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Entries in Lawsuit (27)

Saturday
Jun292013

Woman Disfigured by Generic Drug Loses $21 Million Award

iStockphoto/Thinkstock(WASHINGTON) -- Eight years after she was burned and blinded by a prescription drug, Karen Bartlett feels numb.

On Monday the Supreme Court ruled that Mutual Pharmaceutical Co., the maker of the drug Bartlett took for shoulder pain, should not be held responsible for her injuries because the company had copied the brand drug's formula and warning label.

"I was numb," Bartlett said of the moment her lawyer delivered the news. "I don't even have words to describe it because I can't believe that they would do that."

In a five-four decision, the court ruled Monday that generic drug makers could not be sued by patients over defective drug design because they're required by federal law to copy their brand-name counterparts. The ruling overturns the verdict from Bartlett's 2010 New Hampshire Superior Court trial in which a jury awarded her $21 million in damages, as well as the decision by an appeals court to uphold the verdict.

"I can't believe the Supreme Court can just say, 'I'm sorry, you guys are wrong,'" said Bartlett, whose body is scarred from the fierce reaction to sulindac, a generic version of the nonsteroidal anti-inflammatory drug Clinoril. "It boggles my mind. I just don't get it."

Bartlett remembers little from the three months she spent at Massachusetts General Hospital in 2004, "wrapped up like a mummy" as the skin eroded two-thirds of her body. She was diagnosed with Stevens-Johnson syndrome, a rare and sometimes fatal reaction triggered by certain medications, including NSAIDS like Clinoril and sulindac.

The ordeal left her disfigured and legally blind. She also has lung damage and difficulty swallowing.

"I have no independence," said Bartlett, 53, who lives off disability checks for a fraction of the salary she once earned as a secretary at an insurance company in Plaistow, N.H. "This ruined my life, basically."

In a lawsuit against Mutual Pharmaceutical Co., Bartlett's lawyer argued that the company "failed to adequately warn users" about Stevens-Johnson syndrome, one of sulindac's more serious, albeit very rare side effects. A jury in New Hampshire Superior Court agreed, awarding Bartlett the $21 million payout to cover medical and legal costs, and compensate her for "physical and mental pain and suffering" as well as "loss of enjoyment of life," according to the complaint.

At the time of Bartlett's reaction, sulindac's label did not specifically warn about Stevens-Johnson Syndrome, the Supreme Court acknowledged, though it did warn that the drug could cause "severe skin reactions" and "fatalities." But under federal law, generic drugs must be chemically identical to the FDA-approved brand-name drug and don the same warning label.

"Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design," Supreme Court Justice Samuel Anthony Alito Jr. wrote in the majority opinion of the court.

In 2005, one year after Bartlett's reaction, the Food and Drug Administration recommended changes to the labeling of all NSAIDs, including Clinoril and sulindac, to more explicitly warn about Stevens-Johnson syndrome.

Alito noted that Bartlett's case "arises out of tragic circumstances" and "evokes deep sympathy.
"But sympathy for [Bartlett] does not relieve us of the responsibility of following the law," he wrote.

Jay P. Lefkowitz, the lawyer who represented Mutual Pharmaceutical Co., said the ruling "vindicates the authority" of the FDA, the federal agency charged with assessing drug safety.

"The FDA has the scientific and medical expertise to make decisions about the safety and efficacy of drugs based on all of the data," said Lefkowitz, whose office is based in New York City. "State court juries that are only looking at one example of a tragic side effect don't have the ability to make an assessment about the safety and efficacy of a drug that millions of people use with good results."

Lefkowitz said his "heart was filled with sympathy" for Bartlett.

"Every one of us takes prescription drugs. We give them to our kids, and this can happen to anyone," he said. "But I think the court got it right, even though it's obviously a tragic set of circumstances."

Bartlett said, "I walk away with nothing except disability checks. They don't seem to care that this has affected me for rest of life."

Copyright 2013 ABC News Radio

Thursday
Feb212013

Encinitas Union School District in California Sued over Yoga Classes

iStockphoto/Thinkstock(SAN DIEGO) -- What was intended as a fun addition to physical education in a California school district has sparked controversy among parents who feel Ashtanga yoga infringes on their religious beliefs.

The National Center for Law & Policy (NCLP) is representing a family that is suing the Encinitas Union School District for "civil rights violations resulting from its inherently and pervasively religious Ashtanga yoga program."

"If you research yoga and Hinduism, most people would say Hinduism is yoga and yoga is Hinduism," Dean Broyles, an attorney representing the family, told ABC News. "It's a situation where the state is endorsing religious beliefs and practices, which is forbidden under California and federal law."

The lawsuit was filed in San Diego Superior Court Wednesday and outlines the concerns of the plaintiffs, Stephen and Jennifer Sedlock, whose children are in the Encinitas Union School District.

According to a news release, the family is not seeking money damages, but instead is requesting to have the Ashtanga yoga program suspended entirely.

"The goal would be to have a judge order the district to comply with the law," added Broyles. "If they comply with the law, they will need to suspend the yoga program and offer physical education that complies with the law to their students."

Yet, Encinitas Superintendent Timothy Baird said the yoga classes are a "typical P.E. class" that have been a successful and positive component to the district's health and wellness program without any religious implications.

"If you were to walk in there, you would feel like you're going into a gym," Baird told ABC News. "The students come in, do some warmups, do the typical stretching and movement. There's absolutely no religious instruction that goes on, whatsoever."

"I believe what he is saying is just the motions of the yoga stretching is somehow invoking Hinduism -- and in America, where 90 to 95 percent of the practitioners are not even Hindu," Baird said.

The Jois Foundation, named after a noted pioneer of Ashtanga yoga, awarded the school district a $550,000 grant to introduce yoga. The group said on its website that it "is working to provide schools with health, wellness, and achievement during a time of massive budget cuts."

Since the grant, Baird said, all schools within the district offer the classes to approximately 5,500 students. However, Baird added, the yoga classes are not actually Ashtanga yoga because it is too demanding for students, but rather a modified version for the K-6 students.

"We are probably using some of the poses found in Ashtanga yoga," Baird told ABC News. "But we have modified this extensively to be done by students of this particular age. And all body types can be successful [with] what we are doing in our classes."

In the news release, NLCP called the yoga "inherently and pervasively religious, having its roots firmly planted in Hindu, Buddhist, Taoist and western metaphysical religious beliefs and practices." NCLP also cited a religious studies professor's support of the claim.

Approximately up to 30 families approached the district with concerns about the classes before the lawsuit was filed, Baird said.

"We have answered questions, we have had them observe classes, and where they were still uncomfortable we had the ability for students to opt out and do other activities," he said. "We thought we addressed the parents concerns here."

Regardless of the lawsuit, the classes will still be offered in all schools within the district, Baird said.

Copyright 2013 ABC News Radio

Friday
Jan182013

Massachusetts Case May Spur Food Allergy Lawsuits

iStockphoto/Thinkstock(NEW YORK) -- In the wake of a landmark settlement, restaurants and other food service outlets may now have to go the extra mile to serve sensitive customers in order to avoid a lawsuit.

Lesley University in Cambridge, Mass., is under orders to offer safer options after a student with Celiac disease complained that the school refused to exempt her from its meal plan but wouldn't serve gluten-free food.

The settlement could pave the way for people with allergies -- and other health conditions -- to sue businesses that are subject to the Americans with Disabilities Act.

Copyright 2013 ABC News Radio

Tuesday
Nov272012

Gay Men, Moms Sue Jewish Gay Conversion Therapists

Hemera/Thinkstock(NEW YORK) -- Four gay men and two of their mothers filed a lawsuit Tuesday against a New Jersey conversion therapy group that claims to rid men of same-sex attractions and turn them straight.

The lawsuit, filed in Superior Court of New Jersey Hudson County, alleges that methods used by the Jersey City-based Jews Offering New Alternatives to Healing (JONAH) do not work and constitute fraud under the state's consumer protection laws.

Arthur Goldberg, JONAH's co-director, and Alan Downing, a "life coach" who provides therapy sessions, were also named in the suit.

The plaintiffs include Michael Ferguson, Benjamin Unger, Sheldon Bruck and Chaim Levin, all of whom used the services of JONAH when they were in their teens or early 20s.

Two of the men's mothers, Jo Bruck and Bella Levin, who paid for therapy sessions that could cost up to $10,000 a year, were also plaintiffs. They are seeking declaratory, injunctive and an undisclosed amount of monetary relief, as well as court costs, according to the lawsuit.

The plaintiffs have received legal help from the Southern Poverty Law Center (SPLC), which claims in the lawsuit that conversion therapy is a dangerous practice that has been "discredited or highly criticized" by every major American medical, psychiatric, psychological and professional organization.

The lawsuit alleges that some of the methods used included: telling boys to beat a pillow, the "effigy of the client's mother," with a tennis racket; encouraging "cuddling" between younger clients and older male counselors; and even instructing attendees to remove their clothing and hold their penises in front of Downing.

"It's definitely cruel and unusual and doesn't work," said SPLC lawyer Sam Wolfe. "They are peddling bogus techniques that have no foundation in science and are basically ridiculous and even harmful."

Wolfe paraphrased JONAH's message as: "All you have to do is put in the work to overcome your sexual attractions. If you follow our program your true orientation emerges and will turn you into a straight person."

Arthur Goldberg said he "knows nothing about the lawsuit," which was filed this morning, and referred ABC News to JONAH's website.

"We have a lot of people who were a success and were healed," he said of JONAH's 14 years in service. "Hundreds of the clients we serve are satisfied ... Our therapy is very conventional."

When asked about instructing boys to take off their clothes, he said, "I know nothing about that."

Goldberg also said he had "no idea" how to reach Downing because he was an "independent contractor."

According to JONAH's mission statement on its website, the nonprofit group is "dedicated to educating the world-wide Jewish community about the social, cultural and emotional factors which lead to same-sex attractions."

JONAH's Goldberg, who runs the business side of the nonprofit, says on the website that "change from homosexual to heterosexual is possible … homosexuality is a learned behavior which can be unlearned, and that healing is a lifelong process."

The American Psychiatric Association and the World Health Organization, among other mental health groups, have cited the potential risks of reparation therapy, including "depression, anxiety [and] self-destructive behavior," according to the lawsuit.

Chaim Levin, the most vocal of the plaintiffs, is now 23 and a gay rights advocate.  He grew up in a Jewish ultra orthodox community in Brooklyn where religious leaders threw him out of the Hebrew-speaking yeshiva at the age of 17, when they learned he was gay.

Levin told ABC News that he had been abused as a boy and that he was "confused" by his sexuality. At a rabbi's advice, he began 18 months of gay conversion therapy at JONAH.

When Levin met co-director Goldberg, he said the defendant told him JONAH could change his sexual orientation, "as long as I tried hard enough and put enough effort into it."

"He told me, 'You will marry a woman and have a straight life,'" said Levin.

Today, Levin no longer identifies as orthodox, but said his parents have been "supportive" of the lawsuit.

Some Jewish denominations and many congregations are inclusive of homosexual congregants, and even New York's orthodox communities are more open-minded now, according to Levin.

Copywright 2012 ABC News Radio

Thursday
Nov082012

Consumer Group Sues 7UP Makers for Antioxidant Claims

Scott Olson/Getty Images(WASHINGTON) -- A consumer advocacy group is suing Dr. Pepper Snapple Group, the makers of 7UP, for marketing "nutritionally worthless" sodas as healthy, fruit-filled antioxidant drinks.

In its recent ads, and on its website, the manufacturer says “There’s never been a more delicious way to cherry pick your antioxidant!” The word “antioxidant” is emblazoned across the front of the bottle along with pictures of fruit.

But the Center for Science in the Public Interest says the drinks contain no fruit at all and only a “small amount” of added Vitamin E, which the group claims has no proven antioxidant benefits.

After touting added antioxidants in its regular and diet Cherry Antioxidant, Mixed Berry Antioxidant and Pomegranate Antioxidant 7UP beverages, the company is facing a lawsuit filed on behalf of a Sherman Oaks, Calif., man who says he was duped. He says he purchased the drinks not knowing they didn't really contain juices from the advertised fruits.

“Non-diet varieties of 7UP, like other sugary drinks, promote obesity, diabetes, tooth decay, and other serious health problems, and no amount of antioxidants could begin to reduce those risks,” said CSPI executive director Michael F. Jacobson.  “Adding an antioxidant to a soda is like adding menthol to a cigarette -- neither does anything to make an unhealthy product healthy.”

The FDA seems to agree. In its current policy, the agency states it, "does not consider it appropriate to fortify … snack foods such as candies and carbonated beverages."  The FDA also nabbed Coca-Cola for similar violations of the policy. Coke received a warning letter from the FDA for the offense.

The antioxidant claims on 7UP's labeling are in violation of several California laws including the Consumers Legal Remedies Act, according to the lawsuit.

The CSPI is acting as co-counsel in the lawsuit with consumer protection class action law firm Reese Richman LLP.

"Every can or bottle of 7UP consumed brings one closer to obesity, diabetes, heart disease, and other serious health problems," said CSPI litigation director Steve Gardner. "So I look forward to having 7UP go under oath and testify before a judge or a jury that this disease-promoting sugar water is actually a source of healthy antioxidants."

Copyright 2012 ABC News Radio

Friday
Oct122012

Meningitis Outbreak: Minnesota Woman Sues Pharmacy

Jared Wickerham/Getty Images(SHAKOPEE, Minn.) -- A Minnesota woman is the first person to sue the compounding pharmacy at the center of a fungal meningitis outbreak that has claimed 14 lives.

In a class action filed Thursday in U.S. District Court, Barbe Puro of Shakopee, Minn., claimed she developed symptoms of meningitis after receiving a spinal injection of methylprednisolone acetate tainted with fungus.

The drug, a steroid used to treat back and joint pain, was made by the New England Compounding Center in Framingham, Mass. Fifty sealed vials of the drug, obtained by the U.S. Food and Drug Administration, were found to contain fungus. The company has recalled all its products and shut down operations.

Calls to the compounding pharmacy were not immediately returned, and its website is down.

Puro is one of roughly 14,000 people believed to have been exposed to the suspect steroid. The U.S. Centers for Disease Control and Prevention confirmed that 169 people in 11 states have contracted fungal meningitis after spinal injections of the steroid. One person has contracted a joint infection after receiving an injection for ankle pain.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.

Puro claimed she received a spinal steroid injection Sept. 17 and developed headaches and nausea -- subtle symptoms of fungal meningitis. The following week, she received a call from the clinic that administered the shot, saying she might be at risk for fungal meningitis. The results of her spinal tap, a diagnostic test for meningitis, are pending, according to the lawsuit.

Puro filed the class action on behalf of all patients in Minnesota who received the recalled steroid. So far, the state has three known cases of infection and no reported deaths. Infections have also been reported in Tennessee, Michigan, Virginia, Indiana, Maryland, Florida, North Carolina, Ohio, New Jersey and, most recently, Idaho.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he said, adding that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

People affected by the current outbreak are being treated with two different types of antifungal medications until the type of fungus causing the infection -- aspergillus or exserohilum -- can be identified.

The CDC has confirmed one case of aspergillus meningitis and 10 cases of exserohilum meningitis. It's unclear how the fungi landed in the steroid vials.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Puro claims the New England Compounding Center "was negligent because it failed to use reasonable care when it designed, tested, manufactured, marketed and sold doses of methylprednisolone acetate," and that she and others who received the recalled drug have "suffered serious bodily harm, other personal injuries and emotional distress, and have incurred medical and other expenses." She is seeking compensation for damages, attorney fees and other costs.

Copyright 2012 ABC News Radio

Friday
Oct052012

Man Sues Philly Strip Club for Bladder Rupture During Pole Dance

iStockphoto/Thinkstock(PHILADELPHIA) -- A bachelor party celebration at a Philadelphia strip club turned painfully dangerous for Patrick Gallagher, who says his bladder was ruptured while participating in a pole dance on stage.

Gallagher, of Lansdale, Pa., filed a lawsuit in Philadelphia's Court of Common Plea last week, alleging that a dancer at the Penthouse Club caused him serious injury, including a ruptured bladder, when she fell on him during the dance routine in November 2010.

According to the complaint, Gallagher was lying at the bottom of the pole when a dancer climbed to the top of it and slid down "from a great height and slammed her body on top of" Gallagher.

The suit alleges the force of her slide ruptured Gallagher's bladder and caused nerve damage.

Gallagher's attorney, Neil Murray, told the Philadelphia Inquirer that his client had been directed to lie on the stage as part of the bachelors' package that his friends had bought for him.

Gallagher left the club in pain after the incident, and the next morning went to the hospital, where doctors determined his injuries, Murray told the newspaper.

Murray and Gallagher declined to speak to ABC News, and a manager at the Penthouse Club also declined to comment.

Gallagher is seeking damages in excess of $50,000, claiming negligence that resulted in physical injuries that required medical care, according to the lawsuit.

Copyright 2012 ABC News Radio

Thursday
Aug302012

Man Fractures Penis After Taking Sex Pill, Lawsuit Claims

John Foxx/Stockbyte/Thinkstock(NEW YORK) -- A 29-year-old man has sued the manufacturers of a sexual enhancement supplement, claiming it caused his penis to fracture in a horrifying incident at a Houston motel last year.

But though Adrian Carter of Texas blames the supplement, three urologists told ABCNews.com com that penile fractures are most often the result of rough sex.

Adrian Carter of Texas said he purchased VirilisPro in the "early morning hours" at a Chevron gas station en route to the Scottish Inn, where he had sex with his "paramour," according to the lawsuit.

Later, during intercourse, he had "significant pain and observed a large quantity of blood squirting out of his penis onto the sheets, walls and mirror," according to the lawsuit filed Aug. 27 in the district court of Harris County, Texas.

Emergency room doctors had to "deglove" Carter's penis in order to repair it, rendering him unable to have sex or future children, Carter claimed.

The lawsuit said VirilisPro was "defective and unreasonably dangerous for use by consumers."

"It was pretty horrific to view the pictures," Carter's lawyer, Melissa Moore, told ABCNews.com. "I know it sounds unusual. ...He was young and healthy and on no other meds at the time he took the supplement."

Named in the lawsuit were the drug manufacturer, Haute Health Limited Liability Company, Carney & Carney Financial Services, individuals Michael Heilig and Michael and Tyra Carney, and Solid Rock Worship Company, all located in New Jersey.

On its website, the company says VirilisPro is "made with only natural ingredients to prevent harmful side effects."

ABCNews.com was unable to reach any of the defendants for comment.

Carter is seeking medical expenses and punitive damages for product liability, negligence, breach of warranty, deceptive trade, mental anguish, pain and suffering and "past and future loss of consortium."

He alleged that when he purchased the supplement, the store clerk suggested the product as "natural and safe."

Carter's doctor, who is continuing follow-up treatment, "directly linked" the penis injury to the supplement, Moore said.

But urologists said penile fractures usually are caused by traumatic sexual intercourse.

And they are fairly common, according to Dr. Chad Ritenour, associate professor of urology at Emory University School of Medicine in Atlanta. He sees a case -- called "eggplant penis" -- at least once a month.

"I never heard of anyone being put at a higher risk for fracture because of a prescription or an herbal drug," said Carney. "With a fracture, you typically get swelling and the penis looks like an eggplant -- purple and swollen. But blood coming out on the walls, that sounds really dramatic."

"The typical story is that someone is having intercourse and, in the course of an erection, they miss an opening and hit a pelvic bone in their partner," he said. "In the classic case, you hear a 'pop' and feel something immediately."

Carter said he was taken to a local emergency room, where the doctor diagnosed him with "gross hematuria" -- blood in his urine -- as well as penile fracture and a urethral injury, according to the lawsuit.

There, after "initial exploratory surgery," doctors allegedly "degloved," or removed the skin from the penis, and repaired his urethra, which had "separated completely."

Carter was released from the hospital after a few days, but a catheter remained in place for three days, according to the lawsuit.

"Doctors again warned him that he may never have an erection or be able to father children and his ureters [sic] may close, resulting in permanent inability to urinate naturally," according to court papers.

Dr. Jeanne O'Brien, an associate professor of urology and male fertility, said penile fractures can traumatize the urethra.

"They often happen together and it is routine to clear the urethra in cases of penile fracture," she wrote in an email to ABCNews.com. "Surgical repair is the only option in these cases."

Surgery can cause permanent erectile dysfunction, obstruction of the urethra and, rarely, urinary incontinence and "retrograde ejaculation," she said.

According to its website, VirilisPro is a supplement to improve sexual performance that "works to give you a harder erection for natural male enlargement and a more intense orgasm. It also helps lower your recovery time and increase sexual stamina for total sexual enhancement."

Its online advertising says that the product is "made with only natural ingredients to prevent harmful side effects." Its ingredients are listed as a 450 mg "proprietary blend" of epimedium, tribulus terrestris, panax ginseng, rhodiola rosea, lycium chinese and yohimbe extract.

Male consumers are instructed to take it 30 minutes before intercourse and only use one pill in a 36-hour period. The ad warns the user to "always check with a healthcare professional" first.

The Food and Drug Administration does not regulate dietary supplements in the same ways they do food and drugs. The dietary ingredient manufacturer is responsible for ensuring that it is safe before marketing it. The FDA can take action against any unsafe supplement, according to their guidelines.

Alleging that supplements caused penile fracture is "the most absurd thing I have heard of in my life," according to Dr. Jeff Carney, chief of urology at Grady Memorial Hospital and a trauma specialist.

Some of Carter's symptoms as described in the court papers ring true -- pain and swelling, according to Carney, but other details are "overly dramatic," he said.

Degloving would never have been done in an emergency room, but by a skilled surgeon, he said. If the urinary channel is also affected by the fracture, the injury can be bloody, but "blood squirting out helter skelter" is not possible, "I can guarantee you," he said.

"When a man breaks his penis it can be very scary," said Carter. "I believe he took this story and spiced it up."

Carney said that he has heard "everything under the sun" when men arrive in the emergency room with a fractured penis. "The most common one told is they walked into an ironing board."

"I suppose it's possible you could get up in the middle of the night with a hard erection and walk into a wall and break your penis," he said.

Urologist Ritenour agreed.

"You never know if you are getting the real story," he said. "People are embarrassed. The real point of this story is that this is a medical emergency and you really need to come and be seen so it can be handled surgically and fixed."

Copyright 2012 ABC News Radio

Thursday
Jul122012

Woman Anonymously Sues FDA for Right to Free Sperm

iStockphoto/Thinkstock(OAKLAND, Calif.) -- An Oakland, Calif., woman and her long-term female partner wanted to start a family.  But she didn't want to have heterosexual intercourse, nor did she want to use a medical intermediary -- like a sperm bank or doctor -- and pay a fee to get pregnant.

Instead, she wanted to use a free sperm sample from a man she had chosen, and inseminate herself.

However, Food and Drug Administration regulations state that "any establishment that performs one or more manufacturing steps" for donating sperm samples -- from producing a sample, having it analyzed, storing it, to providing it to a recipient -- must register with the agency and get tested for communicable diseases that may be transmitted through artificial insemination.

These regulations may also apply to uncompensated donors, like the one she and her partner sought out.

After the recent cease order issued by the FDA to Trent Arsenault, a free sperm donor from Acampo, Calif., ordering him to stop "manufacturing" and supplying couples with sperm who are seeking to get pregnant, the woman wanted to err on the side of caution.

As a result, she is suing, under the name Jane Doe, the commissioner of the FDA and the secretary of the U.S. Department of Health and Human Services, claiming its regulations violate her rights to privacy for telling her how she should be allowed to conceive a child.

"This means the FDA can reach into your bedroom and tell you how to procreate," said her lawyer, Amber Abbasi, chief counsel for regulatory affairs at government accountability advocacy organization Cause of Action.  "The FDA taking the position that donors, even when there's no commercial element, are 'an establishment,' just like a sperm bank and have to register.  This is a serious burden on the reproductive freedoms of both the recipient and the donor."

Abbasi said her client wanted to obtain fresh donor sperm from an individual she selected and implant it herself in a process known as intracervical artificial insemination -- injecting the semen into her cervix -- using a syringe, which does not require medical supervision.

According to the lawsuit, Doe felt it was important for the biological father to be present in her child's life, if he or she so desired.  Doe did not want to visit a sperm bank for an anonymous sample, a process noted to be "costly and burdensome" for couples looking to get pregnant.

Doe had selected a donor and did a review on his personal and medical history before attempting to conceive through intracervical insemination, said the suit.  She did get pregnant, but she miscarried.

Doe wants to try again, but is concerned that "her choices of conception partner and method of conception are directly barred by FDA regulations," and is worried she will be charged with a federal crime if she opts to get pregnant in the way that she wants to, according to the lawsuit.

Doe's suit was filed in U.S. District Court for the Northern District of California on July 2.  Abbasi said the FDA has not responded, and no court date has been set yet.

Copyright 2012 ABC News Radio

Wednesday
Jun062012

Woman Wins $1M Suit against Dentist Who Gave Her STD

Hemera/Thinkstock(PORTLAND, Ore.) -- Unsafe sex can be costly, nearly a million dollars in this case. After four days of testimony and two hours of deliberation, a jury has awarded an Oregon woman $900,000 in damages because she contracted genital herpes after a liaison with a retired dentist.

“The jury essentially said if a person knows he has an STD, he has a duty to inform a sex partner before, not after,” said Randall Vogt, the woman’s attorney.

Vogt’s client, who sued under a pseudonym, met the retired dentist, 69, on an Internet dating website in 2010 and went on three dates, he said. On the fourth, they had sex.

The woman, 49, handed her partner a condom, but his sexual advances took over too quickly, she says. After intercourse, as the two lay in bed discussing their connection, the man decided to open up and revealed he had herpes, according to the lawsuit. The woman kicked him out of her home.

Eleven days later, the woman had a painful outbreak, which she continues to have periodically. Antiviral medication caused her to lose her hair and she has since gained weight from the drugs she takes to treat the depression caused by the herpes, the lawsuit alleged.

Defense attorney Shawn Lillegren argued that the woman was careless and money-hungry.  “Grow up. Come on. You’re an adult. He’s an adult. They had sex,” Lillegren said, according to the Oregonian.

But the jury didn’t buy it, and Tuesday found the man 75 percent liable for negligence and completely liable for civil battery.

Vogt said this kind of lawsuit is “extremely rare” because it’s often hard to prove where the victim contracted the STD. He also said embarrassment plays a factor in deterring victims from confronting former partners in court.

He hopes his client set a new precedent.

“When people learn they can be sued for transmitting an STD to another person,” he said, “it is going to encourage people to be more careful and less reckless about their contact.”

Copyright 2012 ABC News Radio







ABC News Radio