerns about the horse's size. For another, Stoffels' expert witness proffered testimony that Glory was a young horse and had demonstrated a propensity to lurch before Cammeyer bought it and that Cammeyer had a limited opportunity to assess the horse before assigning it to Stoffels.

...

One exception [in the Act] is for failure to "make reasonable and prudent efforts to determine the participant's ability to safely manage the particular equine animal, based on the participant's representation of his ability." Another is for "[a]n act or omission ... that constitutes negligent disregard for the participant's safety, which act or omission causes the injury."

Cuff wrote that the failure to take reasonable measures to match the rider to a suitable mount could lead a jury to find conduct fitting those exceptions. "Here, we are not satisfied that defendant's conduct in assigning Glory to plaintiff is so one-sided that a reasonable jury would not find her negligent," Cuff concluded.

Labels: Interesting Cases in the News, Personal Injury

From the Trial by Jury Department:

"I consider trial by jury as the only anchor ever yet imagined by man, by which a government can be held to the principles of its constitution."
-- Thomas Jefferson

"The jury system has come to stand for all we mean by English justice. The scrutiny of 12 honest jurors provides defendants and plaintiffs alike a safeguard from arbitrary perversion of the law."
-- Winston Churchill

The jury has the power to bring a verdict in the teeth of both law and fact.
-- Oliver Wendell Holmes, United States Supreme Court Justice

Labels: Quotes: Law and Lawyers

Yesterday I posted regarding the Oklahoma Supreme Court declaring a tort "reform" law unconstitutional with respect to the additional burdens placed on medical malpractice claimants. The court's decision is now available in its unofficial form. It is an important decision for all states since similar attempts to place hurdles in front of claimants takes place on a daily basis around the nation.

The court decision was based on the need for an affidavit from a doctor when bringing a medical malpractice suit. The statute was a general law (as opposed to a special one under OK law), and therefore all claimants had to be treated equally. But, the court found:

The affidavit of merit requirement immediately divides tort victims alleging negligence into two classes -- those who pursue a cause of action in negligence generally and those who name medical professionals as defendants. ...The pleading code does not require negligence claimants generally to have an affidavit supporting the facts alleged and the anticipated basis for the right of recovery to be filed along with the petition. Plaintiffs alleging anything other than medical negligence need only file a petition giving fair notice of the plaintiff's claim and the grounds upon which it rests. These claimants have no affidavit requirement and may commence a cause of action with the filing of a petition, while those alleging medical malpractice must obtain a professional opinion that their cause is meritorious as a prerequisite to pursuing suit or be subject to dismissal.

What's more, the court found, since some medical malpractice claimants can proceed without an affidavit under the doctrine of res ipsa loquitor (the thing speaks for itself - like a retained sponge after surgery), there were actually now three different classes of claimants.

Since OK law mandates uniformity of procedure, all citizens of the state must have equal access to its legal institutions for teh application of the general ordinary forensic process. And this did not happen with the procedures employed.

A second ground for tossing the law was that it created an unconstitutional monetary barrier to the access to courts guaranteed by the Oklahoma Constitution. The court found that:

[T]he additional certification costs have produced a substantial and disproportionate reduction in the number of claims filed by low-income plaintiffs. The affidavit of merit provisions front-load litigation costs and result in the creation of cottage industries of firms offering affidavits from physicians for a price. They also prevent meritorious medical malpractice actions from being filed...Rather than reducing the problems associated with malpractice litigation, these provisions have resulted in the dismissal of legitimately injured plaintiffs' claims based solely on procedural, rather than substantive, grounds.

One comical note in the opinion - though not apparently intended that way -- was this part:

Another unanticipated result of statutes similar to Oklahoma's scheme has been the creation of a windfall for insurance companies who benefit from the decreased number of causes they must defend but which are not required to implement post-tort reform rates decreasing the cost of medical malpractice insurance to physicians. These companies happily pay less out in tort-reform states while continuing to collect higher premiums from doctors and encouraging the public to blame the victim or attorney for bringing frivolous lawsuits.

The funny part is the assertion that the dramatic drop-off in claims, and the insurance company profits that went with it, was somehow "unanticipated." The court's rip at "tort reformers" coming from an 8-1 majority in a very red state, is stunning.

The court was emphatic about the unfair burden that was placed on those of modest means:

Access to courts must be available to all through simple and direct means and the right must be administered in favor of justice rather than being bound by technicalities. Claimants may not have the fundamental right of court access withheld for nonpayment of some liability or conditioned on coercive collection devices. Here, medical malpractice plaintiffs are singled out and must stand the cost of an expert opinion, which may range from $500 to $5,000,83 before they may proceed to have their rights adjudicated. In at least one instance, an affidavit of merit cost the litigant $12,000. A statute that so conditions one's right to litigate impermissibly denies equal protection and closes the court house doors to those financially incapable of obtaining a pre-petition medical opinion. Therefore, we determine that 63 O.S. Supp. 2003 §1-1708.1E creates an unconstitutional monetary barrier to the access to courts guaranteed by art. 2, §6 of the Oklahoma Constitution.

An interesting decision, of which other courts around the nation will surely take notice when efforts to close the courthouse door take place under the pretext of "reform" in their own jurisdictions.

Labels: Medical Malpractice, tort reform

Now this is troubling. In those cases I have brought where sexual assault is a component, I have used "Jane Doe" pseudonyms to protect the privacy of my clients. Now a federal judge says this can't be done in a case he has heard.

In a decision on the front page of today's New York Law Journal by Judge Lynch (Southern District of New York), he denies the plaintiff the right to proceed in such fashion in Doe v. Del Rio (WL 3616963):

In this civil rights action, plaintiffs Jane and John Doe seek damages from defendant police officers and the City of New York for allegedly egregious acts of police brutality and abuse. They have brought the suit pseudonymously, with the permission of a judge of this court obtained ex parte before filing, contending that their interests in privacy outweigh the normal presumption that suits be brought in the parties' proper names. Defendants now move to revoke this permission and require the caption to reflect the true names of the plaintiffs.

After an extensive analysis of the pros and cons of allowing such actions, Judge Lynch goes on to write:

While there may be circumstances where the sensitivity of the subject matter is so great as in itself to justify pseudonymity without a specific showing of harm, this case ... is not of such extreme sensitivity. Plaintiffs allege that defendant Brady “pulled plaintiff Jane Doe towards him and attacked her sexually, by fondling her breasts, arms, neck and back, kissing her, and rubbing his body against her." (Compl. ¶ 45.) The Court is loath to weigh degrees of violation, and does not minimize the wrongfulness of the acts alleged or the suffering of anyone subjected to them; there is no such thing as a "mere" or "minor" forcible indignity. Nevertheless, there are degrees of abuse, and the actions alleged here are no more intimate than those alleged in hundreds of sexual harassment cases that are prosecuted openly in the victims' names every day in our courts. The facts of this case are not the sort of exceptional circumstances that in and of themselves justify overriding the constitutional presumption of openness.

Judge Lynch writes, in a conclusion I think is troubling considering the allegations:

The Court appreciates that the allegations in the complaint concern events that anyone would prefer to keep private, and that there is evidence that Jane Doe has been psychologically harmed by those events. Nevertheless, the nature of the charged acts, repulsive as they are, is not so extreme as to support sufficiently an interest in anonymity. The Court accepts that, as her therapist has attested, revisiting these events may occasion anxiety for Jane Doe. But the greater part of the distress occasioned by the lawsuit is intrinsic to the pursuit of this action, even under conditions of anonymity. Any additional burden resulting from the public revelation of plaintiffs' identities has not been shown to be exceptional, and it must be borne in light of the larger interest in open judicial proceedings.

As plaintiffs have not established that this is an exceptional case warranting pseudonymous litigation, defendants' motion to require amendment of the caption of the case is granted.

Federal judges are powerful. And wide discretion is given to their opinions making a Second Circuit reversal unlikely. But it seems almost as if the individual has been victimized twice, first by an assailant, and then, if she chooses to use the courts, forcing her to reveal herself to the public at large. Judge Lynch has written that he does not wish to "minimize the wrongfulness of the acts alleged", but in forcing the plaintiff to reveal herself to the public, it seems he has done just that.

Labels: Personal Injury

A noxious tort "reform" law -- one that made it more difficult to sue medical practitioners -- was thrown out by the high court of Oklahoma yesterday. The law placed a substantial barrier in the way of claimants, forcing them to produce a doctor's affidavit of merit to be filed in court before discovery even begins in a case. The decision is not on the court's website as of this writing, but should be available in a day or two. From the newspaper article:

The Oklahoma Supreme Court stunned tort reform advocates on Tuesday by overturning a 2003 law credited with cutting malpractice lawsuits in the state by up to 60 percent.

In an 8-1 decision, the court ruled unconstitutional a law requiring that malpractice suits be accompanied with an expert witness affidavit attesting to the case's merits.

The court said the requirement violated the Oklahoma Constitution's ban on special laws because it puts medical negligence cases in a separate class from all other negligence claims.

The ruling in a 2005 Okmulgee County case also found the law creates an unconstitutional monetary barrier to the courts because of the expense of securing the affidavits.

...

Besides invalidating the 2003 law, the decision calls into question the ability of the Legislature to cap non-economic damages. Plaintiff attorneys argue the caps make pursuing expensive liability cases difficult to justify and thus limit access to the court system.

Such caps figure prominently in the plans of lawsuit reformers for the upcoming legislative session.

"Almost every state that has passed them has had them found unconstitutional," said Terry West, a prominent Shawnee attorney and a two-time president of the Oklahoma Trial Lawyers Association.

The New York rule, by the way, is that a "certificate" of merit be submitted when a suit starts, that a reasonable basis exists for bringing the action. This certificate is signed by the attorney, not the doctor, thus preserving confidentiality.

[Addendum: Decision is now available. See my follow-up post at this link]

Labels: tort reform

Since the subject of today's post below was the right to die, and a physician risking prosectution to help, I thought this should be today's quote:

"Each time a man stands up for an ideal,
or acts to improve the lot of others,
or strikes out against injustice,
he sends forth a tiny ripple of hope."

- Robert F. Kennedy (1925-1968, American Attorney General, Senator)

Labels: Quotes: Law and Lawyers

It isn't quite New York personal injury law, but sufficiently interesting to deserve note: An Italian patient that wanted to die by being pulled off his respirator. Since we see "right to die" issues all the time where medicine meets the law, I wanted to share this one:

ROME - A paralyzed man at the center of a right-to-die debate in this overwhelmingly Roman Catholic nation died after he was taken off his respirator, days after an Italian court issued a contentious ruling in the case.

Piergiorgio Welby, 60, died late Wednesday, said Dr. Mario Riccio, the physician who removed the respirator. Riccio said Thursday that Welby had a constitutionally guaranteed right to refuse treatment.

"This must not be mistaken for euthanasia. It is a suspension of therapies," said Riccio, who volunteered to remove the respirator and was not involved in Welby's medical care. "Refusing treatment is a right."

...

On Saturday, a Rome judge recognized Welby's right to refuse treatment but ruled that doctors were not obligated to take measures that would result in the patient's death — even at the patient's request.
...

U.S. law generally permits patients to ask that medical treatment be withheld or withdrawn, even if it raises their risk of dying. Voters in Oregon went further and approved the first physician-assisted suicide law in the U.S. in 1994, but it is now under legal challenge.

In 2001, the Netherlands became the first country to legalize voluntary euthanasia — where patients are killed at their request to ease suffering, even in cases where they might survive without treatment. Belgium legalized it under strict conditions in 2002.

Labels: Interesting Cases in the News, Odds and Ends

When laws become inequitable, there is much to fear:

People crushed by laws, have no hope but to evade power. If the laws are their enemies, they will be enemies to the law; and those who have must to hope and nothing to lose will always be dangerous.

--Edmund Burke (1729-1797) British political writer.

Labels: Quotes: Law and Lawyers

Since the law has produced so many great quotes, it would be a shame not to revisit them on occasion. This is the first in a series:

Ignorance of the law excuses no man; not that all men know the law, but because 'tis an excuse every man will plead, and no man can tell how to refute him.

-- John Selden (1584–1654)

Labels: Quotes: Law and Lawyers

This case in yesterday's New York Law Journal demonstrates once again the single most important aspect of any medical malpractice case: The need for an expert.

In Doe v. Torres (05 Civ 3388), a prisoner attempted to represent himself regarding an allegation of failing to properly treat an injured knee. The facts are almost irrelevant, for the plaintiff violated the cardinal rule of malpractice cases. He didn't have an expert to state that the defendant doctor had deviated from customary and usual practice. He will not make it to trial, with Magistrate Judge Gorenstein recommending a grant of summary judgment to the defendants.

In deeming such expert testimony required, the magistrate judge concluded that plaintiff's case was not a 'rare' instance in which a juror could conclude either that the defendants departed from accepted practice, or that if there was a departure, it proximately caused any injury to plaintiff. Because nothing in the medical records would allow a reasonable juror to conclude that either of the two elements of a medical malpractice claim had been proved, plaintiff failed to make a prima facie showing of medical malpractice.

Labels: Medical Malpractice

The other day I had posted about the worst toys of all time. But one should not be so complacent as to think that bad products are a thing of the past. Below are recent recalls from the Consumer Product Safety Commission, many of which are geared for children:


Children's "Powerpuff Girls" Necklaces

"In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Rhode Island Novelty, of Cumberland, R.I., is voluntarily recalling about 48,000 Children's Powerpuff Girls necklaces. The recalled jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects." Read more information.


Bell Rattles

"In cooperation with the U.S. Consumer Product Safety Commission (CPSC), BRIO AB, of Sweden, is voluntarily recalling about 5,550 BRIO Bell Rattles. The small bell positioned between the wood slats can break and allow access to small parts. This poses a choking hazard to young children." Read more information.

Children's Butterfly Necklaces

"In cooperation with the U.S. Consumer Product Safety Commission (CPSC), U.S. Toy Co. Inc., of Grandview, Mo., is voluntarily recalling about 29,000 Children's Butterfly Necklaces. The clasps on the necklaces contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects." Read more information.

Children's Boots

"In cooperation with the U.S. Consumer Product Safety Commission (CPSC), See Kai Run, of Woodinville, Wash., is voluntarily recalling about 6,500 Children's Boots. Metals snaps on the side closure of the boot can detach, posing a choking hazard to young children." Read more information.

Lemonade Jars

"In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Lifetime Brands Inc., of Westbury, N.Y., is voluntarily recalling about 6,600 Gemco® Lemonade Jars. The metal spigot contains lead and is in direct contact with the contents of the lemonade jar. Lemonade and other beverages can cause the lead to leach from the spigot. Long-term exposure to lead in children may be associated with behavioral problems, learning disabilities, hearing problems and growth retardation." Read more information.

Labels: Personal Injury, Product Recalls

This past week, the Association of Trial Lawyers of America (ATLA), of which I am a member, changed its name to the American Association for Justice. Below, is their explanation:

Dear Colleague:

On December 11, we are entering an exciting new chapter in our association's history. We will officially change our name to the American Association for Justice.

This change was approved overwhelmingly by ATLA's Board of Governors in June and by ATLA's membership at our annual convention in July.

Changing our name to the American Association for Justice is an important step in our campaign to protect and strengthen the civil justice system.

It better articulates what we do: fight to ensure that every person has access to justice and can get a fair shake.

Our opponents - the drug and oil industries, big insurance companies and other large corporations - have spent billions of dollars over the past decades to wage an unprecedented attack on justice. Their plan is simple. They want to eliminate the only thing left holding them accountable - the civil justice system, often the last resort for many Americans.

As attorneys, we work to make sure any person who is injured by the misconduct and negligence of others can get justice in the courtroom, even when taking on the most powerful interests.

Our new name - the American Association for Justice - more accurately reflects our role as advocates for justice. It will further allow us to reframe the debate in the court of public opinion - just like we do every day in the courtroom.

I look forward to moving together in this exciting new direction.

Sincerely,

Lewis S. "Mike" Eidson

This ATLA (now AAJ) member approves. The focus of the organization should not be on us, but on the principles and people that we represent.

Labels: Odds and Ends

Often, medical malpractice occurs for the simplest of reasons: One health care practitioner did not effectively communicate a problem to another. And often, this is simply because of sloppy record keeping or illegible handwriting.

So it is worthy to note from this AP story last week, that the era of electronic medical records may well be here:

WASHINGTON - Five of the nation's largest employers plan to soon give their workers an unusual health-care benefit: their very own electronic medical records that they can take when they travel, change jobs, or see a new doctor.

About 2.5 million workers and their dependents would have access to their health records through their computers. The records would be compiled by an independent, nonprofit organization. The information would be stored in a database that only the employee would supposedly be able to access.

The companies providing the electronic health records are Applied Materials Inc., BP America Inc., Intel Corp., Pitney Bowes Inc., and Wal-Mart Stores Inc.

The companies hope that cutting out the paperwork in health care will reduce administrative costs, duplicative care and medical errors.

Of course, this will raise another problem, that of privacy if too many folks can snoop through the records. But if that issue can be addressed, we may solve one of the many problems that bedevil our healthcare system.

Labels: Hospital Malpractice, Medical Malpractice

Personal injury law goes hand-in-hand with products that maim and kill.

So it is hard to resist sharing this link to the worst toys of all time. With no further introduction needed, in this the season of toys, from RadarMagazine, a little to whet your appetite...but you have to go to this link for the full story...

...
In the last year alone, some eight million units of toys were recalled in the U.S., according to W.A.T.C.H., a toy-safety advocacy group. But Kool Toys and Polly Pockets are kids' stuff compared to the hazardous baubles of yesteryear. In the spirit of the holidays, Radar presents the most dangerous toys of all time, those treasured playthings that drew blood, chewed digits, took out eyes, and, in one case, actually irradiated. To keep things interesting, we excluded BB guns, slingshots, throwing stars, and anything else actually intended to inflict harm. Below, our toy box from hell.

Removable parts? Suffocation risk? Lead paint? Pussy hazards compared to the granddaddy of them all. Lawn Darts, or "Jarts," as they were marketed, would never fly in our current ultra-paranoid, safety-helmeted, Dr. Phil toy culture. Lawn darts were massive weighted spears. You threw them. They stuck where they landed. If they happened to land in your skull, well, then you should have moved. During their brief (and generally awesome) reign in 1980s suburbia, Jarts racked up 6,700 injuries and four deaths. ...

So, which of those top ten (plus honorable mention) toys do you have in your house?

Labels: Personal Injury

Passed by Congress in 1987 and signed into law in 1988, critical portions of the Prescription Drug Marketing Act are still not in effect. Specifically, those parts that deal with certain drug wholesalers maintaining a "pedigree" for the drugs they trade. But the FDA had finally decided after all these years that December 1st of this year would be the magic day.

I discussed some of this back on December 1st when some secondary wholesalers -- those that are not "authorized" wholesalers, for whom the strict pedigree provisions don't apply --had obtained temporary relief in court preventing the PDMA from finally being implemented . This is important because accurately tracking the pedigree (or chain of custody) of a drug is a major way to keep control of the supply chain. This is critical to making sure counterfeit drugs don't leak into our regular drug channels, and thereby into your local pharmacy.

Now a federal judge has ruled on this in favor of the secondary wholesalers, thereby staying the provisions of the law. Since two blogs have already covered this, I won't re-invent the wheel and will direct you to them:

Both Juvan's Health Law Update and Adam Fein's Drug Channels had long discussions on the issues in their blogs on December 10th.

--ET

Labels: counterfeit drugs

The New York Times today jumps into the fray regarding the dangers of counterfeit drugs in an editorial. They do so from the perspective of those buying drugs over the Internet:

Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.

In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.

The editorial goes on to the deaths from counterfeits and the ways developing countries have been fighting it, and otherwise serves to further sound the alarm of buying medication when you don't know its origins.

As those in the pharmaceutical drug trade know, the issue of counterfeits has been a hot topic before the FDA in recent years. It is also, most certainly, not confined to foreign counterfeits as we have purely domestic counterfeiting going on.

After identifying the problem, the Times makes its pitch for action, writing:

An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.

That's a great idea. And we can start right here at home with legislation currently stuck in congressional committees. The pending legislation before both the House and the Senate comes in the form of Tim Fagan's Law, named for one of my clients.

For more on the issues, you can visit my own Counterfeit Drug Resource Page, and read more about the problem by clicking on the Counterfeit Crugs label on your left and seeing other posts on the subject.

Labels: counterfeit drugs, Political Action, Tim Fagan's Law

Some accept as gospel that frivolous lawsuits are a big part of medical malpractice litigation: Baseless claims brought by uninjured people, or whose injuries were not caused by negligence. Not so, according to "Claims, Errors, and Compensation Payments in Medical Malpractice Litigation," a study by the Harvard School of Public Health and the Harvard Risk Management Foundation that was published earlier this year in the New England Journal of Medicine.

The results, in fact, are the opposite of what the tort "deformers" claim, based on results from 1,452 randomly selected, closed medical malpractice files. The reviewers found that 97 percent had indeed suffered harm. In about one-third of these patients, the damage wasn't clearly attributable to negligent medical treatment, a wrong prescription, or a misdiagnosis. Most of those claims were correctly denied compensation, the team reports.

According to the study, 73 percent of plaintiffs whose claims had merit received compensation.

The study also found that just six people had received compensation that were uninjured and 145 had injuries that had not been convincingly linked to medical error. On the other hand, 236 plaintiffs who did suffer an injury from medical error received no compensation. The authors wrote:

One in six claims involved errors and received no payment. The plaintiffs behind such unrequited claims must shoulder the substantial economic and noneconomic burdens that flow from preventable injury. Moreover, failure to pay claims involving error adds to a larger phenomenon of underpayment generated by the vast number of negligent injuries that never surface as claims.

Eighty percent of the claims involved injuries deemed to have caused significant or major disability or death. In only 3% of the claims, no adverse outcomes from medical care were evident.

Since the majority of payments from insurance companies went to people who had been harmed by medical errors and not to people with baseless claims, the authors said that the "moves to combat frivolous litigation will have a limited effect on total costs."

Taking direct aim at politicians and business lobbyists, the authors wrote that:

"The profile of non-error claims we observed does not square with the notion of opportunistic trial lawyers pursuing questionable lawsuits in circumstances in which their chances of winning are reasonable and prospective returns in the event of a win are high. Rather, our findings underscore how difficult it may be for plaintiffs and their attorneys to discern what has happened before the initiation of a claim and the acquisition of knowledge that comes from the investigations, consultation with experts, and sharing of information that litigation triggers. Previous research has described tort litigation as a process in which information is cumulatively acquired."

It is not the first time that a Harvard study has debunked the popular myths spread by insurance companies or politicians with respect to medical malpractice. It had happened back in 1991 by the Harvard Medical Practice Study that found that only eight percent of those injured by medical negligence brought lawsuits. But that is a post for another day.

[Addendum, 1/29/07 -- This blog was cross-posted to TortDeform on January 25, 2007, resulting in much spirited commentary]

Labels: Frivolous Claims, Medical Malpractice, tort reform

Business oriented Bloomberg News did a piece this week on the changing landscape for tort "reform" given the election results. A few snippets from the article:

Trial lawyers, who say they were demonized during 12 years of Republican congressional rule, are seeking vindication with the Democrats' return to power...Their plans include pushing tougher enforcement of workplace-safety rules and enhanced patients' rights.

They say the shift in power also signals an end to the so- called tort reform backed by President George W. Bush, which was aimed at limiting awards in personal-injury lawsuits against doctors and U.S. corporations.

``The Republicans had a hell of a chance for the last couple of years and really didn't get that far,'' said John Coale, a trial attorney at the Coale Cooley firm in Washington. ``And now it's over.''
...

Businesses are girding for a fight in Congress over workplace safety and such other issues as making it a federal crime for chief executive officers and other company officials to knowingly introduce defective products that kill or severely injure consumers.
....
Bush's major victory in limiting lawsuits was 2005 legislation requiring the biggest class-action suits to be filed in federal court rather than state courts, which have been more sympathetic to plaintiffs.

The Republican-controlled Congress failed to pass proposals to place caps on medical-malpractice awards and to create a $140 billion fund for asbestos-exposure victims.

...
Linda Lipsen, chief lobbyist for the [The Association of Trial Lawyers of America] would like to see Congress strip the insurance industry of its exemption from antitrust laws, a move that would pave the way for suits against insurers. She also suggested there might be congressional hearings one day on ``why there are 98,000 deaths per year'' in the medical industry.

Trial attorneys will ``alert the Congress to areas where they can encourage safety,'' including ``cars, airplanes, the environment, clean air and water, medical procedures, hospitals,'' Lipsen said. ``Our job is to make sure these industries are accountable.''

Labels: Personal Injury, Political Action, tort reform

The following comes from the December 2006 issue of Trial Magazine, put out by the Association of Trial Lawyers of America. I would provide a link, but it is members only so this synopsis will have to do:

Following the lead of at least one other judge in his state, a Pennsylvania trial court judge recently refused to seal a settlement in a medical malpractice case, citing the public's right to know that money from a state fund would be used to pay the widow of the patient who died. (Bryk v. Wilcox, No. 9254 (Pa., Luzerne Co. Com. Pleas settled Aug. 30, 2006).) Amanda Bryk considered filing a claim after her husband, Walter, died shortly after undergoing aortic valve replacement. The surgeon allegedly failed to properly tie off sutures in Walter's heart, causing a fatal rupture. Before she filed suit, the case was settled, with part of the settlement to be paid from the state's Medical Care Availability and Reduction of Error Fund (Mcare Fund). The fund provides excess medical malpractice coverage through the state's insurance department and is financed by fees assessed on health care providers, moving-violation surcharges, and cigarette tax monies.

In an interview, the judge explained that, since this was public money, the public had a right to know how it was being spent. In addition, he indicated that doctors had complained that the system wasn't open enough to know what was going on. So, the judge reasoned, if they want to have public disclosure, then it should not be limited to only what the doctors want disclosed, but should instead be full public disclosure.

Labels: Medical Malpractice

I learned at Tortdeform.com that Senator Trent Lott, a long time proponent of reducing the rights of consumers, may be having a change of heart.

The reason? Seems his home got wiped out by Katrina and State Farm won't pay him what he thinks he is owed after they took his premiums. The shoe, it appears, is suddenly on the other foot for Senator Lott, as he now must do battle with his insurance company. He was victimized once by the storm, and doesn't want to see it happen again.

He therefore hired high-profile plaintiff's attorney Richard Scruggs.

The turnabout in personal fortune reminds me of Frank Cornelius, who wrote an op-ed piece for the New York Times back in 1994. Mr. Cornelius tells his story in this excerpt better than I could:

Crushed By My Own Reform By Frank Cornelius
In 1975, I helped persuade the Indiana Legislature to pass what was acclaimed as a pioneering reform of the medical malpractice laws: a $500,000 cap on damage awards, and elimination of all damages for pain and suffering. I argued successfully that such limits would reduce health care costs and encourage physicians to stay in Indiana -- the same sort of arguments that not underpin the medical industry's call for national malpractice reform.

Today, from my wheelchair, I rue that that accomplishment. Here is my story.

On February 22, 1989, I underwent routine arthroscopic surgery after injuring my left knee in a fall. The day I left the hospital, I experienced a great deal of pain and called the surgeon several times. He called back the next day and told my wife to get me a bedpan. He then left on a skiing trip. I sought out another surgeon, who immediately diagnosed my condition as a reflex sympathetic dystrophy -- a degenerative nervous disorder brought on by trauma or infection, often during surgery. * * *

At the age of 49, I am told that I have less than two years to live.

My medical expenses and lost wages, projected to retirement if I should live that long, come to more than $5 million. Claims against the hospital and physical therapist have been settled for a total of $500,000 -- the limit on damages for a single incident of malpractice. The Legislature has raised that cap to $750,000, and I may be able to collect some extra damages if I can sue those responsible for the August 1990 incident that nearly killed me. But apparently because of bureaucratic inertia, the state medical panel that certifies such claims has yet to act on mine.

The kicker, of course, is that I fought to enact the very law that limits my compensation. All my suffering might have been worthwhile, on some cosmic scale, if the law had accomplished its stated purpose. But it hasn't.

Indiana's health care costs increased 139.4 percent from 1980 to 1990 -- just about the national average. The state ranked 32nd in per capita health spending in 1990 -- the same as in 1980.

It is understandable that the damage cap has done nothing to curb health care spending; the two have almost nothing to do with each other. In 1992, the Congressional Budget Office reported that medical malpractice litigation accounted for less than 1 percent of total healthcare spending. I doubt that the percentage in Indiana is much different.

Make no mistake; damage caps are arbitrary, wholly disregarding the nature of the injury and the pain experience by the plaintiff. They make it harder to seek and recover compensation for medical injuries; extend unwarranted special protection to the medical industry; and remove the only effective deterrent to negligent medical care, since the medical profession has never done an effective job of disciplining negligent doctors.

Medical negligence cannot be reduced simply by restricting consumers' legal rights. That will happen only when the medical industry begins to effectively police its own. I don't expect to see that day.

Labels: Medical Malpractice, Personal Injury, tort reform

I never liked the "Blue Code of Silence" that cops use to protect the bad apples, and I don't like the "White Coat of Silence" that some doctors use to protect each other. So if I don't like it for others, then I won't do it myself.

Which brings me to this AP story that appeared last week in Newsday:

NEW YORK (AP) - Two personal injury lawyers who pleaded guilty to stealing hundreds of thousands of dollars from clients were sentenced Thursday to community service and five years probation after repaying the money they stole.

Michael Mann, of Little Silver, N.J., and Joshua Just, of Manhattan, pleaded guilty in August to scheme to defraud. They admitted that from 2003 through 2005 their Manhattan law firm, Mann & Just LLP, stole at least $275,000 from at least 10 clients by charging for expenses the firm never incurred.

While some in other professions may look away from their own problems -- and every business or industry has them, from teachers to clerics --I don't think that we should follow that script. There are bad actors in every business, and the others in the business ought to be on the front lines of cleaning it up, not hiding it. And so I give this story just a tiny bit more of publicity.

Because the plea deal was for felony conviction, both people will be disbarred. As they should.

Labels: Interesting Cases in the News, Personal Injury

The issue of punitive damages in personal injury cases came before the Supreme Court recently. For the second time in this case. And based on the oral argument, possibly not the last.

In a highly watched case, Philip Morris v. Williams (05-1256) was argued October 31st, with the Justices hinting it may send the case back to the state court from which it came, instead of resolving an open question: How much in punitive damages should a jury be allowed to award?

In Williams, an Oregon jury returned $800,000 in compensatory damages and $79.5M in punitives. Thus began a journey up the appellate ladder in Oregon, where the verdict was affirmed by the state's highest court, and then on to Washington for an ultimate review by the US Supreme Court. But the Supremes, in the meantime, had decided another punitive damage case (State Farm v. Campbell) and sent Williams back to Oregon to reconsider in light of its opinion.

So after doing an extraordinarily detailed analysis of State Farm, the Oregon Supreme Court affirmed the punitive damage award in this personal injury tobacco case that was almost 100x the compensatory award, writing:

Philip Morris showed indifference to and reckless disregard for the safety not just Williams, but of countless other Oregonians, when it knowingly spread false or misleading information to keep smokers smoking. Philip Morris's actions were no isolated incident, but a carefully calculated program spanning decades.

Thus, Philip Morris asked the US Supreme Court to review again.

The State Farm opinion has been the source of much legal discussion. In part, it seems to put limits on the amount of punitive damages that can be awarded, and discusses a ratio of compensatory damages to punitive damages. At one point the court mentions a multiplier of 4x and another of 10x, and in other parts specifically saying that there are no "bright line" tests for how much is too much. The source of the limits is that some justices believe that a large punitive damage award violates the due process clause of the 14th Amendment.

What makes Phillip Morris interesting is that it is a personal injury matter, not some commercial dispute. It thus differs from the other cases the high court has heard on the issue. It remains to be seen if the court will create constitutional protections for reckless conduct that endangers the health, safety and welfare of the public, where no such protection presently exists.

So what happened before the US Supreme Court on the new review? Well, it seems that right after oral argument started, the justices got caught up in a contradictory jury instruction that had been requested by Philip Morris. If you read the second sentence, which I placed in italics, you see the contradiction:

"The size of any punishment should bear a reasonable relationship to the harm caused to Jesse Williams [the deceased smoker] by the defendant's punishable misconduct. Although you may consider the extent of harm suffered by others in determining what that reasonable relationship is, you are not to punish the defendant for the impact of its alleged misconduct on other persons, who may bring lawsuits of their own in which juries can resolve their claims and award punitive damages for those harms, as such other juries see fit."

So Philip Morris was claiming the jury may consider the harm suffered by others, but can't punish them for it. What, exactly, does that mean? Perhaps it is no wonder the court refused to give the instruction. The high court justices themselves were confused, as you can see in this ScotusBlog note regarding the argument. A transcript of the oral argument is here. Justice Ginsburg got the ball rolling with this:

JUSTICE GINSBURG: You don't think that
would confuse the jury if they are first told that they
may consider the extent of harm suffered by others, and
then the next instruction seems to say they can't?

The court will likely decide the case by June. But don't be surprised if they avoid the issue and send it back (again) to the Oregon courts to flesh out the issue of the jury instructions.

Labels: Damages, Personal Injury, Punitive Damages