ThePopTort

Meningitis Cases – No Preemption Problem Here!

Let’s hear it for the FDA’s failure to regulate the New England Compounding Center!  (You know, the source of the fungal meningitis outbreak that’s already killed over a dozen people.)  Don’t worry, we haven’t been hacked.  Let us explain.

As we noted earlier this week, compounding pharmacies are not regulated by the FDA.  Now, it’s possible the New England Compounding Center was acting more like a drug manufacturer than a compounding center in this case.  Members of the U.S. House and Senate are currently demanding investigations over those allegations, including whether a crime may have been committed, and Massachusetts Governor Deval Patrick said the Center “may have misled regulators and done work beyond the scope of its state license.”  That all may be true, but for the victims of this tragedy, the fact that there was no FDA oversight, while decidedly unhelpful to their health, may be very helpful to their quest for justice.

First, note that the first case has now been filed.  It was filed today in Minnesota by a woman who was given a steroid injection for back pain and “has experienced symptoms consistent with meningitis.”  As these cases move forward, it will no doubt come up that this company’s owners have some history of negligence and have forced victims to settle confidentially in the past.  USA Today reported yesterday,

Long before the current rash of fungal meningitis, the compounding pharmacy suspected in the outbreak settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.. …

A 2004 lawsuit filed in upstate New York's Monroe County claimed New England Compounding Center produced a tainted shot that caused William Koch to contract bacterial meningitis at Rochester General Hospital on July 17, 2002. Koch died Feb. 28, 2004, at the age of 83. …

The compounding pharmacy reached a settlement with Koch's widow in 2007 before the case went to trial, according to her lawyer Mark S. Nunn. He declined to elaborate Wednesday because the terms were confidential.

That said, it is important to note the following. Had the contaminated steroid been regulated by the FDA and you happen to live in Michigan, no lawsuit would be possible – at all.  Had the case involved a misleading label on a generic drug, and the brand name version has been approved by the FDA, no lawsuit would be possible – at all.   Had the case involved a Class III medical device approved by the FDA (as opposed to an injected steroid), no lawsuit would be possible – at all.  And had the contaminated steroid been regulated by the FDA, and H.R. 5 (the federal medical malpractice/drug immunity bill) were law, a lawsuit might be possible, but the Center might not be liable for any punitive damages - despite how many were sickened and killed.  (I only say “might not” because the bill exempts "knowing misrepresentations" to the FDA, which may or may not be provable in this case.) 

That’s all to say, while FDA regulation is certainly preferable to no regulation, history shows that many FDA-approved drugs and devices have caused some of the most serious injuries and death.  Yet, the fact that a drug or device is regulated, no matter how unsafe, might present legal defenses that could prevent a patient’s legal case from going forward - at all.  This legal doctrine is known as “preemption" and fortunately, they don’t apply here.

Nuclear Power – Federal Preemption’s Hideous Upshot

After the 1979 Three Mile Island nuclear accident – still the worst commercial nuclear accident in U.S. history - there was a widespread attempt by the state of Pennsylvania and others to stop the restart of the undamaged TMI reactor, which had been shut down at the time of the accident.  Understandably, practically no one in the vicinity of that plant wanted TMI to operate again. 

The residents and their officials sued and had a pretty good case.  Company officials created the conditions that led to the accident, then withheld the information about its seriousness from the public, state and federal officials for two days. This was even though the plant was minutes from melting down, which would have spewed lethal radioactivity far and wide. After the accident, company officials lied to the government regarding its causes and covered up facts, which eventually led to the criminal conviction of the company that ran the reactor. Rather than fire anyone, the company rewarded and promoted those who were responsible and who had lied, and then engaged in an ongoing post-accident cover-up of the accident's seriousness. There's more, but that gives you some idea.

Unfortunately, nothing was going to stop the federal government via the Nuclear Regulatory Commission (NRC) from restarting that plant - or the Courts allowing it to happen.  In TMI’s case, this occurred despite the objection of then Governor Thornburgh (who had sued), both U.S. Senators from Pennsylvania, the area congressional delegate, a resolution of the Pennsylvania Senate, countless local officials and community sentiment, which had voted 2 to 1 and 3 to 1 against restart in surrounding county referendums. 

To put it simply, states have almost no power to stop the federal government when it wants to plop down a nuclear plant in some random community. This area of law is entirely preempted by the federal government, at least according to Court decisions (see the TMI decision) that have done their best to eliminate any say that a state, its political representatives or its people might have over nuclear power plants situated in their own backyard.  (The latest example concerns the state of Vermont, where the state has tried – so far unsuccessfully - to block the relicensing of the 40-year-old Vermont Yankee plant.) 

I say “almost” because incredibly, NRC Chairman Gregory Jaczko has broken ranks with the rest of the agency over the licensing of new plants.  Last week, the NRC approved plans to build and operate construction on two 1,100-megawatt reactors at the Vogtle facility in Georgia -  the first new nuclear power plants in the U.S. since the TMI accident – but Jaczko objected.  He wants safety concerns addressed first, the kinds of concerns that arose following Japan's 2011 Fukushima disaster.  (Isn't the incredible thing that  four other Commissioners don't?)  Said Jaczko, “I cannot support issuing this license as if Fukushima never happened …I believe it requires some type of binding commitment that the Fukushima enhancements that are currently projected and currently planned to be made would be made before the operation of the facility.”

A split decision isn’t going to stop Vogtle, of course.  TMI was given the OK to restart despite a split vote - both by the NRC and the Court - back in 1985.  But it’s surely given hope and ammunition to the dozen environmental and anti-nuclear groups who have now sued to stop Vogtle “saying public safety and environmental problems since Japan's Fukushima Daiichi nuclear reactor accident have not been taken into account.” 

The environmental groups have asked the U.S. Nuclear Regulatory Commission to stop construction until judicial review. They also want the U.S. Department of Energy to force Southern's utility Georgia Power to release details about scheduling delays and construction cost overruns.

"The U.S. taxpayers are being kept in the dark about the huge safety and financial risks on the project," said Jim Warren, executive director of NC Warn, a nonprofit environmental group.

I wish them luck, and they're gonna need it given the massive federal preemption of this area of law.  Maybe Fukushima will finally give Courts the reason they need to actually start “second-guessing” the NRC, an agency that has always seen its legal mission to regulate nuclear power as a mission to promote and protect it.

Meanwhile, it should also be noted that that another post-Fukushima legal effort has begun:

Thirty-seven safe-energy groups, including the local Three Mile Island Alert, have submitted a formal petition  to the federal Nuclear Regulatory Commission seeking adoption of new regulations to expand emergency evacuation zones and improve emergency response planning around U.S. nuclear reactors.

Calling on the NRC to incorporate the real-world lessons of the Fukushima nuclear disaster, the proposed rules would expand existing emergency evacuation zones from 10 to 25 miles around nuclear reactors and establish a new zone from 25 to 50 miles around reactors for which utilities would have to identify and publicize potential evacuation routes.

Also sought is a requirement that utilities and state and local governments practice emergency drills including preparing for a natural disaster that either initiates or occurs concurrently with a nuclear meltdown.

You're probably shocked to learn that a petition like this is even needed.  Or that given it’s history, the NRC will probably ignore it (save Commissioner Jaczko, perhaps).  This is what happens when an ultrahazardous and little-understood technology is entirely controlled by greedy corporations and a federal agency –the NRC – that has been almost entirely captured by the industry it is supposed to regulate. 

Where’s the Tea Party when you need them?

Don't Forget that Other Branch

Among the three branches of government, the judicial branch is probably the one NOT on everyone’s mind this election day, let alone tomorrow when the results starts sinking in.  We just don’t want you to forget about the branch that’s not supposed to be political - but is. 

Tomorrow, the U.S. Supreme Court will hear the case Williamson v. Mazda Motor of America, in which it is going to decide whether or not auto companies are immune from liability for not installing safety devices in cars even though the National Motor Vehicle Safety Act, 49 U.S.C. §§ 30101 et seq., itself reads, “[c]ompliance with any Federal motor vehicle safety standard issued under this subchapter does not exempt any person from any liability under common law.”  Seems like the answer should clearly be "No Immunity", right?  That’s except when you have an activist U.S. Supreme Court, which despite decades of caselaw allowing injury cases to go forward, decided in 2000 to answer that question, “Yes, Immunity!”  That confused everybody, including lower courts, and apparently itself, when several years later it went in the complete opposite direction in a case involving unsafe drugs.

Bloomberg writes that the Court "might deadlock 4-4 because Elena Kagan, the newest justice, has disqualified herself. As the Obama administration’s solicitor general earlier this year, she urged the court to take the case. A tie vote would leave intact a lower court ruling that favored automakers without setting a national precedent."  Ugh.

Here are the case facts: Thanh Williamson, 32 years-old, died in 2002 in Utah when the minivan in which she was riding "struck a Jeep Wrangler that had become detached from a motor home that was towing it. The collision forced Williamson’s body to jackknife around her seatbelt, causing severe abdominal injuries and internal bleeding."  There were no shoulder restraints at her seat even though car companies knew that seatbelts without shoulder belts caused this kind of injuries.  Federal regulations required them later. 

The family says the car was not reasonably safe, and the only thing they want is to argue this before a judge or jury.  No matter what happens in these elections, I’m pretty sure that the right to trial by jury isn't up for a vote, right?   We should be good.

Supreme Court Hears Case About Vaccine Court and its Failures

In the early 1980s, parents across the nation began filing lawsuits against vaccine manufacturers and health care providers after their children suffered harmful side effects from the DTP (diphtheria, tetanus, pertussis) vaccine.  Pharmaceutical companies responded with a threat — they would stop making vaccines unless federal lawmakers shielded them from liability. 

So in 1986, they did.  Congress passed a law that forces victims of vaccine-related injuries or death out of the tort system and into an administrative "no-fault" compensation scheme run by the federal government, called the “Vaccine Court."

Though Congress intended claims to be handled “quickly, easily and with certainty and generosity,” the Vaccine Court has failed in every respect.

For example,  HHS’s removal of covered injuries over the years has morphed the Vaccine Court into an increasingly fault-based system, requiring costly and time-consuming causation hearings, and a long time to adjudicate claims – but without the protections of the civil justice system for victims.

In a November 18, 2008 statement, National Vaccine Information Center (NVIC) co-founder and President Barbara Loe Fisher told HHS’s Advisory Commission on Childhood Vaccines how contentious the program had become:

What I heard most often when speaking with parents and plaintiff’s attorneys was that the compensation process is filled with a ‘mean-spiritedness’ and a growing hostility on the part of DHHS, Justice and U.S. Court of Claims officials toward plaintiffs, their families, experts and attorneys...  [T]here certainly is a sense that parents feel their children are pawns in a political tug of war that compels those in government responsible for administering the compensation program to protect the reputation of the current vaccine system at all costs — even if it means denying compensation to vaccine victims in order to limit the numbers of children acknowledged by government as having been harmed by vaccines being promoted by government.

You can see it in the stats: 13,546 petitions have been filed since the program began, yet only 2,503 awards. 

So along comes Hannah Bruesewitz and her family.  Hannah, who suffered a series of seizures within hours of receiving a DTP vaccine in 1992 when she was six months old, is among the many victims denied recovery.  Hannah, now a teenager, continues to suffer from seizure disorder, is non-verbal, non-communicative and needs round-the-clock care.  When Hannah was denied compensation under the federal program, her parents filed a lawsuit against the vaccine maker, Wyeth, in state court, alleging that the company could have made a safer vaccine.  Today, the U.S. Supreme Court is hearing her case, and will decide if state lawsuits like hers, alleging a design defect, can even go forward - or did Congress decide to immunize all vaccine manufactures, no matter what. 

As the New York Times reports today,

Ms. Bruesewitz’s parents have contended in court papers that the vaccine’s manufacturer, which is now a part of Pfizer, knew at the time that their daughter was immunized that there was a safer version of the D.T.P. vaccine but did not produce it. The company rejected that contention, and [l]ower court judges have ruled that her claims are barred by the federal Vaccine Act.  As a result, Ms. Bruesewitz, who lives with her family in Pittsburgh and requires specialized care, has not received any compensation.

 “What we want and are concerned about is to make sure that the safety of vaccines in this country is constantly enhanced,” Mr. Bruesewitz said.

What's also clear is that the Vaccine Program has not provided justice for many injured victims and their families, as it was designed to do. 

Huff Post Repost: America Wakes Up to the Importance of Liability and the Stupidity of “Caps”

Teachable moments can come almost anytime, from anywhere. The recent history of corporate and professional breakdowns and mess-ups should provide a number of them. Bob Herbert raised the issue in a stinging New York Times column recently when he asked, "Will we learn anything from this disaster ...?" BP was his focus but also on his mind was "how the giant financial firms almost destroyed the American economy" and the "devastating mine explosion in West Virginia -- at a mine run by a company with its own hideous safety record ..."

We'll add to that list the Toyota debacle, drug companies marketing contaminated childrens' medications, builders who pushed defective Chinese drywall into thousands of homes, Delaware doctors who covered-up a pedophile pediatrician who raped children, not to mention more and more dangerous hospitals everywhere. What a couple of months.

Keep reading.

Immigration and Abortion Lawsuits Move Forward; Dystopia Averted?

Opponents of two of the most controversial and extreme state laws passed in recent memory (see one funny take here, if that’s possible) are headed straight to court. 

First is the Arizona immigration law, which may be challenged by the U.S. Department of Justice on a very familiar (to us, at least) theory – federal preemption (i.e., the state law interferes with immigration enforcement, which is the feds job).  This suit would be in addition to the challenge by civil rights groups. Now admittedly, we didn’t like it too much when the Bush administration used this theory to try to protect reckless drug companies, and the Supreme Court didn’t either (except when it came to dangerous medical devices!).  But we do look forward to seeing if the argument can be played out here.  It’s all about what Congress intended, after all.

Second, a lawsuit has now been filed to invalidate two pretty shocking anti-choice laws enacted this week in Oklahoma, over Governor Henry’s veto.  One law forces women to see and hear about a fetus’ physical details before she is allowed to get an abortion.  The second law immunizes doctors who deliberately “withhold information about birth defects while the child was in the womb. Opponents argue that the law will protect doctors who purposely mislead a woman to keep her from choosing an abortion.”

The Governor called this law “immoral” and said, "It is unconscionable to grant a physician legal protection to mislead or misinform pregnant women in an effort to impose his or her personal beliefs on a patient."

Or as the Comedy Central blogger put it, “Oklahoma, it seems, is doing it's level best to out-Arizona Arizona this week in the on-going battle to be the most dystopian state in the union.”

Happy as a Pig Farm in Slop

That silly “lipstick on a pig” brouhaha during the 2008 presidential election campaign came to mind today when we read about a Missouri jury verdict yesterday.  The jury awarded around $11 million to folks living near an 80,000-head hog farm run by industrial food giant Premium Standard Farms, now owned by Smithfield Foods and the state's largest hog producer, over the operation’s stifling and intolerable odors. The awards weren’t huge: “$825,000 for each of the 13 plaintiffs. A 14th plaintiff was awarded $250,000, and the 15th got $75,000” and included no punitive damages.

The company is appealing, calling it a “gang trial” and a “gang verdict.” They also believe it was unfair because the company complied with government regulations – an argument we’ve heard before and one that the U.S. Supreme Court isn’t too fond of.

Mostly what the families want is odor abatement.  Their attorney said, "’If we sit down and talk, we can include more than money,’ ... ‘It's common sense. Nobody wants to live across the street from 80,000 hogs.’”

Premium Standards Farms has itself had its own problems.  Last month, 1,500 northern Missouri residents met with the state Attorney General because of an upcoming deadline for the company to comply with a 1999 court order to implement “$25 million in pollution-reducing equipment” – the deadline has been expanded since “and is still being implemented.”  Meanwhile, “In January, the U.S. Justice Department also reached a $900,000 settlement with Smithfield Foods Inc. and Premium Standard Farms over premerger rule violations.”  (here)

Missouri, it turns out, has a strong history of trying to get local control over operation of these huge corporate hog farms.  The Wall Street Journal wrote:

As livestock operations have grown more industrialized, residents across rural America have banded together to try to keep them out. They say the bigger farms are wreaking havoc on their communities, polluting waterways with manure that can kill fish and sicken people. A popular tool has been county-level "local control" ordinances that govern where a large farm can locate.

While many states have retained authority over the siting of livestock farms, Missouri has a staunch local-control movement that took root in the early 1990s as corporate-controlled hog processors moved in. In 1999, the Missouri Court of Appeals held that a county can implement an ordinance governing livestock farms, including where they are located, if it is rooted in concerns over public health. Today, more than a dozen of Missouri's 114 counties have the ordinances.

Another thing lipstick clearly can’t mask – the smell of rotten eggs. 

The Toyota NHTSA Blame Game

What happens when you combine a reckless corporation and a feckless regulatory agency?  You can certainly find one answer on today’s New York Times front page.  The Times has a searing article about Toyota’s sudden-acceleration crisis, nudged into the public spotlight by the horrific crash of the Saylor family, whose 911 call can be heard here. 

Yes it’s true that the National Highway Traffic Safety Administration (NHTSA) eventually “prodded” Toyota to stop manufacturing and selling eight car models with this problem, and the agency does not like anyone blaming them.  And certainly, as the U.S. Supreme Court has said in the context of federally-regulated drugs, safety is the “ultimate responsibility” of the manufacturer “at all times.”  But NHTSA is not innocent here, and of course, there was good reason to distrust that agency’s ability to protect us from unsafe cars, especially during the last Administration.  The Times writes:

At almost every step that led to its current predicament, Toyota underestimated the severity of the sudden-acceleration problem affecting its most popular cars. It went from discounting early reports of problems to overconfidently announcing diagnoses and insufficient fixes.

As recently as the fall, Toyota was still saying it was confident that loose floor mats were the sole cause of any sudden acceleration, issuing an advisory to millions of Toyota owners to remove them. The company said on Nov. 2 that “there is no evidence to support” any other conclusion, and added that its claim was backed up by the federal traffic safety agency.

…

Six separate investigations were conducted by the agency into consumer complaints of unintended acceleration, and none of them found defects in Toyotas other than unsecured floor mats.

In at least three cases, the agency denied petitions for further investigative action because it did not see a pattern of defects and because of a “need to allocate and prioritize N.H.T.S.A.’s limited resources” elsewhere, according to agency documents.

In one federal inquiry on Toyota models built from 2002 to 2005, investigators found that 20 percent of the 432 complaints studied involved “sudden or unintended acceleration.”

But no defects were uncovered in any of the vehicles, and the rate of incidents was considered “unremarkable” in the context of the millions of cars on the road.

Our good friend Sean Kane, of Safety Research and Strategies, said NHTSA “did not push Toyota for more data, and too quickly accepted the company’s explanations about floor-mat problems.”

Some of the problems at NHTSA clearly were lack of resources. Wisconsin attorney Donald H. Slavik, of Milwaukee, said the agency “simply doesn’t have the resources to analyze the electronic systems of these cars.”  (By the way, for anyone complaining about our “too big government” and wanting to cut back on the government’s resources and regulatory power, well this is what you get.)

We are now seeing litigation, some of which has been “in the works for five months,” and class actions “that “are expected to focus on why the government and the carmaker were unable to identify problems beyond the floor mats, despite mounting instances of runaway cars.”  Again, with everyone pointing the finger, it’s going to take litigation to figure out what really happened here – as usual.  And maybe we’ll learn why families like the Saylor’s had to die. 

Swine Flu Vaccine Production – More Craziness from Big Business

The conservative Federalist Society held a little pow-wow yesterday to strategize about “federal preemption” - immunity for corporations that produce unsafe products - which the U.S. Supreme Court rejected earlier this year. 

Perhaps unsurprisingly, it didn’t take long for the discussion to go off the rails, thanks to panel member Daniel Troy, Chief Counsel at the FDA from 2001 to 2004, who prior to that, represented pharmaceutical and tobacco companies in cases against the agency, and who ultimately became one of the major architects behind the whole cockamamie version of preemption which had federal agencies protecting industry from liability rather than the other way around, and was ultimately rejected by the Supremes in Wyeth.

According to Troy, who now works as General Counsel for pharma-giant GlaxoSmithKline, “[O]ne reason for the delay in swine flu vaccine to the public this year has been manufacturers' fear about litigation over thimerisol, a preservative he said is needed to safeguard multi-dose vials of the vaccine,” and has been the source of heated controversy among many who feel it can contribute to the development of autism.

Ugh! Where to start with such an outrageous “don’t blame us, it’s those victims, judges, and juries again” comment???

First of all, the notion that drug companies are trembling in the boots over the prospect of vaccine lawsuits is patently absurd.  Ever since Congress created special “vaccine courts” in 1986, taking away the right to jury trial against drug companies for families with children injured by vaccines, the road to justice for those folks has been anything but wide open.

Secondly, talk about not taking responsibility.  Every health official who knows anything about this knows that the companies providing the “bulk” of H1N1 vaccines to the U.S., like his, are still using snail-paced technology to create vaccines (i.e., “a slow and antiquated process that relies on millions of chicken eggs”). 

"We wish we had better ways to produce vaccines perfectly predictably, but this is how influenza vaccine production often goes," Dr. Anne Schuchat, who heads the immunization and respiratory disease section at the Centers for Disease Control an Prevention, said last week. 

The delays have led to renewed demands for a quicker, more reliable way of producing vaccines than the chicken-egg method, which is "50-year-old technology and involves injecting the virus into eggs and allowing it to feed on the nutrients in the egg white."

Clearly the solutions lie with better technology.  But with the "Daniel Troys" of the world trying to shift the blame to a non-existent lawsuit problem instead of dealing with a technology problem that needs a major overhaul, we all may suffer. 

Just another example about how Big Business and their lawsuit obsessions are harming the public good.

Senate Committee to Take Up the Medical Device Safety Act Today

The Health, Education, Labor and Pensions Committee of the U.S. Senate is holding a hearing today about the Medical Device Safety Act that we’ve been talking about  ever since the U.S Supreme Court’s disastrous decision in Riegel v. Medtronic, which immunized medical device manufacturers from liability for deaths and injuries caused by FDA-approved products.

Said Senator Tom Harkin (D-IA), a senior Democrat on the committee, "For a patient to undergo a device malfunction and then learn that they have no legal recourse against the device manufacturer after it fails them is a one-two punch.”

Needless to say, we couldn’t agree more, and you can bet we’ll be watching.  Keep you posted…