September 17, 2014
This is epic! There are often times when I suspect a defense firm of playing not entirely by the rules, but those suspicions always remain at the suspicion stage and do not end up translating themselves into actual proof of malfeasance–although it is not the result of a lack of trying, it is just that either we are overly suspicious or those who do this sort off the rules acts are just very good at it. This finding however, makes me feel that perhaps I am not overly suspicious… Read on!
Last week, an extraordinary decision was issued by the federal Third Circuit Court of Appeals in an asbestos case, which really should rock the corporate defense bar. In the case, Kimberlee Williams, et al. v. BASF Catalysts LLC, et al., asbestos victims provided evidence to the court that “that BASF and [‘the New York law firm that defended it for years in asbestos cases, Cahill Gordon & Reindel LLP’] systematically collected and destroyed or hid evidence of asbestos-contaminated products produced by a BASF predecessor, Engelhard, in order to evade liability and forge quick settlements.” See more here. It was enough evidence to revive a fraud case against BASF and its law firm for “lying about the toxic material, then depriving those injured by it of their day in court.”
This federal decision comes in the wake of fraud allegations made against a company called Garlock Sealing Technologies, which makes asbestos-containing gaskets. In that case, victims’ lawyers were initially accused of withholding certain information from Garlock – an absurd claim because, as I wrote in an earlier post, the supposedly “withheld” information was already in the company’s possession. If I were accused of committing fraud when I did no such thing, I’d start looking into it. And that’s exactly what happened, leading to a brief filed in June by Caplin & Drysdale, finding a ton of evidence proving the exact opposite to be true; that Garlock was the party that “violated [the judges’] discovery orders, hid evidence from the bankruptcy court and presented false testimony …. ‘Garlock has committed a fraud upon the court,’ the accompanying memo said in its first sentence.'” It’s a brutal brief, which you can read here.
September 9, 2014
This is very important news. Releasing publicly and naming providers who commit easily preventable mistakes such as leaving a foreign object inside a patient after a surgery is done will go a long way in helping these Hospitals to improve their practices. The important thins to remember is that these are mistakes that are preventable and leads to patient death or further injuries and complications.
This is very different and distinct from an operation that does not lead to an expected result–medicine is an art and human body is a complicated machine and bad results may occur absent any sort of negligence.
Federal regulators are reversing course and will resume publicly releasing data on hospital mistakes, including when foreign objects are left in patients’ bodies or people get the wrong blood type.
USA TODAY reported last month that the Centers for Medicare and Medicaid Services quietly stopped publicly reporting a host of life-threatening mistakes, after denying in 2013 that it would do so.
CMS says it will make this data on eight “hospital-acquired conditions” HACs available on its website.
“We are working to make it available as a public-use file for researchers and others who are interested in the data,” CMS spokesman Aaron Albright said in an e-mail. “It’s been requested, so we will make it available.”
December 14, 2009
Sen. Leahy on Taking Away Insurance Cos. Anti-trust Exemption; Wants Public Option
No one knows why the Insurance Industry has an exemption from the rules of Capitalism to allow the forces of the market to set the price. It is time that Insurance Industry’s exemption from the anti-trust laws.
August 7, 2009
FDA Commissioner Margaret Hamburg, MD, vowed that the agency would be more aggressive in enforcing food and drug safety regulations and quicker to act when a company breaks the law.
In a speech at the Food and Drug Law Institute, Hamburg said that some FDA enforcement actions over the past several years have been “hampered by unreasonable delays” and that there has been a “steep decline in enforcement.”
“In some cases, serious violations have gone unaddressed for far too long,” Hamburg said. “These include violations involving product quality, adulteration, and misbranding, false, misleading, or otherwise unlawful labeling, and misleading advertising.”
The new FDA — the one Hamburg took the helm of just eight weeks ago — will be much more aggressive and visible. “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” she said.
Specifically, she said, the agency will do the following:
* Create a clear timetable for companies to respond to FDA inspection findings, generally no more than 15 days after the inspection. If the company fails to respond, the agency will issue a warning letter or take other enforcement action.
* Streamline the warning letter process by limiting legal review of letters to those that might actually present major legal issues, and prioritize the follow-up process on warning letters.
* Rely more on local, state, and international officials in food safety situations that require quick action.
* Be prepared to act “swiftly and aggressively” when dealing with significant public health concerns, possibly even before a formal warning letter is issued. The agency will no longer issue multiple warning letters before dealing with a violation, Hamburg said.
* If a company has corrected whatever issues were raised in a warning letter, the FDA will publicly clear the company on its Web site. Hamburg called it a “close out process.”
By beefing up its enforcement efforts, Hamburg said the FDA will ensure that “violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”
Since Hamburg took the helm of the FDA, the agency has been aggressive in cracking down on the makers of misleading or potentially dangerous products.
For instance, the FDA recently issued 65 warning letters to Web sites hawking phony products that supposedly prevent, diagnose, or treat the H1N1 (swine flu) virus — including a “virus killing” shampoo. According to Hamburg, 80% of the Web sites contacted by the FDA have removed the products.
Where 10 such products were popping up every day, the FDA is now aware of about two new ones a week.
Also, the FDA last week sent warning letters to companies that sell dietary supplements containing anabolic steroids, and posted a public health advisory warning consumers to avoid body-building supplements that contain androgen, estrogen, and progestin-related ingredients.
December 2, 2008
With the FDA having become a politicized entity, I am not sure I can trust any of its findings and especially when they contradict itself. So which is it: melamine and cyanuric acid in baby formula is OK or not OK?
Levels of melamine found in a sample of U.S.-made infant formula do not pose a safety risk, the FDA said.
The agency detected trace amounts of the toxic chemical in a single sample of Nestle Nutrition’s Good Start Supreme Infant Formula with Iron.
Melamine was found in concentrations of 137 and 140 parts per billion. In an updated risk assessment, the FDA said that concentrations less than 1,000 parts per billion do not raise safety concerns. Earlier the FDA had said no level of melamine was safe. (See: FDA Says No Safe Level of Melamine in Baby Formula)
Agency testing also found cyanuric acid — a chemical relative of melamine — at concentrations of 247, 245, and 249 parts per billion in a single sample of Mead Johnson’s Enfamil Lipil with Iron. Levels below 1,000 parts per billion are considered tolerable, according to the updated risk assessment.
The FDA is still awaiting results from 13 of the 87 samples tested.
October 15, 2008
September 25, 2008
I don’t think so…
NEW YORK TIMES
April 13, 2008
Drug Makers’ Advantage
To the Editor:
Re “Drug Makers Near Old Goal: A Legal Shield” (front page, April 6):
is a kind of Alice-in-Wonderland quality as the Supreme Court comes
closer to affirming Food and Drug Administration pre-emption.
Every few months, another study concludes that the F.D.A. cannot fulfill even its basic responsibilities. Until the Bush administration, the F.D.A.
itself viewed civil liability and its own regulation as complementary
systems of consumer protection. And yet we are about to throw one of
those systems away.
Like the doctrine of pre-emptive war that led to Iraq, F.D.A.
pre-emption is a policy concocted in oblivion, an ideology without
connection to the ways the agency and industry actually work. The
editors of The New England Journal of Medicine recently wrote that that
policy would have cataclysmic consequences for patients’ rights,
industry accountability and public health.
It is not often that
doctors defend trial lawyers. Having now heard what the most respected
voice in American medicine has to say, we should have no illusions
where we are headed.
Henry Greenspan, Ph.D.
Ann Arbor, Mich., April 7, 2008
September 24, 2008
One thing I have a difficult time in apprehending is how is it that unapproved drugs and solutions can find their way into the market place so easily? Isn’t the purpose of the Food & Drug Administration to oversee and make sure that food and drugs sold in the market are safe before they are found to be unsafe? It does not take much to know a product is unsafe when people have been hurt… Unless people are used in the testing of a product placed into the market place all with the FDA’s blessing.
All this just does not make sense to me.
The U.S. told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with both products.The Food and Drug Administration warned it may act against companies that continue to sell ophthalmic balanced salt solution for the eyes and topical drugs containing papain, drawn from papayas, without regulatory approval, the agency said today in a statement.
After years of devoting few resources to unapproved drugs, FDA officials in 2006 said they would begin to crack down on the medicines. The agency has estimated they account for about 2 percent of prescriptions.
Companies selling unapproved versions of the eye drug and lesion treatment “have bypassed the requirement of the law and put consumers at risk,” said Deborah M. Autor, director of the FDA’s drug compliance office, on a conference call with reporters.
Unapproved versions of the eye drugs have been sold by Deerfield, Illinois-based Baxter International Inc., Lake Forest, Illinois-based Hospira Inc. and B. Braun Medical Inc., part of B. Braun Melsungen AG, a closely held company based in Melsungen, Germany, according to the FDA.