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Elder Care Issues?...You Don't Have to Face Them Alone

Carrie Strasser — Fri, 25 Sep 2009 15:20:19 GMT

The New York Times reported on a new trend in dealing with caring for elderly parents: hiring geriatric care managers. These professionals act as caseworkers for a family grappling with housing issues, difficult diagnoses, and a barrage of legal documents.

Unfortunately, regular insurance does not cover geriatric care managers, so you must pay for their services yourself. Managers charge by the hour and prices generally range from the $50 to $200. However, their assistance can provide you with much-needed advice in a very stressful and confusing time.

Additionally, the care manager can persuade elderly parents to make healthy changes in their lives that their children were unable to do.

That is another great reason to use a care manager: they can play the bad cop, taking away car keys or insisting that an aide move in, so you don’t have to.

The care manager can also be an objective and reasonable voice when family members disagree about the care plan for an elderly relative.

There are a number of ways to find a geriatric care manager in your area. Much of their work comes through referrals, so speaking with friends who have elderly parents is a good place to begin. Also, www.caremanager.org can assist you in locating a care manager in your area.

Be sure to consider the specific needs of your elderly parent when choosing a care manager and researching their background. Ask whether the person is a member of the national care managers' association, which has strict requirements.

Our office is here to assist you with any estate planning or elder care needs.

Originally posted at InjuryBoard by Carrie Strasser

Hemophilia and AIDS: William Modestino, Jr. Tribute to a Son

Bruce Bierhans — Fri, 08 May 2009 14:20:07 GMT

As I read the corporate blather this month about "tort reform", I am reminded of a case I tried in May and June of 2001. It was about Bill Modestino, Jr. a courageous young man and hemophiliac that died from AIDS after being infected with tainted clotting concentrate. It was the most difficult, but rewarding case I have ever tried.

As a tribute to Bill and his parents, Bill and Brenda Modestino, I thought readers would enjoy reading a story about the case that was published in Lawyers Weekly in 2001, after the verdict. It's also a tribute to all parents that have lost children.

Attorney Bruce A. Bierhans looked across his desk at Bill Modestino and his wife, Brenda. Their son's short life had been filled with illness - first, severe hemophilia, and then the devastating AIDS virus that killed him in 1993.

But Bierhans had to be honest."You're never going to get an expert witness to testify against the doctors. I can't help you," he apologized.

The Modestinos had come to Bierhans' office in search of an attorney to help them sue the doctors who had treated their son Bill Jr. for his hemophilia in the 1980s.

They claimed that these doctors knew about the AIDS virus and its potential to be transmitted through the blood products used by hemophiliacs like their son. But instead of warning the Modestinos about the danger, the doctors continued to prescribe infusions of clotting factor for Bill Jr. "These doctors were the safety net. They failed. I want to tell the story," Bill Modestino told Bierhans.

When the couple left his office that afternoon, Bierhans assumed that he would never see them again. He hoped that they would be able to receive some compensation from the blood-products companies that were being sued for products liability in AIDS-tainted blood class actions. Bierhans never expected to be the one who would help them tell their story.

But one year later, Bill Modestino walked back into Bierhans' office. He had found a doctor to testify against the hematologists who had treated his son.

Dr. Ben Dawson, a hematologist at Johns Hopkins Medical Center in Maryland, had been persuaded by the persistent client to testify in the case.

"His affidavits got us over the first medical malpractice hurdle in this case," recalls Bierhans, who agreed to represent the Modestinos after their second visit to his office.

It was a pivotal decision for the lawyer, and the inception of what is believed to be the first medical-malpractice case involving blood tainted with AIDS to go to trial.

The case held remarkable challenges for Bierhans and Stephen J. Delamere, in tracking down expert witnesses, reconstructing the history of a blood supply (and, in some ways, the AIDS virus itself) and overcoming tenuous notions of causation.

And while the Modestinos would not win a money verdict in the case, a jury would make a critical finding of negligence on the part of doctors - a ruling that could pave the way for future trial wins.

Severe Hemophilia

William M. Modestino Jr. was born on Jan. 13, 1961 in Scituate, the fourth child and only son in a close-knit family. Shortly after he was born, doctors told his parents Brenda and Bill Sr. that their new baby was a hemophiliac.

Bill Jr. had been born with the genetic code for Hemophilia B, meaning that he lacked the protein known as Factor IX, which would enable his blood to clot.

Bruises, bumps and stress that would hardly slow a normal child could be life threatening for Bill Jr., and his parents quickly learned that his life could depend on a blood coagulation product known as factor concentrate. In the 1960s and early '70s, the Modestinos would take their son to the hospital for infusions. But eventually they learned to use factor concentrate at home, where his mother or sister - who is a nurse - would infuse him.

Factor concentrate contains the clotting factor that stops bleeding in people without hemophilia. Each vial of factor concentrate contains the coagulating factor from the blood of approximately 20,000 donors.

In 1974, at the age of 13, Bill Jr.'s parents took him to see Dr. Peter H. Levine at New England Medical Center in Boston. A renowned hematologist, Dr. Levine and his team began treating Bill Jr. The Modestinos eventually followed their doctor to Memorial Hospital in Worcester, where he established the New England Comprehensive Hemophilia Treatment Center.

Bill Jr. was treated for his hemophilia at the Worcester clinic until his death in 1993. Soon after Dr. Levine started the clinic, Bill Jr. began seeing Dr. Doreen B. Brettler. The Modestinos were concerned about Bill Jr. seeing anyone other than Dr. Levine, but he assured them that although he had less patient contact, he was still running the clinic, and the doctors there were as qualified as he was.

In the late 1970s, the Modestinos began a home infusion program for Bill Jr., which enabled them to treat his "bleeds" without a trip to the hospital. Bill's doctors encouraged his parents to treat him "early and aggressively" by infusing him with factor concentrate when he had a bleed, or in anticipation of a stressful event like a math exam.

In September of 1982, Bill Jr.'s doctors prescribed a new and more effective factor concentrate, Autoplex, to treat his bleeds. A vial of Autoplex contained the coagulating factor from the blood of approximately 100,000 donors.
Deadly Blood Supply

Unfortunately for Bill Jr., more potent factor concentrate was not the only change to blood products in the United States in the early 1980s. Patients were showing up in hospitals across the country with a terrifying and unknown disorder that shut down their immune systems and made them vulnerable to a host of horrible illnesses.

We now know that these patients, at that time most often homosexual men or IV drug users, were suffering from AIDS. And in the early 1980s, Bill Jr.'s family and lawyer contest, his doctors knew it too.

According to Bierhans, blood products are big business. Families of hemophiliacs spend up to $100,000 a year on factor concentrate. And donors are literally the lifeline of the blood products industry.

Frighteningly, the donors who were targeted well into the 1980s were often homosexual men, IV drug users and prisoners. They were the population most likely to be infected with Hepatitis, and the blood companies wanted their blood because it contained antibodies needed to make hepatitis vaccine.

Advertisements ran in gay men's magazines soliciting blood donors who had had hepatitis. What the ads didn't say was that blood left over after the hepatitis vaccine was created would be added to the blood supply to make factor concentrate.

Remarkably, the vast ocean of blood use to treat hemophiliacs was carelessly being poisoned with hepatitis - or worse.

"Hepatitis was always in the factor," says Bierhans. "Doctors knew for years that factor concentrate carried hepatitis. So if you're treating hemophiliacs and you now know about AIDS, you'd have to say, why couldn't factor concentrate also carry AIDS?" Bierhans argued that Bill Jr.'s doctors should have made the connection, and that they had enough information to make it as early as July 1982.

"A lot of meetings were held nationally with the Center for Disease Control and the National Hemophiliac Foundation, and physicians like Drs. Levine and Brettler attended and read about these meetings," says Bierhans.

The doctors at the Worcester clinic "had more access to knowledge about the AIDS threat to hemophiliacs than other doctors all over the country," Bierhans notes, pointing to CDC meeting minutes with Dr. Levine's name on them.

Safety Net Fails

But, says Bierhans, Bill Jr.'s doctors did not warn him or his family about the threat of AIDS. They did not suggest that he attempt alternatives, such as rest and immobilization, to infusing himself with factor concentrate.

"He could have stayed home. He might not have worked full time. If he had a minor bleed, he might have chosen not to use factor, but to stay home and immobilize the joint to stop the internal bleed rather than injecting himself with something that we now know killed him," says Bierhans, pointing out that the doctors' silence did not give Bill Jr. these choices.

Instead, in 1983, Bill Jr.'s doctor prescribed 20 vials of clotting factor from a lot known as NC9117. His mother infused him with the factor, and as parents of all hemophiliac children do, she logged the date, lot number and number of units in an infusion log book.

This simple entry would prove crucial in a courtroom nearly 20 years later.
'Choice Between Life And Death'

When Bierhans took the Modestinos' case, he focused on an informed consent theory.

"How could infusion with infected factor concentrate have potentially been averted? That is the question I wanted answered in the case," says Bierhans.

The theme of the lawyer's opening statement was that "he had a right to make a choice between life and death. It was his right, not his physician's, to make a choice about whether to use factor concentrate or not," Bierhans recounts.

Bierhans used documents gathered from earlier blood products litigation to support this theory of negligence and medical malpractice by Bill Jr.'s physicians.

"A lot of the information wasn't produced to us by the doctors in discovery, but was available to us through the document depository in the earlier class action," notes Bierhans, referring to the class action brought by hemophiliacs and their families against the blood products manufacturers.

That case settled for more than $1 billion after "60 Minutes" aired a searing expose entitled "Bad Blood," covering what the blood products companies knew about AIDS-tainted blood, and when they knew it.

The Modestino family opted out of that settlement, which would have paid them approximately $100,000. With Bierhans' help, they later settled with the blood products companies for more than three times that amount, and funded their medical-malpractice case with that money.

One of the documents from the blood products litigation ended up being marked as Exhibit 15 in the Modestino case.

It was an excerpt from the MMWR - Morbidity and Mortality Weekly Report - dated July 16, 1982, and was frighteningly prescient.

The document stated that the "CDC recently received reports of three cases of Pneumocystis carinii pneumonia among patients with hemophilia A and without other underlying diseases. Two have died ... all three were heterosexual males: none had a history of intravenous drug abuse. ... The clinical and immunologic features these patients share are strikingly similar to those recently observed among certain individuals from the following groups: homosexual males, heterosexuals who abuse IV drugs, and Haitians who recently entered the United States. Although the cause of the severe immune dysfunction is unknown, the occurrence among the three hemophiliac cases suggests the possible transmission of an agent through blood products."

Bierhans argued that information like this was widely available to hematologists in 1982 and 1983, and that Bill Jr.'s doctors camped on the blood products companies' party line that a hemophiliac's chances of getting AIDS from factor concentrate were a million to one. Unfortunately, they were wrong.

By the time "60 Minutes" aired "Bad Blood," 10,000 hemophiliacs had been infected by AIDS-tainted blood products.

On the program, interviewer Ed Bradley sat with Dr. Don Francis, a world renowned epidemiologist who was heavily featured in Randy Shilt's 1987 bestseller "And The Band Played On: Politics, People and the AIDS Epidemic" as one of the first doctors to sound the alarm about AIDS.

Bradley turned to Francis, and asked him point blank if he thought the blood products companies had murdered 10,000 people. The camera closed in on Francis, who said that yes, they had.

Francis likened infusing with just one lot of factor complex to having sex with 20,000 people - many of whom were donors targeted for their contribution to hepatitis vaccines, meaning that they were often gay men from big cities and IV drug users.

Bierhans knew he needed Francis to testify as an expert in the Modestino case.

A hero to the hemophiliac community, Francis had taken on the blood companies during the '80s, had testified in hundreds of lawsuits, and had been portrayed by Matthew Modine in HBO's version of "And The Band Played On."

But Francis was through testifying in lawsuits. In fact, as Bierhans prepared the Modestino case, "Don was in Thailand with his company VaxGen, doing Phase III clinical trials on what will probably be the world's first HIV vaccine," recalls the lawyer.

Bierhans explains that Francis had stopped testifying in blood-products lawsuits because it had become almost a full-time job for the former CDC epidemiologist.

Fortunately for the Modestinos, Bierhans had a connection to Francis.

"I met Marcus Conant, who was the dermatologist in 'And The Band Played On,' in New York in 1998. He had testified in the products cases, and he agreed to testify as our AIDS expert in the Modestino case," recalls Bierhans, adding that Conant has treated more than 5,000 AIDS patients since he first noticed the new outbreak of Kaposi's sarcoma, a rare cancer, among his gay patients in San Francisco in 1981.

In further meetings in California, Conant told Bierhans, "I think I can get Don." The two doctors were friends, brought together by their work with HIV, and Conant thought Francis would be willing to testify in the first medical-malpractice case involving AIDS-tainted blood.

He was right.

"I flew to San Francisco and had dinner with Don Francis and Marc Conant. I flew back that night with an agreement from Francis to testify in our case, and he did," remembers Bierhans.

Learn As You Go

From what began as an initial client meeting in which Bierhans told the Modestinos that they would never find an expert, the case "took on a life of its own."

"It was like a huge snowball rolling down a hill," says Bierhans, who now had Conant as an AIDS expert, Francis as an epidemiologist, and the head of a hematology clinic at Children's Hospital in Orange County, Calif., Dr. Geni Bennetts, as a hematology expert. Bennetts had taken almost all of her patients off of factor concentrate as soon as she learned of the possible AIDS risk, and had lost only one patient to the disease.

But Bill Modestino Sr. felt that there was another chapter of the story that needed to be told.

"Bill's father's chief complaint was always that the doctors had not treated his son properly once they knew that he was a potential victim of AIDS," says Bierhans.

"I was always more focused on informed consent, but as the case developed, the AIDS treatment aspect of the case became equally important," Bierhans admits.

Bierhans and Delamere found a lab report showing that Bill Jr. had given blood in 1984, which was not tested for HIV until 1987. A blood test for HIV was available in 1985.

Delamere also found a crucial document cataloging Bill Jr.'s CD4, or "helper cell," counts. This report showed that "his CD4 count was 228 in 1986, and in 1989, it had dropped to literally nothing, meaning that he had no helper cells left, no immune system," explains Bierhans.

Even more disturbing was the fact that Bill Jr.'s blood was not tested for two years. No samples were taken in 1987, or 1988.

"His AIDS was neglected for two years, and possibly during the most important years for him, because AZT became available in 1987," notes Bierhans. "He was not even told that he had AIDS until 1988."

Had Bill Jr.'s AIDS been treated aggressively, there is a possibility that he would have lived to receive the "cocktail," a combination of drugs that allows many people with HIV to live healthy lives long past the initial incubation period of 10 years.

"The AIDS treatment aspect of the case really developed while the case was being tried. We had the evidence, but its significance took on meaning as the case was being tried," Bierhans explains, adding that medical science was constantly changing even while the Modestino case was progressing between 1995 and 2001.
Putting The Puzzle Together

Everything was coming together for Bierhans and Delamere. They now had a log proving that Bill Jr. had infused with NC9117 in 1983. They also had a February 1984 letter from the National Hemophilia Foundation, sent to doctors across the country, which stated that NC9117 had been recalled by its maker, Cutter Laboratories, because a donor whose plasma had been used in that lot had developed AIDS.

"We were actually able to match up [one of Bill's] infusions with a lot that was recalled because there was an AIDS victim in the donor pool," Bierhans says. "Bill Jr. was never informed of this recall. His family didn't even know about NC9117 until we made the discovery in this case.

"He died in July of 1993, and infused with NC9117 in July, 1983, exactly 10 years, which was the accepted CDC incubation period for AIDS."

Bierhans knew that it was going to be difficult to prove with medical certainty that NC9117 had been the factor concentrate that killed Bill Jr. A severe hemophiliac who needed large doses of factor concentrate to stop his bleeds, Bill Jr. had infused with many lots in the early 1980s, and any one of them could have contained the HIV bullet that eventually caused his death.

But Bierhans and Delamere now had strong support for the argument that the Modestinos' doctors knew about the AIDS risk in the early 1980s, that they were negligent in failing to warn Bill Jr. of the risk, and that they were negligent in failing to aggressively test him for AIDS or treat him for it.

"Dr. Brettler didn't start Bill Jr. on AZT until 1989. It was licensed in 1987. She tried to use the excuse [at trial] that AZT wasn't used in hemophiliacs then, but she wasn't able to produce any evidence that AZT was used in hemophiliacs any later than it was used in other AIDS patients," says Delamere, noting that he thinks Brettler's weak testimony on this subject led the jury to find her negligent in tracking and treating Bill Jr.'s AIDS.

After listening to Bierhans' stable of world-renowned experts, the Worcester Superior Court jury also found Dr. Brettler negligent in failing to inform the Modestinos about the potential that their son could contract AIDS if he continued to infuse with factor concentrate.

The Modestinos were thrilled. Six years of emotionally and physically exhausting preparation had resulted in a trial that allowed them to tell the story of "the safety net that failed."

"Very often people make the tired remark that the case wasn't about money. This really wasn't about money for the Modestinos. They accomplished exactly what they set out to accomplish," Bierhans smiles, noting that the Modestinos have two grandchildren who are hemophiliacs.

He admits that the six years leading up to trial were difficult and draining for both him and Delamere, as well as the Modestino family.

"There were times when they were close to giving up. But they felt that they owed it to their son to follow this case all the way through," says Bierhans, admitting that the case was also a strain on his small practice.

"We have attempted to run a law practice at the same time we've been doing this, but I'd be lying if I didn't tell you that this took up a substantial portion of the last six years," admits Bierhans.

Although the jury found Dr. Brettler negligent, it could not make the causal connection between her negligence and Bill Jr.'s death.

So the amount of the verdict totaled $0.

But Bierhans dismisses the notion that the case was a "loss."

"The importance is that we got the verdicts on negligence, which is something that had never been decided before," says Bierhans, noting that he was aware all along that proving that Bill Jr. died as a result of the factor concentrate that Dr. Brettler prescribed, or that he would have lived to receive the AIDS cocktail if she had started him on AZT sooner, was close to impossible.

"But even if they couldn't have saved the lives of severe hemophiliac adults like Bill, they could have saved the lives of children," Bierhans adds, noting that he has a similar case close to trial that involves a hemophiliac AIDS patient who was 4 years old at the time that the CDC recommended that children under 4 stop using factor concentrate until it could be treated to kill the AIDS virus (a process that is used now).

Bierhans and Delamere hope that the negligence finding in the Modestino case will open the door for the families of other hemophiliac AIDS patients, and that their hard work and the Modestinos' perseverance will have paid off.

"It was unbelievable when the jury came back and the verdict was read, because I never really thought we'd get there, but we did. Because of the relationship I developed with this incredible family, I'd do it all over again," concludes Bierhans.

In a few months, when Bierhans tackles his second hemophiliac/AIDS case, he will do just that.

Postcript: The second case, involving the death of a teen, settled before trial. Bill and Brenda Modestino have been like family to me throughout the years.

Bruce Bierhans

Originally posted at InjuryBoard by Bruce Bierhans

New Proposal to Examine Drug Safety

Carrie Strasser — Wed, 25 Nov 2009 09:54:22 GMT

Yesterday, the New York Times reported that a new plan to monitor the safety of drugs could identify a particular drug's risks long before they might have otherwise been discovered. The study that devised this plan was published Monday in the Archives of Internal Medicine.

The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits.

This database would be constantly updated as the results of studies were published. This could allow a "real-time" analysis of the various risks and benefits associated with certain drugs.

Dr. Joseph Ross is the lead author of the study and proposed this plan as a new model for post-market surveillance of drugs. Dr. Ross's study used Vioxx as an example and determined that Merck could have discovered the cardiovascular risks of Vioxx many years before it took the drug off the market in 2004.

Merck questioned the methods used by Dr. Ross and his colleagues in the study, stating that the categories used were too broad and included patients who suffered heart attacks after they had stopped taking Vioxx.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, stated that the type of cumulative analysis proposed by Dr. Ross's study requires an act of Congress. Although the FDA has increased its efforts to ensure drug safety in the past few years, critics call for Congress to grant the FDA more power and resources in order to provide detailed information to patients and doctors.

“There is this kind of dogma in medicine that you shouldn’t use any drug for the first seven years after it’s released, because it takes that long to figure out its harms and benefits,” said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco.

While there are many proponents of the study and its potential to identify drug dangers even faster, some say the number of drugs on the market today would make it nearly impossible, and perhaps too expensive, to cumulatively track every single one of them.

For more information on the FDA and prescription drugs, click here.

To read the study, click here.

Originally posted at InjuryBoard by Carrie Strasser

What is "Unfair and Deceptive" in Massachusetts Consumer Law?

Bruce Bierhans — Thu, 12 Feb 2009 19:55:06 GMT

There exists two important components of the Massachusetts Consumer Protection Act, chapter 93A. One is section 2 of the Act which relates to situations where a consumer maintains a claim against a business; and section 11 which relates to a claim by one business against another business.

There are countless Massachusetts court decisions that actually describe what is "unfair and deceptive" in a variety of contexts. However, I like to use one case in particular to describe the terms in the business to business context, and the Attorney General Reulations promulgated pursuant to ch. 93A to explain the consumer to business cases.

In 1979, the Massachusetts Appeals Court issued a decision in the case of Willard S. Levings v. Forbes & Wallace. Levings (Trane Air Conditioners) brought an action against Forbes to recover money alleged to be due for repair to an air conditioner in a Sprinfield Mass department store. Forbes refused to pay, and the plaintiff alleged that they were "duped" by Forbes into performing the work. In essence, it appeared to be a garden variety breach of contract claim. In discussing what constitutes a business to business unfair or deceptive act, the court stated that the conduct must be "immoral, unethical, oppressive or unscrupulous", or "must attain a level of rascality that would raise an eyebrow of someone inured to the rough and tumble of the world of commerce." In other words, mere breach of contract is not an unfair or deceptive act. The court concluded that if, in fact, the goods and services were ordered with no intent to pay, there could be a 93A violation. But, if there was a legitimate dispute regarding the services performed or the issue of payment, there would not be a 93A violation.

In the consumer area, the standard of "rascality" required is not as great as that required in the business to business context. In those AG regulations, known as 940 CMR Chapter 3, the regulations describe the following as potential unfair or deceptive acts or practices: false advertising, deceptive advertising of guarantees, deceptive pricing, general misrepresentations, advertising "easy credit" sales, failure to perform warranties, misrepresentations in home improvement transactions, misuse of the word "free", bait and switch practices, deceptive use of "loss leaders" to induce the purchase of another product, certain landlord tenant violations, and certain unfair insurance practices. Unfair insurance practices are also governed by another stautute, known as ch. 176D. That statute will be a topic for a seperate blog.

There is no "demand letter" requirement in the business to business claim, but there is such a requirement in consumer/business claims. The letter and what is required to be in the letter will be discussed in another blog.

The bottom line is that ch.93A is a very broad and powerful tool in Massachusetts that can be used by both small businesses and consumers to advance legitimate claims. As an attorney that often represents small businesses (Davids) against mega corporations (Goliaths), 93A truly helps level the playing field.

Originally posted at InjuryBoard by Bruce Bierhans

Nissan Recalls Murano SUVs

Chrissie Cole — Mon, 25 May 2009 15:31:00 GMT

Nissan is recalling more than 360,000 Murano SUVs from the 2003-2007 model years due to a defect in the intake air ducts which may cause the engine to stall, increasing the risk of a crash.

A defect notice filed with the National Highway Traffic Safety Commission Administration (NHTSA) says “the intake air ducts, which are connected to the intermediate resonator in the air intake system of the engine, may separate from the resonator with engine movement which can occur due to premature aging of the material used in the intake air ducts which causes excessive shrinking.”

Nissan dealers will inspect and replace the necessary parts for free. Murano customers will receive a recall notice on or before July 6, 2009. For more information, consumers can contact Nissan at 1-800-647-7261.

Consumers may also contact the NHTSA at 1-888-327-4236 (TTY: 1-800-424-9153) or at www.safercar.gov.

Originally posted at InjuryBoard by Chrissie Cole

Risks of Ortho Evra

Carrie Strasser — Thu, 22 Oct 2009 09:58:23 GMT

The Boston Globe reported yesterday on the risks associated with the birth control patch, Ortho Evra, manufactured by Johnson & Johnson. The article reported the story of an otherwise healthy 17-year-old, Adrianna Duffy, who recently died from a pulmonary embolism after being on the patch.

Thousands of lawsuits have been brought against the makers of Ortho Evra, Johnson & Johnson, by women who used it and suffered heart attacks, strokes, or blood clots. At least 20 of the women named in the lawsuits died after using the patch. Though sales of the drug have plummeted by about 75 percent since word of its side effects spread, at least 2 million women still use it, and it’s still approved by the Food and Drug Administration.

So far, Johnson & Johnson has paid out $70 million to settle the suits. Claims arose that Johnson & Johnson was ignoring the risks that were associated with such high estrogen levels. Although Johnson & Johnson has dismissed these claims, it has changed the label on Ortho Evra three times to show its estrogen levels and to warn of the possible risks associated with such high levels.

Sidney Wolfe, director of the Health Research Group at Public Citizen, says that the estrogen levels in Ortho Evra are far higher than in birth control pills and these levels greatly increase a woman's risk for blood clots.

For more information on prescription drugs and their associated risks, click here.

Originally posted at InjuryBoard by Carrie Strasser

Strollers Recalled By Baby Jogger

Chrissie Cole — Thu, 27 Aug 2009 22:44:00 GMT

Baby Jogger voluntarily recalled Baby Jogger City Mini Strollers because the restraint buckles could break or unlatch, posing a fall hazard to children.

To date, the agency has not received any reports of incidents and/or injuries associated with the recalled products.

Baby Jogger City Mini single and double strollers are included in the recall. The CPSC Web site has a full list of recalled Baby Jogger products along with the affected item numbers and manufacturing date codes.

The items were sold nationwide at mass merchandisers and department stores as well as various Web sites, which include Amazon.

Consumers should stop using the recalled strollers and contact the company for a free replacement buckle and instructions.

Consumer Information: Contact Baby Jogger at 877-506-2213 between 8:30 a.m. and 6 p.m. ET, email the firm at recall@babyjogger.com, or visit BabyJogger.com.

Originally posted at InjuryBoard by Chrissie Cole

Vermont Legislature Passes Most Stringent Law Yet on Drug Makers' Gifts to Doctors

Carrie Strasser — Thu, 21 May 2009 17:36:52 GMT

The New York Times reported on Wednesday that Vermont is putting its foot down on medical industry payments and gifts to doctors and other health care providers. The law passed by the Vermont legislature requires drug and device manufacturers to publicly disclose all money given, including the names of the doctors gifts were given to, and the dollar amounts given.

This is the strictest state law yet because it would ban almost all industry gifts, like free meals to doctors, staff, pharmacists, etc. Other states have enacted similar laws. Minnesota requires the drug industry to report payments to doctors. Massachusetts limits gifts to health care practitioners and requires disclosure of payments over $50.

“This is a much more comprehensive law because it makes clear — whether devices, biologics or drugs are involved — the issue is inappropriate gift-giving,” said Sharon Treat, the executive director of a nonprofit group, the National Legislative Association for Prescription Drug Pricing, and a Democrat in the Maine House of Representatives.
...

Makers of medical products spent about $2.9 million in fiscal year 2008 on marketing to health care professionals in Vermont, according to a report last month from the state’s attorney general. Of Vermont’s 4,573 licensed health practitioners, almost half received remuneration, including payments for lectures, meals or lodging from pharmaceutical companies in the 2008 fiscal year, the report said.

The highest amount spent on one person in Vermont was $112,000.00 given to a psychiatrist. However, other specialists also received over $100,000.00 during the year. The Vermont Medical Society supports the bill and represents 65% of the physicians in the state.

Peter Shumlin, who is the president pro tempore of the Vermont state senate, hopes that Vermont could be a model for the rest of the country and emphasized that their goal was to advocate for public disclosure and not to prohibit the practice all together.

Originally posted at InjuryBoard by Carrie Strasser

Swine Flu Vaccine Makers Get Immunity

Carrie Strasser — Mon, 20 Jul 2009 13:58:16 GMT

Secretary of Health and Human Services, Kathleen Sebelius, signed a document last month that gives vaccine makers and federal officials immunity from lawsuits that might arise surrounding any new swine flu vaccine. The Boston Globe reported last week that the immunity sought by drug manufacturers was spurred on by vaccines created for the last swine flu outbreak and the resulting thousands of lawsuits filed against those vaccine makers for side effects suffered from the shots.

The document signed by Secretary Sebelius allows for a compensation fund, if needed, for claims made against the drug manufacturers. The government has taken these steps in order to encourage drug companies to actually make the vaccine and so far, five manufacturers have contracted with federal officials to make a swine flu vaccine.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

Because vaccines are not as profitable to drug companies as other products, many will not pursue the manufacturing of vaccines unless immunity is guaranteed. However, some worry about the costs to consumers. Because the government will most likely campaign for people to get vaccinated to prevent further spread of the disease, some question whether or not these people will truly be protected if they are actually harmed by the vaccine.

Originally posted at InjuryBoard by Carrie Strasser

Teen Killed In Car Accident In Falmouth

Chrissie Cole — Sun, 12 Apr 2009 14:26:00 GMT

A teenager was killed in a car accident when the vehicle he was driving ran off the road, rolled over and landed in the ocean in Falmouth Sunday morning.

According to police, the vehicle crashed at the intersection of Maravista Avenue and Menhant Road. One of the teens, 17, was able to get out of the vehicle and run to a nearby residence to seek help.

The other teen, 18, was trapped in the vehicle submerged in the ocean.

Upon arriving at the scene, two officers jumped into the water and pulled the unresponsive teen to safety. He was rushed to Falmouth Hospital where he was pronounced dead shortly after.

The names of the teens involved in the accident have not been released. And the cause of the crash is currently under investigation. #

Originally posted at InjuryBoard by Chrissie Cole