FDA Seizes Tainted Ultrasound Gel In Newark

0 comments

Posted on 19th April 2012 by gjohnson in Uncategorized

, , ,

Well, here’s another case of a medical product being contaminated with bacteria, allegedly making hospital patients ill.

U.S. Marshals, acting at the request of the Food and Drug Administration, have seized bottles of Other-Sonic Generic Ultrasound Transmission Gel, which were  located at Pharmaceutical Innovations Inc. in Newark, N.J. An FDA analysis had found that product samples contained dangerous bacteria, according to an FDA press release.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm300838.htm

The gel was confiscated after the FDA received a report involving 16 surgical patients being infected with Pseudomonas aeruginosa, reportedly in Michigan. The patients had transesophageal ultrasound procedures, while undergoing heart valve replacement, using the Other-Sonic gel.

Under the Federal Food, Drug, and Cosmetic Act, the seized gel is adulterated, because product samples were contaminated with two strains of bacteria, not only Pseudomonas aeruginosa but Klebsiella oxytoca, the FDA said.

The gel is also misbranded because it is dangerous to health when used in the manner suggested in the labeling. These bacteria pose serious risks of infection to individuals exposed to the product, the FDA warned.

The seizure included all lots of the gel product manufactured between June 2011 and December 2011.

Until they were seized, the products were held under embargo by the New Jersey Department of Health and Senior Services at FDA’s request.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

Ultrasound is an imaging method that uses high-frequency sound waves to produce precise images of structures within the body. Ultrasound transmission gel improves the transmission of the ultrasound waves.

According to the complaint filed in the U.S. District Court for the District of New Jersey, FDA analysis of product samples collected in February revealed the presence of the two bacterial strains.

The affected gel products include 250 milliliter and 5 liter containers of Other-Sonic Generic Ultrasound Transmission Gel. The FDA warns health care professionals who perform ultrasound procedures to stop using Other-Sonic gel manufactured from June through December 2011, because of the risks posed by bacteria contamination.

The FDA issued a safety communication alerting health care providers that bacteria found in non-sterile Other-Sonic Generic Ultrasound Transmission Gel poses risks of infection.

http://www.nj.com/news/index.ssf/2012/04/thousands_of_bottles_of_ultras.html

 

 

Parents Settle Lawsuit Over Son’s Death In Contaminated Swab Case

0 comments

Posted on 19th April 2012 by gjohnson in Uncategorized

, , ,

The family of a Houston toddler, who alleged that a contaminated alcohol swap caused their son’s death, have settled their suit against the Wisconsin company that made the wipes, according to the Milwaukee Journal Sentinel.

One left, another 10 to go.

http://www.jsonline.com/features/health/parents-settle-suit-over-death-related-to-contaminated-wipes-375217r-147902735.html

Shanoop Kothari and his wife Sandy settled their litigation against Triad Group and its unit, H&P Industries. The terms of the settlement weren’t released.

The Kotharis’ 2-year-old son Harry died in December 2010. His death was one of 11 reported to federal authorities as possibly being linked to  products made by Triad, which denies that its swabs and wipes hurt anyone, according to the Journal Sentinel.

Triad still has about 10 lawsuits pending against it, according to the Milwaukee newspaper.

After the Food and Drug Administration discovered that some batches of alcohol swabs and wipes were contaminated, Triad and H&P voluntarily recalled them in January 2011, the Journal Sentinel reported. Some of the swabs had Bacillus cereus, the same bacteria that killed Harry Kothari.

 

 

Johnson & Johnson Fined $1.2 Billion Over Marketing Of Risperdal

0 comments

Posted on 14th April 2012 by gjohnson in Uncategorized

,

Johnson & Johnson is taking a hit to its wallet over its antipsychotic drug Risperdal:  A judge last week fined the pharmaceutical giant $1.2 billion for misleading patients and doctors about the dangers of the drug.

http://www.nytimes.com/2012/04/12/business/drug-giant-is-fined-1-2-billion-in-arkansas.html

The judge’s verdict was in Arkansas, and it ranks “among the largest on record for a state fraud case involving a drug company,” according to The New York Times. And it is just the latest in a series of legal hits Johnson & Johnson has taken regarding its marketing of Risperdal.

In the latest case, Arkansas Circuit Court Judge Tim Fox fined Johnson & Johnson $1.19 billion for roughly 240,000 violations of the state’s  Medicaid law, The Times reported. There was also a fine of $11 million for violating the Arkansas deceptive practices act.

In January Johnson & Johnson unit Janssen Pharmaceuticals settled a similar case in Texas for $158 million, according to The Times. And in South Carolina, a judge fined Janssen $327 million, while a Louisiana jury awarded roughly $258 million in damages.

According to The Times, Janssen issued a statement in response to the Arkansas ruling, saying it would ask for a new trial or appeal.

“The state did not show that any Arkansas patient was ever harmed by using Risperdal,” Janssen said.

Johnson & Johnson has been accused of  hiding the dangerous side effects of  using Risperdal, which is approved to treat schizophrenia, bipolar disorder and autistic children. Its risks include an increased risk of diabetes and stroke, as well as weight gain.

 

 

Tennessee ER Doctors Don’t Need Special Protection From Malpractice Suits

0 comments

Posted on 1st April 2012 by gjohnson in Uncategorized

, , , , ,

In Tennessee, emergency room doctors may soon be given extra protection from malpractice suits, legislation that doesn’t leaves physicians culpable enough for their actions and mistakes.

Under the pending legislation, a patient in Tennessee would have to meet a pretty high test, proving gross negligence by a doctor in an ER, in order to bring a successful malpractice case, according to a recent story in the Johnson City Press.

http://www.johnsoncitypress.com/Opinion/article.php?id=99061

The bill’s sponsors are two Republicans, Rep. Glen Casada and Sen. John Jackson, and they have trotted out the usual justification for this type of malpractice legislation: That it will put a damper of frivolous lawsuits and therefore help keep health care costs down.

Opponents of the bill, who I agree with, include the Tennessee Association for Justice. In the Johnson City Press, the president of the association, Keith Williams, maintains that under the proposed law, if you went to an ER with chest pains and were diagnosed with bronchitis — but then went home and died of a heart attack — your survivors would have no legal recourse.

As the the Association for Justice points out, ER doctors are already protected from frivolous malpractice suits in Tennessee. As the law stands now,  if ER doctors provide care “that is consistent with standards set by their peers” they would not be liable in a malpractice case, Johnson City Press reported.

Opponents of the pending Tennessee legislation are also disturbed, rightfully so, that the bill also provides extra protection to surgeons whose patients are admitted through the ER.

Even though an estimated 98,000 people die in Tennessee each year due to medical errors, the state seems to be bending over backwards to help doctors, not patients.

As the Johnson City Press pointed out, last year Tennessee legislators passed a law that limits non-economic damages, including pain and suffering, at $750,000 for medical malpractice cases. Punitive damages were capped at $500,000.

At first blush, $750,000 might sound like a lot of money. But if your spouse, or parent, or child died because of a doctor’s negligence, you wouldn’t think that $750,000 is enough for a life.

State lawmakers have already given the Tennessee medical community too much protection. They should not dole out any more breaks to doctors.

 

Florida Man Suffered TBI, Was Paralyzed In Crash: When Will He Get His $10.75 Million Award?

0 comments

Posted on 20th February 2012 by gjohnson in Uncategorized

, , ,

Florida’s law regarding caps on jury awards is disgracefully flawed.

Just consider the case of a Sunrise, Fla., man who sustained severe brain injury, and was paralyzed, in a crash 14 years ago.  His family has been trying to get his judgment of $10.75 million approved for four years now, according to The Ledger of Florida.  

http://www.theledger.com/article/20120218/NEWS/120219322/1001/business?Title=Damages-Claims-Against-Public-Agencies-Advance-in-the-House-

You see, under the law in the Sunshine State lawmakers have to sign off on judgments against the government that are more than $200,000. And Eric Brody’s case involved a public official: a Broward County sheriff’s deputy, according to The Ledger.

Brody, 32, was paralyzed and must now use a wheelchair — and suffered traumatic brain injury — when he was struck by the officer’s car in 1998.  

Last week a subcommittee of the Florida House passed 16 “claims bills,” meaning they reviewed the cases of plaintiffs who were killed or hurt in incidents involving police officers, bus drivers and other public employees, The Ledger reported. And Brody’s case was one of those approved.

In the case of Brody’s family, they have been coming to Florida legislators for the last four years, without having their claims bill aproved. But now the family has at least two lawmakers on their side: Rep. Marty Kiar and Senate President Mike Haridopolos.

Kiar was apparently part of the subcommittee that voted in favor of Brody getting his $10.76 million award, and Haridopolos told The Ledger that getting the Brody family its money was one of his priorities this year.

But there’s still several catches before Brody can get his $10 million award.

“A discrepancy between the House and Senate over caps on fees for lawyers and lobbyists will have to be ironed out,” The Ledger wrote of one of them.

Why should a plaintiff such as Brody have to go through hoops to get the award a jury believes he deserves?

It’s absurd that Brody and his family have to wait for their money.

 

 

Johnson & Johnson Consumer Unit Recalls 574,000 Bottles Of Infant Tylenol

0 comments

Posted on 19th February 2012 by gjohnson in Uncategorized

Pity the public relations executives at Johnson & Johnson. They’re working overtime again.

The New Brunwick, N.J.-based pharmaceutical giant has another recall on its hands. The company’s McNeil Consumer Healthcare unit, which according to the Associated Press has had about two dozen recalls since September 2009, now has another one on its hands.

On Friday the company announced that it was recalling 574,000 bottles of grape-flavored Infants’ Tylenol from retailers across the nation.  

http://www.philly.com/philly/health/139511008.html?cmpid=15585797

There’s much irony in this, irony a PR person won’t find amusing. These recalled bottles, which had been redesigned to supposedly make it easier to measure Tylenol doses, were unveiled three months ago. Johnson & Johnson boasted that this was a big safety improvement. 

But there soon was a hitch: Consumers started complaining that the plastic syringe, used to give babies their Tylenol, was pushing a so-called “flow restrictor,” into the bottle. Hence the recall.

And here’s my favorite understatement of 2012 so far:

“Today’s news about the Infants’ Tylenol recall is clearly disappointing after all the progress that McNeil has been making to ensure it products meet the highest level of quality and consumer satisfaction,” CEO William Weldon said in a prepared statement.

Disappointing, indeed. 

Cerebral Palsy, Dementia Victims Beware Of Shady Stockbrokers

0 comments

Posted on 30th January 2012 by gjohnson in Uncategorized

, , ,

Here is a cautionary tale for anyone who has ever received a malpractice judgment. The case, chronicled in Forbes by lawyer Bill Singer, involved a cerebral palsy victim being defrauded by a stockbroker. 

http://www.forbes.com/sites/billsinger/2012/01/24/stockbroker-defrauds-cerebral-palsy-victim-and-elderly/print/

Ralph Thomas of Baltimore was a broker and financial planner for Harbor Financial, and from February 2004 until July 2010, he worked for Wells Fargo Advisors.

Thomas met a woman, only identified as KL, who was trustee for a $3 million settlement for her daughter, who developed cerebral palsy from injuries she sustained at birth. Thomas, allegedly got KL to transfer the trust to Harbor Financial, according to Forbes.

Then Thomas allegedly did his dirty work. He was accused of stealing $757,000 from the trust account, using the money to pay off his credit cards and other personal bills.

Then , from June 2006 to May 2009, Thomas took out three mortgages in KL’s name on her home. He put that money in her Harbor Bank account, and then allegedly withdrew that money, about $27,000. He was also accused of takingt $100,000 from the  trust account to buy a home.

But that wasn’t all.     

In 2009, the retired LM made Thomas her financial advisor. LM had an 85-year-old sister with dementia, and she and her sister shared money from an annuity, according to Forbes. Thomas allegedly took $75,000 from LM’s accounty, one again using the money to trim his credir card bills.

A federal indictment outlining Thomas’s alleged crimes was handed up last August. He was facing up to 20 years in jail, a $250,000 fine for mail fraud, and forfeiture of $838,000 in funds and luxury items that he had.

But in September, Thomas entered a plea bargain, where he only pleaded guilty to mail fraud. He has to make $838,000 in restitution and forfeit some of his property. And he can’t can’t associate with any firm that’s a member of the Financial Industry Regulatory Authority (FINRA), which agreed to his settlement offer to dispose of the allegations pending against him. 

Columnist Bill Singer said that letting Thomas, who he described as a “low life,” just make a settlement — with no admission of wrongdoing — is just wrong.

“Armed with with a fuller understanding of Thomas’s crimes, I re-read FINRA’s self-regulatory case and realized how pathetic Wall Street regulation truly is,” Singer wrote. “Notwithstanding the epic nature of Thomas’s atrocities, FINRA stil felt it okay to accept a settlement that did not require him to admit its charges. Seriously?”

That’s what I would ask myself, about a guy who allegedly robbed a cerebral palsy victim and a woman with dementia.  Seriously?     

 

   

Two Brain Injury Verdicts Make Top 10 List For 2011

0 comments

Posted on 21st January 2012 by gjohnson in Uncategorized

, , , ,

Lawyers USA’s list of the Top 10 Jury Verdicts in 2011 includes two cases involving traumatic brain injury, with one of them regarding Botox.  

The unusual Botox case resulted in a $212 million award against Allergan, which makes Botox, by a federal jury in Virginia last April. The sad part is that Virginia has a state cap on punitive damages, which could knock down the jury’s $200 million in punitive damages to just $350,000, according to Lawyers USA.

http://lawyersusaonline.com/blog/2012/01/17/%e2%80%98ground-breaking%e2%80%99-botox-case-results-in-212-million-jury-verdict/

The Botox case involved Douglas Ray Jr., 67, who had developed hand tremors ever since his return from Vietnam. Ray’s doctor told him to get Botox treatments for his hand. After his third visit and injection, Ray first got a rash, then appeared to be confused and eventually sustained brain damage, according to Lawyers USA. Now he can’t walk, talk or feed or dress himself.

Ray’s lawsuit charged that Allergan failed to warn him about the risks of Botox. In Ray’s case, apparently the active ingredient in Botox –  botulinum toxin type A, made from botulism – moved from his arm muscle to his bloodstream and traveled to his brain.      

Botox doesn’t have Food and Drug Administration approval to be used to treat hand tremors, according to Lawyers USA. In fact, last year Allergan forked over $600 million in fines for marketing Botox for off-label uses.

The second case on Lawyers USA’s Top 10 List involving brain damage was a $144 million verdict for the birth of a baby who developed cerebral palsy. The lawsuit involved the botched birth of Kimberly VanSlembrouck’s daughter at William Beaumont Hospital in Michigan. It  charged that her baby should have undergone a Caesarian, not a vaginal, birth.

http://lawyersusaonline.com/blog/author/carollundberg/

According to Lawyers USA, VanSlembrouck had gained a lot of weight during her pregnancy, and her doctor should not have risked her doing a vaginal birth. Markell, the newborn girl, suffered serious injuries coming through the birth canal, including three brain hemorrhages, Lawyers USA reported. She was purple with bruises.

The hospital did testing on Markell after she was born, and found that she had abnormal brain development, which it later blamed on a genetic condition called pontocerebellar hypoplasia.   

After being in intensive care for three weeks, doctors determined that Markell had cerebral palsy secondary to birth trauma, according to Lawyers USA.   

The girl is a 15-year-old now, and can’t walk or talk. She needs 24/7 care and assistance doing everything from eating to dressing.

After a three-week trial, the Michigan jury granted the $144 million award. It looks like it didn’t buy the hospital’s gambit that Markell’s medical problems were genetic.

Johnson & Johnson Settles Texas Risperdal Case For $158 Million

0 comments

Posted on 21st January 2012 by gjohnson in Uncategorized

, ,

Johnson & Johnson Thursday agreed to pay a $158 million settlement to end a trial over Texas officials’ charges that the pharmaceutical maker improperly marketed  its antipsychotic drug Risperdal. 

In the Johnson & Johnson case, officials in the Lonestar State back in 2004 alleged that the drugmaker’s Janssen unit  defrauded  Texas’s Medicaid program by marketing Risperdal for unapproved uses. A trial had been in progress for four weeks before the settlement, according to Bloombeg News.   

http://www.bloomberg.com/news/2012-01-19/johnson-johnson-to-pay-158-million-to-settle-texas-risperdal-drug-case.html

The Food and Drug Administration had approved Risperdal for uses as treatment of schizophrenia. But Janssen also began promoting the drug for other treatments, including psychiatric problems in children and adolescents, Bloomberg reported.  

The drug maker in 2004 mounted a campaign to “flood clinics” with Risperdal and increase its usage for children, according to Bloomberg. The strategy was to compete against drugs such as AstraZeneca’s Seroquel.

Although the $158 million seems like a large sum, Texas had been seeking $579 miillion, according to Bloomberg. Sources also told Bloomberg that about a month ago Johnson & Johnson agreed to pay a $1 billion settlement to several states and the U.S. government in order to put an end to a probe of fraudulent Risperdal marketing.  

 

Novartis Recalls OTC Drugs For Fear Of Contamination By Prescription Pain Killers

0 comments

Posted on 10th January 2012 by gjohnson in Uncategorized

, , , ,

With the Food and Drug Administration warning Monday of the potential danger, Novartis AG has voluntarily recalled batches of  over-the-counter drugs – Excedrin,  Bufferin, No-Doz and Gas-X — for fear they may contains bits of prescription pain killers.

The FDA held a press conference on the recall, which involves 1,645 lots of the OTC drugs.

http://online.wsj.com/article/SB10001424052970204124204577150901110351484.html?KEYWORDS=Novartis+recall

The problem stems from a plant in Lincoln, Neb., that was closed last month. In addition to making Novartis products such as Exedrin, that plant also manufactured  prescription drugs such as Percodet and morphine tablets for Endo Phamaceuticals, according to The Wall Street Journal and other press reports.

A press release from Parsippany, N.J., based Novartis Consumer Health Inc. (NCH) said, “NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.”

 http://www.novartis.com/newsroom/media-releases/en/2012/1575836.shtml

The recall involves Excedrin and NoDoz products with expirarion dates of Dec. 20, 2014, or earlier as well as Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013 or earlier, in the United States.

” The Novartis Consumer Health Inc. Lincoln, Neb., facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site,” the drug maker said. “This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).”

http://www.fda.gov/Safety/Recalls/ucm286240.htm

According to NCH, “Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.”

However, NCH said that it is not aware of adverse events reported with the issues leading to the recall.

The recalled OTC products were distributed nationwide to wholesalers and retailers. NCH is notifying its distributors and customers and is arranging for return of all recalled products.

“We are committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these are implemented across our entire network,” Swiss Novartis CEO Joseph Jimenez said in a statement.  “The high quality of our products and operations has been critical to building the Novartis reputation over the past 15 years. We are committed to ensuring the highest standard for patients who rely on our products and medicines.”

NCH said that it is is recalling these products as a precaution due to an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, where a potential for a tablet mix up could not be ruled out.

NCH plans to gradually resume operations at its Lincoln site following implementation of planned improvements and in agreement with the FDA. That plant produces a variety of products mainly for the U.S. market with annual sales value of less than 2 percent of Novartis Group sales.

At this stage, the drug maker said that it’s  not possible to determine when the plant will resume full operations and the full financial impact of these events. NCH will take a one-time charge currently estimated at $120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln facility.

Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.

Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

 

 

« Older Entries