Milwaukee Personal Injury Lawyer - Defective Products

Divided Supreme Court Affirms Decision In FDA Preemption Case

David Lowe — Mon, 03 Mar 2008 18:06:08 GMT

In the wake of last month's Supreme Court decision in Riegel v. Medtronic, holding that Federal Drug Administration approval of medical devices shielded manufacturers from product liability lawsuits by injured patients, concerns have mounted that the Court will confer similar protection to drug manufacturers whose products have received FDA approval. This would leave injured consumers to the protection of the understaffed and underfunded FDA, whose lapses in the approval of drugs such as Ketek and Trasylol have been discussed here.

Today, in a four to four split decision, with Chief Justice Roberts not participating, the Supreme Court affirmed the decision of the Second Circuit in Warner Lambert v. Kent,which held that a drug manufacturer that failed to warn the public about the dangers of its product -- and may have concealed key information from the FDA regarding the risks of the drug -- cannot hide behind a Michigan state law that provides immunity to prescription drug manufacturers. Oral argument in the Kent case was heard only last week.

Kent raised the preemption issue in the context of Michigan's somewhat unique statute that shields drug manufactures from product liability lawsuits if the drug was approved by the FDA unless it could be shown that the FDA was defrauded during the approval process. The drug involved in Kent was Rezulin, a diabetes drug that was withdrawn from the market after widespread reports of liver damage and deaths. Its manufacturer argued that federal law pre-empted the Michigan statute's statutory exception for instances where fraud was perpetrated on the federal agency. The Public Justice organization provided important assistance in the defense of the injured consumer. The amicus brief it filed in the Supreme Court can be viewed here.

Because of the 4-4 split and per curiam affirmance, the Kent case will be a minor footnote next to a more important case looming on the coming year's docket, Wyeth v. Levine, in which the Supreme Court has agreed to decide whether a musician who lost her arm after receiving the anti-nausea drug Phenergan via an off-label injection method may recover under Vermont tort law despite FDA approval of the drug's label. The Vermont Supreme Court ruled that the state court product liability lawsuit was not preempted by the FDA approval of the drug's label, a significant ruling for those seeking to preserve consumer rights. The Levine case is the likely forum for the definitive word on the implied preemption issue in pharmeceutical litigation. We'll be following the case closely.

Originally posted at InjuryBoard by David Lowe

FDA Raises Number of Potential Heparin Related Deaths to 21

David Lowe — Fri, 29 Feb 2008 07:31:33 GMT

Today's New York Times reports that as many as 21 deaths may be linked to the drug heparin, and the number of reported adverse reactions (mostly decreased or low blood pressure and fast heart rate) has risen to 448, according to the FDA.

Baxter International, whose heparin seems to be involved with the problems, announced that it was expanding a recall to include most of its heparin products, including multidose vials, single-dose vials and its diluted solution of heparin used to keep blood clots from forming in intravenous lines.

The FDA investigation has revealed problems associated with unregulated local suppliers to a wholesaler that provided ingredients to the Chinese plant, but the root cause is yet to be determined.

Originally posted at InjuryBoard by David Lowe

FDA Inaction Leads to 22,0000 Patient Deaths From Trasylol, Drug Researcher Claims

David Lowe — Fri, 15 Feb 2008 00:11:57 GMT

Stay tuned this Sunday for another FDA failure story on 60 Minutes in which Dr. Dennis Mangano, a respected drug researcher, asserts that 22,000 Trasylol deaths could have been avoided if the Food and Drug Administration had paid heed to his published research about Trasylol's dangers, and removed the heart surgery drug from the market two years ago, when his study revealed its widespread association with reports of patient deaths.

The drug Trasylol, manufactured by Bayer AG, was withdrawn in November, 2007 at the request of the FDA after a study linked the medicine to kidney failure requiring dialysis and increased death of those patients. Trasylol, also known as aprotinin, was given to as many as a third of all heart bypass patients in the United States at the height of its use over a period of many years, according to the report.

Sadly, Dr. Mangano's research was initially vilified by an FDA panel whose chairman had connections with Bayer. "I told you so" provides little solace to families who have lost loved ones due to FDA inaction.

Originally posted at InjuryBoard by David Lowe

Wrongful Death Suit Filed Over Ketek

David Lowe — Fri, 25 Jan 2008 11:28:08 GMT

A lawsuit was filed this week against the makers of Ketek on behalf of the widow of Otto J. Laven, a Milwaukee man who died of respiratory arrest shortly after taking the antibiotic for treatment of his bronchitis. The suit, filed in the Milwaukee County Circuit Court, alleges that Ketek (also known as "Telithromycin") was defective and unreasonably dangerous for use by patients with a condition known as myasthenia gravis a rare neurological disorder. The suit also alleges that the manufacturer misrepresented the drug's risks, which included liver disease, respiratory failure and death, in order to obtain approval from the FDA.

Ketek is manufactured by Sanofi-Aventis, the third largest pharmaceutical company, and was originally approved by the FDA to treat bronchitis, sinusitis and mild-to-moderate pneumonia. The circumstances under which the Ketek's drug was approved have been mired in controversy, with FDA scientists concerned about the reliability of the manufacturer's data and clinical studies conducted during the pre-approval stage. Fabrication of clinical data was discovered at the site of the clinical investigator who had the largest number of enrollees, Dr. Anne Kirkman Campbell, leading to that doctor's criminal conviction for fraud.

In June, 2006, after conducting its safety evaluation, the FDA announced its conclusion that Ketek's benefits outweigh its risks, but it determined that additional warnings were required, and advised both patients and doctors to watch for signs and symptoms associated with liver injury. By December 2006, an FDA committee was investigating reports that linked Ketek to liver failure, with 53 reported cases, including two people who needed liver transplants and five deaths.

In February, 2007, the FDA removed its approval of Ketek for treatment of bronchitis and sinusitus, having determined that the "balance of benefits and risks no longer support approval for the drug for these indications." The FDA also required that Ketek's instructions include a black box warning--the strongest warning available--indicating that the drug was not to be used for patients with myasthenia gravis. The only application for which the drug remains approved is for the treatment of community acquired pneumonia of mild to moderate severity.

The FDA actions limiting the use of Ketek have certainly helped many patients avoid suffering, and saved some lives, but it is too late for Otto, who died three years ago today. Hopefully, the civil justice system will provide some solace and compensation to the wife and children he has left behind.

Originally posted at InjuryBoard by David Lowe

Popcorn Chemical Responsible For Lung Disease Dropped From Recipe

David Lowe — Wed, 19 Dec 2007 07:32:47 GMT

The nation's leading makers of microwave popcorn are removing the flavoring chemical diacetyl from their recipes. ConAgra announced the change Monday and similar moves have been made by General Mills, American Pop Corn Co. and Weaver Popcorn Company.

I have commented previously on the dangers to consumers and food industry workers, many of whom have suffered serious injuries or died due to the severe lung disease bronchiolitis obliterans, which has been linked to the disease.

The manufacturers have already paid out millions of dollars in settlements for "popcorn workers lung" to food industry workers

It remains to be seen what the manufacturers will use to replace diacetyl. The manufacturers are not sharing that information in their announcements of the move, and some have voice concerns that similar dangers could persist if the new flavorings have concentrations of the same ingredients. Also, diacetyl is used in other food products and workers continue to be exposed to whikel working with this dangerous ingredient.

The removal of this ingredient from the plants and products of the major food manufacturers is a welcome development. But OSHA and the FDA should be vigilant about the ongoing risk of bronchiolitis obliterans to which workers and consumers are exposed.

For more information on this subject, please refer to the section on Defective and Dangerous Products.

Originally posted at InjuryBoard by David Lowe

Banquet Pot Pies and Salmonella

Paul Jacquart — Thu, 11 Oct 2007 09:45:05 GMT

The Associated Press has reported that Con Agra, maker of Banquet pot pies, has voluntarily stopped production due to reports of consumers contracting salmonella. The Centers for Disease Control and Prevention have reportedly investigated numerous cases in Wisconsin, Missouri and Pennsylvania. The Banquet pot pies under investigation are of the chicken and turkey varieties and have a "P-9" code printed on the side of the box above the use-by date indicating they are from the Missouri plant which is the suspected source of the problem. Con Agra has a history of selling salmonella tainted products to consumers. Earlier this year there were mass reports of salmonella tainted peanut butter made by Con Agra which caused consumers to become ill and, reportedly in some cases caused death. The CDC has not reported any deaths to date linked to the tainted Banquet pot pies.

Originally posted at InjuryBoard by Paul Jacquart

Baby Crib Recall Announced After Three Infant Deaths

David Lowe — Fri, 21 Sep 2007 13:36:34 GMT

The Consumer Products Safety Commission has announced a voluntary recall of Simplicity and Graco cribs after three infant deaths.

According to the CPSC news bulletin announcing the recall,

"The drop-side can detach from the crib, which can create a dangerous gap and lead to the entrapment and suffocation of infants... The drop-side failures result from both the hardware and crib design, which allow consumers to unintentionally install the drop-side upside down. This, in turn, can weaken the hardware and cause the drop-side to detach from the crib. When the drop-side detaches, it creates a gap in which infants can become entrapped.

In addition to the deaths, there have been 55 incidents, including seven cases of children becoming entrapped in the drop-side according to the CPSC.

The cribs were sold nationwide from January 1998 through May 2007 for prices ranging between $100 and $300.
Here are the crib models affected by the recall, according to Simplicty's website:

"The recalled Simplicity crib models include: Aspen 3 in 1, Aspen 4 in 1, Nursery-in-a-Box, Crib N Changer Combo, Chelsea and Pooh 4 in 1. The recall also involves the following Simplicity cribs that used the Graco logo: Aspen 3 in 1, Ultra 3 in 1, Ultra 4 in1, Ultra 5 in 1, Whitney and the Trio. The recalled cribs have one of the following model numbers, which can be found on the envelope attached to the mattress support and on the label attached to the headboard: 4600, 4605, 4705, 5000, 8000, 8324, 8800, 8740, 8910, 8994, 8050, 8750, 8760, and 8996."

Simplicity's website is giving the following instructions to Simplicty and Graco crib owners:

"Consumers should immediately check the crib to make sure the drop side is securely fastened and correctly installed. Consumers with affected drop side cribs will receive a drop side replacement track kit. As an immediate precaution, consumers should check to see if the drop-side is installed right side up. To do this, check to see that the slightly rounded rail with the decorative groove is installed at the top and the plain rail is on the bottom. Next, consumers should make sure the drop-side is securely attached to the tracks in all four corners."

For more information on this subject matter, please review our section on Defective and Dangerous Products.

Originally posted at InjuryBoard by David Lowe

Can Eating Microwave Popcorn Lead to Lung Disease?

David Lowe — Tue, 04 Sep 2007 23:22:04 GMT

I have previously blogged about the lung disease danger to workers in the microwave popcorn manufacturing industry exposed to diacetyl, a food flavoring. Now there is a story reporting that eating microwave popcorn may potentially cause obstructive lung disease.

Because Wisconsin is one of a handful of states where microwave popcorn is manufactured, Milwaukee Journal Sentinel reporter Raquel Rutledge has been following the connection between worker exposure to the food flavoring diacetyl and the disproportionate occurrence in this population of the serious and irreversible disease bronchiolitis obliterans. Her story about the newest concern, that all of us who eat microwave popcorn could be at risk, will surely draw some attention.

For more information on this subject matter, please refer to the section on Defective and Dangerous Products.

Originally posted at InjuryBoard by David Lowe

Fentanyl Pain Patch May be Dangerous

Paul Jacquart — Tue, 28 Aug 2007 14:15:02 GMT

The LA Times has reported that numerous deaths across the country have been linked to the drug Fentanyl, a narcotic delivered through a pain patch. According to the article, medical experts are concerned that the pain patch, though a convenient method of delivering pain medication, can deliver the drugs too fast and that other variables, such as skin temperature and skin thickness can affect the rate at which the drug is delivered to the system of an individual and in some cases can lead to overdose.

The Duragesic brand Fentanyl patch, known as the "fentanyl transdermal system", is manufactured by Janssen L.P. of Titusville, N.J., and was approved by the FDA in 1990. A generic version of the drug delivery system, manufactured by Mylan Laboratories Inc. of Canonsburg, Pa., was approved by the FDA in 2005.

In 2005, a FDA Fentanyl pain patch safety warning , recommended that patches should be prescribed at the lowest dose required for pain relief, should not be used to treat short-term pain or pain after an operation, and should only be used by patients already established on opioid drugs. Additional guidance on the proper use of Fentanyl patches was published in 2006.

Experts are concerned that not enough medical practitioners are heeding these warnings. There are also reports about drug addicts abusing Fentanyl pain patches.

To stay current on developments and FDA recommendations and warnings concerning Fentanyl pain patches and other drugs, check out the FDA website: http://www.fda.gov/

Originally posted at InjuryBoard by Paul Jacquart

Lawsuits Say Laxative Causes Kidney Damage

Paul Jacquart — Mon, 20 Aug 2007 08:57:11 GMT

More than 50 lawsuits have been filed across the country claiming that Fleet Phospho-soda, a laxative made by C.B. Fleet Co. Inc. of Lynchburg, Va.,caused serious kidney damage, sometimes leading to death, reports the Associated Press. According to the lawyers that filed the suits, the Food and Drug Administration lists Phospho-soda as safe when used as a single-dose laxative, but in the early 1990s the company began promoting a double-dose regimen for people about to undergo colonoscopies and surgical procedures. The drug is used to flush out the bowels before these procedures. The AP reports that the FDA never certified the double-dose regimen.

The FDA issued an alert in May 2006 warning about 21 documented cases of kidney failure associated with the use of oral sodium phosphate solutions such as Phospho-soda and its generic competitors. The current FDA information sheet about oral sodium phosphate products renews the May 2006 warning:

A rare, but serious form of kidney failure has been associated with the use of oral sodium phosphate (OSP) products (e.g., Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets) for bowel cleansing. No cases of kidney failure have been associated with a recently approved OSP product (OsmoPrep tablets) for bowel cleansing.

C.B. Fleet Co. Inc. denies that the double-dose regimem is unreasonably dangerous when used in patients with proper hydration and that the risks associated with the solution are outweighed by the benefits.

While there is always a risk-benefit analysis performed with the prescription of any drug, it is imperative that manufacturers make the risks well known to doctors and their patients or the risk-benefit analysis is a useless exercise. These court cases will expose whether the manufacturer of sodium phosphate solutions for bowel cleansing failed to disclose what it knew about the risks to patients.

Originally posted at InjuryBoard by Paul Jacquart