Yourlawyer.com (PPA News) http://www.yourlawyer.com/topics/overview/ppa Sat, 21 Nov 2009 20:28:35 -0800 pixel-app en El Pasoan Gets $400,000 In Lawsuit Against Bayer http://www.yourlawyer.com/articles/read/8667 Sun, 17 Oct 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8667
The verdict for Miguel Valverde was delivered in El Paso County Court-at-Law No. 5 on Wednesday against Bayer Corp., the company that makes the cold remedy.

The jury decided that Bayer was not negligent or malicious but said that the product had a "design defect" and that a "safer alternative design" was available that would have prevented or significantly reduced the risk of injury.

The lawsuit claimed Bayer participated in a conspiracy to conceal the dangers of the drug, but the jury rejected that argument.

Valverde fully recovered from the stroke.

"Bayer's actions indicated that they valued profits over the safety of their customers," said, Valverde's lawyer. "That is unacceptable corporate conduct, and we are all pleased that a jury has finally held them accountable."

A call left late Friday at Bayer's U.S. headquarters in Pittsburgh seeking comment wasn't immediately returned.

The award included $300,000 for pain and anguish, $70,000 for medical care and the rest for disfigurement, physical impairment and loss of earning capacity.

Valverde claimed a chemical called phenylpropanolamine, known as PPA, in the Alka-Seltzer Plus caused his stroke.

The U.S. Food and Drug Administration has asked companies to voluntarily discontinue marketing drugs or pharmaceutical products containing PPA, which is a nasal decongestant and appetite suppressant. ]]> Legal Blow Prompts Bayer Warning On Settlements http://www.yourlawyer.com/articles/read/8648 Fri, 15 Oct 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8648
A spokesman for the company told The Times that Bayer might have to compensate as many as 1,200 Americans who suffered severe strokes after taking phenylpropanolamine (PPA).

The chemical, which was used in more than 30 different products ranging from cold and cough medicines to anti-obesity pills, was withdrawn from pharmacy shelves in 2000 after regulators decided that it could cause strokes in younger people.

The spokesman said that Bayer may have to make provisions which could have a negative impact on the results of our operations, our financial position and cash flows.

The warning accompanied a statement that Bayer would consider settling outstanding lawsuits relating to PPA on a case by case basis and without conceding liability.

The statement follows a ruling by a court in El Paso, Texas, ordering the company to pay $400,000 (224,000) in damages to a man who suffered a stroke after taking a cough remedy containing PPA.

The case marks the first time that a US judge has upheld a claim for damages against Bayer in relation to PPA. At its peak, the chemical is estimated to have generated more than $1 billion a year in sales for Bayer.

Until yesterday, the group and other companies that used the chemical in their medicines, such as GlaxoSmithKline and Novartis, had successfully fought claims that they had made an unsafe drug.

Bayer emphasised yesterday that PPA was a safe and effective ingredient when used in accordance with the directions on the label. The company added that it would continue vigorously to defend those cases that end up in court.

The ruling comes at a bad time for Bayer, which is about to use up the last of more than $1.2 billion in insurance cover earmarked to settle other product liability litigation.

The company admitted last month that it had spent all but $100 million of the sink fund made available to it by its insurers to cover payouts relating to Baycol, a cholesterol-lowering drug. Americas Food and Drug Administration ordered Bayer to pull Baycol in August 2001 after it was linked to more than 100 patient deaths.

Earlier this year Bayer said that it would set aside an extra 300 million over and above its insurance cover to meet damage claims from more than 1,600 patients who suffered heart problems after taking Baycol.

Analysts last night said that the Texas court ruling marked another worrying development for big pharma at a time when the industry is struggling to bring new drugs to market. One analyst, who declined to be named, said that Bayers exposure to PPA could make it an easy target for class action lawyers. ]]> Drug Agency Bans 167 Cold Medicines Over Stroke Risk http://www.yourlawyer.com/articles/read/8290 Mon, 02 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8290
Nearly 170 medicines manufactured or imported by 75 companies are subject to the government interdiction, the Korea Food & Drug Administration said. The major companies included Yuhan Corporation, Choongwae Pharma Corp., Daewoong Co. and Hyundai Pharm.

PPA is an ingredient that was used in many over-the-counter and prescription cough and cold medications as a decongestant and in weight loss products.

At issue is hemorrhagic stroke, which causes bleeding into the brain or into tissue surrounding the brain.

The alleged relation of PPA and increased risk of hemorrhagic stroke is based on a recent government-commissioned examination of more than 900 local patients suffering from the disease, officials said.

In November 2000, after warnings by U.S. Food & Drug Administration, the government asked drug companies to voluntarily reformulate their products to exclude PPA. Some of drugmakers and import companies complied with the government recommendation but many of them did not.

Some local pharmaceutical companies reformulated their medicine exported to the United States but continued to manufacture PPA-containing medicine for the local market, a government official said.

Seventy-five drug import companies or manufacturers are banned from manufacturing, importing and shipping the cough medicines and required to take them off shelves and dispose them.

According to the U.S. FDA, taking PPA increases the risk of hemorrhagic stroke in women and men may also be at risk. Although the risk of hemorrhagic stroke is very low, KFDA recommended that consumers not use any products that contain PPA.

The drug companies may face a series of lawsuits by patients, consumer rights groups say.

"Those who took medicines containing PPA were twice more likely to suffer from hemorrhagic stroke than those who did not," said a Seoul National Univeristy professor who participated in the investigation.

A controversy over the ban is expected as some of the companies plan to raise objections to the KFDA study.

Crititcism of the KFDA also came from the general public. Many citizens criticized the KFDA for making the announcement on a weekend when people were less likelly to be paying attention to news developments.

They also said the government should have imposed a formal ban four years ago rather than request voluntary compliance that failed to adequately protect public health. ]]> FDA Warns of Over-the-Counter Drug http://www.yourlawyer.com/articles/read/7782 Fri, 05 Mar 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7782
The ingredient, called phenylpropanolamine or PPA, is found in products ranging from Dexatrim to Triaminic.

The FDA said it is taking steps to formally ban PPA, but in the meantime wrote manufacturers asking them voluntarily to immediately quit selling products containing the ingredient.

The risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user. But with millions of Americans swallowing PPA every day, the FDA determined the ingredient could be to blame for 200 to 500 strokes just in people under age 50 - those who typically are too young to be at risk for strokes.

``We suggest you stop taking the drug immediately and use an alternative,'' says an FDA warning issued for consumers Monday.

Consumers should check the ingredient list of all nonprescription cold relievers for PPA and avoid those products, the FDA said. Instead, they could use cold pills containing the ingredient pseudoephedrine, or use nasal sprays.

However, PPA is the only nonprescription diet ingredient on the market. There are prescription weight-loss drugs, so dieters should consult their physicians about their options, said FDA nonprescription drugs chief Dr. Charles Ganley.

Drug manufacturers had fought the FDA's decisions, arguing that concern over the decades-old ingredient was overblown. But in a public hearing less than three weeks ago, FDA's scientific advisers dealt manufacturers a blow by voting unanimously that PPA is unsafe.

Hemorrhagic strokes, while the least common type of stroke, often are deadly and can leave survivors disabled. They are very rare in people under age 50; the risk rises with age, as well as with high blood pressure, smoking, alcohol and use of blood-thinning medicines.

Doctors' first warning sign about PPA came in the 1980s when medical journals cited several dozen puzzling cases of young women who suddenly had strokes within days of taking appetite suppressants.

The FDA's own records show 44 cases of hemorrhagic stroke among PPA users in the past 30 years. Most were women; the median age was 35.

But the drug industry successfully argued more research was needed to prove if PPA was to blame. So the Consumer Healthcare Products Association funded a five-year study by Yale University comparing 702 hemorrhagic stroke survivors under 50 with 1,376 similar ``controls'' who had never suffered a stroke. The goal was to see if PPA use was more common among stroke sufferers than among healthy people.

The study found PPA increases stroke risk for young women not men under two circumstances: within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason.

Nobody knows why PPA would have that effect, although first-time PPA use sometimes temporarily raises blood pressure, an effect that wanes as the body gets used to the drug. Risk was highest with the higher doses more than 75 milligrams daily that dieters were more likely to use.

But the FDA ultimately concluded there was no way to predict who was most at risk from using PPA. While the ingredient does clear a stuffy nose, that's just not a big enough benefit to take the chance, the FDA ultimately decided.

``Not to be alarmist it's clear this is a very rare event,'' Ganley said. ``But even though it's rare, it's an irreversible event.'' ]]> Lawsuit Over OTC-Drug Ingredient Begins http://www.yourlawyer.com/articles/read/7099 Sun, 16 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7099
Tomorrow, her lawyers will argue in Superior Court in New Brunswick that her problems can be traced to Tavist-D and the manufacturer, Novartis Pharmaceuticals, knew a key ingredient was linked to hemorrhagic strokes, especially in young women.

The ingredient at the center of this dispute is PPA, which was used in numerous cold remedies and diet pills that were taken by millions of consumers for decades. Among the widely used products were Alka-Seltzer Plus, Contac and Dexatrim.

These items were yanked from the market during 2000 at the urging of regulators. The move followed publication of a study in the New England Journal of Medicine that indicated PPA may increase the risk of strokes.

Until then, about 6 billion doses of PPA were reportedly sold each year in the United States. After the recalls, hundreds of lawsuits were filed against the companies that used PPA in their over-the-counter products, including Wyeth, Bayer and Schering-Plough.

The trial that begins tomorrow is only the second PPA trial in the nation and gathers together lawsuits brought by about 300 people, some of who are New Jersey residents. Kronfeld, a former medical office secretary, is from Illinois.

These trials are part of a wave of litigation against the pharmaceutical industry during recent years concerning serious side effects allegedly caused by its products. Most of the lawsuits, however, have involved prescription medicines, such as the fen-phen diet pills.

The run-up to the PPA trial has been marked by hurdles for the drug makers. Earlier this year, internal memos indicated Novartis and Wyeth knew of the link between PPA and strokes, according to court documents. The companies denied any scientific link.

Last summer, a Superior Court judge ruled the New England Journal study can be used as evidence. Although the drug makers funded the study, they argued for months that Yale University researchers used faulty science to link PPA to strokes.

Court documents also point to an apparent contradiction by Novartis. In a different lawsuit, which was filed by a woman who suffered a stroke after taking one of the company's prescription drugs, the East Hanover-based drug maker blamed PPA.

The other medication is called Parlodel and was designed to suppress the production of milk after childbirth. A Novartis predecessor company, Sandoz, withdrew Parlodel in 1994 under pressure from regulators, who received numerous reports of strokes and seizures.

The woman who sued Novartis in connection with her use of Parlodel also had taken Contac, which contained PPA and was made by another company. In a deposition, a Novartis expert cited PPA as a possible cause of the woman's stroke, according to court documents.

"There is strong evidence that PPA may be an important factor in cerebral hemorrhage," said Sheila Buchbinder, the Novartis expert.

A Novartis spokeswoman declined to comment, citing pending litigation.

In a court filing, lawyers for Kronfeld, the Illinois resident, claim "Novartis had been aware for years that PPA can cause hemorrhagic stroke."

Two more trials are tentatively scheduled in New Jersey next month against other drug makers whose products contained PPA. ]]> Lawsuit Claims Inmate's Death Linked To Decongestant http://www.yourlawyer.com/articles/read/7143 Wed, 12 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7143
Virginia Brejcak, 42, suffered a seizure in her cell on Christmas Day in 2001 and died the next day at a hospital.

Her family sued in August, claiming Bucks County Prison officials ignored Brejcak's complaints that she was suffering from seizures, headaches and a drug-resistant bacteria that has since sickened dozens of other inmates.

In their amended suit, Brejcak's family further blamed her death on a cold medication prescribed by prison doctors about a month before her death.

According to the lawsuit, the drug contained phenylpropanolamine, which was widely used in appetite suppressants and cold medicines until 2000, when studies linked to a slightly increased risk of hemorrhagic stroke in young women.

Lawyers for the family said two doctors who cared for Brejcak and the pharmacy that provided the drugs should have heeded the Food and Drug Administration's year-old warning that drugs containing phenylpropanolamine, or PPA, no longer be sold.

"She never had a chance," said a family attorney. "She is covered with an infection. She is not getting treatment. She is not getting neurological consults, and she is getting this medication that is contraindicated, especially for women. It was a recipe for disaster."

A spokeswoman for Bucks County did not immediately return a phone call Wednesday.

County officials had previously said that there was no evidence that Brejcak's death was caused by methicillin-resistant staphylococcus aureus, a hard-to-treat and occasionally dangerous bacteria that can give its victims abscesses and boils.

Since the death, the jail has been struggling to stamp out the infection. Several current and former inmates and guards have also sued, claiming officials did not do enough to halt its spread.

Hundreds of people across the country have also sued pharmaceutical companies over phenylpropanolamine, claiming they suffered strokes after taking medications and diet pills containing it.

Many drug makers voluntarily removed phenylpropanolamine from their products following the FDA alert and some pharmacy chains stopped selling them, but doing so was not mandatory at the time of Brejcak's death.

An autopsy concluded that Brejcak died of a brain hemorrhage, but did not indicate its cause. Brejcak, who had a history of seizures that predated her time in prison, had been serving a short jail term for a probation violation.]]> Woman Sues Drug Maker, Pharmacy http://www.yourlawyer.com/articles/read/6602 Mon, 08 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6602
Sarah Taylor filed the suit Monday in the Greenville County Court of Common Pleas against GlaxoSmithKline Consumer Healthcare and CVS Pharmacy, Inc.

Officials from both GlaxoSmithKline and CVS declined to comment on the lawsuit.

The suit focuses on the drug Phenylpropanolamine, also known as PPA.The lawsuit says that Taylor bought BC Cold Powder and Contac 12-Hour Cold Capsules from CVS in the fall of 1998.

It alleges that she suffered a hemorrhagic stroke shortly afterward and is permanently disabled. It alleges that CVS failed to remove products containing PPA without warning customers about the risk of hermorrhagic stroke associated with its use.

The lawsuit alleges that for the last 30 years, the over-the-counter pharmaceutical industry has been aware, or should have been aware of reports associating PPA products with hemorrhagic stroke.

As of November 2000, labels on the products containing PPA never contained a warning about the risk of stroke, the suit alleges.

The suit accuses the defendants of negligence, failure to warn, unfair trade practices and fraud.

The suit asks a jury for general damages, medical expenses, loss of earnings, compensatory damages, punitive damages and attorneys' fees. ]]> Judge Allows Study Linking Products To Strokes http://www.yourlawyer.com/articles/read/6345 Thu, 24 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6345
The ruling by Judge Marina Corodemus of Superior Court in New Brunswick is a setback for several major drug companies, including Wyeth, Novartis, Bayer and Schering-Plough.

The ingredient, known as PPA, was used in numerous cold remedies and diet pills, including versions of Dimetapp and Tavist-D, that were taken by millions of consumers for decades. Those products were yanked from the market three years ago at the urging of regulators.

The companies argued that a 2000 study in The New England Journal of Medicine, which prompted regulators to warn consumers of the risks, used faulty science to link PPA to an increased risk of strokes. They maintained the study should not be used as evidence in the lawsuits.

In her ruling, Corodemus wrote the study "dramatically strengthens the plaintiffs' argument that their expert testimony be admitted because it supports and complements other scientific knowledge."

Lawyers for the 300 New Jersey residents who filed lawsuits cheered the decision.

A spokeswoman for Novartis said the drug maker is "disappointed the court has decided to admit the study into evidence" and vowed to contest the issues at trial. A trial is scheduled for October.

A Schering-Plough spokesman declined to comment and a Bayer spokeswoman couldn't be reached. A spokesman for Wyeth said the ruling only permitted some evidence to be submitted but not everything the plaintiffs sought.

More than 1,000 lawsuits have been filed around the country, including several hundred that are consolidated in a class-action lawsuit in federal court in Seattle.

The controversy over PPA, which is known in the pharmaceutical industry as phenylpropanolamine, has raged for years.

The ingredient, which was created in the early 1900s, was marketed for decades in various over- the-counter medicines as a way to suppress appetites or relieve runny noses. Those products included such popular items as Alka-Seltzer Plus, Contac and Dexatrim.

Until the recall in 2000, about 6 billion doses of PPA were reportedly sold each year in the United States. But reports of strokes prompted congressional hearings in 1991.

Regulators proposed additional warning labels on products in 1996 and a comprehensive safety study, which was conducted by Yale University researchers and appeared in The New England Journal of Medicine. ]]> Drug Makers Knew of PPA Link To Stroke http://www.yourlawyer.com/articles/read/5528 Tue, 15 Apr 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5528
The ingredient, known as PPA, was used in numerous cold remedies and diet pills including versions of Dimetapp and Tavist-D that were taken by millions of consumers for decades. They were yanked from the market in 2000 at the urging of regulators.

Their withdrawal was prompted by concerns PPA could cause hemorrhagic strokes, especially in young women. Since then, thousands of lawsuits have been filed by consumers against the manufacturers, including Novartis Pharmaceuticals and Wyeth, both of which are based in New Jersey.

The drug makers continue to maintain there was no reliable scientific evidence to link PPA to strokes and that their products were safe. But internal company documents introduced last month as evidence in the lawsuits indicate the companies were aware of the health risks for years.

For example, in a Jan. 19, 1989, memo, Margaret Flory, an executive at Sandoz Pharmaceuticals, which is now part of Novartis, wrote a Sandoz official that PPA produced "dire outcomes in small doses; it isn't only abuse or overdoses which cause problems."

A three-page memo in 1996 from Allen Perelson of Wyeth-Ayerst Pharmaceuticals, a unit of Wyeth, to a Wyeth colleague in Thailand, acknowledged strokes and other side effects were reported in patients following excessive and recommended doses of products with PPA. However, he also maintained Dimetapp, which was made by Wyeth-Ayerst was safe when taken according to direction.

Spokespeople for the company denied the products were unsafe.

More than 300 individual lawsuits have been filed over the past three years in State Superior Court in New Brunswick. The lawsuits are not a class action, although a federal court in Seattle is presiding over a class action against drug makers involving similar claims.

The companies' "own internal memos reveal that they knew for many years that their PPA products were capable of causing hemorrhagic strokes and other injuries," wrote the attorneys who filed the lawsuits on behalf of New Jersey consumers.

Fran Sullivan, a spokesman for Wyeth, which is based in Madison, said he couldn't comment, because the dispute is the subject of litigation.

A spokeswoman for Novartis, which is based in East Hanover, said "We steadfastly stand by our decisions relating to this product. We do believe that a thorough review of the complete memo would show that statement to have been taken out of context."

Nancy Fitzsimmons, the Novartis spokeswoman, said the 1989 memo that described health risks associated with PPA referred only to cases in which serious side effects were reported. The company maintained that did not establish scientific links between PPA and strokes.

The memo, which said PPA was "reasonably safe," listed side-effect cases and also compared PPA with a different substance, pseudoephredine, which has a similar chemical structure. The memo went on to suggest pseudoephredine may be a "realistic alternative" to PPA as an ingredient.

The controversy over PPA, which is known in the pharmaceutical industry as phenylpropanolamine, has raged for years.

The ingredient, which was created in the early 1900's, was marketed for decades in various over-the-counter medicines as a way to suppress appetites or relieve runny noses.

Those products included many popular products, such as Alka-Seltzer Plus, Contac 12-hour cold capsules and Dexatrim diet pills, which like other over-the-counter medicines, don't require a prescription.

Until the recall in 2000 by the drug makers, which also included Bayer Corp. and GlaxoSmithkline plc, about 6 billion doses of PPA were reportedly sold each year in the U.S., mostly in over-the-counter products.

But reports of strokes prompted Congressional hearings in 1991. And by 1996, the Food and Drug Administration proposed additional warnings on the labeling for all products containing PPA. The agency also pursued a comprehensive safety study.

That study, which was conducted by researchers at Yale University and funded by the drug makers, was completed by the fall of 2000. The results indicated PPA may increase the risk of stroke, so the FDA issued a public health advisory and the products were withdrawn.

Even then, the drug makers acted reluctantly.

A September 2000 memo written to the FDA by an industry trade group known as the Consumer Healthcare Products Association insisted PPA "remains safe and effective as an OTC appetite suppressant and nasal decongestant when used according to directions." ]]> Some Medicines Linked To Strokes http://www.yourlawyer.com/articles/read/6582 Thu, 06 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6582
Loretta Rorie, a Will County, Ill., woman whose lawsuit will go to trial in federal court in East St. Louis, claims she suffered a crippling stroke after ingesting some Alka Seltzer Plus cold medicine in September 2000.

The medicine contained phenylpropanolamine, once a staple of such household brands such as Dexatrim, Robitussin and Alka-Seltzer Plus. It has been indisputably linked to an increased risk for hemorrhagic stroke, bleeding on the brain. In scores of lawsuits filed nationwide, it is being blamed for severely injuring and killing thousands of healthy young Americans.

In November 2000, the federal government recommended that all products containing phenylpropanolamine be pulled from store shelves. Major drugmakers like the Bayer Corp., the maker of Alka Seltzer Plus cold medicine, have replaced it with a far safer ingredient, and drugstore chains such as Walgreens have pulled PPA-tainted products from their shelves.

Still, a tsunami of PPA-related lawsuits continues to roll through America's courts.

The lawsuits assert that Bayer, Walgreens and other major pharmaceutical firms and drugstore chains knew the risks posed to consumers by PPA but did too little, too late to protect them.

"They should've pulled this off the market in the late 1980s, the early 1990s," said Ron Brown, managing partner of the law firm of Brown & Crouppen PC, which has filed eight PPA-related lawsuits since late December in U.S. District Court in East St. Louis.

Drug makers continued to sell products containing PPA long after it became clear it was dangerous, Brown said.

"These drug companies are extremely powerful; they got extremely good lobbies," he said. "It's all about the money."

Chris Placitella, a lawyer for a New Jersey law firm representing dozens of PPA stroke victims, faulted the drug companies and the federal government for not properly warning consumers of the dangers posed by products containing PPA.

"You get these small-town pharmacies; it's pretty clear this stuff is still on the shelves because it's never been pulled," Placitella said. "Just as I'm sure there's tons of this stuff in people's cabinets because they're not tuned in to it."

Walgreens voluntarily removed all PPA-tainted products as soon as the federal government recommended doing so, said Carol Hively, a spokesman for the Chicago-based drugstore giant.

Anne Coiley, a spokesman for the Bayer, a German-owned firm whose American subsidiary is based in Pittsburgh, declined to comment on pending litigation.

"The products currently on the shelves do not contain that ingredient," Coiley said.

In the mid-1980s, medical journals started reporting dozens of cases of young, healthy people suffering strokes soon after ingesting products containing PPA, such as appetite suppressants and decongestants.

PPA's popularity stemmed from that it simultaneously constricts users' blood vessels - helping dry out their stuffed-up noses - while stimulating blood flow and heart rate, which countered drowsiness, said Aaron Dickey, a lawyer in Brown & Croupen's mass torts department.

But the side effects could prove fatal.

"It'd be like jacking up the water pressure in your house, but pumping it through smaller and more delicate pipes," Dickey said.

The result in hundreds of documented cases: a brain aneurysm, or rupture of a weakened blood vessel, that victims experienced as an intensely painful headache, followed by sudden paralysis.

In 1991, the Food and Drug Administration held a hearing on PPA-triggered strokes. When it seemed likely the federal government would ban the drug, the drug companies agreed to spend $5 million on a study into the safety of PPA.

It took five years to work out details of the study, which was conducted by researchers at the Yale University School of Medicine, and another five years to carry it out.

"From our perception, it was a means to delay the inevitable," Brown said. "They already had notice of the side effects of this thing but kept it on the market."

In 1999, the last year before it was banned from the market, Americans swallowed at least 6 billion doses of medications containing PPA.

Meanwhile, as more and more evidence of PPA's dangers emerged, the drug companies continued to reap huge profits off products containing this ingredient, Placitella said.

"The real issue is, why did it take so long?" he said.]]> Allergy Medicine Blamed For Death http://www.yourlawyer.com/articles/read/6586 Wed, 20 Nov 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6586
The lawsuit, filed on behalf of Betty Ladner of Pass Christian earlier this month in Harrison County Circuit Court, also names the drug store that sold the medicine to her husband prior to his stroke in January 1991.

The complaint is the latest in a string of lawsuits filed across the country against Novartis Consumer Health Inc. by people who claim the ingredient phenylpropanolamine (PPA) in the company's allergy medicine caused them to suffer a hemorrhagic stroke.

Kermit Ladner purchased the cold and allergy medicine that contained PPA from Diamondhead Discount Drugs Inc. in Pass Christian, according to the lawsuit.

The lawsuit seeks unspecified damages.

"(Kermit Ladner) did not receive any warnings from the product or Diamondhead Drugs indicating that the product could cause a stroke or other life-threatening injuries," the lawsuit alleged.

David Greenstone, whose Dallas law office is representing Ladner, said his firm had filed "a number of other cases" in several states against drug companies whose products contain PPA.

A call placed to the company Tuesday was not immediately returned.

The Food and Drug Administration in November 2000 issued a public health advisory expressing its concerns about the safety of products containing PPA after a report released by scientists at Yale University School of Medicine criticized the ingredient, said FDA spokeswoman Stacy Below. ]]> Dimetapp maker sued after boy dies from stroke http://www.yourlawyer.com/articles/read/96 Wed, 23 May 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/96
Brad and Donna Walker of Portland accuse American Home Products Corp. of negligence and failing to provide warnings that a key ingredient in the medication could be dangerous for children.

A similar lawsuit was filed in federal court in Philadelphia Monday by a woman who suffered a debilitating stroke a day after taking Dimetapp. Vicki D. Vogt of Honeybrook, Pa., is seeking $40 million.

In November, the Food and Drug Administration warned that dozens of over-the-counter cold medicines and diet pills containing phenylpropanolamine, or PPA, could cause hemorrhagic strokes, especially in young women.

Health Canada didn't issue an official warning at the time but it advised people not to take products containing PPA unless prescribed by a doctor.

The strong warning led major drug store chains to strip the products from shelves while drug makers quickly reformulated the medicines -- including such brands as Alka-Seltzer and Dexatrim -- to remove PPA.

American Home Products, based in Madison, N.J., is the country's fifth-largest drug maker. Spokesman Fran Sullivan said Monday that the company doesn't comment on pending litigation.

Mathew Walker suffered a seizure and lapsed into a coma in June 1996 after his pediatrician told his mother to give him Dimetapp to prevent ear infections from swimming. The boy died in October 1999 after suffering a hemorrhagic stroke, which is rare in children.

"Had somebody warned me, or had it been on the label, I would have chosen another method of treatment," Donna Walker said at a news conference with her husband Monday. "I would never have risked my child's life."

The suit also names pediatrician Steven Burns, whose spokeswoman said he could not comment until he talks to an lawyer.

In the Philadelphia suit, Vogt said she took Dimetapp in November 1998 and suffered a hemorrhagic stroke the next day. She is permanently disabled, the suit says.

More than 9,000 suits have been filed against American Home Products relating to its manufacture of fenfluramine, the "fen" in the fen-phen diet drug. The drug was withdrawn in 1997 after it was linked to potentially fatal heart damage. ]]> Drug stores move to remove cold, diet drugs after FDA warning http://www.yourlawyer.com/articles/read/95 Tue, 07 Nov 2000 00:00:00 -0800 http://www.yourlawyer.com/articles/read/95
The Food and Drug Administration issued an unusually strong warning Monday, telling Americans to immediately quit using drugs containing phenylpropanolamine, or PPA, which is found Dexatrim, Tavist-D and dozens of other over-the-counter medicines. The agency, which intends to ban the ingredient, asked manufacturers voluntarily to stop selling PPA-containing drugs immediately and to replace the ingredient with a safer alternative.

Rite Aid, with 3,800 drug stores in 30 states and the District of Columbia, soon will begin posting warning signs and removing products with PPA, spokeswoman Jody Cook said.

"We would advise our customers to check with the pharmacist about the alternatives," she said.

CVS Pharmacy, which has 4,100 stores, and Walgreen Co., with 3,200 stores, made similar announcements.

Dr. Charles Ganley, the FDA's nonprescription drugs chief, said buyers should be alert for PPA in the ingredient list of nonprescription cold relievers -- both brand names and generic or store brands -- and instead choose decongestant pills with the safe alternative pseudoephedrine or use nasal sprays.

Over-the-counter alternatives do not exist for diet pills, however, so dieters will have to consult doctors about prescription-only alternatives, Ganley said.

Whitehall-Robins Healthcare quit shipping PPA-containing Dimetapp on Monday. New liquid Dimetapp formulas lacking PPA will head for store shelves next week, with pill versions to follow. Also, some stores are selling PPA-containing versions of its Robitussin-CF product, and some are selling a new non-PPA formula, in boxes flagged with a yellow band.

SmithKline Beecham Consumer Healthcare said people should not use its PPA-containing Contac 12-hour Cold Capsules, but five other Contac versions contain the safe pseudoephedrine.

Even though manufacturers learned three weeks ago that the FDA was preparing to act, when the agency's scientific advisers declared PPA unsafe, many scrambled Monday to decide what to do.

Top-selling manufacturers that refused to reveal their plans include Novartis Corp., maker of PPA-containing Triaminic and Tavist-D; Bayer Corp., maker of Alka-Seltzer Plus cold medicines; and Chattem Inc., maker of Dexatrim diet pills.

About 6 billion doses of PPA are sold in this country each year, mostly without prescriptions. There are a few PPA-containing prescription decongestants, and the FDA asked their makers also to stop selling them while it moves to ban prescription use as well.

While the risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user, these are often deadly strokes, and survivors can be left disabled.

With millions of Americans swallowing PPA daily, the FDA estimated it could be to blame for 200 to 500 strokes yearly just in people under age 50.

Hemorrhagic strokes typically occur in the elderly, and are extremely rare under age 50. In the 1980s, however, medical journals cited several dozen young women who suddenly had strokes days after taking their first PPA-containing diet pill.

A five-year Yale University study comparing PPA use among stroke survivors with healthy people concluded that PPA increases stroke risk for young women within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason. In some cases, using PPA increased stroke risk 12- to 15-fold.

Nobody knows why, although first-time PPA use sometimes temporarily raises blood pressure, an effect that wanes as the body gets used to the drug. Risk was highest with the higher doses -- more than 75 milligrams daily -- that dieters typically used.

The study didn't find men at risk, but the FDA cautioned that enough men weren't studied to be sure they're OK]]> Drug Makers Replacing Risky Ingredient http://www.yourlawyer.com/articles/read/93 Fri, 20 Oct 2000 00:00:00 -0700 http://www.yourlawyer.com/articles/read/93
The companies are under pressure to act quickly as a ban on the chemical, phenylpropanolamine (PPA) might imply they knew or should have known about potential dangers of the chemical that has been linked to hundreds of strokes, some attorneys said. The drugmakers may still be open to class-action lawsuits from former users of the over-the-counter products.

"When a drug is taken off the market for safety reasons, especially threatening something like stroke, the threat for legal action is an automatic," said Ramon Rossi Lopez, a pharmaceutical liability attorney based in Newport Beach, Calif., who has represented hundreds of plaintiffs in the fen-phen diet drug settlement with American Home Products Corp.

A five-year review ended in a U.S. Food and Drug Administration panel recommendation to ban PPA after more than 50 years of pharmaceutical use. The recommendation was based on a recent Yale University study showing an increased risk of strokes in people between the ages of 18 and 49. The FDA estimated between 200 and 500 hemorrhagic strokes per year could be linked to PPA.

With that knowledge, major drug firms have begun marketing new versions of over-the-counter products without PPA in anticipation of a ban, industry analysts said. Newer versions of popular cough and cold medicines Dimetapp, Robitussin and Comtrex and diet aids Dexatrim and Acutrim have been marketed.

"This panel was not unannounced," analyst Andrew Wolf of BB&T Capital Markets said. "People knew there was an advisory panel looking at PPA, as did other players in this industry. There has also been switching to more natural drugs. So (there are) both regulatory and market based reasons."

Although the drugs represent a small percentage of sales of large pharmaceutical firms, the products could become a large liability if lawsuits were to be filed related to strokes supposedly caused by the chemical.

"A red flag goes up to start asking whether these firms knew or should have known much sooner than now whether the public was at risk," Lopez said. "If they knew or should have known, in every law in every state that I'm aware of, that's negligence. If they knew and didn't tell anybody, you're talking about conscious disregard which means punitive damages."

Chris Keller, a spokesman for Chattem Inc. makers of diet aid Dexatrim, said the company would not be surprised by a lawsuit.

"If we received notice of a filing, I wouldn't say that we never would have expected it," he said. "If something happened, we'd be prepared to handle it."

Wolf indicated Chattem had hoped to preclude such action with its PPA-free version of Dexatrim, whose sales have been growing.

"Obviously Chattem would like to manage it in such a way that they could switch Dexatrim users into Dexatrim Natural," he said.

Kip Petroff, a personal injury attorney specializing in drug and product liability at Dallas-based Petroff & Kisselburgh, said the drug companies apparently knew five years ago of the FDA review, and developed alternative ingredients.

"It will come down to what did the companies know, when and what did they do about it," Petroff said. "That's the standard question in every drug case."

U.S. sales of cough and cold remedies totaled $3.53 billion for the year ending September 9th, while the market for appetite suppressant diet aids was about $89.4 million, according to market research firm ACNielsen.

However, the makers of many branded versions of these over-the-counter products are giant pharmaceutical companies, for whom the consumer products typically do not represent a large portion of sales.

"I don't see any major financial ramifications at any of the major companies," said analyst Mario Corso of ABN Amro. "Any single OTC product isn't going to break the bank for a major drug company."

For instance, both Triaminic cough medicine and Tavist sinus and nasal treatment, which contain PPA, are manufactured by Swiss drug giant Novartis AG . Meanwhile, cough and cold medicines Robitussin and Dimetapp are made by Whitehall-Robins, the over-the-counter unit of American Home Products Corp., one of the top ten U.S. drug makers.

Fran Sullivan, a spokesman for Whitehall-Robins, said the company in August had removed PPA from the only form of Robitussin cough suppressant that contained it, called Robitussin CF.

"Earlier this year, we decided to take PPA out and make it with pseudo-ephedrine," Sullivan said. He acknowledged that the company was well aware of the Yale study and knew results would come sometime in late 2000.

Pat Donohue, a spokesman for No. 3 U.S. drugmaker Bristol-Myers Squibb Co., said the firm is already planning to remove PPA from its Comtrex and Nadicon flu and cold products.

The company does not yet have a time frame for changing the products, but Donohue said the removal would be based on safety concerns, as sales of the drug are not a large concern for Bristol-Myers.

Donohue said to put perspective on PPA-related sales for the company, 1999 sales for all forms of Comtrex -- those with and without PPA -- were $29 million for a company that has $20 billion in annual revenues.

However, for smaller firms producing PPA over-the-counter drugs, a ban could spell a big financial setback.

Earlier Friday, Chattem estimated that sales of the form of Dexatrim containing PPA would be $20 million for fiscal year 2000. The company said Dexatrim would be expected to contribute between 40 cents and 50 cents per share in fiscal 2001. ]]> PPA Phenylpropanolamine Hemorrhagic Stroke Seizures Injury Lawyer http://www.yourlawyer.com/topics/overview/ppa Fri, 20 Oct 2000 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/ppa DOWNLOAD OUR INFORMATION PACKAGE

Injured by Phenylpropanolamine?

Phenylpropanolamine (PPA) has been linked to dangerous side effects that cause hemorrhagic strokes. PPA is a chemical that was the active ingredient in numerous over the counter and prescription diet drugs, nasal decongestants and cough medications such as Dexatrim, Acutrim, Robitussin, Comtrex, Triaminic, and Tavist D.  In 1990, U.S. consumers bought about 6 billion doses of medication that contained PPA.

In November 2000, U.S. regulators first moved to take Phenylpropanolamine off the market due to the serious side effects. The Food and Drug Administration said it has asked all drug companies to voluntarily stop marketing products containing PPA and is seeking to make the sale of PPA products, both prescription and over-the-counter, illegal. While research pointed to a higher risk of hemorrhagic strokes, or bleeding into the brain, for women, the FDA cautioned that men were also at risk. The strokes occurred within three days after people took the products.

If you or a loved one took a product containing Phenylpropanolamine (PPA) and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>