Maryland Injury Lawyer Blog

Medical device maker Stryker said last week that it will voluntarily recall the hip implant surgery products Trident PSL and Hemispherical Acetabular Cups.

This recall comes on the heels of a warning from the FDA to fix a host of long-standing problems, primarily the failure to function and poor fixation with its hip implant components and in its manufacturing of hip replacement parts. These defective Stryker products have led to numerous complaints and forced some artificial hip implant patients to have additional surgeries. In fact, the FDA told Stryker that it was aware that Stryker had received complaints about the improper fitting of hip implants that caused bone fractures in some patients three years ago.

The following Stryker products were named in the FDA investigation for containing manufacturing defects that are potentially harmful to hip and joint replacement patients:

• Hip Implants with ceramic components

• Solar Plasma Purefix HA Shoulder Stems

• Trident PSL Acetabular Shells

• Duracon Total Knee Modular Femoral Component

• Global Modular Hip Stems

• Trident PSL HA Solid Black 52 MM

• ReUnion Plasma Spray Humeral Stem

• Trident Hemispherical Cluster 50 MM

Almost all products liability cases against medical device manufacturers are design defect cases. In these Stryker Trident hip implant defects cases, the negligence appears to be in the manufacturing process rather than a problem associated with the way the Stryker products were originally designed.

It appears hard to argue that Stryker, a Michigan based company that before this news came out was having a great run of profitability, has done something wrong here. In the FDA’s letter stemming from its inspection of Stryker’s Mahwah, New Jersey manufacturing plant, complaints were that Stryker failed to correct their manufacturing procedures that led to complaints about their hip replacement products in the first place. It says one thing about Stryker when the FDA notes manufacturing deficiencies in the first place. It says quite another thing about Stryker when they fail to fix the defects that have been previously brought to their attention.

A lot of lawyers will be looking at these cases very closely to see whether there are enough injuries for a class action lawsuit against Stryker for these defective hip replacement products. Whether class litigation will be viable will depend on the number of reported injuries and the severity of those injuries.

Our lawyers are currently reviewing cases. If you want to discuss your case with one of our Stryker defective hip replacement lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

Last week, we were talking about the hot water Allstate found itself in with the state of Florida. This week, we look to Mississippi where Attorney General Jim Hood has opened a new hurricane Katrina related criminal investigation of State Farm, which he says is different from the earlier “crimes against policyholders” investigation. Hood had agreed to end that earlier investigation as part of a January 2007 settlement in which State Farm paid the attorney general’s office $5 million in costs and reopened policy holder claims from hurricane Katrina.

In response to an August subpoena for records from the grand jury investigation, State Farm filed a declaratory judgment action seeking to stop the investigation, and by September, had obtained a temporary restraining order. Now in mid-January, Hood has asked another federal judge to lift that order. That motion is still pending.

At issue is whether this is a continuation of the “crimes against policyholders” investigation or whether this is a validly new and different claim not covered by the agreement of January 2007. The focus of this new investigation has not been openly identified by the attorney general. There is speculation that it has to do with the handling of National Flood Insurance Program claims.

Homeowner policies cover wind and rain damage. Separate rising water/flood damage insurance is subsidized by the federal government, but sold through insurers. Some politicians and lawyers have accused insurance companies of fraudulently over-billing the federal government for flood damage claims.

Hood is asking the temporary restraining order banning him from investigating the criminal handling of Katrina claims by State Farm be dissolved. Yet attorney Edwin Snyder, a consultant for Hood, said, “The operative phrase is ‘Hurricane Katrina claims.” If it’s unrelated to that and it’s new, it’s available to investigate.”

I can’t believe I’m saying this but I think the Mississippi Attorney General is looking to take a second bite of the apple when he has already agreed to taking just the one bite. The earlier agreement appears to have resolved any outstanding Hurricane Katrina claims. But this story and the post last week on Allstate’s troubles in Florida underscore that the corporate culture of arrogance is not something that these insurance companies can selectively flash. The same executives that once tried to bully personal injury victims and their lawyers, often with great success, have moved up the food chain. Now, they make corporate policy decisions that no longer impact just individual claims but the entire company. Dealing with politicians requires a certain level of diplomacy and respect. Yet these insurance company executives have embedded in their DNA (at least their professional DNA, a distinction fairness requires) the paradigm of arrogance and obstruction. Why else do you think the state agencies and politicians are getting so riled up?

I’ll admit that I just made up this theory about ten minutes ago, but you have to admit - it makes some sense. Of course, you might also be wondering whether some of these politicians have some other agenda beyond justice in vilifying these insurance companies. But why interrupt a great tale of good versus evil with such nuance?

The New York Personal Injury Lawyer Blog tipped me off to an article in the Chicago Tribune last week about a patient who filed a lawsuit against her eye doctor and his assistant alleging that the patient's toes were licked during her eye exam by the doctor’s assistant in Skokie, Illinois.

Apparently, the Plaintiff went to get an eye exam. The doctor’s assistant entered and dimmed the lights and told the plaintiff he was going to perform a "strip test." He placed a strip over her eyes and told her she would need to keep her eyes closed for 5 to 7 minutes. Feeling something on her feet, she opened her eyes and saw him licking her toes. The assistant reportedly replied, “"I'm sorry, I'm sorry, but I was checking your sugar level."

Many personal injury lawyers are going to disagree with me, but this is my definition of a frivolous medical malpractice action. Her damages were that her toes were licked. Obviously, this is not a good thing, and if it happened to my wife, I might be pretty annoyed and want to do something about it. The Plaintiff did do something about it. She pressed charges and the guy was convicted and sentenced to a year of probation. But now she wants to profit from that moment of having her toes licked and she wants to drag the doctor into it, even though there are no allegations the doctor knew or should have known that this guy was the nutcase that he apparently was. Who knows what a jury will give her but she does not want me on that jury.

I know that the Chicago Tribune sells a lot of papers. You can be sure that someone read this article in the morning on the way to jury duty and then was impaneled for a case where someone was seriously hurt. That deserving injury victim started his or her case behind the eight ball with that juror.

Medical device maker St. Jude Medical reported that regulators both here and in Europe have approved its new Durata lead wires, which attach implantable defibrillators to the heart and regulate heart beat. Ostensibly, the Durata leads have a softer tip and slightly curved coil that will make these defibrillator leads more flexible and durable.

There were reports late last year that the Riata leads, which are similar to the Medtronic Sprint leads that were recalled in October, broke and perforated patients’ hearts in at least four reported cases. St. Jude chose a different path and did not recall the Riata defibrillator leads. It will be interesting to compare the St. Jude defibrillator leads with the recalled Medtronic leads (with the benefit of hindsight) to see whether the St. Jude’s leads are just as defective as the Medtronic leads. As I have written before, there is plenty of reason to be concerned that the St. Jude leads have the very same defects as the Medtronic defibrillator leads.

The wife of former Dallas Cowboys running back Ron Springs has filed a medical malpractice lawsuit against two Texas doctors she accuses of letting him slip into a coma, leaving him mentally and physically incapacitated.

Springs’ case is a wonderful story with a tragic ending. Last March, he received a kidney from ex-teammate Everson Walls and hopes were high for a full recovery, leading to some wonderful stories about Springs' friendship with his ex- teammate Walls. The public's interest in the story was furthered by the fact that Springs' son is professional football player.

I have zero information on the merits of this malpractice case. It could have a great deal of merit, I don’t know. Obviously, the injury is catastrophic. But it does not help the public’s perception of medical malpractice cases when it seems as though every famous person who has a bad medical outcome files a medical malpractice case. Charlie Weis and Dennis Quaid are a few recent examples of celebrity malpractice cases.

Why does this happen? Because many lawyers are more aggressive in taking cases on behalf of people that are famous even when the damages are not extensive or the probability of success is low. Everyone wants to be so-and-so’s lawyer and receive the ensuing publicity. The problem is that the public then perceives that every bad medical outcome case ends up being a medical malpractice case, furthering the acceptance of medical malpractice insurance companies’ argument that people bring lawsuits every time something goes wrong. The reality is that the economic demands of malpractice cases too often lead to the opposite result for most people: they have a meritorious case, but the costs of a medical malpractice case are such that no lawyer is willing to take a risk to pursue the case.

How many times have you Googled for one purpose and then found something interesting completely unrelated to what you were looking for? This weekend, looking for something completely unrelated, I found a New Yorker article from two years ago on medical malpractice in the comments section of a blog. It is an interesting and somewhat balanced article by a doctor writing about the medical malpractice problem in this country. I disagree with his conclusions but it really is a wonderfully well written article that points out the paradox inherent in medical malpractice cases. Three quotes in the article I found of particular interest:

“Malpractice attorneys are hardly the most impartial assessors of care, but medicine has offered no genuine alternative because physicians are generally unwilling to take financial responsibility for the consequences of their [medical malpractice]. Indeed, the one argument that has persuaded many doctors to be more forthright about mistakes is that doing so might make patients less likely to sue.”

“I watch a lot of baseball, and I often find myself thinking about the third baseman's job. In a season, a third baseman will have about as many chances to throw a man out as I will to operate on people. The very best (players like Mike Lowell, Hank Blalock, and Bill Mueller) do this perfectly almost every time. But two per cent of the time even they drop the ball or throw it over the first baseman's head. No one playing a full season fails to make stupid errors. When he does, the fans hoot and jeer. If the player's error costs the game, the hooting will turn to yelling. Imagine, though, that if every time Bill Mueller threw and missed it cost or damaged the life of someone you cared about. One error leaves an old man with a tracheostomy; another puts a young woman in a wheelchair; another leaves a child brain-damaged for the rest of her days. His teammates would still commiserate, but the rest of us? Some will want to rush the field howling for Mueller's blood. Others will see all the saves he's made and forgive him his failures. Nobody, though, would see him in quite the same way again. And nobody would be happy to have the game go on as if nothing had happened. We'd want him to show sorrow, to take responsibility. We'd want the people he injured to be helped in a meaningful way. This is our situation in medicine, and litigation has proved to be a singularly unsatisfactory solution. It is expensive, drawn-out, and painfully adversarial. It also helps very few people. Ninety-eight per cent of families that are hurt by medical errors don't sue. They are unable to find lawyers who think they would make good plaintiffs, or they are simply too daunted. Of those who do sue, most will lose. In the end, fewer than one in a hundred deserving families receive any money. The rest get nothing: no help, not even an apology.”

“What would most doctors do if someone close to them was hurt by a medical error? In a recent national survey, physicians and non-physicians were given the following case: A surgeon orders an antibiotic for a sixty-seven-year-old man undergoing surgery, failing to notice that the patient's chart says that he is allergic to the drug. The mistake is not caught until after the antibiotic is given, and, despite every effort, the patient dies as a result. What should be done? Unlike fifty per cent of the public, almost none of the physicians wanted the surgeon to lose his license. Medical care requires that a thousand critical steps go right every day, and none of us would have a license if we were punished every time we faltered. At the same time, fifty-five per cent of the physicians said that they would sue the surgeon for malpractice.”

Continue reading "Article on Medical Malpractice in the New Yorker" »

No blog post today on the Maryland Injury Lawyer Blog but I did put up a post today on the Trial Lawyers Resource Center Blog discussing the circumstances under which a videotaped deposition of an expert might be preferable to bringing the expert live at trial. You can access that post by clicking on the link above.

There is an interesting story today in the New York Times on the chief justice of the West Virginia Supreme Court, Elliott E. Maynard, and his relationship with coal-company executive Don L. Blankenship. Apparently, these two met “accidentally” in Monte Carlo in the summer of 2006, sharing several meals even as the coal executive’s company was appealing a $76.3 million jury verdict against them to the court. A little more than a year later, Justice Maynard was the swing vote in a 3-to-2 decision in favor of Blankenship’s company, nullifying the jury’s verdict.

Apparently a spokesman for the coal company said the whole thing was a coincidence. The two men were vacationing separately, although the spokesman allowed that they met occasionally for lunches and dinners. These men were photographed together on July 3, 4 and 5, 2006.

I don’t know about you, but I can’t tell you how many times I have been vacationing in Monte Carlo, randomly bumped in to a friend there, and then met with that friend at least three days in a row. This does not happen to everyone? Who knew? Do you people even have private jets?

In 2004, Supreme Court Justice Antonin Scalia famously refused to disqualify himself from a case involving Vice President Dick Cheney, although the two were friends who had taken trips together. Justice Scalia contended that disqualification was not required because Mr. Cheney had been sued in his official capacity.

I disagree with Justice Scalia on this point. Actually, I think I disagree with him on pretty much every point where reasonable minds could differ. But at least that conflict was out in the open. So whatever you think of Justice Scalia’s decision, at least it was above board. In this Monte Carlo mess, no one knew until these pictures surfaced of these guys together in Monte Carlo.

Apparently, hundreds of West Virginia miners lost their jobs as a result of this decision. If you are one of those miners, how exactly do you feel seeing those pictures?

Metro Verdicts Monthly has a graph in this month’s issue that reflects the median verdicts and settlements when the injury victim loses vision in one eye in Washington, D.C., Maryland, and Virginia. The median for the loss of vision in one eye in Maryland is $231,000. You could drive a truck through the gap between Washington, D.C. and Virginia’s median settlements in verdicts with loss of vision in one eye cases: Washington, D.C.’s median is $162,500; Virginia’s is $320,000. If you read graphs regularly, you would expect Washington, D.C. and Virginia to be reversed because Virginia as a whole typically has more conservative verdicts.

These numbers are a bit misleading I think because most loss of vision cases are products liability cases. Many products liability cases have questionable liability which decreases the average and median recoveries. If liability is not an issue, the values of these cases are much higher.

On the Maryland Lawyer Blog today, I discuss one of our products' cases against Home Depot and Chapin International involving one of Chapin's sprayers.

I read an interesting article in The Oregonian on Sunday discussing the growing phenomenon of jurors turning to the Internet for information while the jury is still deliberating.

The article was precipitated by an Oregon DWI criminal case involving reality TV star Matt Roloff (who I have never heard of and cannot muster up the energy to Google). The jury had been deliberating for more than four hours over two days when the jury foreman told the judge one juror had done research on the definitions of “implied consent” and “beyond a reasonable doubt” and another had researched the accuracy of field sobriety tests. Interestingly, the parties avoided a mistrial by allowing the judge to reach a verdict. The judge found that Mr. Roloff was not guilty.

There is no real solution to this. There is not the will or the funding to sequester jurors. As reports of independent research by jurors grow, the only meaningful response we are likely to see are judges making a bigger point of clarifying to jurors their obligations not to turn to outside sources. But, really, it is already pretty clear so I don’t think their making a bigger issue of it is going to do a whole lot of good.

Reading this article reminded me of a comment jury consultant David Ball made at a seminar that I had forgotten about until now. Mr. Ball said that jurors read the lawyers’ websites so you should make sure that nothing you have on the website would offend their sensibilities. I looked at our website again yesterday, wondering if our website had anything on it that I would not want a juror to see. I didn’t find anything but it is something that every personal injury lawyer with a website should keep in mind.

An editorial in the Wall Street Journal last week discusses the Medtronic recall of its Sprint Fidelis defibrillator leads. On October 15, 2007, due to reports of at least five patient deaths associated with defects in its Sprint Fidelis defibrillator leads, Medtronic withdrew from the market all defibrillators with those leads. Leads are connected to a defibrillator that both transport information of an irregular heartbeat to the defibrillator and carry what are often lifesaving electric impulses to the heart. The Sprint Fidelis leads were withdrawn because many of the leads were either not performing at all or were administering unnecessary shocks to the heart.

This editorial, as you would expect in the Wall Street Journal, has a pro-medical device manufacturer slant. The article claims that cardiologists have been calling for smaller leads because they are easier to thread through the veins when implanting the defibrillator and because they are less likely to lead to blood clots or distort heart valves. The actual evidence as to this groundswell among cardiologists for thinner leads is less clear.

This editorial argues that in the post-Vioxx era, drug and medical device companies “are under pressure to get out in front of even modest risks in spite of the fact that all therapies carry some risk.” The editorial opines that these withdrawals “strip choices from patients and their doctors.”

But this editorial does not point to a single medical doctor in the country who has stated that he/she would still rather use the Sprint Fidelis leads instead of the Sprint Quattro leads that were working just fine before the Fidelis leads came along. In fact, the editorial does not refer to any recent time when doctors protested the withdrawal of any drug or medical device because risk/benefit analysis favored continued use of the drug.

The editorial also expresses concern that Republican Senator Chuck Grassley is pushing legislation to require full disclosure of the terms of drug and medical device companies’ financial relationships with doctors to resolve the problem of pharmaceutical companies buying the allegiance of the leading doctors and researchers.

Trust me, as someone who has gone around the country developing experts for both drug and medical device companies, this is a huge problem. With certain drugs and medical devices, it is impossible to find a doctor who is an opinion leader with no financial ties – directly or indirectly – to a pharmaceutical company. Most of these doctors are good, honest doctors trying to do the right thing by patients, but it is hard even for the straight shooters not to be influenced by financial ties with these companies. And if you do cross these companies, look out. They very well may come after the doctor’s career. (This post discusses just one example.)

On this issue, this Wall Street Journal editorial goes to the tried and true: blame the trial lawyers. It claims that publishing the names of doctors will “create a registry of the deepest pockets for trial lawyer browsing,” which will have a chilling impact on the participation of the best doctors needed to conduct the studies to get these drugs on the market.

Continue reading "Medtronic Recall: Comment on Wall Street Journal Editorial" »

The Washington Post and the Baltimore Sun wrote yesterday about a new report that Maryland faces a doctor shortage that may well become severe by 2015.

We already have a shortage of doctors and things will get worse? I don’t know anyone – family, friend or client – who could not find a medical doctor when they needed one. Ever.

Who wrote the report? Well, if you go to the fourth paragraph of the Washington Post article, you learn that the report was commissioned by our good friends at MedChi, the Maryland State Medical Society. These are the same folks who warned of impending doom for doctors as the result of escalating medical malpractice cost. The same folks that came out with data supporting the future abyss.

Of course, that data turned out to be nonsense as evidenced by the fact that malpractice claims in Maryland dropped 32% over the following three years. But the MedChi cry of wolf did lead to new caps on medical malpractice cases in Maryland.

Another coincidence is the timing. Before the Maryland legislature began a special session to deal with the “medical malpractice” crisis, MedChi put out tons of information about how the sky was falling. Now, this report comes out – surprise! – just as the Maryland General Assembly goes into session. Having hoodwinked the Maryland legislature last time around, MedChi knows there is no chance of imposing new restrictions on damages in medical malpractice cases. Instead, I think their goal is to stop any groundswell to roll back those new restrictions and to apply pressure on the insurance companies to increase compensation.

Look, I’m all in favor of the insurance companies increasing doctor reimbursement rates. This issue makes the cost associated with medical malpractice claims seem like chump change. The only reason that MedChi targets medical malpractice cases is that medical malpractice lawyers are easy targets and injury victims are relatively small in number, so medical malpractice insurance rates are just an easier target for MedChi than taking on the insurance companies and their lobbyist.

This is not the first jurisdiction where doctors have complained about a doctor shortage where no shortage exists. Following this is a good editorial from Arizona on this topic.

I am not saying that there will never be a shortage of doctors in Maryland. What I am saying is that considering the messenger, I’m going to wait for an impartial study that tells me there is a crisis or until I talk to one person – anyone – who tells me they cannot find the medical care they need.

Reading back over this post, I hate that I sound so anti Maryland doctor. I'm not. I love Maryland doctors. I have three kids and I hope all three of them become doctors in Maryland. Years ago, I had cancer twice. Maryland doctors saved my life and I will be forever grateful to them. I'm not anti-doctor. And most doctors that I talk to don't have strong opinions on these medical malpractice issues, with respect to insurance premiums, caps, or anything else. They just want to help their patients and earn the decent living to which they are entitled. I also realize that MedChi is doing their job, fighting for these doctors. I just think they are advocates without any credibility on these issues. So I find it incredibly annoying when the Washington Post and the Baltimore Sun publish their findings as fact without questioning the source and MedChi's possible ulterior motives.

The Maryland Court of Special Appeals found in a 2-1 decision last month that a reduction of 30 percent in the survival chances of a woman with uterine cancer as the result of medical malpractice is not actionable as a matter of Maryland law.

Marcantonio v. Moen is a case about the delay in diagnosing cancer. Plaintiff claimed that his wife died as the result of her doctors misinterpreting a sonogram and failing to order sufficient tests to follow up on the woman’s symptoms. Because of this failure to diagnose, the Plaintiff claims that his wife’s chances of survival went down from 80% to 50%-60%. So while she was statistically likely to beat the cancer even with the malpractice, she died.

The Maryland Court of Special Appeals found that the “major issue to be decided is whether proof that a health care provider was responsible for a twenty to thirty percent reduction in the decedent's chance of survival is sufficient to prove that the malpractice caused the death. We shall hold that it is not," wrote Judge James P. Salmon.

In other words, the court is saying that there has to be a 51% likelihood that the person would have died but for the negligence. So in this case, she would have to have a 29% chance of living as a result of the negligence to recover.

But what the plaintiff and the minority opinion (a very well reasoning dissent from Judge Timothy E. Meredith) argue is that the 51% math is illogical because the majority opinion is doing the calculation pretending it does not know the outcome. So if you have a 90% chance of living and defendant’s negligence takes you down to 60% and you die, there is a 75% chance you died as a result of the negligence.

Doesn’t this make sense? In the scenario I just gave, it is more likely than not that the person died because of the negligence of the doctor. Shouldn’t that be enough? Yet you can’t recover in Maryland as a matter law in a wrongful death case when clearly the doctor’s negligence is likely the cause of the death.

The only way to make this right is going to be with help from the Maryland legislature because I don’t see the Maryland Court of Appeals fixing this.

You can read the opinion here or this summary of an article written by Scott Daugherty of the Capital Gazette (which contains a brief quote from me).

Seroquel (generic quetiapine fumarate), is an antipsychotic medication manufactured by AstraZenica. The drug was approved in 1997 for treatment of schizophrenia, but additional off-label uses to treat anxiety, obsessive compulsive disorders, dementia and autism are where the big money is for AstraZenica. And big money it is. Seroquel had $3.4 billion in sales in 2006 alone. Seroquel has been approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for bipolar depression. Last week AstraZenica sought approval for its more recent creation, Seroquel XR (quetiapine fumarate) both in the treatment of manic episodes and the treatment of depressive episodes associated with bipolar disorder.

It may well be that Seroquel is efficacious in treating these symptoms. But there are increasing reports about the increased risk of diabetes pancreatitis in patients taking Seroquel. The FDA has warned of diabetes risks from Seroquel and the labeling has changed in Seroquel. But it remains on the market today.

At a congressional hearing on drug safety, Dr. David Graham, an FDA drug safety expert, was asked about concerns he had on drugs currently available today. Dr. Graham testified that “I would pay careful attention to antipsychotic medications. ... The problem with these drugs are that we know that they are being used extensively off-label in nursing homes to sedate elderly patients with dementia and other types of disorders... But the fact is, is that it increases mortality perhaps by 100 percent. It doubles mortality. So I did a back-of-the-envelope calculation on this and you have probably got 15,000 elderly people in nursing homes dying each year from the off-label use of antipsychotic medications.... With every pill that gets dispensed in a nursing home, the drug company is laughing all the way to the bank."
Fifteen thousand people are an incredible number of people to die. But there is no uproar and the drug remains on the market.

You might be asking how Seroquel has achieved sales of $3.4 billion dollars while the FDA has only approved atypicals for bipolar disorder and schizophrenia, diseases that affect just 1 percent of us. In fact, Seroquel is third on the hit parade – two other atypicals, Risperdal and Zyprexa sell a great deal more than Seroquel. The sales reps for the companies that sell Seroquel, Risperdal, and Zyprexa are pretty good at their jobs and they know how to push these drugs on doctors who they well know are not treating bipolar or schizophrenic patients.
AstraZeneca’s creative marketing efforts do not stop there.

Continue reading "Seroquel Lawsuits: The Problem with Off-Label Use of Seroquel" »

Plaintiffs’ lawyers in the Vioxx litigation are running away from a key term in an agreement that was signed about twenty minutes ago – the requirement that plaintiffs’ lawyers advise either all or none of their clients to accept the deal.

Think about that for a second. The quality of Vioxx cases varies wildly because the most difficult part of making the case was proving specific causation for the individual plaintiffs. Lawyers with clients injured by Vioxx are required by the agreement to give the same advice to all of their clients.

A first year law student can figure out that this is unethical. How this group of plaintiffs’ lawyers, some of whom are amongst the most talented lawyers the plaintiffs’ bar has to offer, could have agreed to this in the first place is incredible.

It is easy to understand why Vioxx’s lawyers would like to have such a provision in the agreement. Eighty-five percent of the pending cases must settle under the current agreement for the settlement to be effective. But the value of the remaining 15% is still quite high because the very best cases – young people at low risk for heart disease would appear to be the best cases – can opt out of the settlement.

The agreement has another provision that I think is unethical because it bars lawyers with participating clients from representing the others who opt out of the deal and continue with their lawsuits. This is going to completely screw the people who suffered the most in these cases because it will deny those people access to Vioxx lawyers with experience to prepare and try a Vioxx case. By contact, lawyers are selling out their clients who will no longer have a lawyer to handle their case. Ironically and tragically, many of these people are the clients who have suffered the most and who are now going to struggle to find competent counsel.

Thankfully, there is time to sort out this whole mess. No, wait, there is virtually no time at all. The deadline to submit these claims is next week, January 15th. Plaintiffs who hope to qualify for shares of the settlement must submit the details of their case on or before this date. They must commit to the settlement by March 1. Merck is expected to start making payments in August. This is a complete mess. I hope the court lets the plaintiffs’ lawyers out of this mess but, if not, this is a debacle of their own doing.

There is an editorial in this month’s New England Journal of Medicine on Riegel v. Medtronic, the preemption case soon to be decided by the Supreme Court that has pharmaceutical and medical device companies sitting on the edge of their seats.

Quick background: A man was injured when a balloon catheter exploded during an angioplasty. The manufacturer, Medtronic, moved to dismiss the case on the grounds that the Food, Drug, and Cosmetic Act of 1976 immunizes Medtronic from any state law torts claims for medical devices because the device received pre-market approval from the FDA.

The authors of the New England Journal of Medicine editorial set forth the history and rationale of the Food, Drug and Cosmetic Device Act, pointing out that arguments in this case are just another version of the same arguments Medtronic offered in Medtronic v. Lohr, a case in which the Supreme Court rejected the preemption of state court claims arguments. The authors note that this case addresses “just how reliable the FDA pre-marketing approval process is and how much weight to give it.” The authors do not explicitly answer this question but it is hard to argue that the FDA is an effective watchdog of pharmaceutical and medical device companies. (For some of the reasoning as to why the FDA regulatory paradigm is flawed, read this blog post.)

The authors close the editorial with a list of questions that the Supreme Court should address to determine what is best for the country. “Is it in the people's interest to shield medical-device companies from product-liability claims? Would such a decision benefit patients by making more lifesaving medical devices available, or would there be adverse effects on the overall safety of devices? Is the FDA pre-marketing approval process sufficiently rigorous and comprehensive enough to justify immunization of the industry against tort claims? And if medical-device manufacturers are shielded from liability, what about drug manufacturers? Or would society be better served if patients retained their right to seek legal redr