Source: https://thelegalintelligencer.typepad.com/tli/pharma/
Timestamp: 2019-04-22 05:23:37+00:00

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A petition for allocatur has been filed in the case of a woman who claimed that her use of an antidepressant during pregnancy caused birth defects necessitating an abortion.
The petition for allowance of appeal before the state Supreme Court in Thomas v. GSK was filed Thursday. The petition challenges the Nov. 27 Superior Court ruling that GlaxoSmithKline (GSK) did not fraudulently conceal information about the U.S. Food and Drug Administration birth-defect risk classification of its drug Paxil from plaintiff Joanne Thomas. Given there was no fraudulent concealment to toll the statute of limitations, the Superior Court ruled the case was time-barred.
Additionally, the court ruled that since Thomas' unborn baby did not reach the fetal gestational age of 23-24 weeks, it was not considered "viable" in terms of a wrongful death/survival claim.
Thomas, who said this case is one of first impression, is seeking to appeal on two main issues: whether the court’s prior rulings on what constitutes a viable fetus should be reconsidered and whether the statute of limitations should be tolled in this case or “is a defendant shielded from liability, when a defendant fraudulently conceals information from the general public and the plaintiff that is necessary for a plaintiff to determine that a cause of action exists against the defendant generally or under the Wrongful Death Act,” Thomas said in the petition.
GSK’s attorney, Joseph O’Neil of Lavin, O'Neil, Ricci, Cedrone & DiSipio, and Mary Anne Rhyne, director of U.S. external communications at GSK, did not immediately return calls seeking comment. Havertown-based Daniel J. Siegel is appellate counsel for Thomas.
Judge Paula Francisco Ott wrote in the court's unpublished memorandum that GSK did not take affirmative measures to conceal from Thomas specifically any potential risk of birth defects related to taking Paxil during pregnancy.
"This court has emphasized that the alleged act must have caused the plaintiff 'to deviate from the right of inquiry' as to the matter upon which [s]he has commenced suit," Ott said. "The trial court determined that ... GSK's conduct did not amount to fraudulent concealment. Based on our review, we find no error. The trial court's decision is sound."
In a separate concurring memorandum, Senior Judge Eugene B. Strassburger III said that while the court's ultimate decision was correct, he took issue with its reasoning on the issue of alleged fraudulent concealment.
On April 26, 2001, Thomas voluntarily chose to have a therapeutic abortion after a pediatric cardiologist informed her that her unborn son, Ryan Swindle, at the estimated fetal age of 22-and-a-half weeks, had congenital heart defects, according to Ott.
Thomas alleged that during a phone call to a GSK consumer line March 8, 2007, nearly six years later, a GSK representative incorrectly told Thomas that Paxil was a "Category C" drug in relation to the FDA's fetal injury risk categories. According to Ott, the representative later confirmed that Paxil was a "Category D" drug, or one that presents a greater risk of fetal injury than "Category C."
According to Ott, Thomas claimed that the state's fraudulent concealment doctrine tolled her claims until December 2005, when GSK changed its warnings on Paxil.
In terms of the statute of limitations, Ott cited the trial court's opinion, in which now-retired Judge Sandra Mazer Moss wrote, "There are exceptions that act to toll the running of a statute of limitations. The discovery rule and the doctrine of fraudulent concealment are such exceptions," however, "in order for fraudulent concealment to toll the statute of limitations, the defendant must have committed some affirmative independent act of concealment upon which the plaintiff justifiably relied."
P.J. D'Annunzio can be contacted at 215-557-2315 or pdannunzio@alm.com. Follow him on Twitter @PJDAnnunzioTLI.
AG Settles Vioxx Claims With Merck for $8.25 Mil.
Pennsylvania has settled with pharmaceutical company Merck for $8.25 million over the company’s failure to warn the state of the harmful health effects of prescription painkiller Vioxx.
The money will go toward the state’s PACE program, a prescription assistance program for Pennsylvania’s seniors. The state government was assisted in settlement negotiations by Cohen, Placitella & Roth. After the law firm is paid its fees and expenses, $6.9 million will go to the PACE program.
This is the second time Pennsylvania has entered a settlement with Merck related to the Vioxx litigation. Pennsylvania was one of several states that participated in a $58 million settlement in 2008 over allegations Merck deceptively marketed the drug. Pennsylvania’s cut of that settlement was $2.9 million.
Pennsylvania declined to participate in a $950 million federal and multistate settlement with Merck in 2011 that would have split about $200 million among 43 states.
Harry M. Roth of Cohen Placitella said Pennsylvania was put in the position of having to give up its more lucrative PACE claims for a piece of the $950 million settlement to resolve Medicaid claims. It objected to that settlement and ultimately withdrew from the settlement discussions.
Pennsylvania then continued litigating its claims regarding PACE and other government third-party payers such as Medicaid. During the course of that litigation, all of the other third-party payers were voluntarily dismissed, leaving only the PACE claims. Today’s $8.25 million settlement announcement resolves those PACE claims.
Pennsylvania’s lawsuit against Merck alleged the company failed to disclose its studies, which showed the use of Vioxx increased the user’s risk of serious illnesses, such as heart attack and stroke. In the lawsuit, the state said it would not have purchased the quantities of Vioxx it did had Merck properly disclosed the studies revealing the associated health risks.
While Pennsylvania has been unsuccessful so far in bringing state court claims that it was defrauded by off-label marketing by Janssen Pharmaceuticals of its antipsychotic drug Risperdal, the state will now share in a $181 million settlement with the company over similar claims.
The settlement proceeds will be shared by 37 states and was said by some of the states’ attorneys general to be the largest multistate settlement to be reached with a pharmaceutical company.
According to the settlement agreement Pennsylvania filed in Dauphin County Court of Common Pleas today, the state’s claims in Commonwealth v. Ortho-McNeil-Janssen Pharmaceuticals for more than $150 million in damages related to payments state Medicaid made to Janssen are expressly excluded from the general release in today’s settlement. That means the state, which just lost its battle in the Commonwealth Court to rejuvenate that case, could continue to appeal if desired.
While that lawsuit raised fraud and misrepresentation claims, the multistate settlement reached today raised claims under the Pennsylvania Unfair Trade Practices and Consumer Protection Law.
According to a statement from Pennsylvania Attorney General Linda Kelly, the states alleged that Janssen promoted Risperdal for off-label purposes to the geriatric and pediatric populations and specifically targeted nursing-home patients with Alzheimer’s disease, dementia, depression and anxiety. The states argued those uses were not FDA-approved nor shown to be safe or effective.
After a four-year investigation, Janssen has agreed to change how it promotes and markets its antipsychotic drugs, according to Kelly. Under the terms of the settlement, for the next five years Janssen must disclose the FDA-identified risks of its drugs in its promotional materials. It must present information about the drugs’ effectiveness in a balanced manner, Kelly said.
Additionally, personnel trained in science, not marketing, must develop the medical content or communications addressed to health care providers. Also, grants cannot be used to promote its atypical antipsychotic drugs. Janssen must also refrain from having policies that offer financial incentives to sales professionals that would reward off-label marketing, Kelly said.
Aside from Pennsylvania, the states involved in the settlement are Alabama, Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming. The District of Columbia is also part of the settlement.
Drinker Biddle & Reath, which represents Janssen in the state court lawsuit, was also involved in today’s settlement, according to the settlement agreement.
The settlement is not an admission of guilt, nor is it a fine or penalty, the agreement notes.
"We have chosen this path to achieve a prompt and full resolution of these state claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness," Janssen President Michael Yang said in a statement today.
The top story this morning is the First Judicial District reopening the door to allowing punitive damages in pharmaceutical cases. As reporter Amaris Elliott-Engel writes, if the Complex Litigation Center coordinating judges rule that there are sufficient requisite proofs to support the claim going to trial, the claims will be allowed to proceed.
Also above the fold on Page 1, reporter Ben Present writes a preview of today’s action in the Jerry Sandusky trial, where the prosecution has rested and the defense will now take its turn.
Below the fold on Page 1, reporter Zack Needles writes that Pittsburgh-based Babst Calland has opened an Akron, Ohio, office in response to the shift occurring in the drill industry, as the focus moves away from Northeastern Pennsylvania and toward Western Pennsylvania.
In more Regional News on Page 3, reporter Saranac Hale Spencer writes that allegations that Cephalon illegally marketed its pain medication called Actiq have survived a motion from the drug company that the court reconsider its denial of summary judgment from a year ago.
In an Antitrust Law column on Page 5, Carl W. Hittinger and Lesli C. Esposito ask if it might be time for the Supreme Court to jump in regarding health care mergers.
In this week’s Law Technology News page, Kenneth Jones writes about the benefits of timeshare staffing.
Also above the fold on Page 1, reporter Saranac Hale Spencer writes that a federal judge has rejected three Harrisburg residents’ challenge to Act 47, the Financially Distressed Municipalities Act. The judge said the challengers lacked standing to seek the injunction.
Below the fold on Page 1, Gina Passarella writes that the state Supreme Court has denied the appeal of a Luzerne County prothonotary who sued when the county decided to dissolve the elected office and create an appointed system for overseeing judicial records.
In more Regional News on Page 3, reporter Jeff Mordock writes that insurance liabilities may be transferred to trusts in asbestos claims.
In a Securities Law column on Page 5, Katayun I. Jaffari and Jill M. Stadelman write about the JOBS Act and wonder whether it will be able to kick start employment growth.
This week’s Young Lawyer column is on Page 7, as Lisa Myers write about a year spent as an assistant district attorney and the lessons she learned.
Topping today's front page, reporters Zack Needles and Ben Present write that the state Superior Court has dismissed a claim of double jeopardy made by state Sen. Jane C. Orie, R-Allegheny, as frivolous, saying an Allegheny County trial court properly granted a mistrial based on allegedly forged defense documents.
Sharing the top of the page, senior reporter Gina Passarella writes that former City Councilman Rick Mariano, who spent years in jail for fraud convictions, is allowed to keep more than $65,000 in pension contributions, the Commonwealth Court ruled. The case involves what the city had to pay Saul Ewing for representing Mariano during the investigation of the criminal charges prior to the indictment.
Below the fold, Gina has another big story from Commonwealth Court, where a judge who presided over trials in Pennsylvania's suits against pharmaceutical companies for overcharging the state for prescription drug reimbursements has denied post-trial motions from both the state and two drug companies.
Our Page 3 Regional News story today is from one of The Legal's affiliate publications, the New Jersey Law Journal. Reporter David Gialanella writes that the 3rd Circuit has ruled that a clause in Verizon cellphone service contracts that makes arbitration of disputes mandatory but prohibits arbitration as a class is enforceable under federal law, despite New Jersey Supreme Court precedent to the contrary.
Page 7 features our weekly YL or "Young Lawyer" page, which today has a column by solo practitioner David Koller. Koller shares his story of recently suffering from a brain hemorrhage and reveals what he took away from the experience.
But more about Delaware in a bit … let’s get to today's Legal.
U.S. Courthouse Correspondent Shannon P. Duffy leads this morning's front page with a pharma decision from the Eastern District: A jury must decide whether pharmaceuticals giant GlaxoSmithKline used a series of illegal tactics to delay the approval of generic versions of Flonase, a popular allergy drug, Judge Anita B. Brody has ruled.
Below the fold, reporter Amaris Elliott-Engel has the latest on a developing business of law story involving some well-known names. A Philadelphia judge ruled Tuesday that plaintiffs law firm Kline & Specter is entitled to a preliminary injunction barring a former attorney from practicing law anywhere else but at the firm until September.
One Page 3, reporter Jennifer Zimmerman tells the success story of a case with local ties heading for the U.S. Supreme Court. The court has granted a petition for writ of certiorari filed by the Civil Rights Appellate Clinic of Penn State's Dickinson School of Law.
As always, our People in the News section is on Page 2, and the top stories from our sister publications across the country are on our Page 4 National News page.
On Page 5, we have our weekly "GC Mid-Atlantic" page, which appears every Wednesday. Today's column by Shannon Green is a summary of the findings from the GC Compensation survey conducted by our sister publication, Corporate Counsel magazine. If last year’s survey showed the after-effects -- the hangover, if you will -- of the deepest trough of the recession, this year's results show that chief legal officers made steady gains and recovered some momentum.
Our Page 7 contributed piece is our Securities Law column by Brian M. Rostocki of Reed Smith, who writes: On July 7, the Delaware Court of Chancery issued an opinion in Sagarra Inversiones v. Cementos Portland Valderrivas, in which the court denied a plaintiff's motion for a status quo order that would prohibit the defendant from transferring funds under a stock purchase agreement during the pendency of the litigation.
First up is a story on the Delaware Office of the Public Defender, which is poised to assume control of the judiciary's conflict attorneys later this year. While the office touts the change as a way to reduce the unit's bureaucracy and eliminate possible conflicts of interest, lawyers have expressed some concerns about the move.
Next up, the Delaware Supreme Court, reversing a previous Superior Court decision, has ordered a new trial for a man accused of robbing a bank customer. In issuing the opinion, the high court ruled that the trial judge overstepped his authority by prohibiting a witness from testifying on the accused's behalf.
Finally, we'd like you to meet (if you haven't already) the Delaware Business Court Insider. As the name suggests, this is a national product covering the latest news, analysis and cases from the Delaware Chancery Court, Bankruptcy Court and Supreme Court. The accompanying website is www.delbizcourt.com, where you can go to subscribe to this newsletter weekly. You can also follow us on Twitter at: http://twitter.com/delbizcourt.
- A group of institutional investors has amended a derivative suit it filed in the Court of Chancery in March against Rupert Murdoch and other directors of the media conglomerate News Corp.
- Vice Chancellor Donald E. Parsons Jr. has cleared the way for a possible trial in a two-year dispute between two pipe manufacturers by ruling that there was a valid and enforceable contract between the companies, but that the form and content of the contract remain to be determined.
We hope you'll take a look!
Have questions or comments about today's issue? E-mail me or any of the reporters directly. Have a great day, andl enjoy today's Legal!
Generic v. Brand Drugs -- Will There Be Different Federal Standards?
In an attempt to dispel misconceptions about generic drugs, the FDA posted Facts and Myths about Generic Drugs on its website. Fact: approximately 70 percent of all prescriptions are for generic drugs. Fact: research shows that generics work just as well as brand name drugs. Fact: on average, the cost of a generic drug is significantly lower than the brand name product. One reason generic prescriptions are likely on the rise is due to the increase in patent expirations, which has opened the prescription drug market to generic counterparts.
Despite these facts, Consumer Report surveys in 2009 and 2010 showed that more than 40 percent of people said they had concerns about generic drugs, fearing that they weren’t as safe or as effective as brand-name medications, had different side effects, or came under different federal standards.
I find the final point -- “different federal standards” -- to be most interesting. As I discussed in my blog last month, the 9th U.S. Circuit Court of Appeals issued an opinion finding that a generic drug manufacturer’s duty to warn under state law was not pre-empted by federal law. This opinion was in keeping with the 8th Circuit in Mensing v. Wyeth and the 5th Circuit in Demahy v. Actavis.
So now we have three circuits applying the same federal standard to generic drugs as the U.S. Supreme Court did to a brand drug in Wyeth v. Levine. The Supreme Court, however, has granted appeals in Mensing and Demahy, which could put the rulings of the three circuits in jeopardy. On March 30, 2011, the high court will consider whether the state law failure-to-warn claims are pre-empted by the Drug Price Competition and Patent Term Restoration Act, fondly referred to as the Hatch-Waxman Act in honor of the act’s two sponsors.
The Hatch-Waxman amendments facilitated the availability of generics by greatly reducing the burden on manufacturers to get a generic drug approved for sale. A generic manufacturer can file an Abbreviated New Drug Application (ANDA) to get approval for an existing licensed medication or approved drug. A generic drug is comparable to a brand drug in dosage form, strength, route of administration, quality, performance characteristics and intended use; however, a manufacturer of a generic drug is generally not required to include preclinical and clinical data to establish safety and effectiveness. In essence, a generic manufacturer can ride the coattails of the brand.
Although it’s unlikely for the everyday citizen to contemplate the federal standards of pre-emption when deciding between a generic and brand prescription drug, the Supreme Court’s decisions in the Mensing and Demahy appeals may give rise to real concern. Will the Supreme Court find that a generic drug manufacturer may have a duty to warn above a brand manufacturer? Or will the Hatch-Waxman Act pre-empt a state failure to warn claim against a generic manufacturer that uses the same label as its brand equivalent? Stay tuned.
Adrianne E. Walvoord is an associate at Anapol Schwartz Weiss Cohan Feldman & Smalley handling pharmaceutical and medical device litigation involving complex medical, scientific, and legal issues. She practices in federal court, as well Pennsylvania and New Jersey state courts. She also currently represents juveniles affected by the Luzerne County Juvenile Detention Center scandal. Contact her at awalvoord@anapolschwartz.com.

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