Medical Device Safety Act would restore needed safeguards and allow victims to be compensated
When 2 ½ year old Avery DeGroh’s defibrillator shocked her nine times because of a broken lead, her mother “grabbed her to hug her, and…could feel all the electricity jolting back and forth, cycling through her body.” (Details here.) The defibrillator lead was soon recalled by manufacturer Medtronic, but the DeGroh family was still stuck with $30,000 in medical bills for the cost of replacing the device, not to mention the trauma of Avery’s experience. DeGroh’s mother explains that “as the law stands, we don’t have any way to seek compensation for what Avery has gone through…we were just asking for her hospital bills [to be paid].”
The DeGroh family and others testified before the Senate’s Committee on Health, Education, Labor, and Pensions on August 4 in support of the Medical Device Safety Act (MDSA), which will restore an injured patient’s right to sue manufacturers.
Without a change in the law, medical device manufacturers will continue to enjoy complete immunity from liability under the Supreme Court’s 2008 Reigel v Medtronic decision. This is true even if a defectively designed or manufactured medical device injures or even kills patients.
The MDSA, sponsored by Sen. Edward Kennedy (D-MA) and by Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), would restore the right to seek justice in state courts for patients who are injured by faulty medical devices. MDSA (designated H.R. 1346 in the House and S. 540 in the Senate) would simply overturn the 2008 Supreme Court decision which found that a 1976 federal statute allowing FDA to regulate and approve the marketing and sale of medical devices also broadly preempts state authority, including those state laws that allow injured consumer to sue a manufacturer.
At the hearing, Dr. William Maisel, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center, testified that while “we are fortunate to have the preeminent medical regulatory system in the world,” the FDA must regulate “more than 100,000 different medical devices manufactured by more than 15,000 companies.” After approval, the FDA must rely on manufacturers to report problems because they simply do not have the resources to adequately monitor all of the devices on the market.
Before Riegel, lawsuits were the main incentive for device companies to report problems. But in light of the Riegel decision, manufacturers have little, if any incentive to report problems, because to do so might decrease sales. In short, now that consumers cannot sue, there is very little incentive for manufacturers to act responsibly and inform FDA as soon as they have evidence of public health risks associated with their devices.
Bill cosponsor Senator Harkin described the ability to sue manufacturers as an important “safety net” that is complementary to FDA regulation. “In our system of justice, access to the court system is critical in exposing dangers and bringing about remedies.” (Watch the hearing here.) Another victim of Medtronic’s defective defibrillator lead, Nick Evola, was shocked 43 times. According to his lawyer Wendy Fleishman, “Medtronic put profits ahead of patient safety. They were aware the device was failing at abnormally high rates but continued to market it as alleged in lawsuits filed against the company.” (See article here.)
The profits on medical devices are significant. In 2008, Medtronic’s revenue topped $13 billion, with $10 billion in profits, according to the American Association for Justice, an advocacy group supporting the MDSA.
In support of the bill, Dr. Maisel cautioned that “the Riegel decision eliminates an important consumer safeguard – the threat of manufacturer liability – and will lead to less safe medical devices and an increased number of patient injuries.”
Senator Harkin explained at the hearing that “this bill is really about real people, who have been…let down, sometimes catastrophically. Right now they have no access to justice and no ability to hold those that cause them harm accountable.”
Janice Baird, another supporter of the bill whose son died due to a defective pacemaker, explained that the law is needed because manufacturers “have to be responsible, and [because the law] will also, in my heart, give me some peace to know that Robert’s death was not in vain.” (See article here.)
Today, the Supreme Court rejected arguments by the prescription drug industry that having their labels approved by the Food and Drug Administration should be a shield from state law tort liability.In a rousing victory for consumers of prescription drugs, the Supreme Court rendered a decision preserving consumer rights to access the courts when injured physically or financially by prescription drugs.
In the case Wyeth v. Levine, the Court ruled 6 to 3 that the FDA’s approval of a drug label does not preempt consumer’s rights to sue the manufacturer for their failure to warn of knows risks associated with the drug.
The lawsuit was brought by Diane Levine, a musician from Vermont who while suffering from a migraine was given the anti-nausea drug Phenergan. Her physician’s assistant did so in a manner that caused the drug to contact her arteries, which caused gangrene and resulted in the loss of her arm. Ms. Levine sued and settled with her doctor. She also sued the drug’s Manufacturer, Wyeth. In its defense, Wyeth argued that the FDA’s approval of the label under federal law preempted Ms. Levine’s rights under state law, but lost. After a 5-day trial, a Vermont jury concluded that the drug maker did not adequately warn of the known risks of gangrene associated with the use of the drug, and awarded Ms. Levine $7.4 million.
After losing in appeals all the way up to Vermont’s Supreme Court, Phenergran’s manufacturer, Wyeth appealed to the U.S. Supreme Court. The Court accepted the case, and addressed the issue
whether federal law preempts Levine’s claim that Phenergan’s label did not contain an adequate warning about using the IV-push method of administration.
In today’s decision, the Court decided that there was no preemption, and found in favor of Ms. Levine.
The Court first noted that it was not impossible for the drug maker to comply with both state law and federal requirements in preparing the drug’s label.The court concluded that the drug maker could have added warnings to the label at any time to reflect the risks of gangrene that had occurred to over twenty people since the labeling was approved by FDA. Wyeth had incorrectly argued that the federal regulations prohibited their changes to the label, because they must have been based on “newly acquired information….”The Court countered that Wyeth was incorrect, and that they could have added warnings to reflect the 19 amputations that had arisen from Phenergan’s use before Ms. Levine’s case.
The Court also concluded that Wyeth suffered from a “more fundamental misunderstanding” about the duty to warn consumers of the risks of prescription drugs.The Court noted that
Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.
Wyth also argued that the Ms. Levine’s lawsuit should be preempted because it interferes with “Congress’s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives.” The Court rejected this argument as being both out of line with the intent of Congress, and as based on “an overbroad view of agency’s power to pre-empt state law.”
On the first point, the Court notes that “[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA’s 70-year history” like it did with a 1976 amendment allowing “express pre-emption … for medical devices….”
The Court also spoke to the FDA’s role in the preemption debate, especially it’s position in favor preemption announced in the preamble to the 2006 regulations that redesigned the format and content requirements for prescription drugs.The Court also assessed how much weight to give an agency position that “state law is an obstacle to achieving its statutory objectives….” The Court found that in cases lacking express authority by Congress, the deference given to an agency “depends on its thoroughness, consistency, and persuasiveness.”Based on this, the Court decided that FDA’s position “does not merit deference.”
First, the Court pointed out a glaring procedural lapse by FDA in adopting the position that their regulations and approval of drug label preempts state law. In proposing the draft rule in 2000, the FDA had stated that the rule would “not contain policies that have federalism implications or that preempt State law.”
Despite this, FDA adopted a position in favor of preemption upon publishing the final rule in 2006. FDA did so “without offering States or other interested parties notice or opportunity for comment….” As a consequence, the Supreme concluded that “[t]he agency’s views on state law are inherently suspect in light of this procedural failure.”
The Court also noted that the FDA position on preemption “is at odds with … Congress’s purposes, and it reverses the FDA’s own longstanding position….” The Court summarized the history of FDA’s relationship to state law, noting that
the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market,and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.
The Court also stated that
State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.12 The agency’s 2006 preamble represents a dramatic change in position.
We recognize this decision as an important victory for consumers, and we applaud the Court for this decision.
We hope to post more details on this decision, and its potential impact on our other lawsuits, soon.
The good folks over at Alliance for Justice are premiering a new 22-minute documentary about Diana Levine, the Vermont musician who lost her forearm to gangrene caused by a prescription drug made by Wyeth, and whose suit against Wyeth has gone all the way to the Supreme Court.
Here’s the description:
When Diana Levine went to the hospital in April 2000 seeking relief for a severe migraine headache, the professional musician and children’s record producer never imagined that faulty drug labeling would result in the amputation of her arm. Today she is at the center of a closely-watched Supreme Court case and a national debate about the federal courts and corporate accountability.
Produced in conjunction with 12-time Emmy award-winning producers/directors Jon Alpert and Matt O’Neill, Alliance for Justice’s documentary Access Denied?: The Fight for Corporate Accountability tells Ms. Levine’s powerful story and exposes the slow but steady transformation of our federal courts into institutions that favor corporate interests over everyday Americans. Through an examination of Diana Levine’s case against Wyeth Pharmaceuticals – and the experiences of others like her – Access Denied? takes the legal issue of preemption out of the courtroom and into the real world, where millions of Americans find themselves unable to access the courts and hold corporations accountable for their misconduct.
And here’s the trailer:
Bradley Whitford, of West Wing fame and other films & TV shows, is promoting the film. (If I may digress for a moment: Your humble blogger once was a humble stage crew intern at an off-off-Broadway theater in Hell’s Kitchen in New York in 1987. A then-completely-unknown Bradley Whitford was in a one-act play in said theater. So was Marisa Tomei, who at the time was NOT unknown, because she was in the Cosby Show spinoff series “A Different World.” One exciting night saw Lisa Bonet and then-hubby Lenny Kravitz come to see the show.)
And speaking of celebtrity actors, one can’t help but wonder: Who would play Rep. Henry Waxman in the feature film?
There are plenty of good candidates in the roster of bald actors, such as:
Sir Ben Kingsley:
Or perhaps Alan Arkin:
Or Robert Duvall:
We could do this all day! Your other Waxman portrayal suggestions welcome in the comments.
Through Executive Orders, a President exercises his broad authority over the executive branch; and in so doing can have a profound influence on how the federal government responds to important policy issues. By directing federal agencies to focus on particular priorities, and by reshaping the internal processes by which agencies do their business, President Obama can impose new policies, while at the same time sending a clear message to Americans and the world that change is under way.
Readers of this blog know that we frequently write about FDA preemption of consumer lawsuits against drug companies. The Supreme Court just heard on November 3 arguments in Wyeth v. Levine, a case that could very well shut the Courthouse doors across the U.S. to consumers who’ve been injured by unsafe drugs. Wyeth, the drug company defendant in the case, argued that the lawsuit against it for failing to warn musician Diana Levine and the medical staff that cared for her that a particular method of administering the anti-nausea drug Phenergan could cause gangrene should be preempted by the FDA’s authority to approve prescription drug labels. Most observers expect the Supreme Court to decide in Wyeth’s favor, and to say that consumers cannot file lawsuits alleging drug company “failures to warn.”
But the push for preemption in the past several years has not just been in the Courts. The FDA too has been aggressively arguing for preemption for the past 8 years. The FDA actively intervened in numerous lawsuits on unsafe drugs and medical devices to argue for preemption. In 2006, the FDA included a lengthy “preamble” in its revised rules on drug labelling requirements that argued that such lawsuits are/should be preempted. And the FDA’s new “Changes Being Effected” regulations, enacted in late August, (about when drugmakers can change the label of their drugs to include new information on risks) seems designed to preempt such suits as well.
This 8-year push for preemption is in stark contrast to the FDA’s previous approach to the subject for many years, which was to treat such suits as complementary to the FDA’s regulation of drugs and not antagonistic.
CPR proposes that the Obama administration adopt an Executive Order on preemption, or, specifically an order that would amend the existing Executive Order on Federalism. The main feature of their proposed Order would be to restore the traditional “presumption against preemption” (i.e. in order to preserve the powers that States are granted under the constitution — see, e.g. the Tenth Amendment– it should be presumed that state laws do NOT conflict with federal law unless shown otherwise.) They also propose a number of specific procedures that federal agencies like the FDA would need to follow to get White House approval before they take an action or position in favor of preemption.
Such an Executive Order would be a step in the right direction, at least in terms of halting the FDA’s (and other federal agencies) eight-year battle to limit the rights of states to protect public health and safety. But such an Order would not do anything to reverse a finding in favor of the pharmaceutical industry in Wyeth v. Levine (a decision is not expected from the Supreme Court until sometime in the first half of 2009).
To do that, Congress would have to step in and pass a law essentially reversing a Supreme Court decision in favor of preemption. Earlier this year, in Riegel v. Medtronic, the Supreme Court held that patient claims about unsafe medical devices are preempted, and more than 80 members of Congress and Senators are trying to restore patients’ rights to sue device companies in such cases with the Medical Device Safety Act. (H.R.6381 and S.3398). It is virtually certain that a similar bill will be filed if and when the Supreme Court decides in Wyeth’s favor.
An Executive Order also arguably wouldn’t do anything to affect the preemptive effect of the FDA’s Changes Being Effected regulations, which have already been promulgated and which stand as the “law of the land” for now. To undo the preemptive effect of those rules would most likely require that the FDA amend those regulations. Whether the new administration at the FDA will seek to tackle that remains to be seen — given the scandals that have rocked the FDA over the past few years, there may be bigger fish to fry (food safety, inspections of foreign drug manufacturing plants, etc.)
But an Executive Order would be important – not just to ensure that the Executive branch thinks long and hard before it tramples on the traditional powers of the States to protect public health and safety, but to change the tone and tenor of federal agencies’ approach to the issue. A restoration of the “presumption of preemption” in the FDA (and other federal agencies) would naturally affect what new regulations are promulgated, what old regulations are amended or scrapped, whether the FDA chooses to intervene in private lawsuits and what position it takes when it does so, what the FDA’s overall priorities are, and even what laws and regulations States pass – right now, the fear of preemption has a chilling effect on what measures States and state agencies will put into place to protect the public from unsafe drugs, food, and medical devices.
Tomorrow we’ll all be glued to our TVs, radios, computer screens, teletypes and telegraphs for news of the Election. But today it’s all about Wyeth v. Levine, the critical case addressing whether consumers’ lawsuits against drug companies for failing to warn them of the risks of dangerous drugs are preempted by federal law. For previous posts on this topic and background, go here.
The Supreme Court heard oral arguments in the Wyeth case today, and reports from the hearing are starting to trickle in. The transcript is now up on the Supreme Court’s website. Here’s an analysis posted at the Drug and Device Law Blog, which is written by lawyers who represent drug and medical device company defendants. Here’s a report on Pharmalot. And this morning the Wall Street Journal Health Blog wondered allowed “Would an Obama Victory Preempt Wyeth v. Levine?”
We here at Prescription Access Litigation make no secret of the fact that we oppose preemption here. We joined an amicus curiae (“friend of the Court”) brief with AARP and the National Women’s Health Network in the Wyeth case. You can view that brief here.
The LA Times ran an article today (Legal fight over drug liability law) on Wyeth v. Levine, the case being heard by the U.S. Supreme Court this fall that could very easily slam the Courthouse doors on consumers who have been injured by drug companies’ failing to warn them of risks from prescription drugs.
As we reported recently (PAL joins “friend of the Court” brief in Supreme Court preemption case), Prescription Access Litigation joined a “friend of the Court” (amicus curiae) brief, arguing that the Supreme Court should find in favor of Diana Levine, and hold that state court lawsuits arguing that drug companies failed to warn consumers about prescription drug risks should not be barred on the grounds that the FDA’s authority “preempts” them. To see other posts from this blog on preemption, go here.
The LA Times article starts out by saying it’s going to answer this question:
If you experience a serious reaction that you suspect may be linked to a medication you took, what can you do now, and how would a ruling in favor of the drug companies change that? We asked some consumer healthcare advocates.
After describing how patients and their doctors can file a report to the FDA about a serious reaction that they believe was caused by a prescription drug (at www.fda.gov/medwatch, it begins to describe what’s at stake in the case before the Supreme Court.
But rather than focus on how this would really impact patients, much of the balance of the article focuses on how a change in the law in favor of drug companies would affect lawyers’ willingness to bring cases against them. Of course, whether or not a lawyer would bring such a case determines whether or not the consumer can seek redress for their injuries. But the article places way too much emphasis on this, such as in this section:
Because plaintiffs’ lawyers foot the bills on product-liability cases — working for a slice of the award — they take cases they think they can win.
“If you take the most likely cause of action away, the calculations for the plaintiff’s lawyer become much more dire,” says Gary Marchant, professor of emerging technologies, law and ethics at Arizona State University. “It will change the dynamics of which cases are brought. Only the much stronger, the real sure-win kind of cases will be brought. The iffy ones will become financially unviable.”
Personal-injury lawyers hope the ruling goes toward the plaintiff. “Pharmaceutical drugs right now are probably the hottest area of liability,” Marchant says. The pharmaceutical industry and the Bush administration believe the excess of product liability cases must be reined in, Wolfman says.
While much of this true, it’s not the point. If Wyeth is successful in this case, consumers will have no ability to hold drug companies accountable in court when they are injured by a prescription drug and when the drug company failed to warn them about a risk that was known, but not disclosed. Given how much the FDA has demonstrated its inability and unwillingness to really monitor the activities of the drugs and drug companies they regulate, this should frighten every one who ever puts a pill in their mouth.
In addition to compensating consumers who’ve been injured or even killed by inadequate warnings on drugs, lawsuits against drug companies for “failure to warn” act as a deterrent – the threat of someday being held accountable in court discourages a drug company from keeping a risk secret. The FDA’s powers are limited — yes, it can force a drug off the market, but it can do next to nothing for the people who’ve been injured while the drug was on the market — such as the tens of thousands of people whose heart attacks were caused by Vioxx.
And lawsuits such as these often bring critical and previously hidden information to light. A great article in the Journal of the American Medical Association, The Role of Litigation in Defining Drug Risks, discusses this, and gives examples in which previously unknown information about drugs came to light only as a result of litigation, including cases on the drugs Vioxx, Zyprexa, Paxil, Bextra, Baycol, Rezulin, and others.
In sum, press reports on the Wyeth v. Levine case need to focus on the very serious impacts that a ruling in favor of drug companies would have on patients and consumers. In an environment in which the FDA is reluctant to use its already limited powers to police drug companies and hold them accountable, litigation plays an essential role. If state court lawsuits on failure to warn are preempted by the Supreme Court, the public will suffer, and the public’s confidence in the safety of drugs will suffer as well.
Wyeth v. Levine, a case being heard by the Supreme Court in November, has been in the news a lot lately. The case concerns the injuries suffered by Diana Levine, a professional musician in Vermont who Wyeth [NYSE:WYE] nausea medication called Phenergan in a visit to the emergency room. The drug was given incorrectly, causing her to lose her right arm below the elbow. She sued Wyeth, arguing that Wyeth’s warning in its FDA-approved labelling for the drug was insufficient.
A Vermont state court jury awarded her $6 million, and Wyeth appealed, all the way to the Vermont State Supreme Court, which sided with Levine. Wyeth argued that Levine’s state law personal injury and failure-to-warn claims should be “preempted” by the FDA’s authority to regulate the labels of prescription drugs. Since their argument is based on federal law, on which the U.S. Supreme Court is the ultimate authority, they were able to appeal the decision to the Supreme Court.
We frequently get on our soapbox here at the PAL blog on the topic of preemption – to see our previous posts on this subject, go here.
Earlier this year, the Supreme Court ruled in Riegel v. Medtronic that state law claims concerning medical devices are preempted, by the federal Medical Device Amendments. However, that decision does not mean that the Court will necessarily rule the same way in the Wyeth case, since they concern two different federal laws — and the Medical Device Amendments specifically address preemption, while the Food Drug and Cosmetics Act (FDCA) does not. (PAL joined an amicus brief in that case too, arguing against preemption).
The issue is hardly academic. If Wyeth prevails, injured consumers will be all but precluded from suing drug companies when they are injured by unsafe drugs. The FDA’s authority to approve prescription drugs and their labels will stand as a shield to liability — and therefore to accountability. Given that the drug safety scandals of the past four years have underscored the FDA’s inability and unwillingness to do its job, this should scare the daylights anyone who ever takes a pill. It is part of a larger attack on consumers’ access to the Courts by industries that seek to avoid responsibility when they harm, deceive, injure and even kill consumers through carelessness and greed. Preemption, as some like to say, is the new tort reform.
Prescription Access Litigation has joined an amicus curiae (“friend of the Court”) brief in the case, supporting Diana Levine and arguing against preemption. The brief was written by AARP, and is also joined by the National Women’s Health Network, a member of the PAL coalition.
We’ve often gotten on the soapbox here at the Prescription Access Litigation blog to preach against the evils of preemption. Preemption is the constitutional doctrine that when state law and federal law are in conflict, the federal law trumps or “preempts” state law.
Pharmaceutical companies and the FDA have been arguing aggressively in the past few years that consumers should not be allowed to sue drug companies under state law when they are harmed, injured or killed by defective or dangerous drugs, as long as those drugs have been approved by the FDA. For years, the FDA’s position was the lawsuits under state law did not interfere with the FDA’s regulation of drug safety. But that position changed abruptly under the current administration.
The issue has been a hot one – the Supreme Court recently decided (in Riegel v. Medtronic) that consumers’ lawsuits against medical device manufacturers are preempted. In October, the Supreme Court will hear arguments in Wyeth v. Levine, and will decide whether consumers’ cases against drug companies are also preempted.
The hearing had numerous noteworthy and learned people presenting testimony, but most of them were not the source of the press attention that is certainly unusual for an issue as arcane as federal preemption. It was actor Dennis Quaid, who testified, who was the source of the sudden press interest in this arguably vital but obscure constitutional debate.
Dennis Quaid testified because his newborn twins nearly died when they were given 1,000 times the correct dose of the blood thinner heparin. The overdose was the result of a mixup, caused by the fact that the labels of the vial for the correct dose and the vial for the dose that is 1,000 times higher are virtually indistinguishable. Quaid and his wife have sued the manufacturer, Baxter. He testified against limiting consumers ability to file lawsuits to hold drug companies accountable for the kind of harm that his newborn twins suffered.
We blog about this here today because Mr. Quaid’s testimony is so harrowing and so underscores the need to protect consumers’ access to the Courts. Rather than offer our own commentary on this subject, we’ll let Mr. Quaid’s testimony speak for itself. We repost here in its entirety. (You can also find links to the other panelists that testified here, on the Committee’s website.)
Here is Dennis and Kimberly Quaid’s written testimony:
Testimony of Dennis Quaid and Kimberly Quaid Before the Committee on Oversight and Government Reform of the United States House of Representatives May 14, 2008
Chairman Waxman and Members of the Committee:
Thank you for inviting my wife, Kimberly, and me here today to share our experience as parents of two infants harmed by the negligence of a prescription drug manufacturer. As I’ll explain, our newborn twins nearly died because of a drug company’s failure to put safety first. It is our hope that these proceedings will raise public awareness of the issue before the Committee today: When the U.S. Food and Drug Administration (FDA) approves the sale of pharmaceutical drugs, does that preempt the right of consumers to sue the manufacturer if the drug later causes injury or death?
This is an issue, I’m sure, most Americans are not aware of, but it is one that could adversely affect all Americans, our family included. As many of you already know, our twins received a potentially fatal overdose of the bloodthinning medication Heparin last year.
Our Life-Altering Story
Thomas Boone and Zoë Grace Quaid were born on November 8, 2007.
They were four weeks premature, but healthy and beautiful, and, after three days in the hospital, we took them home to begin our new life as a happy, much-expanded family.
On their eleventh day of life, Kimberly noticed an irritation on T-Boone’s belly button and Zoë Grace’s finger. Being nervous new parents, we took TBoone and Zoë to the pediatrician immediately, and, after examining them, he sent us to Cedars-Sinai Medical Center – one of the top hospitals in Los Angeles – for a more in-depth diagnosis. Lab tests at Cedars revealed that both of our twins had a staph infection, and we were told that they would have to be admitted to the hospital to be put on a continuous intravenous drip of antibiotics. Our hearts sank as we accompanied the twins to the pediatric ward, where they were placed in a room to begin their treatment.
At about 11:00 am the next day, a nurse came to the room and said she needed to replace the now empty bags of antibiotic. According to standard procedure, the nurse was supposed to clean the IV lines connected to our twins’ little arms with 10 units of a blood thinner medication called Hep- Lock, the idea being that the very small dose of heparin contained in Hep- Lock allows the IV to flow freely. What was not standard procedure was that she mistakenly injected the twins with a massive overdose of 10,000 units of the drug Heparin, which is 1,000 times the normal 10-unit dose of Hep-Lock our babies should have received. This happened while Kimberly and I were present in the room.
Unaware of the catastrophe that had just occurred, Kimberly and I spent the afternoon and early evening standing vigil over our twins until our doctor suggested we go home and get some rest. We were exhausted, not having slept the night before. The twins seemed to be resting comfortably, so we decided to go home, but not before leaving express instructions to the doctors and nurses to call us if anything changed in our infants’ condition. We had no way of knowing at that point that the potentially lethal quantity of Heparin in their tiny bodies was turning their blood to the consistency of water.
After we left, a nurse on duty noticed that Zoë Grace had an abnormal seepage of blood coming from a place on her foot where blood had been drawn. No alarms were raised. Incredibly, sometime after 7:00 pm, both babies were injected with yet another 10,000-unit overdose of Heparin. One nurse prepared the medication, and then handed it to the instructor nurse, who then handed it to the nurse in training as the instructor lectured the trainee on how infants must only receive a 10-unit dose of Hep-Lock. They then left the room and continued their rounds.
At about 9:00 pm, Kimberly and I were at home trying to get some restless sleep when Kimberly was suddenly struck with a hammer blow of overwhelming dread. She became inconsolable, crying out with a mother’s intuitive certainty that our babies were in trouble: “They’re passing,” she said. This did not make sense to me. I had called the nurse’s station an hour and a half earlier and had been told that the twins were fine. But, to calm Kimberly’s fear, I called again and was put through to the nurse in our room. Kimberly wrote down the time for some reason. The nurse told me in a measured tone that the twins were fine. I was assured. Kimberly became less frantic, and we both eventually fell into a fitful sleep.
But the twins were not fine. In fact, they were fighting for their lives. Their now water-thin blood was flowing out of every place that they had been poked or prodded. They faced the very real possibility of hemorrhaging through a vein or artery, causing massive brain damage or failure of one of their vital organs.
Our babies could have died that night, and we would not have been there for them.
Early the next morning, Kimberly and I arrived at the hospital, only to be met at our babies’ room by our pediatrician and hospital staff. We were taken aside and told what had happened. Suffice it to say, it was the beginning of the most frightening day of our lives. It was spent helping tend to our infants who were still bleeding profusely and severely bruised from internal bleeding. They were both screaming in pain, and God only knows what they were feeling. I am not sure even a lab rat had ever received such a high dose of the Heparin that was causing them to bleed out. At one point as the doctors tried to clamp shut a bleeding wound in the remnant of TBoone’s umbilical cord, blood spurted six feet across the room and splattered on the wall. The bleeding went on all day. Although the twins had been administered Protamine, a medication to counteract the Heparin overdose, their blood’s inability to coagulate literally remained off the charts all day and into the night. Kimberly and I did a lot of praying.
Finally, after more than forty hours, their coagulation levels dropped into the measurable scale and continued to fall, eventually back into the normal range. T-Boone and Zoë Grace had survived, apparently with no damage so far, thank goodness. But we have no way of knowing what the long-term effects may be.
We Were Not Alone
How had this happened? The answer became apparent after interviewing the doctors and nurses. We discovered that the bottle of 10-units of Hep-Lock and the 10,000-unit bottle of Heparin – both manufactured by Baxter Healthcare Corporation – were deadly similar in labeling and size. The 10,000-unit label is dark blue, and the 10-unit bottle is light blue. And if the bottles are rotated slightly, as they often are when stored, they are virtually indistinguishable.
We later learned that the similarity of the labels for the two products had led to the overdose of infants at a hospital in Indianapolis little more than a year earlier, in September 2006. Just like with T-Boone and Zoë Grace, hospital staff used the 10,000-unit Heparin product, rather than the 10-unit Hep- Lock, to flush the infants’ IV lines. Tragically, three infants died, and three others were severely injured.
More than four months after the Indianapolis incident, Baxter sent out a warning to hospitals concerning the potential for deadly mix-ups in the two products. A full seven months after that – in August 2007 – Baxter submitted changes in the labeling of the higher-concentration Heparin to the FDA. Baxter was permitted by FDA regulations to revise its labels, without prior FDA approval, to add or strengthen a drug warning or precaution, or to enhance drug safety by strengthening an instruction about a drug’s dosage and administration. So, although the FDA did not approve the changes to the Heparin label until December 2007, Baxter starting using its new labels in October 2007. Baxter described the changes to the Heparin labels as “an increase of 20 percent font size, a unique color combination, and a large cautionary tear-off label” warning that the product is not intended for “lockflush.”
Baxter explained that the new labeling was designed to help reduce the risk of medication errors. But, shockingly, Baxter failed to recall the misleadingly labeled bottles that were still on the market and stocked in hospitals ready for use. Kimberly and I think that this was a dangerous, potentially deadly decision, made by Baxter for financial reasons. Companies recall automobiles, they recall toasters, they even recall dog food, but Baxter failed to recall a medication that, due to its labeling, had killed three infants and severely injured three others. More than a year after the Indianapolis tragedy, the same medical nightmare happened to our twelve-day-old infants – and all because Baxter had not acted as a responsible corporate citizen.
Baxter knew that an estimated 7,000 Americans die each year as a result of medication errors, knew that 61 percent of life threatening or lethal errors involve intravenous drugs such as Heparin, and also knew that Heparin was among eight high-alert products that were involved in more than 31 percent of all medication errors that caused harm to patients. Yet, even with all of this knowledge, Baxter did not change the labeling of its Heparin injection products until months after the Indianapolis tragedy. And Thomas Boone and Zoë Grace would have to fight for their lives because the new product labeling, introduced by Baxter only one month before, had not yet made it to the shelves of Cedars-Sinai, and Baxter had done nothing to see that the look-alike Heparin products were removed from pharmacy shelves immediately.
Although mistakes occurred at Cedars-Sinai hospital, doctors, nurses, pharmacists, or other staff who make medical errors are not bad people. Indeed, choosing a career devoted to curing the sick and easing the suffering of others is one of life’s highest callings. But the overdosing of our twins was the result of a chain of events, and the first link in that chain was Baxter Healthcare. Because of Baxter’s inaction, a tragedy was waiting to happen again.
What Can Be Done?
Since this brush with tragedy, I have found out that medication errors are unfortunately all too common. Approximately 100,000 U.S. patients die every year because of medical errors in hospitals alone. It’s a toll we would never tolerate in aviation, nearly the equivalent of a full 747 crashing every single day.
I have also learned a lot about the legal system – and it was surprising, I have to tell you. Like many Americans, I believed that a big problem in our country was frivolous lawsuits. But now I know that the courts are often the only path to justice for families that are harmed by the pharmaceutical industry and medical errors. Yet the law is stacked against ordinary people.
For instance, in my home state of California, a 1975 law caps compensation to malpractice victims. The cap has never been raised for inflation. The practical effect is that people without the wealth to pay legal fees up front are unable to get their cases before a judge or jury.
Now we face something with potential to be even more sweeping and even more unjust: federal preemption. The Supreme Court is about to decide whether to bar most lawsuits over drugs and their labeling, as long as the drug was approved for marketing by the FDA. After many years of rejecting arguments that FDA actions should preempt lawsuits involving injuries from products regulated by the FDA, White House appointees at the FDA reversed that position in 2002, and now argue that FDA approval immunizes the manufacturers of dangerous products from liability for the deaths and injuries they cause.
We sued Baxter Healthcare Corporation in November 2007. Baxter has filed a motion to dismiss the case, relying on the same preemption argument that the drug industry and the FDA has made before the Supreme Court – that when the FDA allowed its Heparin drug onto the market, it gave Baxter the government’s seal of approval – a “get out of jail free” card that denies us the right to hold the company accountable. (Of course, Baxter never mentions the FDA regulations that encourage and sometimes require manufacturers to fix their drug labels immediately, without getting the FDA’s permission first.) So, says Baxter, our suit may not be heard by a judge or jury.
It is hard for me to imagine that this is what Congress intended. You tell me, Mr. Chairman: When it passed the Food, Drug, and Cosmetic Act in 1938, did Congress intend to give appointed bureaucrats at the FDA the right to protect a drug company from liability, even when the company cuts corners and jeopardizes our safety?
A federal ban on lawsuits against drug companies would not just deny victims compensation for the harm they experience. It would also relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered – years after their drugs are on the market.
Permitting bureaucrats who are under pressure from their bosses and the drug companies themselves to yank our access to the courts is incomprehensible. We have all heard about understaffing and backlogs at the FDA, and about drug-safety scrutiny that is patchy at best. If the Supreme Court rules in favor of the drug companies, it will eliminate one of the most effective deterrents to letting the bottom line win out over public health and safety.
I am in the entertainment industry, but what happened to us, and what is happening in the courts of our country, is no fiction. It is all too real. That is why I have decided to speak out and try to do something.
Kimberly and I have established a non-profit foundation to call attention to medical safety issues and seek ways to improve medical safety from the bedside up. Everybody gains from a safer health care system—from patients to nurses and doctors to hospitals and insurance companies.
We are meeting with experts from all over the country to formulate a strategy for safer health care. Americans pioneered the safest aviation system in the world; though highly complex, it is 99.9% error free. The human body is also very complex and hard to perfect. But we should strive for perfection, and we know that at the very least we can do much better. We can hope that the Supreme Court will not put more barriers in front of patients who are harmed by drug companies. But if the Court goes along with the FDA and rules for the drug companies, I respectfully ask this Congress to pass corrective legislation on an emergency basis, just as it should do immediately to correct the recent Supreme Court decision immunizing the makers of defective and mislabled medical devices. We Americans need some balance on the scales of justice in our country.
My family blessedly survived a huge drug error, triggered by the misconduct of a drug manufacturer. Others are not so fortunate. If they are denied access to our courts, they will have no compensation for their injuries, and society will lose one of the most effective incentives for safer drugs.
Critics of drug ads have been calling for restrictions ever since the ads hit the airwaves back in 1997. The pharmaceutical industry has always been able to block any Congressional attempts at putting meaningful regulation into place. This past year, a number of Congressional Reps and Senators tried to put in place a “moratorium” in which new drugs would not be able to advertise to consumers for a certain length of time (say, two years). Even that modest reform was removed from the final bill, which became the FDA Amendments Act of 2007. (FDAAA, which we prefer to pronounce as though it’s “open wide and say FDAaaaaaa….”).
One reform did make into the final legislation, however. But don’t fret — the ad agencies that produce drug ads won’t be showing up on your street corner with “Will Shill for Food” signs anytime soon. The FDA has never had the power to require drug companies to submit their ads before they hit the airwaves, and they still don’t. But, now, drug companies can voluntarily submit drug ads to the FDA for “pre-broadcast review.” If they choose to do so, they have to pay a fee for that review. And the FDA has just announced that the fee for each ad in 2008 will be $41,390. That’s a pretty modest fee – most ads no doubt cost much more than that to produce and to air.
How did the FDA arrive at this seemingly odd number? Why $41,390 and not $57,642? The FDAAA called for the FDA to raise $6.5 million for the program in the first year. The FDA asked drug companies to estimate how many ads they’d submit in 2008, and then divided $6.5 million by that number. Which means that drug companies estimated that they’d be submitting 157.04 ads for pre-broadcast review in 2008 (I, for one, look forward to seeing the .04 ad – I imagine it won’t get past “Ask you doctor ab…”).
What if a drug company goes over its estimate? It pays a 50% surcharge.
Now one might reasonably ask “Why would a company submit an ad for pre-broadcast review if it’s voluntary?” And that’s a good question. Arguably, many won’t. Those that will are hoping to avoid the FDA later issuing an enforcement letter citing violations in their ads. Better to get “clearance,” if you will, beforehand, than a rebuke after the fact. This is the reverse of the old saw that it’s better to seek forgiveness than permission.
Here’s what’s unclear: What legal status will an FDA pre-broadcast approval of an ad have?
What if, for instance, consumers are deceived by an ad that overstates a drug’s effectiveness or understates its risks, despite the FDA’s pre-broadcast review, and file a lawsuit claiming that the ad violates state consumer protection acts? I have no doubt that drug companies will argue that an FDA pre-broadcast approval of an ad “preempts” any claims under state law that an ad was unfair or deceptive. The industry has been arguing that virtually any claim under state law that a person was harmed, deceived, injured or even killed is “preempted” by the FDA’s authority to regulate prescription drugs. (We’ve written about the preemption issue ad nauseam on this blog — see archived posts on the topic here).
Arguably, the standards that the FDA will apply in its pre-broadcast review are different than those that are relevant to state consumer protection laws, which aim to protect the public from “unfair or deceptive” conduct in the marketplace. The FDA is primarily concerned with making sure that drug ads do not “misbrand” drugs a term from the Food, Drug and Cosmetics Act and the FDA’s regulations.) Conduct that is “unfair or deceptive” under state law is arguably broader than conduct that constitutes “misbranding.” But conduct that constitutes “misbranding” is most likely also “unfair or deceptive” under these state laws. This is a good example of how state consumer protection law and the FDA’s authority are complementary, rather than contradictory. So I would argue that an FDA pre-broadcast approval should not insulate a drug company from liability under state law. Whether or not courts will agree is an open question — the jury, as they say, is still out on the issue. The Supreme Court just recently took up the preemption issue generally in the case of Riegel v. Medtronic, a case that concerned medical devices, not drugs. (PAL joined an amicus brief in that case, and we’ve blogged on it here before.) The Supreme Court’s ruling on preemption in that case is likely to have some effect on how Courts address drug preemption issues, although not as much as if the Supreme Court directly addressed the question of preemption in the realm of drugs.
It will be interesting to see how the FDA pre-broadcast review program shakes out in its first year. Will it result in fewer enforcement letters being issued? Will it change the tone and tenor of drug ads in any meaningful way? To find out, all you’ll need to do is stay tuned to your TV, where drug ads will continue to bombard you on a regular basis. Enjoy!
Readers of this blog know that we here often get our knickers in a twist over federal preemption arguments by pharmaceutical defendants seeking to avoid liability in lawsuits. Prescription drug and medical device companies have been arguing with increasing frequency in recent years that lawsuits against them brought under state law are “preempted” by the FDA’s authority under federal law. (Remember that 8th Grade U.S. Civics course? Under the Constitution’s “Supremacy Clause,” federal law trumps state law when the two conflict).
Unfortunately, the FDA has been aiding and abetting them by intervening in products liability lawsuits and by adding a preamble to a Guidance on Drug Labellng, making the same arguments. Given the FDA’s abdication of its responsibility to aggressively enforce drug and device safety, this amounts to “We won’t enforce it, and we won’t let anyone else either.”
There’s a pendulum effect to corporations’ approach to federalism, and we’re at one apex of its swing. When the federal government is aggressive with regulation and enforcement, business is all about “states’ rights.” When the federal government moves away from enforcement and regulation, states step in to fill the void. Suddenly, the federal government is paramount to business, and those pesky states are “interfering” in the unique and exclusive prerogatives of federal agencies. We’ve witnessed the recent odd spectacle of various industries pushing for federal regulation, as ably documented in this recent New York Times article: “In Turnaround, Industries Seek U.S. Regulations” (Sept. 15, 2007). The shifting allegiance of course reeks of what it is – opportunism.
But the Constitution remains, and its delicate balance of federal and state powers. (Digression into the 10th Amendment omitted for your comfort). The Supreme Court has agreed to hear two cases concerning whether federal law preempts the rights of consumers to bring lawsuits under state law against drug and device manufacturers. The first, Riegel v. Medtronic, is summarized below, by Public Citizen Litigation Group, which represents the Riegels:
After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his wife sued the catheter’s manufacturer, Medtronic, Inc (NYSE:MDT). Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The court agreed and dismissed the case.
Public Citizen represented the Riegels on appeal and represents them now before the U.S. Supreme Court. The Supreme Court granted cert. on June 25, 2007, and will hear the case next Fall. The question before the Court is whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.
[PAL joined an amicus curiae ("friend of the Court") brief submitted by Community Rights Counsel to the Supreme Court. That brief can be found here.]
The case involves a product liability lawsuit against Pfizer’s (NYSE:PFE) Warner-Lambert unit. A group of Michigan plaintiffs led by Kimberly Kent in April 2000 sued Warner-Lambert Co. over alleged injuries caused by its Rezulin diabetes drug. Rezulin was ordered off the market in March 2000 by the Food and Drug Administration after it was linked to nearly 400 deaths and hundreds of cases of liver failure.
The District Court dismissed the case, arguing that a Michigan state law that prohibits virtually all lawsuits against drug companies applied, and then also ruling that a narrow exception in that law — that suits are allowed when the drug company misled the FDA to get the drug approved — was preempted. Talk about damned if you do, damned if you don’t! The Court basically ruled that state law applied, except when it might benefit the injured consumers, in which case federal law applied and preempted the exception written into state law. The 2nd Circuit Court of Appeals disagreed, reinstating the suit, and of course Warner Lambert appealed to the Supreme Court, which agreed to hear the case.
Hopefully the Supreme Court will rein in the running joke that federal preemption has become, acknowledge that state law litigation does not interfere with the FDA’s regulation of drugs (a position the FDA itself took for years, and only changed under the current administration) and restore the balance set out in the Constitution that protects the states’ historic “police powers” to protect the health and safety of their citizens.