Maryland Injury Lawyer Blog

The FDA yesterday raised from 19 to 62 its estimate of the number of people who may have died as the result of the Baxter heparin recall.

Regrettably, this number is going to continue to rise well past 62 fatalities. Our law office alone has received calls in scores of heparin related death cases. Because people taking heparin often have quite complicated health problems, not all of these deaths will be the result of the use of heparin. But a substantial percentage of these deaths are the result of the contaminated heparin Baxter received from China.

Our Baxter heparin recall lawyers are accepting both individual and class action defective heparin recall cases throughout the country. If you want to discuss your heparin case with one of our Baxter heparin recall lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

A House committee this week approved legislation that would give the FDA new authority over the tobacco industry, giving the FDA the ability to regulate the sale and marketing of tobacco products such as flavored cigarettes and "light and low tar" products. A floor vote on the House of Representatives is expected soon.

Okay, the FDA is unable to inspect Chinese factories leading to the deaths of scores of people in the Baxter heparin recall debacle because it is under funded and stretched too thin. So our Supreme Court responds by making them the ultimate gatekeeper and the "great decider" as to whether drug companies are negligent (as opposed to the cute, yet silly, citizens of our country), and Congress responds by giving them even more work – regulating the behemoth this is big tobacco.

Now, incredibly, to complete the governmental insanity trifecta, we need President Bush to join in the fun. Who knew he would be the holdout? My guess is that he will find a way to oblige. He’s good like that. Maybe next week he will declare his plan that if the FDA approves a doctor – a one page Internet application by the doctor should do it - then no medical malpractice action can be brought against the doctor.

The FDA said yesterday it is looking into a possible association between Merck's allergy and asthma drug Singulair and suicide. The FDA has received reports of mood changes, suicidal ideation and suicide in patients who have taken Singulair. Trying to get out on the front of the curve with its package insert, Merck has previously updated Singular’s drug labeling four times to include potential risks of tremors, anxiousness, depression and suicidal behavior that has been reported in some users of Singulair.

To call Singulair a popular drug is an understatement. Singulair is Merck's biggest selling drug and one of the world's top selling medicines with $4.3 billion in sales. Singulair is also a leukotriene receptor antagonist. These types of drugs have previously been linked to suicidal ideation and suicide. Two similar drugs, AstraZeneca's Accolate and Critical Therapeutics's Zyflo, will also be reviewed by the FDA. Neither of these drugs have suicide warnings.

Singulair/suicide litigation just might be the next big mass tort. But I doubt it. Unfortunately, 40,000 people a year commit suicide and when you have a drug like Singulair that is used by millions, some of those people are going to take Singulair and commit suicide. Some will even take Singulair and commit suicide in close temporal relationship with the initiation of the drug which really leads people to assume that it must be the drug. But it does not automatically follow that Singulair causes suicide. That remains to be seen and my guess is that Singulair does not cause suicidal behavior. Either way, it is nice to see the FDA is trying to get out in front a potential risk (for once).

When I started practicing law, I spent most of my time defending a pharmaceutical company in AIDS/hemophilia cases, litigation involving approximately 10,000 completely innocent people who contracted HIV from the use of Factor VIII and Factor IX blood products. Regardless of how you viewed the liability of the involved drug companies, everyone agreed on the magnitude of the tragedy (which was very underreported in the media). My experience in those cases eventually lead me to becoming a plaintiffs’ lawyer because I quickly realized I would be far more energized by representing innocent victims who needed my help than large pharmaceutical companies. After I became a plaintiffs’ lawyer, I thought I would never be involved in a mass tort lawsuit with facts as tragic as the AIDS/hemophilia cases, but the gadolinium MRI contrast litigation, while on a thankfully smaller scale in terms of number of patients, is in the same league of suffering - a cruel, progressive disease that you contracted through absolutely no fault of your own.

Gadolinium is the contrast given before a MRI (or MRA, magnetic resonance angiograph, although this practice was never FDA approved) to increase the contrast of blood vessels during an MRI procedure so that the reviewing radiologist can better diagnose abnormalities. While gadolinium did improve MRI diagnostics, nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD) resulted for many patients with kidney issues who received a gadolinium contrast MRI. NSF/NFD causes thickening or tightening of the skin and connective tissues, which severely limits a patient’s ability to move, and it also causes pain, muscle weakness, scarring of internal organs and difficulty bending joints. It seems that patients’ lives are potentially at risk because of the damage to their organs, and destroyed by their inability to move. What we can all hope for is that science will move quickly forward to find ways to make this NSF/NDF more manageable.

More than 215 cases of NSF/NFD have been documented in the last decade, but despite ongoing research, the etiology of the disease was originally unknown. Now, it is clear that use of gadolinium contrasting agents in patients with kidney failure is the culprit. In June 2006, the FDA first said that NSF/NFD can be caused by the use of gadolinium contrast MRI. Last year, on May 23, 2007, the FDA asked manufacturers to include a new boxed warning with gadolinium contrast informing health care providers that patients with severe kidney insufficiency who receive gadolinium contrast are at risk for developing NSF/NFD. Additionally, the warning states that patients with liver problems are also at risk for developing NSF/NFD if they are experiencing kidney problems.

The lawsuits against the five manufacturers of Gadolinium have a simple premise: these companies knew that gadolinium is toxic and, if misused, could lead to serious injury. Accordingly, these companies should have properly designed and tested the gadolinium MRI contrast and given more consideration to vulnerabilities of the different types of patients who would be using the contrast, in this case, patients with kidney disease or renal dysfunction.

I met recently with a confirmed NSF/NFD client here in Maryland. These cases are just absolutely heartbreaking. This client I met with is a wonderful woman who was struck down in the prime of her life by NSF/NFD. Thankfully, she is in better spirits than most people you meet.

The gadolinium MRI cases around the country have been consolidated in MDL-1909 in Ohio. Our gadolinium MRI NSF/NFD attorneys are investigating these cases throughout the country. If you or a loved one has been diagnosed with NSF/NFD, call one of our lawyers for a free consultation at 800-553-8082 or click here to discuss your gadolinium MRI case via the Internet.

The Boston Globe published an article on Friday about the concerns surrounding the manufacture of drugs and medical devices in China. Looking at the Baxter Heparin cases and seeking input from the perspective of a plaintiff’s lawyer, the Globe called me for an interview. This is an excerpt from the article:

“But there are also risks, as evidenced by the heparin incident, that could damage a company’s reputation and lead to expensive litigation. Ronald V. Miller, Jr., a Baltimore lawyer who is considering filing a lawsuit on behalf of patients injured by heparin, said it is easier to win damages against a company that sells defective products made in China instead of the United States.”

“Reasonable people understand that there is some level of concern about Chinese manufacturing,” said Miller, a partner in the law firm Miller & Zois, LLC. “Indeed,” he said, “jurors might conclude that companies make products in China to cut costs at the expense of safety.”

I think this is true. In fact, I think it would be difficult to argue with that statement. But that does not mean that any manufacturing defect case against a Chinese made drug is a slam dunk by any stretch. But if you are going to manufacture a drug or medical product, particularly a life saving drug like Baxter’s heparin, in China or anywhere outside of the United States, you are distancing yourself from the product. This is okay, as along as you take the proper precautions. Here’s a quick checklist companies might want to consider:

•Has the FDA inspected the manufacturing site? (heparin:no)

•Has the foreign version of the FDA inspected the manufacturing site? (heparin:no)

•Is there any final means to verify the product is safe after that stage through the manufacturing process? (heparin:no)

•Is the product one where, if there is a mistake in the manufacturing process, it is likely to have serious or fatal repercussions? (heparin: no)

Obviously, for Baxter with Heparin, it failed every element of this list and, as a result, its Heparin product was transformed from lifesaving to fatal for many consumers.

Concerns about the loss of jobs at home notwithstanding, drug companies may be serving their customers well by manufacturing their products abroad to cut costs because they pass along, in whole or part, these savings to their customers. But if that is the plan, they have to realize that the further they ship away the nuts and bolts of the manufacturing process the more they need to make sure there are adequate safeguards in place to keep the product safe.

Alexandra D. Lahav, a law professor and editor of the Mass Tort Litigation Blog, has an interesting blog post on choice of law made by the MDL Panel in cases consolidated for discovery where the applicable law chosen may foretell the outcome of the case.

To receive certification by the MDL Panel, under Rule 23 you must have: (1) plaintiffs so numerous that joinder is impossible (numerosity); (2) class claims which present common questions of law or fact (commonality); (3) plaintiffs' claims that are typical of those of the class (typicality); and (4) plaintiffs who are adequate representatives of the putative class (adequacy).

This blog post addresses the third prong, commonality of law. In some cases, like the Michigan law at issue in Warner-Lambert v. Kent, with different statutes of limitations, the issue can be a case breaker for the plaintiffs. In MDL cases now, the MDL Panel determines which law will be applied by selecting where to send the case - wherever the case is sent, that forum's law applies. As Ms. Lahav's post points out, the MDL Panel is placed in a terrible situation when the outcome of the case is based on transfer and is already known in advance of the transfer.

Ms. Lahav's blog post, which she says will be the subject of an upcoming law review article, says the MDL panel should consider "transferring and centralizing the cases to several regional forums. I suggest two forums. Plaintiffs who filed within the regions covered by the preemption precedent would be consolidated in one court; plaintiffs who filed in the regions covered by the non-preemption precedent would be consolidated in another court. This would not lead to duplicative discovery because all the cases in region 1 would be dismissed, and all the cases in region 2 would proceed."

I do not appreciate the nuances of the law involving the seven judge MDL Panel's decision making process or the possible ramifications of Ms. Lahav's remedy. While this decision might hurt some plaintiffs who might be able to backdoor otherwise barred claims, I have to admit is appears to be a reasonably fair solution in cases where the choice of law is dispositive of the claim.

The FDA performed MRI tests on Baxter's heparin blood thinner that has already caused at least 21 deaths. The MRI found that as much as 20 percent of the drug's active ingredient was made from an undetermined counterfeit material. Although our lawyers did not "rush to judgment," we strongly suspected that there was a manufacturing defect with heparin that originated in China. It now appears virtually certain that this is exactly what has led to these deaths and injuries from the use of Baxter's heparin.

Our Baxter heparin recall lawyers are reviewing both individual and class action defective heparin recall cases throughout the country. Our law firm is handling only serious injury and death cases in the heparin defect cases. If you or a loved one has suffered a serious injury or death from the use of heparin and want to discuss your potential heparin lawsuit with one of our lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

According to a recent poll on jury duty, the answer is yes. Fifty-eight percent of those surveyed believe that a jury is fair and impartial all or most all of the time. Even more interestingly, half of those surveyed said they would expect a jury to give a fair verdict as opposed to a judge. Only 23% selected a judge over a jury (27% were unsure). In other words, by a margin of more than 2 to 1, we trust juries more than judges. Only 18% of African-Americans and 19% of Hispanics chose a judge.

Maybe our founding fathers were on to something with this whole “jury of our peers” thing. But I don’t think this is a knock on our judges. Instead, I think people would prefer to be judged by regular everyday people like themselves who are outside of the process.

In light of the recent Medtronic ruling and drug preemption cases pending before the Supreme Court, I would like to add one more question to the survey: Do you think a jury or the FDA is more likely to protect you and your family from a defectively designed pharmaceutical drug or medical device? Someone do this survey and send the results to the Supreme Court.

Thanks to the Florida Jury Selection Blog for the link to the study.

The Supreme Court opinion in Riegel v. Medtronic was issued this morning. I'm just starting to read it now and will comment later today about the holding once I get a chance to actually read the case. Scalia wrote the opinion which scares me but seven justices join Scalia's opinion so I do not think the holding will be too radical. But I will get back to you later today...

Follow-up note: I just finished the case and will not give a full response today. Quick summary is that we lost. The good news is that Medtronic v. Lohr still appears to be good law and the Supreme Court's holding (I think) will be limited to medical devices that receive premarket approval from the FDA (but Scalia even appeared to hedge on that). The Court decided to ignore its own rule of statutory construction not to be "guided by a single sentence or number of sentences" but to instead look to the "provisions of the whole law, and to its object and policy." Instead, it turned to a few sentences to its liking and ignored what the Court knew was the intent of Congress. Classic Scalia.

I think everyone agrees that there is no suggestion in the legislative history of § 360k(a) that injury victims would lose their only vehicle for recovering compensation for injuries caused by negligent or inadequately labeled PMA devices. Say what you want about the value of legislative history but not a single member articulated the view that this statute would preempt state tort law claims. In fact, a House Report of the bill notes with apparent approval that California already had adopted a regulatory scheme for medical devices which completely contradicts the Court's holding. The legislative history of the MDA is so in conflict with the Court's holding that it might as well have made a new rule that legislative history is never of probative value.

More generally, the whole purpose of this statute was patient safety. In fact, as Scalia points out, it was the Dalkon Shield debacle that lead to the MDA in the first place. Okay, I'm rambling at this point. I'm not proofreading this. I'm just going to hit send. Then, I'm going to go home and play with my kids. When they are in bed, I'm going to send some money to Obama (gee, can you do that on-line?) and hope that he will help Congress sort out this mess in January.

With the preemption arguments raging on in the Supreme Court and in circuit courts around the country, we have yet more evidence that making the FDA the gatekeeper for product liability claims is tantamount to naming Roger Clemens the new performance enhancing drug czar. The FDA is under fire for approving the sale heparin, Baxter’s blood-thinning drug, without bothering to inspect the plant in China that manufactured the heparin's active ingredient. Peter Barton Hutt, a former top FDA lawyer, said that since 1980 the FDA has had a policy requiring that plants be inspected before drugs are approved for sale. “It was obviously a glitch” that the FDA didn't bother to inspect the site, said the F.D.A. through a spokesperson.

On Monday, Baxter announced that it had temporarily halted production of its version of the anti-clotting drug heparin because of about 350 bad reactions linked to heparin, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery. The active ingredient used to produce heparin was sold by Baxter International until sales were suspended after the aforementioned fatalities and complications.

I love the FDA's response. "While no FDA inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible. We have already requested expedited access to the facility, facilitated through a recently signed agreement with the Chinese State Food and Drug Administration. FDA also has requested the facility's inspectional data and adverse event reports connected to the product." Thanks guys. Now that the horse is out of the barn, we are so grateful for you to take the time to close the door. United States Supreme Court? Are you there? I hope you are paying attention.

Our Baxter heparin recall lawyers are reviewing both individual and class action defective heparin recall cases throughout the country. If you want to discuss your case with one of our Baxter heparin recall lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.

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" »

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 redress when they believe they have been damaged by a faulty medical device? In the long run, would this result in safer medical devices for patients?” The authors conclude if the Supreme Court wants to protect patients, it should reject Medtronic’s request for immunity.

The authors also note that if the Supreme Court comes to the “wrong conclusion” patients injured by defective medical devices have a remedy in Congress (who, by the way, have never to my knowledge questioned the Court’s holding in Medtronic v. Lohr). This is how it might play out because I think Congress would then clarify its position on preemption. But if this happens, it might jeopardize the claims of patients who currently have lawsuits pending against medical device companies, most notably and ironically, the thousands of Medtronic defibrillator lead recall class action lawsuits pending around the country.

By the way, the Drug and Device Law Blog has a ton of posts on Riegel v. Medtronic. If drug and medical device manufacturers were like political parties, the Drug and Device Law Blog would serve as the text of the party platform for drug and medical device manufacturers. The authors, Jim Beck and Mark Herrmann, two mega-firm pharmaceutical defense lawyers, rarely if ever deviate from the party line. But the blog is incredibly well written and provides quality and current analysis of the issues in medical device and pharmaceutical drug litigation. It is a shame that more quality defense lawyers do not blog because the truth is that most of the great writing talent among lawyers resides in huge defense firms.

You can access the New England Journal of Medicine article here although I’m not sure how long it will be available for free.

Today, the Supreme Court will hear argument in Riegel v. Medtronic Inc. The issue is whether the Food, Drug and Cosmetic Act forecloses state law personal injury lawsuits for injuries from the design, manufacture and labeling of a Medtronic medical device that was granted pre-market approval by the Food and Drug Administration. This case is a product defect case involving a Medtronic balloon catheter that killed the patient but, this case could have ramifications for the Medtronic lead recall lawsuits that are being filed all over the country. While technically this case focuses on a specific statutory provision, no one would be surprised if the Supreme Court’s holding provides a comprehensive framework for preemption that would apply to all drug and medical device cases.

Naturally, the Bush administration has lined up squarely behind the pharmaceutical companies. This is ironic because there is a strong presumption against preemption, particularly in cases where the issue involves the individual states’ power to protect public safety and health. The Supreme Court has consistently found that preemption of state law does not apply unless “the nature of the regulated subject matter permits no other conclusion” or “the Congress has unmistakably so ordained.” Chicago & N.W.Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317(1981) (quoting Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142 (1963)).

Preemption limits the states’ ability to protect its own citizens. The requirement that express preemption provisions be unambiguous follows this administration’s line of thinking: the states should be allowed to decide what is best for its citizens whenever possible, accordingly we should err on the side of states’ rights unless the preemption provisions are crystal clear. Yet, in this case, this administration supports usurping the states’ power even when it is clear that there is no express legislative intent for preemption.

The Bush administration is a big proponent of states rights. The President clearly believes that if the state of Kentucky finds that all of its citizens should be permitted to walk into shopping malls with AK-47s, it is all good and the federal government should just stay out of it. Yet all of this high minded capital “F” Founding Fathers and Federalism gets trumped because pharmaceutical and medical device companies do not want to be held accountable for their own negligence. The lesson, as always, is that protecting big business prevails over all, even at the expense of deeply held core values.

The Medtronic recall and the concern being expressed about the St. Jude Riata leads has left patients in fear that they have defective defibrillator lead wires in their chest that cannot be removed. Both Medtronic and the FDA have suggested that for most patients, removing the leads is not the best option because of the risks associated with the removal.

The good news, according to a recent article in Medical Device Week, is that medical technology is moving towards a safe and effective way to remove leads if they become damaged or dangerous to the patient.

Leads can become hazardous for any number of reasons, whether it is a question of faulty manufacturing like the defective Medtronic leads, or because they become infected or blocked over time. In the 1980s, most implantable leads were removed by mechanical sheaths. However, they were eventually replaced by power sheaths which were in turn abandoned for the newer laser sheaths. Cook Medical in Bloomington, Indiana has taken a more traditional approach in creating Evolution, their new tool for defibrillator lead removal and throwback to the mechanical sheaths of the ‘80s.

According to Cook Medical, the new Evolution mechanical dilator sheath boasts improvements over the traditional mechanical sheaths and has none of the drawbacks which plague the power and laser sheaths of today. The design of the original mechanical sheaths caused them to be somewhat awkward and require a large degree of physicality to operate. The new Evolution design has eliminated this concern. They are not as bulky or as costly as the current electronic sheaths, and they are able to avoid the unintentional damage to surrounding tissue sometimes caused by their electronic counterparts. The mechanical Evolution does not require the additional capital equipment, annual maintenance and calibration, biomedical inspection, electricity source, or on-site laser officer necessitated by a laser sheath. Reportedly, the mechanical sheath also maximizes physician control.

Continue reading "Medtronic Lead Recall: Possible Good News for Medtronic Defibrillator Patients with Defective Leads" »

When writing about the Medtronic lead recall last month, we wrote that the St. Jude Medical Riata defibrillator leads might also be suspect, noting that either St. Jude similar leads were technologically superior or that data had not caught up to the problem because St. Jude has less market share than Medtronic. Both the Medtronic Sprint lead and the St. Jude Riata lead are smaller than other defibrillator leads. Certainly, they are easier for cardiac surgeons who are threading the defibrillator leads through the patient’s blood vessels than the Quattro lead or other available leads. The question is whether these newer and thinner defibrillator leads are safe. The Medtronic lead recall and the reports we are getting from clients all over the country make clear that the Medtronic Sprint lead is defective.

Now, the question is whether the St. Jude Riata lead is similarly flawed. According to a Wall Street Journal article last week, reports are emerging that some St. Jude defibrillator wires may be defective. As opposed to staying attached to the heart where they belong, there are reports that the St. Jude leads are puncturing holes in the hearts of defibrillator patients. The punctures are not insignificant; some reportedly are nearly poking through the patients’ skin.

If the lead is not attached to the heart, it creates the same (failure to shock the heart) concerns we now have with the Medtronic Sprint leads. Even more problematic, the detached wires can cause the heart to bleed, creating a potentially life-threatening condition.

There is no question that in rare cases this can happen to any defibrillator lead. St. Jude claims that there is no evidence that Riata leads are more likely to perforate the heart than any other defibrillator leads.