Articles Posted in Medical

Greenfield, Indiana – Plaintiffs Sherry Childers and Diana Polston, along with others, have filed a class-action lawsuit against Hancock Regional Hospital (Hancock Health) in Greenfield, Indiana. They accuse the hospital of disclosing their private medical information to third parties like Facebook and Google. The Plaintiffs argue that mishandling medical data can lead to severe consequences such as workplace discrimination and denial of insurance coverage. They stress the importance of maintaining medical information confidentiality to uphold public trust in the healthcare system.

HancockRegional-300x100The complaint cites the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which includes the “Privacy Rule” established by the United States Department of Health and Human Services (HHS). This rule outlines guidelines for safeguarding individually identifiable health information and prohibits healthcare providers from sharing such data with third parties without explicit written consent from the individual.

Court documents claim that Hancock Health, a trusted healthcare provider, used a “Tracking Pixel” on its website to collect and transmit the Plaintiffs’ sensitive patient information to third parties without their knowledge. This alleged action is seen as a breach of the HIPAA Privacy Rule.

Indianapolis, Indiana – Cook Medical was granted a new trial after the Honorable Richard L. Young, a judge for the United States District Court for the Southern District of Indiana, admitted to errors in allowing inadmissible evidence to be presented to the jury by counsel for Plaintiff, Tonya Brand.

Ms. Brand was implanted with a Cook Celect® Inferior Vena Cava Filter (“Cook IVC Filter”) prior to undergoing a complex spine surgery in March 2009. The next month, imaging was taken that showed the filter perforating Ms. Brand’s IVC in multiple places and that one of the filter’s “struts” was hooked on a bone spur. The Cook IVC Filter later fractured in three places in just over two years after its initial placement. A piece of the Cook IVC Filter emerged through Ms. Brand’s thigh. After a failed attempt by Ms. Brand’s doctor to retrieve the filter in July 2011, the doctor and Ms. Brand elected to leave the fractured Cook IVC Filter in place until it was removed in 2015. Ms. Brand filed a products liability suit in November 2014 and was awarded a jury verdict in the amount of $3 million on February 1, 2019.

A new trial may be granted if the trial was not fair to the moving party or if the improper admission of evidence has a “substantial influence on the jury” and the result was “inconsistent with substantial justice.” The main piece of evidence objected to by Cook was Brand’s trial exhibit 1913 (“PX-1913”). This exhibit was an email chain between Cook employees including multiple instances of hearsay and a table with details of 27 deaths associated with Cook IVC Filters. The Court on review found Ms. Brand’s injuries were not substantially similar to those patients listed on the table and the emails contained inadmissible hearsay and therefore PX-1913 was improperly admitted. Further, Ms. Brand’s counsel relied heavily on the connection between the Cook IVC Filter and death based on PX-1913 which was found to be inappropriate and prejudicial on review. Finally, the Court found “a jury could have just as easily found in Cook’s favor.” and because this trial was so close it, “is more likely to have been affected by errors.” Therefore, the Court granted Cook’s Motion for New Trial.

Kosciusko County, Indiana – Attorneys for Plaintiff, Rick C. Sasso, M.D. (“Dr. Sasso”) of Carmel, Indiana, originally filed suit in the Kosciusko County Superior Court in Indiana alleging that Defendants, Warsaw Orthopedic, Inc., Medtronic, PLC, and Medtronic Sofamor Danek, Inc., haveSassoBlogPhoto-266x300 denied him and his accounting firm access to their sales ledger per two separate agreements. Dr. Sasso is seeking an injunction ordering Defendants to provide full access to its sales ledger to determine royalties owed to Dr. Sasso under two separate agreements. As of April 12, 2019, Defendants filed a Notice of Removal to remove the case to the U.S. District Court for the Northern District of Indiana.

Per the complaint, Dr. Sasso is a board-certified orthopedic surgeon specializing in the treatment of the spine. Dr. Sasso claims the Defendants, together, are top manufacturers for spine implants. It is claimed Dr. Sasso entered into two separate agreements with Sofamor Danek Holding, Inc., which was later acquired by Warsaw Orthopedic through a merger. The first alleged agreement, is the 1999 Screw Delivery System Agreement on November 18, 1999 (the “1999 Agreement”). The second alleged agreement is the 2001 Vertex Agreement, entered into on July 26, 2001 (the “2001 Agreement”). Dr. Sasso claims that these agreements have clauses that enable him to “inspect, examine, audit, and copy [Defendants’] records” relating to the agreements once per calendar year.

In August 2013, Dr. Sasso filed a different suit against the Defendants for unpaid royalties under both the 1999 and 2001 Agreements. Dr. Sasso was granted royalties in the amount of $79,794,721.00 for the 1999 Agreement and $32,657,548.00 for the 2001 Agreement, which has been appealed by Defendants. According to the complaint, the 1999 Agreement requires the Defendants to continue paying royalties until the expiration of U.S. Patent No. 6,287,313 and U.S. Patent No. 6,562,046, on or about November 23, 2019. Dr. Sasso also claims the 2001 Agreement requires Defendants to pay royalties to him so long as “the Medical Device is covered by a valid claim of an issued patent arising out of the Intellectual Property Rights.”

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Indianapolis, Indiana – Attorneys for Plaintiff, Eli Lilly and Company of Indianapolis, Indiana filed suit in the Southern District of Indiana alleging that Defendants, Dr. Reddy’s Laboratories, LTD. of Hyderabad, Telagana, India, and Dr. Reddy’s Laboratories, Inc,. a NewLilly-v-Reddy-BlogPhoto3-181x300 Jersey corporation, infringed its rights in U.S. Patent No. 7,772,209 (“the ‘209 Patent”).

The ‘209 Patent at issue here is a method patent for administering pemetrexed disodium, a chemotherapy drug, with vitamins, the combination of which is marketed as ALITMA® by Lilly. This invention helps to solve the toxicity issue in chemotherapy patients being treated with pemetrexed. The particular regimen of vitamin  and folic acid are important for the pretreatment of these patients. As of December 2015, Dr. Reddy’s informed Lilly that it had submitted a FDA New Drug Application for a product that would be marketed as a competing product to ALITMA®.

The first issue the Court had to decide was whether Lilly was barred from asserting the doctrine of equivalents under prosecution history estoppel. The Court held that Lilly had not surrendered the equivalent in question because their decision to use the choice pemetrexed salt was tangential to the reasons for the amendment. The choice to narrow was simply to overcome a rejection in view of a prior art article about a different antifolate, methotrexate.

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New Jersey – In February of 2005, Attorneys for Plaintiff, Howmedica Osteonics Corp., of Mahwah, New Jersey filed suit in the District Court of New Jersey alleging that Defendants, Zimmer, Inc. of Warsaw, Indiana, Centerpulse Orthopedics, Inc. of Austin, Texas, and Smith & Nephew, Inc. of Memphis, Tennessee infringed itsZimmer-BlogPhoto-300x179 rights in United States Patent No. 6,174,934 (“the ‘934 Patent”) for “Non-oxidizing Polymeric Medical Implant”, United States Patent No. 6,372,814 (“the ‘814 Patent”) for “Non-oxidizing Polymeric Medical Implant”, United States Patent No. 6,664,308 (“the 308 Patent”) for “Non-oxidizing Polymeric Medical Implant”, and United States Patent No. 6,818,020 (“the ‘020 Patent”) for “Non-oxidizing Polymeric Medical Implant”.  Plaintiff sought judgment for damages including interest and costs, treble damages, expenses, and attorneys’ fees.

Plaintiff is a corporation that develops, manufactures, and distributes orthopedic products, generally used in hip and knee procedures and other bone replacement procedures. Defendant is a corporation based in Warsaw, Indiana, that also focuses on products for joint and extremity replacements.

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Lilly-1-300x132Indianapolis, IndianaEli Lilly and Company of Indianapolis, Indiana filed a federal lawsuit in the Southern District of Indiana alleging patent infringement. Defendants are Actavis LLC of Parsippany, New Jersey; Teva Pharmaceuticals USA, Inc. of North Wales, Pennsylvania; and Teva Pharmaceutical Industries, Ltd. of Petach Tikva, Israel.

At issue is a patent for Antifolate Combination TherapiesPatent No. 7,772,209 (“the ‘209 patent”) which has been issued by the U.S. Patent and Trademark Office.  This patent covers intellectual property embodied in Alimta®, a drug therapy used for the treatment of various types of cancer.

In a complaint filed by an Indiana patent litigator, Lilly states that Defendants filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to manufacture and sell generic equivalents of ALIMTA® prior to the expiration of the ‘209 patent.  It asserts that this filing constitutes and/or will constitute infringement of the ‘209 patent, active inducement of infringement of the ‘209 patent, and contribution to the infringement by others of the ‘209 patent.

Lilly seeks, inter alia, injunctive relief, costs and attorneys’ fees.

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Lilly-300x132Indianapolis, IndianaEli Lilly and Company of Indianapolis, Indiana filed a patent infringement lawsuit in the Southern District of Indiana asserting infringement of U.S. Patent No. 7,772,209 (‘209 Patent).  Defendant is Amneal Pharmaceuticals LLC of Bridgewater, New Jersey.

Lilly states that Amneal filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to manufacture and sell two “Pemetrexed for Injection” products prior to the expiration of the ‘209 patent.  Lilly contends that the ‘209 patent, which was issued by the U.S. Patent and Trademark Office, protects the Pemetrexed products.

In this patent litigation, filed by attorneys for Lilly, a single count is listed, “Infringement of U.S. Patent No. 7,772,209.”  Lilly seeks relief from the Indiana court including a judgment of infringement, injunctive relief, costs and attorneys’ fees.

Practice Tip: Lilly has had some success protecting its ‘209 patent, which relates to the cancer drug Alimta®, against generic manufacturers.  See, e.g., U.S. Court of Appeals Rules In Lilly’s Favor on Alimta Vitamin Regimen Patent.

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Figure-6_903-Patent-300x283Washington, D.C. — The Federal Circuit ruled on two patent infringement decisions, Los Angeles Biomedical Research Institute v. Eli Lilly & Co. and Eli Lilly & Co. v. Los Angeles Biomedical Research Institute, that involve Indianapolis-based Eli Lilly and Company.

These companion cases pertain to a pharmaceutical patent, U.S. Patent No. 8,133,903 (“the ’903 patent”), owned by Los Angeles Biomedical.  Also at issue is one prior art reference, International Patent Application No. WO 01/80860, published Nov. 1, 2001, common to both lawsuits.

Los Angeles Biomedical Research Institute v. Eli Lilly & Co. arose as an inter partes review of a decision by the Patent Trial and Appeal Board holding all claims of the ‘903 patent to be obvious.  The Federal Circuit reviewed claims in a provisional application relating to a study involving rats in combination with a method in an uncited reference to convert those results to apply to humans.  It held that the rat study and uncited conversion method did not support the claimed dosage for humans.  It further concluded that claims directed to an underlying condition should not be construed broadly to treat symptoms of that condition, holding that the Board had not adopted the broadest reasonable interpretation of the claims but instead had adopted an overbroad interpretation. The panel remanding, stating:

The question remains whether a person of skill in the art would have had a reason to combine [the three cited references relating to the medical condition] and would have had a reasonable expectation of success from doing so.  Because the Board’s obviousness analysis was based on an erroneous construction of the claim language and an overly broad interpretation of [one of the references], and because the Board did not address the record evidence summarized above, we remand for the Board to make new findings as to whether there was an apparent reason to combine the prior art references and whether that combination would have rendered [the treatment] obvious.

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Indianapolis, Indiana – The matter of Eli Lilly and Company, et al. v. Apotex Inc., et al. has been stayed pending a ruling by the U.S. Court of Appeals for the Federal Circuit.

This Indiana lawsuit was initiated by Lilly, an Indianapolis pharmaceutical company, in conjunction with other Plaintiffs.  Patent attorneys for Plaintiffs filed a lawsuit asserting patent infringement after Defendants filed an Abbreviated New Drug Application seeking approval to market a generic version of the drug Axiron® before various patents related to the drug expired.  Among Plaintiffs’ contentions were claims of patent infringement of seven patents pertaining to Axiron.861-Patent_Fig-2-300x219

In this motion, patent lawyers for Plaintiffs have asked the court to stay its proceedings pending a ruling in a similar case, Eli Lilly and Company, et al. v. Perrigo Company, et al.  The Perrigo case was filed in the Southern District of Indiana in 2013.  After a trial, the court issued findings including that one claim in one of the Axiron patents was invalid, while two claims pertaining to another Axiron patent were valid.  That ruling was appealed to the Federal Circuit; that appeal remains pending.

LillyHeadquarters-300x127Indianapolis, Indiana – A patent lawyer for Eli Lilly and Company of Indianapolis, Indiana, Eli Lilly Export S.A. of Geneva, Switzerland and Acrux DDS, Pty Ltd. of West Melbourne, Australia filed an intellectual property lawsuit in the Southern District of Indiana.

Two Defendants are listed, TWi Pharmaceuticals, Inc. of Paramus, New Jersey and TWi Pharmaceuticals USA, Inc. of Taipei, Taiwan.  In a 28-count complaint, Defendants are accused of infringing seven patents by filing an Abbreviated New Drug Application with the U.S. Food and Drug Administration for approval of a generic version of the pharmaceutical product Axiron® before the expiration of the patents under which the drug is protected.  The patents at issue in this litigation are U.S. Patent Nos. 8,435,944; 8,993,520; 9,180,194; 8,419,307; 8,177,449; 8,807,861 and 9,289,586.

The counts against Defendants include “direct patent infringement,” “inducement to infringe” and “contributory infringement” as well as counts requesting declaratory judgment.  Lilly et al. are seeking declaratory relief, injunctive relief, costs and attorney fees.

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