Friday, August 8, 2014

Key Attorney in NYS Anti-Tenure Case Was Defender of Maker of Flesh-Eating Drug Whose Maker Benefited in Supreme Court Case

Why this case mattered for U.S. health policy & What it represents for the litigants' anti-tenure fight - Democrat-Republican cooperation

Jay Lefkowitz, the lead attorney in ex-journalist Campbell Brown's Vergara-like anti-New York teacher tenure lawsuit, was the lead attorney in the defense of a drug manufacturer in a case that stemmed from a drug's incomplete labeling. The Supreme Court ruled for the manufacturer in ''Mutual Pharmaceutical Company, Inc. v. Bartlett'' on the basis of federal preemption. As press coverage around the a Samuel Alito-written 5-4 Supreme Court decision in 2013 indicated, in the Whiteout Press blog, "Supreme Court rules Drug Companies exempt from Lawsuits,"
Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward. 
Now [2013], nine years after the tragedy began, the US Supreme Court overturned the state court’s verdict and award. Justices cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs. In short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.
Karen Bartlett, after and before she took Mutual
Pharmaceutical's Sulindac. StudentsFirstNY's Jay
Lefkowitz (&Mutual's lawyer) stands by bad FDA doctors.
Bartlett suffered from the side effect of the flesh-eating disease toxic epidermal necrolysis after taking the anti-inflammatory medication Sulindac manufactured by Mutual Pharmaceutical. She lost 60 percent of her skin, suffered lung and esophageal damage and became legally blind as her body reacted to the drug. (This is the generic form of the drug Clinoril.) She became physically disfigured over most of her body, with skin peeling off as in a third-degree burn.

As noted at the above blog, the drug maker concealed the potential side-effect but later had to disclose this in warnings. "But the highest court in the land ruled that the victim had no legal grounds to sue the corporation because its drugs are exempt from lawsuits." As the Whiteout Press blog noted, "as Karen Bartlett can now attest, it [the Court's decision] leaves 240 million Americans unprotected from the deadly and torturous side effects of pharmaceutical drugs." Michael Carome, director of Public Citizen's Public Health Research Group, said, "Today's court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients." For other references on this under-reported story, read here and New York Times coverage here.

A pro-business, anti-consumer Supreme Court
The trial law firm, Tomasik, Kotin and Kasserman, aptly wrote of the decision under the title, "U.S. Supreme Court Quietly Limits Rights of Victims" on their site,
In a lengthy dissenting opinion, Justice Sonia Sotomayor said that this decision was a disturbing expansion of the concept of “impossibility preemption”. [Read here and here on this concept.] Traditionally, impossibility preemption exists when one government system requires something that another system prohibits. Here, the Court is expanding it to allow federal premarket review procedures to preempt state common law remedies. 
In addition to the absurdity of generic drug manufacturers having immunity from liability when their brand name counterparts may not, this decision is particularly alarming since generic drugs now account for more than 80% of all prescriptions. 
What’s the larger lesson from this decision? Well, despite the fact that rulings from this Supreme Court related to the Affordable Care Act and DOMA might lead some to conclude that the Court’s current balance is rather moderate, rulings such as this one which further infringe on victim’s rights, simply confirms that this Court is increasing pro-business and anti-consumer.
From Justice Stephen Breyer's four page dissent:
“Without giving [FDA’s] views special weight, I would conclude that it is not impossible for petitioner to comply with both state and federal regulatory schemes and that the federal regulatory scheme does not pre-empt state common law (read as potentially requiring petitioner to pay damages or leave the market).
From Justice Sonia Sotomayor's 26 page dissent:
“Today, the Court unnecessarily and unwisely extends its holding in Mensing to pre-empt New Hampshire’s law governing design-defects with respect to generic drugs. . . . If our established pre-emption principles were properly applied in this case, and if New Hampshire law were correctly construed, then federal law would pose no barrier to Karen Bartlett’s recovery.”
Bi-partisan political bedfellows: Boies and Lefkowitz
With the legal team behind the legal challenge to tenure, we see a liberal - conservative, Democratic and Republican alliance, as Democrat David Boies who represented Al Gore in Bush v. Gore and helped overturn California's ban on same-sex marriages and Republican Jay Lefkowitz, a defender of corporations in some of their most egregious actions. (Boies also sits on the board of Michelle Rhee's StudentsFirstNY. Lefkowitz had sat on the general counsel of the Office of Management and Budget for George W. Bush. Elsewhere in the U.S. former Democratic White House aides Robert Gibbs and Ben LaBolt have joined to battle teachers unions.) Once again, Democrats and Republicans can align when it comes to fighting public school teachers.

Lefkowitz shows a bias for doctors, including those whose bad performance is indicated in their Food and Drug Administration decisions. His argument in the Bartlett case was that deference should be given to the FDA. He argued in the Bartlett case,
“It makes much more sense to rely on the judgments of the scientific and medical experts at the FDA, who look at drug issues for the nation at large, than those of a single state court jury that only has in front of it the terribly unfortunate circumstances of an adverse drug reaction."
So we can ask, "FDA doctors can get off the hook for their bad medicine?" Interesting, the media was virtually silent on this story last summer, save for an article in the New York Times, an article in Reuters and another in USA Today. But given a chance to go after teachers, there are thousands of stories.